Innovations in Pharmaceutical Development by Sven Boermeester

IN PHARMACEUTICAL DEVELOPMENT

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INNOVATIONS® IN PHARMACEUTICAL DEVELOPMENT – WHY THIS BOOK? SHANE SENIOR, CO-FOUNDER, CROSSTREE CAPITAL PARTNERS PURPOSE The “INNOVATIONS® in Pharmaceutical Development” publication is an in-depth Industry Resource Guide that showcases the people, companies, products and services that are leading innovation within the industry. A book with augmented reality videos and an online platform networked with a common goal of ensuring the world’s best innovations and innovation enablers in the Pharma Services industry connect and succeed. The targeted audience for this publication is the pharmaceutical sponsors and decisionmakers seeking innovative solutions to clinical development. In addition, it is aimed at business leaders, market analysts and investors seeking innovative growth opportunities, partnerships and investments. This publication is for forward-thinking professionals who want to know what and who

there is to know in the ecosystem and play an active role in its growth and development.

FUTURE EDITIONS “INNOVATIONS® in Pharmaceutical Development” is the inaugural edition of a series of Industry Resource Guides to be published on a biennial basis. The next books in the series will be “Clinical Commercial Services” and “Clinical Supply Chain”. Crosstree intends to use the same processes and rigor to help professionals in our industry better identify innovative growth opportunities, partnerships and investments.

THE SELECTION PROCESS Crosstree’s Managing Directors selected two panelists from each industry segment being evaluated (Clinical Services, Pharma Technology & Information Systems, and Lab Services). Each of the panelists then reviewed extensive lists of companies segmented by industry

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identifying those companies they perceived to be the most innovative leaders in each category. The panelists also helped to identify Thought Leaders who demonstrate exceptional innovative influence within their industry.

Thought Leaders Crosstree and its six panelists collectively identified the most innovative leaders in the Pharma Services industry. These top-innovators hold a wide variety of positions among companies, academia and research institutions globally. All have the common desire to see our industry grow through the creation of more efficient and lower cost development of novel lifesaving therapies.

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Crosstree has developed a list of candidate companies by assessing company capabilities and influence they are creating in each’s respective space. The list of candidate companies was then narrowed down by our six panelists (two per primary node) to focus in on the most inspiring group of companies to represent our profiled innovators. The resultant list is in no way meant to be exhaustive. The companies selected represent those who are seen as the greatest current disruptors during both the extensive review by our research team and in discussion amongst our panelists.

Companies Crosstree’s expansive knowledge of the industry has allowed us to take a step back and assess “Who are the most innovative and forward-thinking companies in our space.”

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ABOUT CROSSTREE As one of the leading investment banks in pharma services, Crosstree combines data, financial analysis, and an in-depth industry knowledge with real-world execution experience. Crosstree’s consultants, advisors and bankers work with a world-class network of industry experts, executives, and investors in order to help formulate and execute the most accretive transactions possible for our clients. Crosstree’s deep expertise in pharma services, diagnostics and tools, and digital health provides an unprecedented advantage to prospective strategic partners in today’s market. Because Crosstree works with such a comprehensive understanding of the pharma services industry, it can synthesize a company’s capabilities, financial data, and market position to communicate a compelling value creation strategy or proposition to buyers, sellers and other strategic partners. Deep insights into converging market trends are remarkably powerful for building a client value thesis that both informs the buyer and drives transformational outcomes. No other advisor has a deeper understanding of how the confluence of industry trends, market conditions, and growth opportunities will shape a company’s value and strategic outcomes in the pharma services space. We strongly believe that innovation in the form of doing things better, faster and more efficiently will continue to be the engine for growth in the pharma services industry for decades to come. To that end, we have developed the “Innovations” series starting with this inaugural version of “INNOVATIONS® in Pharmaceutical Development”. We hope that you find this resource guide helpful and at the same time inspiring. There is much to be proud of in our; your industry and we are happy to be able to help highlight some of these amazing people and companies contributing to its growth.

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CHAPTER ONE

OVERVIEW

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PANELISTS

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PHARMA TECH

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CLINICAL SERVICES

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SPONSORS Global Village Publishing Team CEO Sven Boermeester COO Callie Van Graan CMO Belinda Van Graan Managing Editor Meghan Tear Percy

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ASSOCIATIONS, EVENTS AND MEDIA Project Manager Art Direction & Design

Gia Bischofberger Susan Heiman

Crosstree Project Coordination Team Gordon Ryerson and Patti-Ann Dresback

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INTRODUCTION TO THE WHEEL The Wheel establishes Crosstree’s industry-defining taxonomy to represent the capabilities of our profiled companies and give the reader a feel for what services each provides within the Clinical Development space. The Wheel guides the reader through this journey by highlighting nodes for which the profiled company provides services. Providing this visual representation allows for anyone to easily decipher where a company’s strengths lie and helps connect interested parties with the provider that best suits their needs.

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METHODOLOGY Industry Defining Taxonomy Crosstree has taken the liberty to establish a more formalized approach to defining the Pharma Services industry by creating what we believe is an easily understandable and concise taxonomy from which we can better identify company groupings, sectors and market trends at a more granular level. Within the Pharma Services space, Crosstree has identified three sectors: Development, Supply Chain and Commerce; we further delineated the Development sector into three primary nodes: Clinical Services, Laboratory Services and Pharma Tech and Information Systems. From these primary nodes, we have developed sub-nodes based upon core capabilities within each sector to round out our full taxonomy structure. By establishing this Industry-Defining Taxonomy, we anticipate that seasoned Pharma experts and newcomers alike will find value in our organization and definition of the Pharma Services industry and its components that are oftentimes viewed as daunting and complex.

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Management Systems help trial sponsors manage operational aspects associated with clinical trials. CTMS systems may facilitate study or program management, scheduling, site management, finance and budgeting, regulatory compliance, workflow management and other logistics associated with administering trials. • Source Capture – Source Capture refers to tools and technology to directly capture source data within clinical trials. • Interactive Response Technology (IRT) – Interactive Response Technologies refer to the usage of interactive technologies to facilitate site, study, subject, and drug supply management and communications.

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INDUSTRY TAXONOMY GLOSSARY OF TERMS PHARMA TECH & INFOSYS

• DATA SCIENCES – Data Science is the extraction of structured or unstructured data generated by doctors, nurses and the healthcare system and the subsequent analyzing of this data to support drug project decision making and drug and platform development. • Data Analytics – Software created to facilitate important healthcare processes. Tools are designed to catalogue patient information and analyze it statistically and qualitatively to establish models for explaining current trends and predicting future trends. The data provided through analysis is used to indicate gaps in care, problems with provision and opportunities for cost savings and management.

Software, technology, e-clinical solutions, and data subscription services related to the development of drugs. • DATA ACQUISITION – Data Acquisition and Repositories tools refers to technology that is utilized to capture, store, and analyze data used in clinical trials. • Clinical Trial Management System (CTMS) – Clinical Trial

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• Artificial Intelligence & Machine Learning Tools – Tools that are created to learn and adapt throughout the clinical trial. Uses include analysis of Big Data which assists in trial design, patient recruitment, monitoring, and patient characterization. • Master Data Management – Technology which is used to define and manage the critical data of clinical trials to provide, with data integration, a single point of reference. This assists in data integration across organizations, insights into corporate decision making, improved patient data collection, and complete data lifecycle visibility for regulatory compliance. • REGULATORY AND SAFETY TECH – Technology systems and solutions used to manage regulatory affairs, pharmacovigilance and safety requirements in clinical trials. • Regulatory Information Management System (RIMS) – Regulatory Information Management System (RIMS) is a document and information management system for the collection, maintenance, and reporting of regulatory information. • Electronic Trial Master File (eTMF) – A Trial Master File is a set of content that contains essential documents that individually and collectively permit evaluation of the conduct of a clinical trial. Essential Documents are those documents which individually

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and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with applicable regulatory requirements and Good Clinical Practice. A TMF is required to be organized and held by the sponsor organization or Contract Research Organization before any clinical trial is initiated. • Electronic Investigational Site File (eISF) – An Investigational Site File (ISF), in electronic format, contains Essential Documents for the conduct of a clinical trial. Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with applicable regulatory requirements and Good Clinical Practice. Investigative sites are required to maintain an ISF before any clinical trial is initiated. • Electronic Common Technical Document (eCTD) – The Common Technical Document (CTD) was developed by the International Conference on Harmonization (ICH) and is fast becoming the preferred or required submission format by regulators in the world’s major marketplaces and beyond. Since July 2003, the CTD has been mandated for marketing and post-marketing applications in Europe, Japan, and Canada. The Food and Drug Administration (FDA) has required eCTD submissions since 2008.

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• Electronic Informed Consent (eConsent) – An informed consent document is a legal document explaining the purpose, duration, risks, benefits, trial procedures and volunteer’s rights. The document requires at least a signature from the clinical trial participant and another from the health care professional conducting the informed consent discussions with the participant. eConsent solutions use an array of digital elements, such as videos and interactive surveys, to provide insights into patients understanding of risk and benefits of participation in a clinical trial. • Publication Management – Systems that manage and track publication delivery and support related regulatory reporting requirements. • Learning Management Systems (LMS) – Learning Management Systems are applications for the administration, documentation, tracking, reporting and delivery of educational materials or training programs for clinical trials and related protocols or systems. Learning Management Systems are used by sites to ensure researchers are adequately trained to conduct clinical trials. • Registries – Registry and Phase IV software and database for observational trials. • Site Payments – Site payment systems transfer, track funds and payments made to sites, and track such payment data to meet global transparency reporting requirements.

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• Pharmacovigilance & Safety Reporting – Pharmacovigilance and Risk Management Systems manage, identify, collect, organize, report and submit safety and adverse event related information. • OPERATIONS TECH – Technology and related solutions used in the execution of clinical trial operations. • Virtual Trials – Technology systems and platforms that provide clinical trial volunteer recruitment and retention services. • Content Management Systems (CMS) – Electronic content management systems for documents and forms used in clinical trial operations and execution. • Patient Tech – Digital technology with which patients interact to engage in clinical trial activities. • Trial Administration – Systems that help facilitate and monitor the administrative aspects of clinical trials, including preparing and organizing essential clinical trial documents; patient enrollment; protocol initiation, activation, coordination and administration; facilitating coordination of ethics, regulatory and research and development submissions; and reviewing study protocols.

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A facility for the biological, microbiological, serologic, chemical, hematology, immunohematologic, biophysical, cytologic, pathologic, or other examination of materials derived from the human body for the purpose of providing information for diagnosing, preventing, or treating disease or impairment of, or assessment of humans. • IN VIVO LABORATORY TESTING – Medical tests and/or experiments or procedures that are done on (or in) a living organism, such as a laboratory animal or human. In Vivo studies are conducted to look at the actual effect on how the living organism (body) will respond. • Efficacy – Drug efficacy testing services are performed in order to determine the safest and most efficient compounds to produce a desired result. In Vivo efficacy testing is typically conducted through a rigorous set of procedures and methods in animal models designed to test the drug’s intended purpose and benefits. • Safety – In Vivo safety pharmacology and toxicology programs help further drug development by investigating the potential undesirable effects of a compound

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on physiological functions and determination of potentially harmful physiological effects. • BIOANALYTICAL LABORATORY TESTING – Bioanalytical Testing is an integral part of the pharmacokinetic/pharmacodynamic characterization of a novel chemical entity (new drug) from the time of discovery and during various stages of development, leading to market authorization. Bioanalysis is a term generally used to describe the quantitative measurement of a compound (drug) or their metabolite in biological fluids, primarily blood, plasma, serum, urine or tissue extracts. • Small Molecule – Small molecule bioanalysis is defined as the chemical analysis of low molecular weight compounds used to regulate biological processes within a biological matrix such as a serum or plasma. • Large Molecule – Large molecule bioanalysis is a category of analytical chemistry in which a large molecule therapeutic is analyzed in a biological matrix, typically a serum or plasma. • Specialized Assays – A procedure in molecular biology for testing or measuring the activity of a drug or biochemical in an organism or organic sample. A quantitative assay may also measure the amount of a substance in a sample. Bioassays and immunoassays are among the many varieties of specialized assays.

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• CORE LABORATORIES – A core lab typically serves researchers working in R&D laboratories. Core labs frequently are subject matter experts when it comes to certain equipment and/or techniques and are used by independent research labs to conduct highly specialized/technical assessments. • Imaging Core Lab – Imaging Core Labs are designed to provide comprehensive image management, quality control infrastructure, analysis, and answers to scientific questions for clinical trials involving various types of imaging technology. • Observer Reported Outcomes – ObsRO is a measurement based on an observation by someone other than the patient or a health professional. This may be a parent, spouse, or other non-clinical caregiver who is in a position to regularly observe and report on a specific aspect of the patient’s health. An ObsRO measurement does not include medical judgment or interpretation and is typically for patients who cannot otherwise respond for themselves (i.e. infants or those who are cognitively impaired). • ECG Core Lab – ECG core labs acquire and analyze ECG, Holter, Lead Telemetry, and BP Monitoring data utilizing international regulatory standards, devices and systems, allowing for test results to be

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interpreted in the context of all data associated with cardiac safety studies within the broader scope of a clinical trial. • OTHER LABORATORY SERVICES – Analytical chemistry services for drug discovery and development that are broader in scope such as exploratory, micro-dosing and characterization studies, as well as method development & validation; among others. • CENTRAL LABORATORIES – A place, establishment or institutional laboratory that is responsible for conducting and consolidating laboratory testing, reporting and data originating in different clinical sites in order to standardize analytical platforms, kits, techniques and reference values allowing for the creation of harmonized processes and more consistent assessments. • GENOMIC TESTING – The process of observing an entire genome (all the genes that make up an organism). Genomic testing evaluates all a person’s genes, rather than focusing on a specific gene, or set of genes. Genomic testing looks broadly for gene alterations, or harmful changes, anywhere in the genetic code.

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Clinical Services are provided by researchers and investigators for trials in which people volunteer to test new drugs, interventions or devices as a means to evaluate the effects of these new treatments on patient health outcomes.

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• REGULATORY SERVICES – Regulatory Services are conducted in an organization or clinical trials in order to provide guidance for the company and make sure that they are following the legal guidelines and policies in regard to its daily business processes. • Medical/Regulatory Affairs – Professionals in Medical and Regulatory affairs ensure the safety and effectiveness during the testing and manufacturing processes of the product, along with being responsible for the approval of the marketing or advertising of the product. In addition, they also make sure the company is abiding to the laws and policies (regulations) of their business. • Institutional Review Boards – A group of professionals that monitor the medical research involving human participants in terms of assuring that the correct procedures and steps are taken to complete the research. The IRB has complete authority over the approval of the research and protection of the well-being of the subjects to trial. • Quality Assurance/Quality Control & Compliance – Quality control is primarily focused on making sure that the company is successfully following the quality requirements of the product or service, while quality assurance enhances that

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they have completed all requirements. They both play a key role in quality management to provide full satisfaction for the customers.

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drafting registration dossiers for EMA or FDA approval. • Systems Integration – Systems integration combines heterogeneous data sources and enables data sharing between other health organizations on various platforms. These companies focus on identifying patients, integrating disparate systems and managing big data and unstructured data.

• DATA SERVICES – Clinical data services allow for standardized and centralized end-to-end data collection, analyzation and publication to ensure a seamless, efficient trial process and drug approval. • Biometrics – Biometrics is the field of collecting, analyzing and reporting medical data. This involves clinical data management, medical dictionary coding, biostatistics and SAS and clinical programming. • Data Science Tools – Tools used for the analysis, management and presentation of data relating to clinical trials. • Publishing & Submissions – Publishing and submissions companies can help plan, manage and prepare for publishing and submissions for global, multi-country simultaneous or sequential filings and meet all product development milestones in specific regional formats. They are also involved in scanning services for legacy document conversion, technical document tracking and regional regulatory consultation. • Medical Writing – Medical writers develop documents from marketing applications to clinical trial documents to increase chances of regulatory success. They also assist in medical conference presentations, peer-reviewed publications in medical literature and

• TRIAL EXECUTION – Trial execution is the initiation of conducting experiments or observations on human participants for biomedical or behavioral research studies. These studies are specifically designed to discover the outcomes of new studies or interventions. • Patient Engagement – Patient engagement is the overarching business of working with patients for clinical trials, especially the patient group involvement in improving the clinical trial enterprise. • Sites – Clinical trial sites are the physical location where drugs, medical devices and other therapies are tested on human patients. The data from these trials are then used by sponsors to seek regulatory approval. • Clinical Operations – Clinical operations is a key component in the success of clinical trials in which the operations team ensures there is proper planning, organization, and execution of all phases involved in the process of the trial.

PHARMA TECH & INFO SYSTEMS Industry Overview Pharma Technology and Information Systems combines scientific aspects that are critical in the development and manufacture of new drugs, handling of medicines and medical devices with software, technology, eClinical solutions, and data subscription services to create an innovative value proposition though process standardization and increased efficiencies. Over the past decade, novel technologies have allowed for the efficient and cost-effective development of precision and specialty medicines. The drug and device development space is poised to make further profound leaps in productivity, cost reduction and pace of innovation as it continues to embrace new technologies and methodologies and exploits them to their fullest potential. Innovative technologies ranging from cloud computing to distributed technology are being used to drive advancement in clinical trials, supply chain logistics and infrastructure efficiencies. Clinical research organizations, pharmaceutical companies, research laboratories, and investors in the drug development industry around the world have demonstrated the desire to accelerate drug and device trials and embrace new forms of validation in order to help speed the delivery of advanced cures and therapies to patients in need. Technical innovation in the clinical development space is driving growth, efficiency and cost reduction in what is becoming one of the most promising drug and device development eras in recent history.

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LABORATORY SERVICES Industry Overview The Laboratory Services market consists of companies that provide diagnostic testing ranging from blood tests to genetic analysis as well as other laboratory examinations of materials derived from the human body for the purpose of providing clinical and research information for the effective development of novel treatments. Such services help deliver effective and efficient information needed in the development of new medicines and therapies. Laboratory Services are used to ensure the efficacy and accuracy of research data. The testing of research subject results of research therapies offers clinicians and researchers the necessary data to create safe and effective therapeutics with a minimum risk of errors. The increase in the number of sophisticated new medicines associated with precision and specialty medicines, such as human and tumor genetics, is helping to drive the uptake of large-scale laboratory services in the development market. Additionally, the need for adherence to international regulatory standards, is providing new opportunities for interoperability and automation of laboratory processes through innovative technologies. The implementation of automated solutions in laboratory workflows is enabling the processing of larger numbers of samples per unit of time, enhancing productivity and efficiencies while minimizing errors and costs. The integration of automated data management and the advent of increased accuracy and technologically advanced products, such as biochips and microarrays, as well as advanced diagnostic modes, such as companion diagnostics, is allowing for the more cost-effective testing and development of novel therapeutics in the once extremely expensive realm of molecular, genetic and genomic testing.

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CLINICAL SERVICES Industry Overview The clinical services market consists of companies who are supporting the development of new drugs and devices from inception through regulatory approval. Key drivers impacting the market’s growth are globalization, new treatments in precision and specialty medicine, and the evolution in technology, all driving the rising demand for these more efficient and costeffective third-party services and expertise. The global availability of a vast array of cost-effective services from drug discovery to post-marketing surveillance has allowed for the increase in near-virtual development of drug and device candidates for mid-size and small-scale organizations allowing them to direct otherwise scarce investment capital directly into expert-driven outsourced services rather than the creation of costly redundant and often less effective internal development efforts. The growing prevalence of precision and specialty medicine, such as gene therapies, to address disease and rare disease cases is expected to propel the clinical services market globally. The worldwide population has varied diseases and disease states not previously addressed due to a lack of effective technology to efficiently develop treatments for small population groups. The continued focus on individuals and small patient group treatments is expected to boost the clinical development of novel treatments for new and rare diseases.

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MR. RICHARD F. CIMINO EXECUTIVE CHAIRMAN OF TWOLABS INC. AND A DIRECTOR OF EVOLUTION RESEARCH GROUP

Mr. Richard F. Cimino is an independent consultant who focuses on growth equity in the Health Services sector. Mr. Cimino has served on serval boards. Currently he is the Executive Chairman of TwoLabs Inc. and a Director of Evolution Research Group. Previously, Mr. Cimino was non-Executive Chairman of the Board of MedAvante Inc., a privately held pharma services sector company. Mr. Ciminos’ primary responsibilities as Chairman included; governance, strategy, succession planning and key initiative planning and implementation. Mr. Cimino also served as an independent director for BioClinca Inc. (NASDAQ: BIOC) for six years. Mr. Cimino is a seasoned executive in the Pharma Services sector where he served as Executive Vice President and Group President Clinical Development and Commercialization Services at Covance, Inc. where he oversaw global operations in 60+ countries for; Clinical Pharmacology, Early Clinical Development, Phase II/IV Clinical Development, Commercialization Services as well as Covance’s Molecule Development Group, were he was a member of the company’s Operating Committee, Executive Committee and Benefits Committee. Mr. Cimino also directed corporate strategy and reported directly to the Chairman and Chief Executive Officer.

as Corporate Vice President, Health Imaging Group, where he was instrumental in the digital transformation of Kodak’s second-largest business; now Carestream Health Inc.

Additionally, Mr. Cimino has held several senior management positions during a 20-year career at Eastman Kodak. Most notably, he served

Mr. Cimino holds a Bachelor of Science degree in biology from the State University of New York at Geneseo.

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DAN SNYDER VICE PRESIDENT, BUSINESS DEVELOPMENT, FREENOME

Former Founder and CEO of Protein Solutions, Vice President, Sales and Marketing at Hemodyne and MolecularMD before becoming its Chief Operating Officer and eventually CEO. Dan is currently serving as Vice President of Business Development at Freenome, Inc. in South San Francisco, California. Freenome has developed an artificial intelligence platform for the early detection of cancer, catering to both clinical diagnostics and clinical research. At Freenome, Dan is integral in developing strategic relationships with biopharma clientele. Dan is a proven, authentic executive leader with over 20 years’ of experience in driving growth and building value in venture-backed health science organizations, including MolecularMD, an oncology focused molecular diagnostic company acquired by ICON plc. Throughout his career, Dan has excelled in matching novel technologies with validated market applications and thrives when working with passionate technology developers and early product champions. Dan is a customer-centric commercial leader who inspires organizations to

succeed by intimately aligning external market indicators with internal organizational vision and strategy. A graduate of the University of Virginia with a BA in Economics and William & Mary’s Raymond A. Mason School of Business with an MBA. Dan is a supporter of high impact missions of non-profit organizations through board leadership roles and fundraising activities. Dan has volunteered on the Board of Trustees for The Leukemia & Lymphoma Society of Oregon Southwestern Washington, Idaho and Montana, as a Board Member for the Oregon Bioscience Association and as a Board Member for the Oregon Bioscience Incubator and OTRADI.

Freenome Holdings, Inc. 259 East Grand Avenue Suite 3434 South San Francisco CA 94080

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RICHARD J. RIEGEL CHIEF EXECUTIVE OFFICER, LMC ADVISORY, LLC

Richard Riegel leads LMC Advisory, LLC, which was established to provide advisory and consulting services for investors and organizations that are focused on high growth solutions opportunities in life sciences. Services provided and experiences include market assessment, buy-side advisory, board membership, mentoring and advising company leadership teams on strategy, go-to-market and building equity value. He is a CEO with a proven track record of successfully transforming solutions companies to higher growth, greater profitability and increased shareholder value. He serves as the Vice Chairman of the board of Phlexglobal, Inc. and previously served as the company’s Chief Executive Officer before his retirement in early 2019. Phlexglobal provides specialized technology and expert services solutions for the pharmaceutical and life sciences industry across the Trial Master File, Clinical and Regulatory processes. Under Riegel’s four years of leadership, Phlexglobal grew significantly, improved profitability, established a significant services operation in Poland, and led the sale process to new private equity ownership. He also serves on the Board of Advisors of Gens & Associates and Adaptive Clinical.

Throughout his 30-plus year career, Riegel has held key positions with increasing responsibilities in the technology and professional services industries as a CEO, vice president, general manager, and head of sales; supporting companies in the pharmaceutical and life sciences industries including IBM, First Consulting Group, Taratec Development and Barnett International.

Previously, as CEO of LIQUENT, he managed the divestiture of LIQUENT out of Thomson Reuters to private equity ownership, and after transforming the company to higher growth and profitability, led the sale of LIQUENT to PAREXEL; a leading Clinical Research Organization.

Riegel earned a Master of Business Administration degree from Villanova University and a Bachelor of Science degree in Mechanical Engineering from Penn State. He lives in West Chester, Pennsylvania, with his wife, Tracy. They have three grown daughters.

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RICHARD THOMAS PRESIDENT & CEO, R VENTURES INC.

Former Board of Directors for Bracket, THREAD research, Signant Health, ProPharma Group and Advarra. Current Strategic Advisory Board Member for Genstar Capital and President & CEO R Ventures Inc., a consulting firm offering a wide range of investment, advisory and consulting services for investors and organizations that are focused on high growth services opportunities in healthcare, life sciences and technology. Richard has been an investor and partner with one of the world’s leading private equity and early-mid market companies focused on technology and services in life sciences and healthcare, investing and providing M&A, operational and advisory services. Over 30 M&A transactions completed since 2016 including many pivotal pharma services deals. Never afraid of a challenge – Richard has built and led innovative technology centric startups inside large corporations as well as ground up ventures addressing unmet market needs

generating hundreds of millions in revenue and significant investor returns. Richard says that he has benefited immeasurably from working with a “tribe” of great people and organizations across multiple industries over his 30 year career – which he now channels and focuses into serving a portfolio of innovative investors and companies that are using technology to effect positive change in healthcare and life sciences.

Tuck School of Business at Dartmouth. Since 2014 Richard has volunteered to serve on the Board of Directors, Executive Committee as the Development Committee Chair with the Museum of Life and Science in Durham, North Carolina. Richard has also been honored as the 2015 Lifetime Achievement Award Winner, 2015 Information Week Elite 10 Winner, 2014 CIO 100 Honoree, 2013 CIO of the Year for a public company and 2013 Computerworld Premier 100 IT Leader.

Richard connects the dots with an eye for innovation and detail, keeps raising the bar and cutting through the hype (especially in technology) – comfortable deep into operations, building products or in the boardroom. A key theme for success has been working with people who like and respect each other; having fun along the way then comes naturally as do multiple “Best 100 Places to Work in IT” awards. A graduate of the University of South Wales with a BSc (Hons) in Computer Science and The

R Ventures Inc. 212 W Millbrook Rd, Raleigh, North Carolina Richard.thomas@rventuresinc.com

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STEPHEN SULLIVAN FOUNDER, CRO ADVISORS LLC

CRO Advisors LLC services include strategy assessment and development, organizational evaluation and design, acquisition targeting and due diligence, bidding, pricing and negotiation support, post-merger integration management, team building, restructuring support, process improvement, governance support for owners and operators, senior leader coaching and interim management services.

include Firma Clinical Research where Steve was Chairman for three years sold to Northlane Capital, PHT Corporation sold to eResearch, MediMedia Pharma Services to Icon. PLC, PDI contract sales to Publicis and BioreclamationIVT to Arsenal Capital. Steve was an infantry company commander in the U. S. Marine Corps and received his MBA from Rutgers University and B.S. from the University of Dayton.

Sullivan was President and CEO of Harlan Laboratories, a major preclinical CRO from 2006-2010. From 1999- 2006 he headed most of the clinical divisions of Covance, Inc. Prior to Covance, Sullivan was Chairman, President and Chief Executive Officer of Xenometrix, Inc., a drug discovery tool company. Previously, He served in several senior management positions at Abbott Laboratories, including Vice President of Worldwide Marketing for Abbott Diagnostics, and Vice President and General Manager of the Diagnostic Assay Sector and also held senior management positions at Lyphomed, Inc., Dart and Kraft Inc., and Baxter International.

Academic experience includes 14 years as an Adjunct Professor of International Business, Policy and Strategy, and Leadership at the Kellogg Graduate School of Management Northwestern University from 19831997. In 2016, Steve created and regularly teaches “Drug Development from Discovery to Post-approval” at Georgetown University, School of Biotechnology, Georgetown University Medical Center where he is an Adjunct Professor.

Sullivan has served on several public, private and not-for-profit boards and is currently Chairman of Interpace Diagnostics, Inc. (NASDAQ:IDXG), a molecular diagnostics lab, Chairman of MI Bioresearch, Inc., a venturebacked oncology discovery services company, Chairman of Analytical Lab Group LLC, comprised of three microbiology service companies, and Board Member of TransnetYX, Inc., the leader in genotyping of research models in drug development. Recent exits/boards

CRO Advisors LLC sullivan.sj@gmail.com Greenwich, CT 06831 (609) 841-4521

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TODD GROSSHANDLER EXECUTIVE VICE PRESIDENT, HEAD OF COMMERCIALIZATION, MONTROSE ENVIRONMENTAL GROUP

Former Co-Founder and owner of Enthalpy Analytical, Executive Director of Sales at Covance (LabCorp’s Drug Development Business), President and CEO of Integrated Laboratory Systems and currently, Executive Vice President, Head of Commercialization at Montrose Environmental Group, a highgrowth environmental services company with more than 50 locations and 1,200 employees throughout North America. Todd currently leads the sales and marketing efforts for all of Montrose Environmental, one of the first companies to see environmental responsibility as not just an imperative but as a strategic asset. Montrose is well ahead of the curve in applying the latest in innovative technologies in practical ways to solve difficult environmental challenges. As an entrepreneur and seasoned life science executive, Todd has a 25-year proven track record in building, growing, and leading successful organizations. Positions have included

being a successful Business Owner, CEO, Board Member, Executive Director, and Executive with responsibilities throughout the United States and Europe. Todd has played critical roles in a variety of venture investments, buyouts, acquisitions, and mergers – from target identification and due diligence through management of the ensuing integration processes. A graduate of North Carolina State University with a BA (magna cum laude) in Chemistry and the University of North Carolina at Chapel Hill.

Montrose Environmental Group 1 Park Plaza, Suite 1000 Irvine, CA 92614, Irvine, CA 92614

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CHAPTER 3

PHARMA TECH

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ANTIDOTE: where patients meet research ANTIDOTE COMBINES DATA-DRIVEN TECHNOLOGIES AND A DEEP NETWORK OF PARTNERS TO PROVIDE HIGH-QUALITY PATIENT ENGAGEMENT, CLINICAL TRIAL RECRUITMENT SERVICES, AND VALUABLE INSIGHTS.

Sandy, living with Alzheimer’s disease, with her husband and caregiver, Ira

Shanelle, living with lupus

Clinical trial recruitment has come a long way since radio and newspaper ads, but even with all of today’s more targeted digital marketing options, it’s still a major challenge for the industry.

Many Antidote partners embed the company’s clinical trial search engine, Antidote MatchTM, on their websites. These searches create a database of engaged, opted-in patients that Antidote can reach out to directly with trial and research opportunities. This outreach is complemented through Antidote partner channels with targeted digital recruitment.

Antidote is tackling this issue head-on with just the right balance between technology and human touch, delivering high-quality patient engagement through data-driven technologies, digital expertise, an unrivalled partner network, and personal patient and site services.

Matching to ensure quality Trial sponsors can screen patients for one or many trials with a customized pre-screener on a study page built and managed by Antidote. Or, to take pre-screening to the next level, Antidote offers a white-labeled version of its signature matching technology, which improves recruitment economics and the patient experience.

Here’s why this matters As the industry shifts to a patient-focused perspective — from subjects to patients, and from referrals to relationships — Antidote is where it’s always been, laser-focused on its north star: helping patients connect with medical research. And this is important. It takes at least 10 years and $12 billion on average to develop a new drug. In talking about the slow speed of clinical research, Eric Valor, an ALS patient and advocate who passed away last year, once said “the cost to patients and to research is too high.” The slow pace of research means that patients continue to wait for the new and better treatments they need now.

Antidote ensures high-quality referrals through its phone validation service and integrated third-party solutions, including lab testing, EMR records retrieval, and transportation and logistics support for patients. Enrolling with ease Antidote’s site follow-up services close the loop for trial sponsors. Recruitment is optimized throughout to reduce site burden and ensure patients reach the finish line. Full transparency through an intuitive site portal and regular reporting provide valuable insights on the entire funnel, from referral through to randomization.

Here’s what this looks like in practice Connecting with the right patients Antidote’s 300+ partner network reaches beyond typical digital channels to achieve recruitment goals faster.

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Antidote is a digital patient engagement company that enables faster recruitment timelines for clinical trials. Antidote’s customized full-service solutions use precision targeting to identify patients and high-touch patient engagement throughout the consent or randomization process.

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Antidote 12 E 33rd Street, Floor 8 New York, NY 10016 +1-888-509-1308 hello@antidote.me

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CLINICAL INK PIONEERING ESOURCE TECHNOLOGIES & ENABLING VIRTUAL CLINICAL TRIALS

Through innovative, configurable direct data capture (DDC) technologies, Clinical Ink has transformed the way clinical trial data is collected and accessed, with cleaner, faster results In 2007, a clinical researcher and a medical forms designer recognized digitization as the solution to laborious, error-prone, paper-based, clinical trial record-keeping. They envisioned an innovative, tablet-based software application that would offer users the familiar features of the paper source while allowing electronic capture, validation, and sharing for cleaner, faster data. Clinical Ink was born. Today, this pioneering company offers an extended ecosystem of configurable, interconnected eSource technologies to save time and reduce errors. The Lunexis™ platform includes capabilities for numerous direct data capture (DDC) modalities, bring your own device (BYOD, in which patients send and receive study-related data via their own phones), electronic patient-reported outcomes (ePRO), electronic clinical outcome assessments (eCOA), risk-based management (RBM), and eConsent. Source data feeds into a centralized monitoring system that allows researchers and safety monitors to keep their fingers on the pulse of a trial, 24/7. The platform ensures greater efficiency, fewer protocol deviations, better data quality, and streamlined regulatory submissions when compared with traditional methods.

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As the leader in DDC, Clinical Ink is poised to support virtual trial conduct. The company has implemented 250 Phase I–IV eSource studies — including an Ebola vaccine study — involving: • >6,000 patients, adult and pediatric • 5 northwest African countries • Rapid enrollment of 3,000 patients in 4 months This level of experience matters. Recently, Clinical Ink purpose-built and deployed the electronic study environment for a COVID-19-related study in just 15 business days. Whether a clinical trial sponsor aims to decrease patient visits by one or eliminate them completely, Clinical Ink has built a vast toolkit of solutions, technologies, and supportive industry guidance through long-term, pioneering focus on DDC and fully integrated patient engagement, making decentralized trials a reality. As a testament to the importance of this work, the 2019 European Medicines Agency (EMA) Qualification opinion in favor of using eSource DDC in clinical trials references Clinical Ink ten times. Drawing data and insights from global Phase I–III studies, the EMA credited Clinical Ink’s eSource platform with: • 6x reduction in time to data availability • 7% increase in “first time right data” • 50% reduction in query response time Additionally, 70% of sites felt the system caught errors that would have been missed on paper.

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Clinical Ink is a global clinical technology company with 132 employees and offices in Horsham, PA, and Winston-Salem, NC.

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The platform Lunexis™ eSource clinical technology with configurable direct data capture, eCOA, ePRO, and eConsent modules is a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source. This technology eases clinical trial workflows and enhances data certainty by reducing manual labor, providing anytime, anywhere data access, and saving resources from start to submission.

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Now, both the FDA and EMA support eSource. In clearing this last regulatory barrier, Clinical Ink played a key role in changing an outmoded industry paradigm and paving the way for the current, crucial expansion of DDC and virtual trial implementation, industry-wide.

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Pioneering Risk-Based Quality Management (RBQM), Risk-Based Monitoring (RBM) and Intelligent Data Surveillance A faster way of identifying, visualizing, managing, and documenting trial risks that could compromise patient safety and delay the approval of Investigational Products. The clinical research industry is adopting RiskBased Quality Management (RBQM) and RiskBased Monitoring (RBM) as primary methods for managing quality. Formally endorsed by both the Food and Drug Administration (FDA) and European Medicines Agency (EMA), and now encoded in the ICH E6 (R2) GCP update, RBQM and RBM encourage relatively less

reliance on traditional on-site monitoring practices including frequent site visits and 100% source data verification/review (SDV/ SDR). It also encourages greater reliance on centralized monitoring including the use of statistical methods to identify quality-related risks (e.g. unusual or unexpected data patterns). There is a growing body of evidence supporting both the importance of Centralized Statistical Monitoring (CSM) and the relatively low value of comprehensive SDV and SDR. CluePoints Inc. is a leading provider of software solutions to enable and support RBQM, which combines a risk planning module (Risk Assessment & Categorization Tool) and a centralized monitoring and analytics platform

(CluePoints Central Monitoring Platform). CluePoints’ innovative software provides Sponsors and CROs with a better and faster way of detecting and managing risks that may impact the outcome of clinical trials. The solutions, all of which are cloud-based and enhanced with machine learning techniques, are driven by CSM, a unique set of algorithms that interrogate clinical and operational data in real-time centrally to conveniently illuminate outliers and anomalies in data. The adoption of statistics to assist with quality oversight in trials is well documented. So much so, that the FDA extended its relationship with CluePoints to further explore a data-driven approach to oversight in trials.

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The following features support effective quality oversight and detection of operational study risk: 1. Data Quality Assessment (DQA) – An advanced suite of statistical tests is executed across all clinical study data to identify unusual data patterns at sites (or regions, patients) representing potential issues. 2. Key Risk Indicators (KRIs) – Any number of standard and study-specific KRIs can be configured to help identify specific risks of interest across sites (or regions, patients). 3. Quality Tolerance Limits (QTLs) – Any number of QTL parameters can be configured to help identify study-wide issues that may impactful to overall study outcomes or patient safety. 4. Patient Profiles – Patient profile reports can be configured for each study and used either to support investigation of identified risks or for medical/safety reviews. 5. Duplicate Patients – This configurable module enables the detection of potential duplicate or “professional” patients. 6. Data Visualizations – An advanced data visualization and reporting engine provides for both pre-configured and real-time dashboards and data exploration support.

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As new clinical trials are initiated, risks should be identified, assessed and mitigated, but the focus should not only be on how monitoring activities will be addressing the risks. Unrelated activities may also help prevent or detect potential issues earlier, including edit checks,

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CluePoints |

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Statistics: Year Founded: 2012 Founded By: Marc Buyse, Francois Torche and Patrick Hughes

CluePoints is the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software. Our products utilize comprehensive statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints® is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation you now have everything you need to adhere with global regulatory guidance. The result is increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBx.

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queries, medical review, safety review etc. CluePoints is passionate about gathering all the knowledge, processing it with novel analytical techniques (i.e. Machine Learning and Statistics) to make clinical trials better, faster and cheaper whilst enhancing patient safety.

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CluePoints New Tech Centre, Avenue Albert Einstein 2A, Louvain-La-Neuve, 1348, Belgium +1-617-765-7129 contact@cluepoints.com

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THE GOLD-STANDARD IN REAL-WORLD EVIDENCE

BUILT ON A FOUNDATION OF PROSPECTIVE OBSERVATIONAL REGISTRIES IN AUTOIMMUNE DISEASES, CORRONA IS A TRUSTED PROVIDER OF REAL-WORLD DATA AND EVIDENCE GENERATION. Despite the myriad of companies that claim to be real-world evidence providers, biopharmaceutical companies face major challenges identifying a reliable, scientifically rigorous real-world data source that can be leveraged for multiple use cases. Sources such as electronic health records (EHR), claims datasets, and EHRbased registries have significant limitations, including a lack of validated outcomes, consistency, clinical granularity, and longitudinality. Corrona is the built-for-purpose provider of gold standard real-world evidence, providing real-world safety, effectiveness, and patient reported outcomes data to support biopharmaceutical companies with post-marketing safety surveillance requirements, secondary indication submissions, label expansions, and market access negotiations. Our team of highly experienced biostatisticians and epidemiologists work collaboratively with our clients to design scientifically rigorous methodologies and analysis plans. Corrona has a strong publication track record, particularly in comparative effectiveness and safety studies, with over 500 abstracts and over 160 full-length manuscripts in peer-reviewed journals. Our registry data is increasingly valued by clinicians, patients, regulators, and payers due to its depth, scientific rigor, and objectivity. Our fundamentally unique approach builds custom datasets that prospectively collect data from providers and patients using structured data fields and include validated outcomes used in clinical trials. Corrona’s registry data has expanded well beyond its flagship Rheumatoid Arthritis Registry, and now includes an expansive list of autoimmune diseases: Psoriasis, Psoriatic Arthritis and Spondyloarthritis, Ulcerative Colitis, Crohn’s Disease, Multiple Sclerosis, and Atopic Dermatitis, collectively representing over 74K patients, in North America and Japan. The growth experienced over the past 20 years continues to the present day, with a Neuromyelitis Optica Spectrum Disorder registry to be launched later this year. Aligned with the vision of creating high quality & differentiated datasets, through its subsidiary Health iQ, Corrona has access to a broad range of UK and international datasets across primary and secondary care, as well as deep relationships with the NHS, Public Health England, and leading UK academic institutions. Corrona’s HealthiVibe business complements and strengthens Corrona’s strong presence in disease registries by providing market-leading expertise in supporting innovative, evidence-based patient engagement initiatives across the product lifecycle.

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ECLINICAL SOLUTIONS ACCELERATING DRUG DEVELOPMENT WITH INNOVATIVE CLINICAL DATA TECHNOLOGY AND SERVICES

elluminate Clinical Data Platform and Technology-Enabled Services Deliver Greater Insights, Access and Data Quality for Increased Efficiency in Clinical Trials eClinical Solutions and the elluminate® platform are transforming the way new treatments are developed. As the pharmaceutical industry transitions from treating disease to improving human health, it has become increasingly important to utilize new sources of data and employ digital platforms. The volume and variety of data sources and systems used in research continues to grow dramatically, as do the number of stakeholders involved. This has made clinical trials and data review overwhelming and complex. In the last two years, data management cycle times have increased by 40% for trials incorporating more than four

data sources, and technology for centralizing and managing numerous data sources has not kept pace. A better approach to maximizing

the value of data in clinical research is needed to speed the innovations required to improve human health.

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“Data is the currency that fuels innovation in the drug development industry,” says Raj Indupuri, CEO of eClinical Solutions. “Companies adopting digital data strategies and modern technology architectures are gaining a competitive advantage in the transition to digital health. Comprehensive clinical data platforms that automate the flow and preparation of data throughout the research enterprise for enhanced review and advanced analytics enable the deep insights that advance the future of drug development.”

Enabling Data-Driven Decisions eClinical Solutions has emerged as a leader in enabling life sciences companies of all sizes to build robust clinical data strategies, acquire data more efficiently and deliver high quality data for submissions, faster. Their offerings are led by the elluminate Clinical Data Platform and technology-enabled data services. elluminate ingests and organizes data from multiple sources into one unified source of truth to optimize data review and improve data analytics.

eClinical Solutions President Bob Arnesen and CEO Raj Indupuri to focus on applying their expertise to the acceleration of drug development.

Robust, self-service analytics and visualizations provide direct access to governed data – empowering data management, clinical operations, medical monitoring and biostatistics

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eClinical Solutions’ software and services form the foundation for a cohesive strategy in centralizing data for improved oversight

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eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. Our intelligent cloudbased platform and services give you real-time, self-service access to all your data, and advanced insights to accelerate your biggest initiatives. Founded in 2012 and headquartered in the Boston, Massachusetts area, eClinical Solutions has offices in India and the U.K.

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Statistics: Year Founded: 2012 Founded By: Bharat Agrawal, Bob Arnesen and Raj Indupuri

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eClinical Solutions 603 West St. Mansfield, MA 02048 +1-877-ELLUMN8 info@eclinicalsol.com

and real-time review. The elluminate platform provides life sciences companies with greater control of their clinical trial data. elluminate software and data-driven services have been used by more than 100 life sciences companies on more than 1,000 trials.

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WE ARE ENNOV. IT’S NICE TO MEET YOU. WE DEVELOP UNIFIED SOFTWARE SOLUTIONS

THAT ARE INTUITIVE, EASY-TO-USE AND ARE AN INTEGRAL PART OF OUR CUSTOMER’S OPERATIONS. For more than 20 years, our customers have been automating their processes, improving compliance, and measurably increasing efficiency using Ennov solutions. Our solutions are designed to support the entire Life Sciences R&D continuum including Clinical, Regulatory, Quality, Pharmacovigilance and Commercial. Because our software can manage regulated processes, content and data, we can provide the most complete and holistic solutions to address our clients’ business needs.

constructed. As a result, our applications are natively connected and do not require integrations or interfaces to facilitate interoperability.

We are recognized by Gartner as a global provider of software technology for the Life Sciences in the areas of Enterprise Document Management (EDM), Regulatory Information Management (RIM), Pharmacovigilance, and Electronic Trial Master Files (eTMF) – a testament to our focus and innovation.

A common, harmonized and configurable data model eliminates redundancy and ensures data accuracy and consistency across all applications. Because all applications share a common UX, users can focus on completing their assigned work and not on mastering the nuances of multiple specialized systems. Common activities such as navigation, searching, item creation and workflow task management are performed identically – regardless of context. This unified approach results in higher user adoption rates, lower training requirements and overall increased productivity.

Our solutions enjoy extremely high user adoption rates, thanks to our intuitive user interfaces and commitment to building software that works the way our users work. Customers report a very high level of satisfaction with Ennov in surveys and interviews, resulting in an annual maintenance renewal rate of 96%.

Our commitment to innovation is unparalleled, with 25% of our revenue invested annually in R&D. Our dedicated research team, Ennov Labs, is solely focused on introducing technical advancements in such areas as machine learning/artificial intelligence, ergonomics, and advanced analytics.

Ennov solutions are built on our unified compliance platform – a highly configurable software architecture that combines a common and engaging user experience (UX) with business process management, document management, data/forms management, learning management and business intelligence to form the foundation on which our applications are

All Ennov solutions are 21 CFR part 11 compliant and are readily integrated with other enterprise applications through our robust REST API. Ennov is 100% web-based, highly scalable, highly secure and available in the cloud or on premises. Ennov is ISO9001:2015 certified for all software products and processes and we boast a 100% success rate in customer audits.

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Statistics: Year Founded: 1999 Founded By: Olivier Pâris

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Headquartered in Paris, with offices in the US and UK, Ennov provides the most original, comprehensive and cost-effective suite of software solutions for the Life Sciences industry. From leading pharmaceutical companies to emerging biotechs, we proudly serve over 200 companies and 150,000 users around the world.

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Ennov 149 Avenue de France 75013 Paris, France +33 (0)1 40 38 81 38 contact-us@ennov.com

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GENS & ASSOCIATES “WHEN RESULTS MATTER”

Our Mission Gens & Associates helps all stakeholders in the regulatory eco-system improve their performance, ultimately shortening new drug approval timelines, increasing consumer access to information, and bettering medicine affordability. We do this through the combination of strategic leadership, informing/ creating industry standards, and providing deep insights derived from our highly respected research platform to identify the most effective investments for improved outcomes. What We Do We are a boutique Life Sciences management and organizational consultancy specializing in strategic planning and roadmap development, industry benchmarking, world-class regulatory information management, organizational transition management, and working with leadership and project teams to accelerate change and value realization. We regularly work with large and mid-tier global bio-pharmaceuticals, small growing biotech, medical device, consumer product, agricultural, regulatory software and service providers, and the investment community.

Our Benchmark Platform – Sharing for Impact We conducted our first study of technology innovations and ICH standard adoption in 2007 and 35 studies later, we are in the middle of the regulatory eco-system and relied upon for strategic trends and operational best practices by all parties. We committed to industry and the providers that serve them to conduct regular, mutually beneficial studies with a simple goal; “Everybody Gets Better.” Our globally recognized benchmarks provide valuable information to inform strategy and key decisions such as: • How do we evolve our systems, processes and organization with our growing work in emerging and secondary markets to streamline how work is conducted globally? • What are the latest technology trends and which ones are worth investing in? • How can regulatory service and software providers better align their products and services to support industry where they will be in 2 – 4 years? • What are the most effective ways to modernize our regulatory capability and program; what makes business and compliance sense?

• How do we increase collaboration and information exchange with our 100 + local offices around the globe and key strategic 3rd party partners? • What are the key non-technology practices to improve our operating performance? For 2020, we have an outstanding Core Research Team comprised of global experts in regulatory, industry standard bodies, technology application, and business process/ organizational excellence. We are extending our regulatory benchmark effort to include a deeper analysis of the vital connections with clinical, safety/PV, label management, R&D portfolio planning, and the supply release process. The Value of a Membership Starting in 2019, we introduced our Premier Benchmark Membership to select industry and provider clients. This program combines our advisory services and benchmarking capability to work with each individual organization, however the program is framed around “community learning.” With an “executive lounge” containing our private research and

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market reports, it’s a collaboration platform consisting of private learning webinars, global survey design events to collaborate and improve the data we collect, and private community debriefs on the latest research and thought leadership. We find that the collective will always learn and innovate quicker; this is why we strongly believe that innovation is a “team sport”!

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Milestones • 2005: Company Founded • 2007: First large study of industry focused on technology innovations and ICH standard adoption (eCTD) – 75% of the top 50 companies (by revenue size) participated • 2009: Follow-up study focusing on collaboration technology and thirdparty information exchange • 2011: Incorporated regulatory service and software providers into the benchmark practice • 2013: First global study on the value and status of Regulatory Information Management • 2014: Incorporated medical device, diagnostic, consumer, small tier biopharmaceutical into the benchmark practice • 2015: Worked with 31 organizations to create a Regulatory Information Management World Class Standard as part of the benchmark analysis • 2017: Recognized in the PharmaVoice 100 as one of the most influential and inspiring organizations • 2018: Extended benchmark to explore the critical interactions of regulatory with clinical, safety/PV, and manufacturing • 2019: Launched our Benchmark Premier Service • 2020: Extended benchmark practice to include agricultural, eye care, and vaccine organizations

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Statistics: Serving over 120 Life Science Organizations Year Founded: 2015

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Our research platform provides vital regulatory benchmark information and insights to the Life Sciences community consisting of sponsors, service and software providers, investment community, and health authorities. With 35 studies conducted to date, our primary goal remains the same; broadly share what we learn so “everybody gets better”.

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InformedDNA PROVEN CLINICAL GENETICS EXPERTISE TO ENSURE SUCCESSFUL CLINICAL TRIAL ENROLLMENT Solu�ons on the Path to Enrolling Pa�ents in Clinical Trials for Gene-based Therapies Network of >80,000 physicians + at home telegene�cs screening

Clinical gene�cs exper�se & na�onal footprint inform datadriven strategies

PATIENT RECRUITMENT

High touch, expertlevel clinical gene�c counseling builds trust & rapport with pa�ents, resul�ng in higher levels of study recruitment

PATIENT ID PLANNING & FEASIBILITY DATA REGULATIONS Physicians engage in PROVIDER clinical trial screening ENGAGEMENT with minimal impact to clinic + retained pa�ent stewardship

IRB-approved, compliant programs with embedded pa�ent consent for clinical and gene�c data repor�ng

POST-MARKET Proven programs to iden�fy rare disease pa�ents as candidates for therapy, Payer policy insights and strategies

InformedRECRUIT™: Designed to optimize patient identification by uncovering targeted populations at the community level and leveraging proven telegenetics methods to screen potential clinical trial candidates.

The gene therapy market is projected to register a compound annual growth rate of 16% over the next eight years. With genetic testing now used in more than half of clinical trials, it is more important than ever for clinical trial/study sponsors to work with genetics specialists to ensure that clinical trials are optimized to identify and recruit patients with rare genetic variants, and that genetic data use is maximized while meeting regulatory guidelines.

This service offers: • Access to our network of patient advocacy groups, physicians ordering genetic tests, and patients and family members from InformedDNA’s 13-year nationwide clinical genetics practice • High-touch patient screening and support • Robust genetic test integration • Proven recruitment and pre-qualification process • Peace of mind with regulatory compliance • Reporting insights

InformedDNA is the largest full-service genetics advisory company in the United States and has a suite of services specifically designed to support clinical trials, natural history studies and research programs. Our services are optimized to reduce time to enrollment, increase screening efficiencies, improve patient retention, mitigate sponsor risk, and reduce clinical trial costs. Our solutions include the following:

InformedACCESS™: In order to ensure success in a post-market environment, sponsors must prospectively plan to identify eligible patients leading up to and following FDA approval. We enable sponsors to maximize the number of patients eligible to receive novel therapy by expanding patient identification efforts to the community level and negotiating successful coverage policies through our relationships with leading health plans. InformedRESEARCH™: Our patient outreach programs include trusted IRB-approved screening tools that simplify the genetic testing process and reduce barriers to clinical trial enrollment. This plug-and-play solution gives sponsors all the benefits of a dedicated research team: Study PI, IRB submission and approval, manuscript preparation and submission, medical writing, and FDA submission support. InformedADVOCATE™: As advocacy organizations strive to improve the lives of patients in their communities, InformedDNA enables acceleration of translational research by growing patient registries with high caliber data and fostering broad collaborations that directly contribute to clinical research and therapeutic discoveries.

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InformedDNA: Uniquely suited to support clinical research • Nearly 100 genetics specialist employees • >2,500 patient referrals/month • Permission to contact patients • Patient satisfaction >97% • >12,000 prior authorization requests/month • Network of >80,000 unique providers who order genetic tests • Sponsor satisfaction = 100%

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Life sciences companies turn to InformedDNA for proven genetics expertise that optimizes and improves efficiencies for rare disease clinical trials, clinical research programs, and natural history studies.

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LOKAVANT A PARADIGM SHIFT IN CLINICAL TRIAL INTELLIGENCE Data is the most valuable resource in the world; however, in and of itself, data’s value is limited. This value is only unlocked when data is captured, understood, and used to generate insight. Every clinical trial is an exercise in data collection — clinical data. But what of the operation of the trial itself? Trial operations leave clues and, in much the same way as we learn about new therapies within trials, the data generated can be used to improve trial conduct — reducing costs, shortening timelines, and ultimately pushing clinical research through its next quantum leap. Leave no stone unturned. Leave no data source untapped.

The insights derived from data analysis are only as useful as their ability to influence human action, so Lokavant ensures that the information is fit for human consumption. Researchers deserve only the very best, so we designed it for them — a seamless, interpretable user interface, that provides real-time trial oversight. By the end of the Lokavant journey, the disorganized, unruly puzzle pieces have been collected, assembled, and presented to the humans who run clinical trials — ensuring that no error escapes their watchful gaze and no patient goes untreated. Lokavant is part of a greater movement, an industry shift towards using Big Data to develop the therapies of the future. When researchers are empowered to wield the insights from the collective intelligence of decades of clinical trials, they will be able to more efficiently develop novel therapies at a faster pace, driving new medicines to critical patient populations with unmet clinical needs. We’re building a new baseline for clinical trial performance — please join us as we forge ahead into a new paradigm for clinical research, accelerating therapies to the patients that need them.

Data is like a puzzle. No individual piece is sufficient, but, together, they elucidate a complete picture. That is why the Lokavant pipeline begins with data consolidation — the creation of a single source of truth to hold all of the pieces. Once contained in this repository, Lokavant’s powerful analytics engine goes to work, digging through the data to uncover the insights that will empower researchers to avoid operational error. No human could possibly grapple with all of the data from a trial at once — let alone thousands! Lokavant reveals the hidden correlations and relationships that exist between datasets, whether it’s all of the repositories from a single trial, or 20 years worth of accumulated trial data.

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Lokavant enables next-generation clinical trials by providing real-time data monitoring with predictive analytics to identify risks in pharmaceutical development. A growing corpus of over 1,000 de-identified clinical trials powers the Lokavant predictive analytics engine. Lokavant works to aggregate and deliver real-time data from disparate trial data sources, predict issues during clinical development to mitigate trial risks and empower monitoring teams by visualizing critical study insights.

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Statistics: Year Founded: 2019 Founded By: Roivant Sciences

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Lokavant 151 West 42nd Street New York New York 10036 United States +1-646-844-3808

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PROMOTING PEOPLE FROM SUBJECTS OF RESEARCH TO PARTNERS IN DISCOVERY THE PUBLIC BENEFIT CORPORATION, LUNAPBC FOUNDED LUNADNA, A DATA-SHARING AND DISCOVERY PLATFORM FOR PEOPLE TO REMOTELY, DIGITALLY, AND EASILY PARTICIPATE IN SCIENCE.

From left to right: CFO David Lewis, CEO Bob Kain, and President Dawn Barry

LunaDNA advances people from subjects of research to partners in discovery so the best questions are answered, the right problems are solved, and individual’s lived experience is included in studies and trials. With LunaDNA, people can remotely, digitally, and easily participate in science with privacy protection, data control and choice consistent with GDPR, and transparent operations. LunaDNA is a data-sharing and discovery platform bridging people and groups – like patient advocacy and support groups – with researchers to conduct studies shaped by the people living with disease and the leaders advocating for them.

through data analysis where shared data can be joined with public and private datasets for discovery in a researcher’s private, HIPAAcompliant, cloud environment.

The technology is seamless from participant-led data gathering and digital community creation

Self-reported outcomes, real-world data, health records, DNA files, and more are included

in LunaDNA. Unlike institutional models, LunaDNA forms a data-sharing relationship directly with the individuals, includes inplatform data return and engagement services, and is qualified with the U.S. Securities & Exchange Commission, as featured in Nature Biotech.

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Reimagine the study participant experience:

1) Organize Study Communities Engage with advocacy groups or define phenotypic criteria to build discovery populations. With members from over 165 countries, LunaDNA is geographically and institutionally borderless because we work directly with people to gather data.

2) Characterize & Message Communities Enrich the dataset in your private study environment with electronic health records, validated surveys, -omics, and more. Shorten the time to finding critical biomarkers, real world evidence, and the essential elements of people-focused drug development detailed by PDUFA VI.

3) Refine & Define Study Protocol Explore inclusion/exclusion criteria to understand the study community’s potential and refine the population to enrich the cohort for greater success in the event of a regulatory submission. Construct your study by phenotype, disease state, or other attributes.

4) Perform Clinical Research in Support of Study or Trial Conduct analysis in your private analytics environment where private and public datasets can be integrated with participant’s shared data. Provenance of real-world data and patient-reported outcomes is maintained. Operate as a GDPR Data Processor while LunaDNA maintains the GDPR Data Controller role. Use our analytical tools or bring yours into the environment.

5) Engage Participants During & Post-Trial

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Deliver value to participants with data return and support services (e.g. advocacy organizations, genetic counselling). Connect post-trial for new questions, check-ins, or to re-enroll. Capture longitudinal, person-reported data for outcomes research.

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Founded in 2017, LunaPBC is a public benefit corporation headquartered in San Diego, California. Our team, investors, and advisors are renowned in the patient-advocacy, health, and science fields. LunaDNA is a memberowned health data-sharing platform making research representative of the real world by giving people a role in science.

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MEDABLE REDUCE CLINICAL TRIAL TIMELINES BY 50 PERCENT

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for participants. Of the 55,000 trials in flight, some are good candidates for a fully decentralized model—while many others can be managed in a hybrid model. Patients can be recruited and consented remotely. Physician “visits” can be conducted remotely via telemedicine. Data can be captured remotely (and frequently) via medical devices and mobile technology.

Medable is on a mission to reduce clinical trial timelines by 50 percent. The company’s global decentralized trial platform streamlines design, recruitment, retention and data quality, replacing siloed systems with integrated digital tools, data and interfaces to accelerate trial execution.

Over the past several years, Medable has built a unified, modular digital platform that works as a service to streamline clinical trials with direct-topatient technologies. The platform connects patients, sites and clinical trial teams to improve patient access, experience, and outcomes. The platform is used by leading biopharma sponsors and clinical research organizations worldwide, and has been used for trials in 30+ countries and 26 languages.

As the world has seen with recent events, traditional trial processes and timelines are insufficient to meet the global need for clinical research. Limiting trials to a handful or two of physical sites inherently limits patient access. Restricting interaction to in-person visits is not only grossly inefficient, but it also limits data frequency and quality. And during a crisis like the COVID-19 pandemic, it’s simply infeasible.

The paradigm is shifting – quickly. Decentralized trials are no longer a niceto-have. Reducing trial timelines has to be a long-term industry imperative, whether it’s streamlining trials for critical vaccines, reducing timelines for other therapies, or initiating new trials to address the 7,000+ rare diseases that have no therapies on the market. Now is the time for decentralized trials, so we can get effective therapies to more patients faster.

Decentralized trials (also known as virtual trials) “untether” trials from physical sites, improving patient access to new therapies while accelerating trial timelines. There are currently more than 55,000 interventional clinical trials underway worldwide, actively enrolling and providing care

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Statistics: Year Founded: 2012 Founded By: Dr. Michelle Longmire, CEO Tim Smith, CTO Perry Robinson, General Counsel, Chief Compliance Officer

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Medable is the leading global platform for decentralized trials. Its software accelerates clinical drug development, enabling effective new therapies to reach patients faster.

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medableinc Medable_Inc Medable, Inc

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Medable 525 University Ave, Suite A70 Palo Alto, CA 94301 +1-877-820-6259 info@medable.com

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Connecting patients with clinical trials to help advance science and save lives With over 55,000 active clinical trials today, patient recruitment is the greatest challenge the industry faces to successfully completing studies on time – sponsors spend large amounts to onboard sites, the sites often fail to meet enrollment targets, and studies often become delayed significantly. Historically, pharma has only relied on research sites to identify and enroll patients in clinical trials, with no direct-to-patient outreach. This model may have worked when the major focus was on chronic conditions and the population sizes were in the millions. However, in the past 20 years and more recently with the help of tech advancements, the pharmaceutical industry shifted focus on rare disease and oncology, which account for nearly 40% of active trials today. In the rare disease and oncology space, where patient populations are extremely small and dispersed across the globe, sites fail to reach enrollment goals nearly 80% of the time, exaggerating the sponsor’s cost to run trials. Pharmaceutical and biotech companies need to engage with patients directly and not rely exclusively on sites to recruit patients, but no industry-wide platform exists that enables sponsors to communicate directly with patients before, during or after clinical trials. We launched PatientWing, a platform that empowers Sponsors to do exactly that – engage with patients, to learn from them and create more patient-centric trials, to enroll patients in their trials, to advance science and save lives. At the surface, our website is a patient-friendly interface where you can search for active clinical trials, synced nightly with clinicaltrials.gov. For sponsors, we offer two main solutions: Enroll., a patient recruitment solution that meets patients where they are to exceed enrollment goals, and Engage., a fully branded, end-to-end solution that enables that communication before, during and after clinical trials. Our platform is GDPR, HIPAA and 21 CFR Part 11 compliant and is designed to give control back to sponsors. With industry regulations and strict patient privacy laws, it has been a common misconception that sponsors are unable to interact with their patients, let alone the recruitment process. By anonymizing patient data for the sponsor, we allow sponsors to review enrollment metrics in real time and make necessary changes to the protocol, marketing spend, or even site locations to improve enrollments and complete trials on time. Clinical trials are a dynamic process with millions of dollars and thousands of lives on the line. Sponsors need to feel empowered to engage with patients but lacked the appropriate tools to date. We’re here to change that.

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PatientWing 3675 Market St Suite 200 – PatientWing Philadelphia Pennsylvania 19104 United States info@patientwing.com

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PHLEXGLOBAL BECOMING TRULY DIGITAL – HOW ARTIFICIAL

INTELLIGENCE IS TRANSFORMING COMPLIANCE IN LIFE SCIENCES Phlexglobal’s investments into cloud computing, innovative machine learning technology and automation, overlaying their leadership and expertise in both the Clinical and Regulatory spaces, will help the industry to master their path to digitalization. Phlexglobal is known for its leading domain expertise in clinical and regulatory matters. It has led the Trial Master File (TMF) evolution, being the spearhead of the TMF Reference Model, an Industry standard for TMF structure – this model has transformed the way in which TMFs are managed globally. Through our innovation in artificial intelligence (AI), we have helped leading life sciences organizations dramatically reduce the time and manual effort involved with regulatory compliance, whether producing high-quality submissions for new marketed products, or effectively managing thousands of pages of Health Authority Correspondence. As a result, Phlexglobal has emerged as a global leader encompassing compliance “from Trial to File™” – giving companies the innovative technology and services they need at every stage in the regulatory lifecycle, powered by deep and broad domain expertise.

requires generating data, which in many cases is trapped in unstructured documents. It results in a new valuation of data. We, as Phlexglobal, via AI technologies such as Natural Language Processing (NLP), have developed text and data mining solutions that help the industry to automate this process. What does this mean in practice: Phlexglobal’s automation technology within its TMF software, now is able to auto index study documents and generate data automatically, which before was required to be generated manually. Furthermore, the technology is able to read and interpret large email communication and can help reducing the quality control process significantly.

As part of the digital evolution, the life sciences industry is experiencing a transfer from a document driven to a data driven process execution. This

In the regulatory landscape data requirements for new compliance regulations such as IDMP (Identification of Medicinal Products) or eCTD (electronic Common Technical Document) have arisen. Extracting data from regulatory content to automate the drug approval or patient safety management process are areas for which Phlexglobal has developed innovative automation software.

to replace it. In practice, this means that regardless of the eTMF, document management, or RIM system a customer has, Phlexglobal’s technology can be overlaid to support a customer’s processes across the Clinical and Regulatory landscape. In summary, with this innovative approach of expert services combined with modern technology, Phlexglobal has facilitated a significant increase of process speed, cost savings and compliance automation and leads the way in the eTMF and Regulatory digital revolution.

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Phlexglobal also aims to offer our customer its so-called “turbo charge” technologies to be plugged into its customer’s IT infrastructure. The aim is to support intelligent augmentation of existing IT landscapes rather than

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United States Headquarters 400 Chesterfield Parkway Suite 120 Malvern, PA 19355 +1-484-324-7921

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Phlexglobal Ltd Global Headquarters Mandeville House 62, the Broadway, Amersham Bucks HP7 0HJ, United Kingdom +1-149-472-0420

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HARNESSING THE POWER OF QUANTUM TO REVOLUTIONIZE DRUG DISCOVERY. POLARIS IS TRANSFORMING THE DRUG DISCOVERY PROCESS BY USING THE POWER OF QUANTUM qb

COMPUTING TO NARROW THE FIELD OF CANDIDATE MOLECULES FROM THE BILLIONS TO THE DOZENS OF POTENTIAL LEADS.

Quantum computing is changing the world, and carries with it potential to revolutionize many industries; from finance, to logistics, to our ability to fight infectious disease. While the promise of this technology is tremendous, currently it faces challenges of scalability and applicability that make it both difficult to implement and commercially unviable. This is where Polarisqb stands apart in the world of quantum drug discovery, bringing market-ready methods that utilize quantum-inspired computing to accelerate the identification of potential molecular assets by up to 90%. This technology can narrow the potential field of candidate molecules from billions to dozens in about the same amount of time that it takes to complete a traditional internet search.

In partnership with Fujitsu Global, we have used the Digital Annealer, a groundbreaking, quantum-inspired technology, to optimize single or multiple objective searches. The Digital Annealer uses heuristic approaches, rather than brute force, to efficiently search very large chemical spaces with unparalleled speed. As a case study, Polarisqb set the objective of identifying potential candidates to treat Dengue Fever, a mosquito borne viral disease that threatens up to 40% of the world population with potentially deadly complications. There is no cure for Dengue Fever, and the current vaccine is effective only for people previously infected, as it may increase risks of severe infections to healthy patients.

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Polarisqb engineers and chemists targeted the RNA-dependent RNA polymerase protein in the Dengue virus and developed a chemical library of over 1 billion molecules. Once this chemical library was constructed, we used the Digital Annealer to identify 977 potential drug candidates from the over billion molecules in the library. We filter out molecules with un-drug-like properties using AI/ML-based algorithms and accurately calculate binding affinity using QM/MM. This process of rapid combinatorial enumeration and the use of more accurate calculations to scan massive libraries has the potential to identify cures to many diseases that are currently untreatable in a fraction of the time and resources required for the traditional drug discovery process.

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Polarisqb is at the cutting edge of the world of drug discovery, slashing timeframes and costs of discovery processes multiple times over. As we continue to grow, the potential applications for this technology will change the world by developing treatments for previously incurable diseases and pandemics, revolutionizing drug discovery with quantum solutions never before used in the biopharmaceutical industry.

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Polarisqb was founded with the mission of creating drug blueprints to treat and cure all diseases for all people. Employing some of the brightest computational chemists, computer scientists, and molecular researchers, the company is driving innovation in the sphere of drug discovery. Polarisqb seeks to create novel solutions to diseases and conditions that have previously proven untreatable.

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PRO-FICIENCY SIMULATION-ENABLED REMOTE SITE TRAINING AND COMMUNICATION TOOLS FOR CLINICAL TRIALS.

Pro-ficiency provides remote, simulation-enabled training, communication, compliance and performance management tools for clinical trial sites. Run more effective IMs and SIVs through Virtual Study TrainerTM. Pro-ficiency’s Virtual Study Trainer TM is the most advanced training, communications, and automated compliance system for virtual, hybrid and traditional clinical trials.

With Pro-ficiency, you can replace face-to-face training with a system that: • Is more effective and consistent • Includes advanced performance analytics • Provides 100% training coverage to all site staff • Is faster and less expensive • Supports enrollment • Predicts protocol errors and confusion • Saves thousands of site staff and study team hours

Virtual-IMTM provides a simulation-enabled live or asynchronous Investigator Meeting via the internet. And Virtual-SIVTM manages the training, compliance and communication you need to remote-activate clinical trial sites and manage their performance throughout the study.

Simulation Training

Pro-ficiency is the eLearning provider for the Association for Clinical Research Providers (ARCP) which provides the industry’s best competencybased training and certification. This includes GCP, pharmacovigilance, and skills training for research staff.

Pro-ficiency simulation training uses real-world scenarios that model the clinical challenges investigators will face in the study, such as enrollment criteria, assessments, and dosing. Simulations engage learners and allow them to apply their knowledge to improve their protocol adherence and better retain information such as enrollment criteria.

The Pro-ficiency platform allows administrators to send important communications to sites, such as Amendments and Safety Reports, with trackable, audit-ready, read-and-acknowledge functionality.

Pro-ficiency provides e-mentoring to reinforce understanding. Traditional face-to-face training is inconsistent, creates duplication and is proven to be ineffective at increasing site staff performance.

COVID-19 showed us that relying on face-to-face training is not only expensive, inconsistent, and slow, it is also fragile. The industry needs systems that utilize the rigor, convenience, durability, and financial benefit of virtual technology without sacrificing effectiveness. An LMS is only as good as the content you put on it. Simulation training content is not only more engaging, and more effective, it also provides predictive analytics to support your RBM and site selection activities.

Automated Compliance The many vendors, technologies, and regulatory requirements that study teams and sites have to juggle, combined with high staff turnover, create a state of perpetual non-compliance. Pro-ficiency eases the burden, automates compliance, and identifies and mitigates study risk.

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Pro-ficiency provides a comprehensive human performance improvement system for clinical trials. We leverage simulation to provide real-world training for sites and subjects. Sponsors use Pro-ficiency to initiate trial sites faster and more efficiently, and to reduce protocol violations. With the help of Pro-ficiency, Sponsors decrease study time, lower costs, reduce meetings, conduct site feasibility, and predict and avoid study errors.

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SAAMA SHORTEN YOUR CLINICAL TRIALS BY SIX MONTHS TO A YEAR OR MORE LSAC Is Your Drug Development Command Center Most clinical studies go over budget, take longer than expected, and fail to get approval – largely due to underlying causes such as insufficient enrollment, adverse events, and protocol deviations. Saama’s Life Science Analytics Cloud (LSAC) platform overcomes these challenges and pioneers transformational changes in the way clinical study data is collected, managed, and understood by sponsors. LSAC is revolutionizing clinical research by empowering pharma and biotech with unprecedented, authoritative oversight of clinical studies, reducing the time, cost, and complexity of the historically long, drawn-out drug development process. Imagine doing your job without having to manually enter data or worry about its quality and completeness. With Saama’s LSAC as your

Drug Development Command Center, you’ll be able to oversee and accelerate activities related to feasibility, contracting, enrollment, site activation, site monitoring, medical review, query management, and biostatistics before they become problems that lead to costly delays. Saama’s LSAC platform seamlessly connects, ingests, integrates, and harmonizes data from disparate clinical study streams coming from most global source systems (EDC, CTMS, eTMF, IVR, Safety, and others) across patients, sites, regions, and CROs. LSAC is a unique platform that exists at the delicate intersection of science and technology, creating a single source of clinical data truth. LSAC accomplishes in hours what traditionally takes months, compressing delays, optimizing biostatisticians’ valuable time, and minimizing FDA submission errors.

Saama Is Constantly Innovating AI plays a crucial role in advancing clinical development. Saama continues to expand the boundaries of AI-powered cognitive platforms by innovating new capabilities for LSAC that enable researchers to connect, contextualize, and converse with their data.

Connection Network-enabled adaptive platform trials require data visibility across large, collaborative ecosystems. One day, a shared Clinical Neural Network will give new trials a powerful head start.

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Contextualization Google can tell you when to leave a meeting, based on traffic, weather, distance, etc. Saama applies the same idea to clinical trials, eliminating waste and empowering researchers to better outcomes. AI is a powerful tool for understanding patients, using algorithms that merge computational biology, translational medicine, EMR, and other datasets. Finding suitable subjects and keeping their numbers to an absolute minimum becomes easier.

Conversation Conversing directly with clinical data can save time and free up key stakeholders. Rather than waiting days for replies from programming experts, medical monitors, or data managers, researchers can simply query LSAC’s Deep Learning Intelligent Assistant (DaLIA) for an immediate answer.

Which Technology Partner Is Right for You?

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Pharmaceutical companies open to transformative journeys should select data analytics partners that have clearly demonstrated such expertise.

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Saama’s award-winning, AI-powered analytics platform shifts the clinical development paradigm, offering time and cost-savings for biopharma.

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SCIENCE 37

Science 37 broke away from the traditional research model to deliver an experience built on human connection, with a mission to accelerate biomedical research by simplifying the patient experience. By creating an environment where participation in clinical research is simple, and people can drive science forward from the comfort of home, so much more is possible. A more diverse group of people can participate. Potential participants can be reached faster. Breakthrough therapies can reach those in need more quickly. It all comes down to making research more human and accessible. By engaging with patients at home, Science 37 provides access to patients who can never be reached by traditional site-based models—in fact, one study saw Science 37 enroll patients twenty-seven times faster than traditional sites in the same study. Reaching people at home also creates an inherently more diverse patient population in clinical trials than research

centers that have to rely on participants who live in relatively close proximity to their facilities. More than half of the patient community within the Science 37 network originate from communities of color. Following this novel approach to research can yield extraordinary results. Science 37: • Has designed and implemented more virtual trials than any other company • Operates an expansive network of investigators and nurses across every major therapeutic area • Powers research with an integrated platform that supports the entire clinical trial lifecycle In the Science 37 virtual model, all aspects of the clinical trial lifecycle are executed virtually—from recruitment to study closeout— and supported by a comprehensive, purposebuilt platform. The company’s high-touch

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patient services include patient visits conducted via telemedicine and mobile nurse visits, both at the patient’s convenience. Study materials are appropriately shipped to the patient’s home. Science 37 can also be a virtual metasite among existing traditional site networks to enable 100% population coverage. Research is powered by the Science 37 platform, which is a key part of the patient experience. It allows patients to arrange at-home mobile nurse visits and physician telemedicine appointments at their convenience, provide consent for study-related documents, and report personal observations throughout their study journey. The platform also provides direct access to the study team. For researchers, the Science 37 platform is a window into a study’s progression—it provides centralized data management with actionable insights available in real time. Study teams have visibility into the study’s progression at any time and can identify trends and determine how milestones are being met. The platform integrates workflow and processes for physician investigators, mobile nurses, and coordinators across the patient journey, and also digitally automates and streamlines all aspects of data collection—alleviating the burden for study teams and minimizing the risk of human error. Science 37 works side-by-side with its clients to design clinical trials that maximize efficiency, reduce time to market, and provide all the necessary accommodations to ensure an optimal patient experience.

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Science 37 is making the promise of virtual trials the new reality. By engaging with patients from the comfort of their own home, we provide access to patients who can never be reached by traditional site-based models. We have proven to enroll faster, retain patients at a higher rate, and reach a more representative population. Science 37 has conducted more decentralized, interventional trials than any other company, using an expansive, in-house network of telemedicine investigators and homehealth nurses, who are supported by the industry’s most comprehensive, fully integrated, decentralized clinical trial platform.

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SIGNALPATH’S UNIQUE APPROACH TO CLINICAL TRIAL EXECUTION

THE SIGNALPATH SOFTWARE PLATFORM IS THE FIRST OF ITS KIND TO BE BUILT BY RESEARCHERS, FOR RESEARCHERS. CTMS Finance

The SignalPath solution streamlines patient management for coordinators, facilitating budget builds, de-mystifying profitability for pre-award finance teams, supporting revenue capture for the post award team, surfacing real-time insights into the study startup process for regulatory teams, and empowering management through real-time insights into enterprise performance.

SignalPath’s sophisticated budgeting tool provides structured exports to support coverage analysis and budget negotiations as well as analytic tools to provide real time insights into study financial metrics, including revenue, costs, and profitability. The Finance module decreases reliance on ancillary systems, supports coverage analysis and budget negotiations, and enhances the profitability of sites by optimizing collections and bad debt. Depending on a site’s workflow, integration into secondary systems, such as the EHR and a general ledger, may further optimize operations.

Study Digitization The digitization workflow supports the translation of complex, unstructured, PDF protocols into structured, digital representations of a given trial. The protocol ingestion process leverages proprietary machine learning tools and patent-pending infrastructure. The client controls the prioritization queue for protocols and amendments as well as the final protocol review and sign off.

Study Startup The SignalPath Startup module provides a technology backbone to facilitate a transparent, efficient, and highly effective startup/enrollment process across many sites/centers and stakeholders/study teams within an organization, enabling internal and external study management. From the time a new trial lead is received, through interest and feasibility surveys, and from document tracking to committee review processes, the workflow management and cycle times are tracked and surfaced in an intuitive dashboard that drives transparency, visibility, and accountability.

CTMS Operations SignalPath’s intuitive design is intended to support research teams at the point of care and move administrative work to the background. By loading all site protocols centrally and putting them through a rigorous quality review process, all that a coordinator or investigator needs to do is login and manage their daily tasks. Execution complexity is captured in the background of the system. A summary “Quicklist” card provides an overview of progress on each trial and easy access to elements like the inclusion/exclusion criteria for a given trial. The platform contains the information coordinators or investigators need to conduct trials with ease.

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out of the trial execution and management process, SignalPath can bring sanity back to your operational teams with a product that makes sense and supports you rather than distracts.

SignalPath captures key data elements through the utilization of the Study Startup, Operations and Finance Modules in the day to day workflow throughout the organization and then surfaces the data in Enterprise Manager (EM). Due to the breadth of reporting needs, SignalPath integrated Tableau into the platform to ensure optimal sophistication and flexibility. Clients’ can build their own reports utilizing the Tableau infrastructure.

Second, we are unapologetically focused on our vision to dramatically improve the ease and efficiency of clinical trial execution and management. In some cases this means to build de novo product (our innovate study start up module), in other cases it means to re-invent a way of thinking (digitization of trials by SignalPath instead of “study builds” by clients), and in still other cases it means to partner vs build (Greenphire or Florence). By staying focused, we can deliver a best in class offering so our clients can focus on what matters most: patients. Third, SignalPath is agile and responsive to the needs of our clients. By way of example, the current COVID-19 crisis has created the urgent need for our clients to conduct virtual visits with study patients in order to maintain continuity with their research programs. Within a matter of a few weeks, SignalPath created, tested, and deployed brand new functionality to support video visits through the SignalPath platform. All these factors set the stage for a fruitful partnership that we believe will drive efficiency, profitability, and sustainability for the client’s research program.

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First, our product supports the end-to-end workflow needs of a complex enterprise with a comprehensive software suite that has greater breadth than our competitors while being delivered within a user-friendly, intuitive, and beautifully designed interface. By taking the guesswork

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SignalPath brings together experienced clinical researchers, technology experts, and designers to meet the end-to-end workflow needs of clinical research teams and their management. The system also offers realtime analytics and dashboards powered through this day-to-day use, dramatically improving the ease and efficiency of trial execution and management.

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AI-POWERED CLINICAL AND DATA ANALYTICS PLATFORM LEVERAGE DATA SCIENCE EXPERTISE USING AI AND ML TO INCREASE R&D EFFICIENCY BY UP TO 30%. ThoughtSphere Cloud accomplishes this by:

ThoughSphere Cloud leverages data science expertise using artificial intelligence and machine learning to increase R&D efficiency by up to 30%. This data promises study teams in-depth, real-time oversight of metrics, making trials safer, faster and more efficient. The problem is clinical trial complexity is increasing, trial sizes are growing, and there is a substantial increase in data being generated. Rather than benefiting study teams, the rapid increase in the volume and variety of data is actually creating challenges. In addition, effective monitoring of clinical trials by sponsors is critical and with decentralized trials there has been a shift towards continuous risk-based data monitoring with a focus on trial activities that are essential to the safety of trial participants.

• Leveraging a big data, data lake architecture (NoSQL) to ingest and aggregate both structured and unstructured data with relative ease. • Being source system-agnostic and highly configurable, loading data from multiple sources and formats. • Using smart mapping for rapid transformation and standardization, all done via configuration with an evolving reusable mapping library based on machine learning algorithms. • Learning data ontology over time using statistical and ML methods and thus identifying risks. ThoughtSphere Cloud enables centralized monitoring to proactively identify and prevent inadequate site behavior and processes early. Remote monitoring and data analysis are made more efficient compared to solely focusing on reducing the amount of source data verification required and reducing visits to sites where there may be a problem. ThoughtSphere enables a change in focus allowing trial monitors to concentrate on preventing quality issues from occurring rather than just fixing problems. This makes on-site visits, when needed, as effective as possible.

Equipped with a thorough understanding of the industry’s pain points, ThoughtSphere created a clinical data and analytics platform that helps life sciences leaders focus on what they know best: their research. The result is an innovative platform that leverages data science expertise and AI/ML to increase R&D efficiency by up to 30%.

ThoughtSphere Cloud is different in three ways:

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• Patented Data Integration – The platform is patented because of how it leverages AI and ML to provide a 360-degree view of clinical trial data and adapt to any data source or format • Intuitive and Easy to Use – The platform was built with business users in mind from data ingestion to analytics and visualization • Time to Value – Clients report implementations can take only days versus standard implementations which might take weeks or months

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ThoughtSphere is a leading cloud-based clinical data hub and analytics company. Our mission is to help life science companies develop and deliver treatments to patients faster and smarter using data science. With our innovative platform, biopharma, medical device sponsors and CROs can reduce clinical development costs and optimize and enhance efficiency and effectiveness in clinical trial processes and gain near real-time actionable insights.

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ThoughtSphere 2445 Augustine Dr. Suite 150 Santa Clara, California 95054 United States +1-408-898-9828

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CLINICAL QUALIFICATIONS MANAGEMENT THE SITE PREFERRED INVESTIGATOR TRAINING AND COMMUNICATION PLATFORM THAT IMPROVES TRIAL CONDUCT AND ENSURES PERPETUAL INSPECTION READINESS.

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training environments, including face-to-face investigator meetings, virtual investigator meetings, in-person site initiation visits, and of course on-demand training via the CQMS portal.

In-person Investigator Meetings and face-to-face Site Initiation Visits were in a downward trend for years as busy sites and monitors avoided the hassle of travel. When COVID-19 arrived, communication between Sites, Sponsors, and CRAs changed forever.

The CQMS can improve conduct by: • Reducing complexity for sites – provide a single platform for sites to record all their training and qualification documentation quickly and easily; • Intelligently eliminate redundancy of training and information sharing, sponsors will easily know which sites already have the required and certified training for specific rater assessment scales, regulatory training and more; • Hybrid approach – capture content at live Investigator meetings, ondemand training, virtual meetings; and • Create a Perpetual State of Inspection Readiness™, for both sites and study sponsors.

Trifecta’s InvestigatorSpace® Clinical Qualifications Management System (CQMS) completely automates the distribution, collection, and maintenance of site personnel qualification information across portfolios of studies and sites. This dramatically shortens start-up timelines, reduces site burden, and delivers efficiency and cost savings for study sponsors and CRA. The InvestigatorSpace CQMS can manage training documentation for non protocol-specific topics, such as GCP training, across multiple studies or even across multiple study sponsors, eliminating redundant training for site staff. Furthermore, a CQMS, unlike a traditional learning management system, has the ability to track training documentation across various

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Qualification Lifecycle Qualification is not just at study start-up. Throughout the individual study and broader compound lifecycle every investigator that touches your clinical trial will require training. No matter if that site is added after your initial start date or you’ve experienced site staff turnover the CQMS automatically recognizes these changes and employs strategies to keep sites in qualified status. Ready and able to conduct your clinical trial.

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Eliminate non-required and redundant notifications while streamlining the process for review and acknowledgement of safety letter notifications. Reduce the burden on investigative sites & increase compliance by eliminating “Over-Distribution” and “Under-

InvestigatorSpace® will easily push safety events, updated IB’s, as well as acknowledgement reports to any eTMF using the client’s specific mapping. Achieve three times average safety letter compliance rates with an intelligent automated approach.

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Distribution” via configurable country-level distribution rules. Adhere to the regulatory guidelines and use Trifecta’s regulatory best practices across 144 countries to efficiently assign letters to designated users. And benefit from the collective regulatory compliance decisions across sponsor organizations.

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The CQMS also solves the growing need for a simple solution that allows unified management

of adverse events (SUSARS & SAEs) across the enterprise to improve quality of documentation. Significantly improve the quality of adverse event documentation with a modern safety notification system allowing sponsor users to assign safety letters to investigators, offering acknowledgement of letter receipt, compliance tracking, and auditable reporting.

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Trifecta Clinical supports custom investigator training, safety letter distribution, and regulatory document management through our InvestigatorSpace® platform. With 15 years of experience, Trifecta stands ready to achieve Perpetual Inspection Readiness™.

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VIRTRIAL VirTrial is on a mission to connect diverse populations with remote access to clinical research sites by combining a winning team of industry experts, proven virtual trial technologies, and key partnerships with leading innovators.

Solution Offerings The VirTrial platform is customized to drive adoption of hybrid decentralized clinical trials (DCTs). By combining best of breed technology, an open API for interoperability with third party platforms, compatibility with digital medical devices, and support for trials that require a combination of in-clinic and virtual visits, the VirTrial platform is the most powerful and flexible solution on the market. It operates on any device (Android, Apple, phone, tablet, computer) and works with any clinical site worldwide enabling sponsors, CROs, and sites to maintain control over their studies and save time and money in getting medications to market faster.

Person on Phone using Telemedicine Virtual Site Monitoring is the industry’s first ‘virtual site monitoring™’ solution. The solution enables pharmaceutical sponsors and CROs to evaluate, qualify, train and routinely monitor research sites for studies without the need for timely and costly travel.

The VirTrial platform currently offers two virtual services, Virtual Visits, and Virtual Site Monitoring.

Virtual Site Monitoring includes delivery of HD live-streaming glasses that supports an intuitive approach for the on-site Clinical Research Coordinator (CRC) to provide a remote CRA insight to their site. The CRC simply wears the glasses, and walks around the site, observing key aspects requested by the CRA. Everything in view of the CRC streams to the CRA’s computer screen, enabling the CRA to verify key aspects of a site monitoring visit. Mark Hanley

Virtual Visits enables pharmaceutical companies to run hybrid decentralized clinical trials using their preferred clinical site networks to replace in person visits with virtual visits, similar to a telemedicine visit. The impact of offsetting burdensome, in person visits with virtual visits, is higher patient retention and engagement resulting in better outcomes for clinical trial research.

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Both solutions are hosted in a secure cloud-based environment and are compliant with 21 CFR Part 11, HIPAA, HITRUST, SOC 2, GDPR, and the Privacy Shield Frameworks.

Partnering with Industry Stakeholders VirTrial is taking a unique approach in the industry by partnering with clinical research industry associations and supporting research site sustainability with free virtual trial capable training for any site worldwide. VirTrial has established relationships with the Society for Clinical Research Sites, (SCRS) the largest research site trade organization in the world, The Association of Clinical Research Professionals (ACRP) the largest research professional trade organization, and some of the largest site networks in the world.

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VirTrial enables greater accessibility to trials for a diverse patient population, higher performance by clinical trial sites, and improved outcomes for pharmaceutical companies.

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VirTrial’s platform enables pharmaceutical companies and CROs to empower their selected clinical research sites to perform virtual visits – a combination of secure video, audio, chat and messaging, which can be used on any device. Incorporating VirTrial’s virtual visits into study protocols opens the door to a wider participant pool, ultimately yielding improved study outcomes and efficient site performance.

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UNLOCKING THE POWER OF DECENTRALIZED STUDIES The clinical research industry continues to evolve and improve, seeking ways to boost participant engagement and facilitate more active, remote data collection. These explorations lead Biopharma and CRO customers toward decentralized study approaches, which are designed to increase operational efficiency and participant convenience. A decentralized study is conducted primarily in a participant’s home using digital tools, such as a telehealth video call.

Leading the way THREAD’s innovations in technology and approach are the result of continued collaborations with sites, participants, regulatory agencies, sponsors and CROs. Through this perspective and experience they solve some of the toughest industry challenges in clinical research study designs and methods.

Turnkey – press launch

Sponsors and CROs can remotely capture data from participants and sites during, in between and in lieu of in-clinic visits – all securely through one unified platform. These solutions are rapidly enrolling hundreds of thousands of participants in studies across the globe, covering a variety of therapeutic areas.

If it’s service you need, initiate the THREAD LaunchKit. Sponsors and CROs engage THREAD’s experts from kick-off meeting to live platform. The LaunchKit is a proven process to help design, configure, deploy and manage decentralized studies.

Being a leader in innovation requires the ability to adapt quickly to a changing environment. As the world braced for impact during the COVID-19 pandemic, THREAD responded to the need for clinical trial risk mitigation tools and launched THREAD Express. By using THREAD Express, customers deploy solutions that are intended to be aligned with guidance provided by regulators, including the U.S. Food and Drug Administration and the European Medicines Agency, to help manage clinical trials during the COVID-19 pandemic.

Power through innovation THREAD’s unified platform provides user-friendly experiences and advanced capabilities. It is a technical technology solution that pulls all facets of clinical study design together – without the strain of managing multiple partners. Sponsors and CROs have an easy-to-use system that delivers flexibility, manageability and scalability while maintaining security and speed. This secure, cloud-based platform provides a self-guiding configurator for easy study start-up. A full suite of fit-for-purpose solutions are available to support the needs of each individual study, including: eConsent, eCOA/ ePRO, surveys, study team portal, site data capture, authentication, telehealth, sensors, site portals and participant engagement tools.

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“Decentralized study approaches make clinical research studies more convenient, engaging, data-driven and efficient.” — John Reites, President

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THREAD 155 El Camino Real, Tustin, Ca, 92780 United States +1-714-730-4958 info@threadresearch.com

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uMotif THE ECLINICAL PLATFORM PATIENTS LOVE TO USE uMotif puts patients at the centre of research with its unique eClinical platform. Through taking a human-centred design approach, uMotif’s modular platform makes the trial experience more engaging for participants, and simpler for site professionals, monitors, and sponsors.

caused by Covid-19 has highlighted that reducing reliance on site and hospital visits can increase study resilience and broaden accessibility, opening research to more diverse patient populations. Key to successful studies – both traditional site-based as well as decentralised models – is engaging patients. Engagement and usability are in uMotif’s DNA. The beautiful software was designed with patients, for patients, to reduce the burden of capturing eCOA/ePRO, symptom, wearable device, and eDiary data. Having powered eConsent and data capture for some of the world’s largest BYOD (Bring Your Own Device)

A decentralised approach to clinical trials has been making its way up the adoption curve in recent years. Life sciences companies have steadily replaced legacy systems and processes (and in some cases paper) with modern cloud-based technologies. Decentralised, or virtual trials, provide a more efficient and faster way of conducting research. The disruption

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studies, the uMotif platform can be accessed on patients’ own devices, or through studyspecific provisioned smartphones and a desktop web backup. Patients want to feel valued and an active part of a research project, helping make an impact for themselves and for others. By truly engaging participants uMotif sees lower dropout rates, larger volumes of higher-quality data captured, and patients keen to take part in future trials. This human-centred design focus extends to a compelling toolkit for site staff, data managers, and monitors. Through ensuring the technology is built around the needs of people running the research trial management and oversight is easier, streamlined, and faster. The platform enables seamless capture of data from sites including ClinROs, either during a sitevisit or through a video consultation with patients.

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Available globally and quickly configured for any therapeutic area, uMotif’s patientcentric approach supports a wide range of decentralised trials, multi-country clinical trials, and innovative Real-World studies.

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uMotif’s mission is to put patients at the centre of clinical research. Designed with patients for patients, the uMotif patient-centric eClinical platform powers site-based to fully decentralised clinical, real-world, and post-marketing research. uMotif are trusted by global pharmaceutical companies, biotechs, CROs, and academic institutions to engage patients and capture eConsent and large volumes of eCOA/ePRO, symptom, and wearable device data.

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CHAPTER 4

LAB SERVICES

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BIOAGILYTIX

Enabling the Biologic Drug Breakthroughs of Tomorrow, Today BioAgilytix is tackling the complexities of large molecule drug development to help improve human health and deliver cures for patients with critical illnesses around the world. What started in 2008 as a small bioanalytical lab and team of 10 in Durham, NC has grown into three global locations, more than 400 employees, and a world-recognized brand for specialized outsourced large molecule expertise. In fact, over the past 2 years (2018-2019), BioAgilytix supported more than 40% of the large molecule (biologic) drugs approved by the FDA. So what are the driving forces that have propelled the CRO to become the innovative and influential organization it is today?

Their development therefore requires extensive specialized bioanalytical expertise, and BioAgilytix has built a world-class scientific team comprised of renowned experts in biomarkers, immunogenicity, biosimilars, gene and cell therapies, and other innovative therapeutic modalities. More than half hold Ph.D. or Masters-level degrees, and the team in total averages over 15 years of post-schooling bench experience. The breadth and depth of both scientific and regulatory expertise available within BioAgilytix makes the organization highly sought-after by pharmaceutical and biotechnology sponsors worldwide – and its ability to deliver quality results is confirmed by the company’s stellar regulatory track record and leading customer service rating.

First and foremost is a founding commitment to scientific rigor, quality, and service excellence. Led by the mantra ‘our IP is our people’, BioAgilytix has invested in finding and developing the best talent with expertise in the field of large molecule bioanalysis. Large molecule drugs, unlike their small molecule counterparts with simple, well-defined structures, are comprised of many heterogeneous molecules and are produced in living cell culture, which makes them much more difficult to control.

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diseases, autoimmune disorders, and more. BioAgilytix has remained committed to strategically scaling its operations to meet customers’ growing needs, adding resources and capacity to support development of more novel drugs that are giving patients new treatment paths. Today, in addition to their expanded GxP laboratory in North Carolina, they have an advanced facility in Hamburg, Germany that enables them to readily support global studies, and recently acquired a second US laboratory in Boston, the world’s largest hub of biotech innovation. Demand for BioAgilytix’s services is being further spurred by the fact that sponsors are shifting more investments into large molecule drugs because they offer greater specificity to target complex diseases at the cellular level. Today, 50% of the global development pipeline is focused on biologics and is expected to grow to over 70% within the next 5 years. This includes therapies addressing rare diseases, cancer, neurological and metabolic

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BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With US headquarters in North Carolina’s Research Triangle area, a laboratory in Boston, Massachusetts, and European headquarters in Hamburg, Germany, BioAgilytix provides global services for biomarkers, immunogenicity, PK, and cell-based assays supporting the development and release testing of biologics across a number of disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, GCP, and CLIA as well as GMP quality control testing (i.e. product release testing, stability testing, etc.).

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As the industry continues to trend toward precision medicine, custom therapeutics, and more targeted large molecule drugs, BioAgilytix is wellpositioned to continue leading its market and enable drug innovators to realize a noble mission: bring lifesaving drugs to the marketplace quickly and safely.

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HAEMTECH BIOPHARMA SERVICES (HAEMTECH) BIOLOGICS DRUG DEVELOPMENT RISK MANAGEMENT THROUGH EXPERT TESTING Haemtech is addressing the complexities of biotherapeutics analytics and specialized clinical diagnostics to propel drug development and improve patient outcomes. Biotherapeutics development is a long, difficult process complete with an ever-changing regulatory landscape. Additionally, the analytical hurdles to drug approval have become more complex as the industry learns more about how biological drugs interact deleteriously with the body. As such, methods used to analyze the safety of biotherapeutics have also become more complex, and manufacturers of these therapies, especially virtual and smaller-sized manufacturers, have needed to outsource analytical activities to service providers with boutique offerings. Since the company’s onset, Haemtech has connected its deep expertise in protein chemistry with excellent customer service to provide biological and analytical solutions to its customers’ more complex problems. With origins as a reagent manufacturing company, Haemtech provided difficult-topurify plasma proteins required by researchers and device manufacturers furthering medical advances on thrombosis and hemostasis pathologies.

that time, and building upon its experience with coagulation protein therapies, Haemtech blossomed into a full-service shop providing hard-tosource research, development, validation, and implementation of complex analytical test methods supporting discovery to release of large molecule biotherapeutics on the path to regulatory approval.

While continuing these activities, Haemtech leveraged its protein chemistry and protein purification expertise to provide analytical services aimed at furthering the development of protein based therapies. Since

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Haemtech continues to focus on addressing specialized and often difficult analytical requirements such as host-cell protein analysis, potency assays, anti-drug antibody detection and hemostatic risk assessment, along with more compendial methods commonly needed in biotherapeutics development spanning GLP, GMP and CLIA requirements. Supporting these activities are more unique offerings in the industry such as thrombin generation assays, industry leading, state-of-the-art High Resolution Mass Spectrometry services for Host Cell Proteins mitigation, and a full complement of analytics on immunoglobulins for stability and release.

from its competitors. Unlike many larger analytical shops that focus on churn we are nimble, flexible, and more responsive to our customers’ needs, and that has resulted in excellent relationships that have lasted many years. We pride ourselves on partnering with our customers to help them through the drug development process with their drug approval being the goal,” said Jean Pineault, Haemtech’s CEO. In the past 30+ years of business, Haematologic Technologies has earned a reputation for doing and supporting highly regarded science. Employing cutting edge protein chemistry expertise, a customer-focused approach, and using integrity in day-to-day activities Haemtech looks forward to the future as it prepares for growth in the constant pursuit of the ultimate goal of saving patients’ lives.

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Statistics: Year Founded: 1987 Founded By: Kenneth Mann, Ph.D., Richard Jenny, Ph.D., and 3 other colleagues. Richard Jenny was the CEO from 1987-May 2020. Jean Pineault is current President & CEO.

Haematologic Technologies (Haemtech) is the leading provider of products and analytical services to support the research, development, and commercialization of large molecule biotherapeutics. Haemtech has deep expertise in protein biochemistry including characterization of plasma proteins and other large molecules, and performs highly advanced assay development and GMP testing in the areas of immunoassays, thrombin generation assays, assessment of hemostatic risk, anti-drug antibody testing (immunogenicity), host cell protein mitigation, stability and release testing, as well as a variety of other specialized assays for biotherapeutics supporting discovery through commercial release. The company’s biopharma services are performed in fully compliant, FDA-inspected GLP and GMP facilities.

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Haemtech Biopharma Services 57 River Road, Unit 1021 Essex Junction, Vermont 05452 +1-802-878-1777 hti@haemtech.com haematologic-technologies-inc.

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Where Haemtech shines is in its unique combination of differentiated expertise and how it interacts with customers. “Client-centric, consultative practices combined with cutting edge science is what sets Haemtech apart

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INSPHERO: TRANSFORMING DRUG DISCOVERY AND SAFETY WITH 3D IN VITRO TECHNOLOGY REBUILDING HUMAN PHYSIOLOGY AT THE BENCH IS A KEY TO DRUG DISCOVERY IN THE 21ST CENTURY

InSphero 3D InSight™ Platforms for Drug Discovery and Safety Testing include multicellular 3D models produced from relevant human primary tissue cells. These models enable researchers to rigorously test compound efficacy and screen for toxicity early in the preclinical stage. The scalable Akura™ plate and organ-on-a-chip technology underlying InSphero platforms ensure continuity and across experimental programs, from simple screening assays to complex multi-organ networks. Innovative pharmaceuticals, such as immuno-oncology, CART-T, and gene therapy, are spearheading a revolution in medicine today—and sparking a technology revolution dedicated to bringing these therapies from bench to bedside, safely and efficiently. The aim of these convergent biomedical movements is to more closely mimic human biology and physiology in the lab and better predict the patient response to novel compounds.

non-physiological cell-based assays, which cannot predict drug effects over real-life treatment periods. Subsequent animal tests often confound more than clarify, especially when used to assess novel treatment paradigms that focus on human targets incompatible with animal biology. InSphero is on a mission to break this cycle—by leading a global effort to make 3D in vitro cell-based assays and organ-on-a-chip technology more human and more predictive. From its early days as a Swiss Institute of Technology (ETH) start-up-to-watch, InSphero has been transforming in vitro science. Its team of cell biologists and bioengineers pioneered 3D cell culture technology that enabled mass-production of scaffold-free 3D spheroid models for the first time, and introduced proprietary protocols for

Lack of reliable predictive information on drug safety and efficacy during the preclinical phase is the primary reason why 85-90% of drugs entering phase 1 trials fail – and why a substantial slice of the global $190bn USD pharma R&D budget must be written off each year. An underlying factor is that the translational value of preclinical data is limited by short-term,

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recapitulating human tissue structure, function, and physiology. InSphero has since developed turnkey solutions for predictive drug screening and modeling diseases with high-unmet medical need, such as NAFLD and NASH, type 1 and 2 diabetes, and cancers. In safety testing, the company quickly gained a leading position in early assessment of liver-toxic hazards through joint studies with Genentech and AstraZeneca. InSphero has won numerous awards for scientific and entrepreneurial achievements, and a solid patent portfolio protects the company’s powerful 3D in vitro technology platforms.

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spheroid models in a flow-through tissue network configuration to assess target expression under even more physiological conditions. It is exploring new applications for iPS cells, particularly in fields where primary materials are scarce. And it’s testing deep endpoints, from 3D high-content imaging to next-gen sequencing and proteomics, to enable scientists to extract even more valuable data from complex 3D models than possible with traditional assays. In the coming years, as even more exciting technological and biological advances emerge, InSphero will be lighting the way forward.

InSphero’s 3D InSight™ Safety and Discovery platforms are: • 6 to 10x faster results than animal efficacy tests • 2x more predictive in identifying hepatotoxic compounds • Real human models, no bio-artificial scaffolds, no animal cells With sites in Switzerland and the US, InSphero collaborates with major pharmaceutical and biotech companies and is growing rapidly. InSphero’s scientific team works closely with its pharma partners in a business model driven by research fees combined with upside sharing, in terms of success-based milestone fees or royalties. This assures a long-term, mutual alignment for creating valuable targets, lead compounds, or combination treatments, by leveraging InSphero’s unique platforms, expertise, and vision.

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Pushing the boundaries of new in vitro technologies to help patients is what InSphero does best. The company has already introduced multi-organon-a-chip solutions that enable researchers to combine multiple types of

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InSphero advances drug discovery and the research community’s understanding of healthy and diseased human biology using an inspired combination of bioengineering, microtechnologies, and computational approaches. Our interdisciplinary team creates miniature organs and biological systems to help pharmaceutical and biotech companies better predict the patient response in vitro.

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Statistics: Year Founded: 2009 Founded By: Jan Lichtenberg, PhD, Wolfgang Moritz, PhD, and Jens Kelm, PhD

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NEXELIS IMMUNOLOGY FOCUS, SCIENTIFIC DISCIPLINED AGILITY, AND HIGH-THROUGHPUT TESTING CAPABILITIES

Nexelis is a contract research organization (CRO) with unrivalled expertise in immunology. With assay development and advanced laboratory testing, the company provides services to companies looking for solutions to infectious diseases, metabolic diseases and oncology challenges. Nexelis has become a reference lab of choice for top 10 global pharmaceutical, innovative biotechnology companies using the CRO’s services to help develop lifesaving innovations. The CRO also have strategic partnerships in place with prestigious governmental or non-governmental organizations funding drug development programs targeting emerging countries. Initially spun-off from GSK Vaccine in 2015 under the name NEOMEDLABS, the management team led by Dr. Benoit Bouche, a CRO veteran, partnered with Ampersand Capital in July 2018, acquired Seattle based bioanalytical and biomarker laboratory Pacific Biomarkers soon after and the Montreal based preclinical immunology CRO PAIRimmune in 2019 and was rebranded at that time. Earlier this year, the company acquired the Belgian specialty immunogenicity and immuno-oncology testing laboratory ImmunXperts and Indianapolis headquartered bioanalytical and mass spectrometry specialist AIT Biosciences. The management intends to announce a third acquisition in Europe before the end of year. Making a long story short, Nexelis will have sextupled its size in two and a half years based on a combination of organic and inorganic initiatives.

By adhering to a strong focus on rigorous scientific discipline and robust protocols, supported by cutting-edge technological platforms, Nexelis is able to address even the most demanding client requirements. Unlike huge generalized CROs who focus on global coverage and logistic capabilities, the scientific leaders at Nexelis focus on versatility and ingenuity, enabling the company to provide highly specialized laboratory testing services. All projects are run in a collaborative client-centric way, and the agility of Nexelis’ team means that urgent projects can be tailored to meet expedited timelines. Avoiding overlong processes or heavy hierarchy, Nexelis’ specialists exchange ideas with colleagues and partner with clients in a collaborative and transparent manner.

This group combines over 20 years of bioanalysis, vaccine and fit for purpose biomarker experience and has been instrumental in the development and testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines and soluble large molecules. Nexelis’ versatile team of scientists, using advanced technology platforms, supports work ranging from lead selection, preclinical to clinical Phase IV clinical trials.

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Nexelis’ flexibility and work ethic has been put to the ultimate test during the COVID-19 pandemic. The company has been supporting the massive R&D efforts within the international community and has demonstrated its leadership in the infectious diseases field through multiple collaborations and has been selected by the Bill and Melinda Gates Foundation and by CEPI as a referral laboratory for their grantees. In an extraordinarily short amount of time, Nexelis was able to dedicate more than 50 scientists to new SARS-CoV-2 developments without pausing any other strategic vaccine development programs in fields such as Meningitis, Flu (seasonal and universal), Chikungunya, RSV, and Malaria.

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In a few short years, Nexelis has become the partner of choice for companies working on vaccine development. Although the contract research organization is relatively young, its roots run deep in vaccine research, with many of its experts originating in GSK Vaccines. A dynamic company, Nexelis is now motivated to apply its knowledge, versatility and drive to further support vaccine efforts against diseases like COVID-19, as well as servicing other areas where new therapies are urgently needed to save lives.

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Statistics: Year Founded: 2018 Founded By: Dr. Benoit Bouche

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Nexelis 525 Boul. Cartier Quest Laval, QC, H7V 3S8 Canada +1-450-239-1605 x 6450

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PYXANT LABS: DATA LIFE FOR

Pyxant Labs provides industry-leading GLP bioanalytical services to pharmaceutical companies developing new drugs for lives in need. help biotech and pharmaceutical companies to minimize regulatory challenges and reduce time to NDA approval. These capabilities derive from experience spanning 1,000,000 sample assays, 800 FDA studies, six successful FDA audits, and hundreds of client regulatory audits.

Our Data for Life® mantra celebrates our participation in an industry which saves lives. We fulfill an essential role in the drug development process. We have developed seminal capabilities which in the past directly supported cures for hepatitis, fundamental understanding of Alzheimer’s Disease, antiviral therapeutics for HIV, antisense therapeutics, and now therapeutics for SARS-CoV-2.

Pyxant Labs scientists and program managers with average bioanalysis experience exceeding 20 years enable industry-leading performance.

Pyxant Labs is a leading bioanalytical CRO in North America. We provide bioanalysis for all stages of the drug development process: discovery to PK/TK to IND-enabling GLP toxicology studies through Phase III clinical development. Using advanced sample preparation techniques and the latest mass spectrometry capabilities, Pyxant Labs develops and validates bioanalytical assay methods to stringent FDA and international regulatory requirements. Such rugged and reliable assays eliminate rework and

• 100% of standard discovery PK data delivered within 48 hours • Assays encompass more than 140 types of biological tissues, in addition to plasma, urine, cerebral spinal fluids, and other biofluids • Bioanalysis of more than 550 unique analytes includes complex bioanalytical assays for innovative therapeutic molecules, including RNA therapeutics, nucleoside antivirals, protease inhibitors, peptides, and large-molecule drug delivery mechanisms

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Innovative Collaboration Pyxant Labs commenced support for a leading RNA therapeutics development company of an early-stage toxicology program which required the assay of lipid nanoparticles (LNPs) for the delivery of microRNA payloads. LNPs are an innovative delivery mechanism of great interest to biotechs developing RNA therapeutics. Within three months, we developed an assay for the LNP, which we applied to discovery-stage

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development and subsequently progressing into preclinical GLP tox studies. The program currently is advancing into first-in-human clinical trials. The client has awarded contracts to Pyxant Labs to provide bioanalytical support through their clinical development program. A VP at this company sought out our CEO during a site visit to emphasize that “Pyxant Labs’ support is an enabling factor for our development program,” without which we might not have been able to satisfy FDA’s safety assessments.

Values Our Values describe our commitments to our clients, and our market proposition.

Forward Client Service

Superior Science

Our teams anticipate, rather than react to, client needs.

Regulatory Leadership

Our scientific expertise leads clients through critical challenges.

Our leadership within regulatory working groups assures proactive compliance.

Performance

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Statistics: Year Founded: 2000 Founded By: Maurice Gaubatz

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Founded in March of 2000, Pyxant Labs is an industry-leading regulatory bioanalytical CRO. Our exclusive bioanalytical focus, forward client service, superior science, and regulatory leadership deliver on-time support from drug discovery through Phase III clinical development. Our experience spans 1,000,000 sample assays and six successful FDA inspections.

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Pyxant Labs Inc. 4720 Forge Rd, Suite 108 Colorado Springs CO 80907 United States +1-719-963-2610

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BIOLOGICAL FLUIDS AND TISSUES

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VIRSCIO BRIDGING THE TRANSLATIONAL GAP

Virscio is solving significant human health challenges by reducing the time, cost, and risk of translating concept to clinical success. Virscio is a mission-driven organization focused on engaging and supporting innovative companies and organizations that share our goal of rapidly translating promising preclinical findings into effective medical interventions to meaningfully impact the lives of patients. We pursue this mission through various partner, collaboration, and contract research activities with a wide range of organizations, spanning venture-backed start-ups, mature biotechnology and pharmaceutical companies, academic investigators, federal health institutes, and patient advocacy groups. Preclinical in vivo studies are a well-established means of characterizing and predicting the human response to novel therapeutic interventions and are required by health authorities to assess safety prior to clinical development. In vivo evaluations in non-primate species that diverge more significantly from humans often fail to predict clinical outcomes for a

Fluorescein angiography and other clinical imaging endpoints highlight the anatomy that green monkeys closely share with humans, driving translational value. variety of established and emerging therapeutic classes. This contributes to substantially reduced research and development productivity and stalled therapeutic advances. The humane and ethical use of nonhuman primates (NHPs) as the most clinically relevant in vivo test system is essential to generate data sufficiently predictive to reduce the considerable risk and cost of clinical candidate failure. Our improved health care future depends on the data-driven, compassionate application of NHP biomedical research resources to which Virscio is fully committed. Virscio maintains state-of-the-art research facilities in a highly accessible and hospitable primate source country, home to an abundance of introduced African green monkeys, a non-endangered, Old World species. This biologically clean population is readily, humanely sourced to support translational development programs and has a well-defined genetic background favorable for study designs with minimal necessary sample sizes.

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to efficiently generate definitive, actionable data that reduce the time, cost and risk of development for central nervous system, ophthalmic, gene therapy and other therapeutic candidates. For investigational new drug (IND)-directed programs, Virscio also executes primate pharmacokinetic characterization and globally accepted good laboratory practice (GLP) toxicology studies to provide a seamless bridge between animal efficacy and clinical development. Innovative Impact: Advanced predictive modeling paradigms in human relevant test systems to de-risk the time, cost, and risk of therapeutic development. Virscio aligns enabling tools and technologies with validated disease models to advance translational development. Multiphoton microscopy of healthy and glial toxin-treated retinas to characterize pathophysiology and evaluate the efficacy of protective interventions. Virscio functions as an extension of your lab; from study design through execution and reporting, Virscio prioritizes transparent, seamless communication with Sponsors to ensure high-quality, actionable scientific results and the generation of unique, strategic biological insights that accelerate and

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Our scientific expertise, collaborative engagement and access to unparalleled primate and related research resources position Virscio as an ideal translational research partner

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strengthen preclinical study design, execution and interpretation.

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Statistics: Year Founded: 2003 Founded By: Matthew Lawrence M.D., Ph.D. (CEO & CSO) and Christopher Stanley (CFO & CBO)

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Virscio is a translational R&D and research services company focused on predicting clinical outcomes through the application of validated nonhuman primate disease models, deep therapeutic area domain expertise, and related research capabilities to support preclinical programs from initial proof of concept through IND-enabling studies.

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Headquarters: Corporate, analytic, data management, and administrative divisions are located in New Haven Connecticut; testing facility and preclinical operations are located on the island of St. Kitts, West Indies. The company employs more than 75 full-time staff.

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Virscio 4 Science Park New Haven, CT 06511 United States +1-203-498-9706 info@virscio.com

R&D Domains: Ophthalmology, Central Nervous System, Cardiovascular, Metabolism, Gene Therapy, and Biologics.

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Photos: Dr. Andrew LaCroiX

USING HUMAN BIOLOGY TO IMPROVE HUMAN LIVES STEMONIX PLACES HUMAN BIOLOGY FIRST TO CREATE BETTER AND SAFER DRUGS. StemoniX is revolutionizing, accelerating, and de-risking traditional drug discovery by putting human biology first. Drug discovery typically starts with isolated targets or proteins, simple cell culture models, and animal studies all before entering clinical trials. The late exposure to human biology is inefficient and costly, resulting in many of the identified compounds failing for toxicity or efficacy reasons and leading to a less than 0.02% chance of making it to patients. StemoniX brings relevant human biology to the beginning of the process with human stem cells, threedimensional (3D) cell culture, and advanced analytical techniques. Placing human biology first ensures that the most promising, safe, and effective compounds are identified and that these molecules have the best chance of progressing to the clinic and having the greatest impact on patient lives. Created from healthy and patient populations and manufactured in ready to use, high-throughput formats, StemoniX 3D microOrgan® platforms accurately recapitulate native human physiology and function and allow for the simultaneous testing of thousands of compounds. Early testing and screening with healthy and disease human models enables the discovery of more effective and safer compounds, reduces the need for animal testing, lowers pre-clinical costs, and maximizes successful clinical outcomes. In short, we believe that upending traditional discovery processes by placing human biology first revolutionizes the discovery of new effective and safe medicines. StemoniX currently has microOrgan platforms for the brain, heart, and pancreas tissue systems: microBrain®, microHeart®, and microPancreas®. microBrain platforms have been used across several therapeutic endpoints including viral infectivity, Alzheimer’s and Parkinson’s diseases, opioid addiction, neurodevelopmental diseases, and aggressive cancers such as

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glioblastoma. microHeart platforms accurately represent human cardiac tissue and have been instrumental in identifying cardiotoxicity; they are being further developed for use in discovering drugs to treat heart failure and increase heart attack survival rates. The microPancreas platform, a human islet cell-based 3D culture and the newest microOrgan member, is being tested by partners for use in diabetes and pancreatic cancer research. Finally, StemoniX created Assay AnalytiX™, a proprietary software program

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StemoniX 13300 67th Ave N Maple Grove Minnesota 55311 United States info@stemonix.com

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StemoniX empowers the discovery of new medicines through the convergence of novel human biology and software technologies. Our predictive, accurate, and consistent high-density, human induced pluripotent stem (iPSC) cell-derived drug screening platforms enable scientists to quickly and economically conduct research on functional human tissues with improved outcomes in a simplified workflow. With leading-edge iPSC technologies and data science, StemoniX is helping global institutions bring the most promising medicines to patients.

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Our goal is simple. We want to identify the most effective and safest drugs possible. By putting human biology first, we can advance drug discovery, improve patient lives, and make medicines work – the first time.

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that more accurately analyzes the data created from our microOrgans and provides a solid foundation for more advanced AI- and machine-based learning discovery algorithms.

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TRANSNETYX – HOW AI CAN LOWER COSTS FOR RESEARCHERS WORLDWIDE SOFTWARE SYSTEMS WILL REVOLUTIONIZE THE FUTURE OF COLONY MANAGEMENT BY AUTOMATING REDUNDANT PROCEDURES AND FREEING RESEARCHERS TO DISCOVER MORE. In the research world a baseline of correct genetic makeup of animals is required to proceed with accurate and reproducible experiments. Transnetyx was designed to take a redundant process that is mandatory in labs and outsource a solution. Today, the procedure that was done almost exclusively in laboratories around the world, is now sent to our lab in Memphis, TN. Our team has processed more that 25 Million biopsies and we are learning that there are ways to make the efficiency of labs even greater. The end goal is to allow our brightest scientists to gain time for activities that lead to discovery.

personnel. This guidance will do what few humans can, which is create efficiency and lean management of the most complex living beings. The workload for a lab managing 50-100 strains and breeding for a study is heavy. The daily need to address the compulsory actions for efficiency is not within the bandwidth of a researcher, post doc or lab manager. To complicate matters, it’s not practical to try and include the animal facility staff in all the labs genetic breeding combinations on a weekly basis. The combinations are ever changing based on outcomes. The technology to address these problems needs to be readily available so that outdated practices do not compound to the point of utter confusion. This is becoming the case in the world of animal husbandry and electronic research notes. The demands of the work have greatly outpaced the development of tools to manage this aspect of the job. Cures and discoveries utilizing gene therapy are more impactful today than ever before and they are being put on hold while researchers shuffle through outdated records. We have never had more work to do to lower the use of unnecessary animals and refine the production of them so that they directly relate to a study.

With our free colony management software, we have begun to see habits that waste thousands of dollars in these same labs. More importantly, there is a loss of accuracy through disorganized recordkeeping, loss of time through ongoing searches for information, and loss of animal life due to the previous two items mentioned. This software will prevent this type of waste. We can reduce and refine irregular procedures in labs. These changes are necessary due to the growth of complex, genetically engineered animal models. These models are required to push forward new techniques that lead to the next generation of cures and therapies. Unfortunately, the complexity of these models has far outpaced the tools to manage them.

The value of the money wasted is offensive. The value of the lives of the animals wasted is more than offensive. It is repugnant. There is technology today that can correct both. It may be a little late, but it is happening. Research and the world are transformed by its adoption.

The future of animal research is rooted in software and tools that will provide actionable and operational guidance for labs and animal staff

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Statistics: Year Founded: 2000 Founded By: Bob Bean and Tim Hodge

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Transnetyx is equipped and prepared to continue functioning at 100% capacity. Our automation and technology afford us the ability to provide uninterrupted testing services without jeopardizing the health and welfare of our employees, or the community in which we live.

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Transnetyx 8110 Cordova Rd Suite 119 Cordova TN 38016 United States geneticservices@transnetyx.com +1-888-321-2113

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CHAPTER 5

CLINICAL SERVICES

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DRIVING POSITIVE HEALTH OUTCOMES FOR REAL WORLD PATIENT POPULATIONS 2M CLINICAL IS A DIVISION OF 2M RESEARCH—2M RESEARCH IS A MINORITY-OWNED, FIRST-CLASS PROFESSIONAL SERVICES CONSULTING FIRM. 2M Clinical provides quality, cost-effective, and timeline driven clinical trial services. Our team has the knowledge, expertise, and hands-on experience to manage phase I-IV domestic and international clinical trials, health services research, and epidemiologic studies. Our team and strategic partner networks provide therapeutic expertise across a range of areas, including immunology, oncology, cardiovascular disease, diabetes, and neuroscience/psychiatry.

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Post Marketing Surveillance Medical Writing Market Access & Health Economics Pharmacoeconomics Decentralized Patient Recruitment Patient Recruitment Diversity

Clinical trials require diverse populations to ensure the validity of results and positive benefits to all. Our experienced team at 2M Clinical understands that the lack of diverse representation in clinical trials (e.g. race/ethnicity, sex, age, geography) can hinder advances in biopharmaceutical research and development. As such, 2M Clinical provides modern solutions to increase diversity in clinical trials for our clients. We utilize GIS technology to improve our outreach strategies to participants, community organizations, and healthcare provider groups with the goal of enriching representation. 2M has a growing network of sites with both diverse clinical investigators and sites located in areas that routinely care for patients who come from medically underserved communities. Our multilevel approach to recruitment incorporates relevant demographic and cultural perspectives into recruitment efforts.

We offer our clients expertise and experience in: • Project Management & Protocol Development • Clinical Site Monitoring • Site Initiation and Close-out • Subject Recruitment/Retention • Feasibility Reports • SOP Development • IRB Selection • Regulatory Affairs • Study Design • Clinical Data Management & Biostatistics • Epidemiological Studies

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2M GEOSPATIAL & STATISTICAL INNOVATION CENTER Utilizes advanced spatial and visual analytics to help carry out complex epidemiologic studies and enhance clinical trial recruitment. Examples include: • Utilizing GIS mapping of relevant data sources for more targeted clinical trial recruitment at the census tract and census block level • Utilizing cognitive mapping as an effective, low cost, and efficient method of helping to recruit from “hard to reach populations” 2M Patient Outreach Center (2POC) 50 CATI (Computer-Assisted Telephone Interviewing) survey stations, allowing us to offer our life science clients: • Customizable survey solutions to meet complex health data collection requirements • A range of survey capabilities including data collection by web, phone, and mail • Expert staff with experience in complex sampling, questionnaire development, and performing complex data analysis

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2M LEVERAGES SPATIAL EPIDEMIOLOGY AND GIS TECHNOLOGY TO ENHANCE PARTICIPANT RECRUITMENT As part of the Novo Nordisk global initiative Cities Changing Diabetes (CCD), 2M recruited participants in three geographic regions of the Houston area. 2M leveraged innovative technology to support recruiters. Specifically, recruiters used handheld tablets with GIS maps and a scheduling app to track both houses and where and when contact had been made with potential participants, as well as to access a real-time calendar to schedule interview times for willing participants.

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2M Clinical is led by a diverse team of experts with extensive handson experience in clinical trials and research. Our knowledge of the pharmaceutical and healthcare sectors and substantial work with regulatory bodies makes us a powerful ally and smart strategic partner.

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4C PHARMA SOLUTIONS YOUR RESPONSIBILITY, OUR PASSION!

OUR HISTORY 4C Pharma Solutions was established in 2014 by Medical Doctors who have practiced medicine in the past. Each individual brings a unique and overlapping complementary expertise from the fields of pharmacovigilance, clinical research operations, medical affairs, clinical medicine, regulatory, and technology implementations. This allows for an in-depth knowledge of drug and device development along with the requirements for maintenance. The aim for the company has been to work with small and large companies alike. With the intent to reduce cost, increase quality, and be compliant, 4C hopes a greater pool of companies bring new techniques to the industry to help a larger patient population.

OUR PURPOSE 4C Pharma is a comprehensive healthcare solutions company. Owned and operated by Medical Doctors with hands-on expertise in pharmacovigilance (drug safety) and regulatory domains, 4C’s core values of transparency, honesty, ownership, success, and enthusiasm allow it to provide high quality solutions that are compliant with current regulations while anticipating and preparing for future ones. Through this approach, 4C Pharma becomes a trusted partner and extension of any company it works for.

OUR HOPES 4C Pharma solutions believes in not only helping their partners but also giving back to the industry and to the educational community. It is the responsibility that comes with success. As a company that offers training for industry experts and newcomers alike, 4C wanted to take it the next level. For that reason, they have partnered with Temple University to further its Scholl of Pharmacy’s advancement of the school of pharmacy. 4C has also worked with the University’s RAQA program. For 50 years, Temple’s School of Pharmacy has been the foremost graduate program of its kind in the nation. Temple’s MS in RAQA transforms graduate education for pharmaceutical professionals. Being a strategic partner, and having invested in the continuing education of students, 4C has been a proud supporter of Temple University’s School of Pharmacy. As this partnership continues, the hopes are that the University and 4C can bring a new dimension to an industry that always needs trained individuals at the helm.

OUR FOCUS 4C Pharma Solutions is a Service Provider Organization with a key focus on delivering service excellence to our partners through years of experience and expertise in the industry. Headquartered in New Jersey, with offices across major locations throughout the globe, they are well versed with FDA, EMA and other regulated as well as emerging markets. 4C is strategically located in the US, Europe, UK, UAE, and India for ease of doing business and allowing for an extensive global reach. The company follows a unique approach, where each solution is customized according to the partner. This reduces time and effort on the part of the end user, allotting it toward further research and development. 4C Pharma Solutions is a leader in pharmacovigilance with services including medical information call centers, case processing (from beginning to end), literature search, electronic submissions, periodic reporting, signal detection, risk management, hosting solutions, medical writing, CDM, QMS, and Regulatory Affairs.

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Founded in 1968, the Regulatory Affairs and Quality Assurance (RAQA) program’s accomplishments are impressive. The program is the oldest, largest, and most comprehensive of its kind in the country. The University has more than 80 courses in Quality and Regulatory topics, and more than 300 students from the US, Canada, and South America take courses during its fall, spring, and summer semesters. Its faculty consists of nearly 100 industry and FDA professionals from across the country who have at least 15 years of experience in their fields. More than 2,500 students have received the MS in RAQA since the program’s inception. RAQA’s mission is to provide excellent, affordable, higher education which prepares students for successful careers in the regulated healthcare industry or FDA. The program has regular meetings with industry and FDA leaders to ensure that courses address the latest trends and practices. Thirteen excellent certificate programs are available. The program offers other industry-focused degrees, including the MS in Pharmaceutics and the MS in Global and Clinical Pharmacovigilance Regulations (GCPR). The latter was the first of its kind in the US and continues to accelerate careers paths in safety surveillance activities. RAQA’s relationship with 4C Pharma provides another layer of hands-on experience for students studying global pharmacovigilance.

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RAQA has pioneered many student-friendly services at the graduate level. Online courses are live transmissions. The dynamic online classrooms feature “learning by doing” and networking. Students engage in interactive discussions and problem-solving workshops. Courses accommodate professionals working full-time in industry who may only be able to pursue graduate studies on a part-time basis. With flexible entry procedures, students can delay applying to the MS while easing into graduate studies by first starting courses towards a certificate. After earning a certificate, students may apply for and complete the MS program or take up to five years off before returning to finish the MS degree.

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4C Pharma is a comprehensive healthcare solutions company. Owned and operated by Medical Doctors with hands-on expertise in pharmacovigilance (drug safety) and regulatory domains, 4C’s core values of transparency, honesty, ownership, success, and enthusiasm allow it to provide high quality solutions that are compliant with current regulations while anticipating and preparing for future ones. Through this approach, 4C Pharma becomes a trusted partner and extension of any company it works for.

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ARTCRAFT HEALTH

DELIVERING HEALTH EDUCATION POWERED BY INSIGHTS AND INNOVATION With a deep expertise and passion for health education, we are known as the Education Enthusiasts. Artcraft Health helps patients, healthcare providers, and all relevant stakeholders develop the skills, knowledge, and motivation they need to understand and communicate their diagnosis, initiate and adhere to their treatment, and experience the best possible outcomes. We specialize in four areas: clinical trials, promotional education, hospitals, and demo devices.

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WHAT SETS US APART

In addition, we look at the whole patient, not just his or her disease. Often, friends and family of the patient are living with the diagnosis as well, so it’s important that all stakeholders are educated throughout the healthcare journey. This means that even though patients are at the center of everything we do, we also engage and educate all of the people who treat, support and

We uncover rich insights along the patient journey and identify the barriers, motivators, and unmet needs that patients encounter, from pre-diagnosis through adherence. Using those insights, we then intervene with the right educational message at the right time, using an engaging innovative solution.

Although everything we do is rooted in health education, behavior change, and health literacy, what’s key is finding compelling ways to engage patients in order to help educate them. When you involve patients in their treatment and surround them with the right mix of solutions, their engagement increases. So our solutions often include a mix of innovative options using technology, video, animation, gamification, AR, IoT, and of course, print technology.

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“Artcraft Health is a hybrid agency delivering both patient engagement and education strategies, and innovative solutions. We’re privileged to service top-tier pharma, biotech, and device companies with a mix of Fortune 500 and Fortune 100 companies.” —Greg Santore, EVP

counsel them––from caregivers and clinicians to pharmacists and providers.

CHANNEL AGNOSTIC SOLUTIONS We have experts in all forms of media, so we’re not predisposed to one particular channel. We recommend the right solution––or right mix of solutions––to make the biggest impact for our clients.

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We develop creative solutions at the appropriate points of the patient journey and experience. From clinical trials to mature brands, effective education should motivate all stakeholders to take action. We educate patients, caregivers and those who treat, support and counsel them, and ultimately build and grow your brand.

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Artcraft Health 39 Highway 12, Flemington NJ 08822, United States +1-908-782-4921

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BBK WORLDWIDE

Transforming the Patient Experience “Our satisfaction comes from making a difference in the lives of patients. When your neighbor, father, or colleague is prescribed a medication we’ve helped bring to market, and they respond to that treatment, there’s nothing more gratifying.” Joan F. Bachenheimer, Founding Principal and CEO

DRIVEN TO INNOVATE

TECHNOLOGY THAT TRANSFORMS

For more than 35 years, BBK Worldwide (BBK) has been instrumental in the development and evolution of the patient recruitment industry. With a commitment to innovate, the company pushes the industry forward with the development of game-changing tools and technologies that enroll and engage patients in clinical trials. BBK was founded by Joan F. Bachenheimer and Bonnie A. Brescia, who were inspired by a shared commitment to advocate for patients and patient-centric care.

BBK’s first-in-class patient experience management system TrialCentralNet® (TCN®) has revolutionized the management of clinical trial recruitment, enrollment, and engagement. A secure and GDPR-compliant Web-based interface, TCN features a suite of modules that support study staff with the management of clinical trial enrollment and engagement. From media performance and referral processing to patient reimbursement and travel coordination, TCN serves as a center for operational excellence.

BBK’s suite of solutions addresses the needs of today’s clinical trial sponsors, with a focus on products and services that educate consumers, engage participants, unburden sites, and support sponsors. Committed to transforming the patient experience, the company’s end-to-end solutions support the entire clinical trial journey.

With advanced versioning capabilities, the document manager module ensures each clinical trial site is associated with final versions of documents approved by internal and external regulatory committees. The referral management module facilitates the efficient processing of patient referrals – ensuring patients are engaged while interest is at its peak. Real-time reporting and website analytics provide insight into enrollment and engagement metrics for clinical teams to leverage in adjusting strategies to maximize campaign performance.

BBK has pioneered several solutions to meet the evolving needs of the clinical trial marketplace, including RSG® Card and RSG® Arrive – reimbursement and travel programs that remove barriers to clinical trial participation and increase access to care. The company’s app platform, My Clinical Study Buddy®, empowers patients and site staff with features that inform, engage, and help organize the study experience.

Now in its seventh release, TCN institutionalizes best practices for patient education, enrollment, engagement, and adherence for clinical trials. A mobile version offers all of the same functionality but with the convenience of an app. TCN integrates with leading third-party point solutions such as EDC, IVR, and CTMS systems.

For clinical trial sponsors embracing virtual models, BBK’s tech-enabled solutions (e.g., apps, patient portals, voice assistants) support enrollment, informed consent, engagement, remote monitoring, drug delivery, data collection, and reporting.

Committed to transforming the patient experience, the company’s end-to-end solutions support the entire clinical trial journey.

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TrialCentralNet® (TCN®) is a tech-enabled solution that creates a positive experience, drives engagement, and delivers efficiencies for the entire clinical study community.

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Headquartered in Needham, Massachusetts, BBK’s global reach is supported by subsidiary offices in Tokyo, Japan, Dublin, and Ireland as well as Global Alliance partners around the world. The company employs more than 60 full-time employees.

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ELLIGO HEALTH RESEARCH ONLY ELLIGO ENABLES ACCESS TO HEALTHCARE FOR RESEARCH AND COMMERCIALIZATION SUCCESS. ®

Only Elligo takes research into the real world. When you need direct access to physicians, patients, and data to enable your healthcare research — there’s Only Elligo. Elligo Health Research® provides you access to the best healthcare experts, patients, and research technologies for fast, cost-effective, high-quality trials from start to finish. As the ultimate healthcare-enabling research organization, we reduce trial delays by activating physicians and local healthcare communities to offer research as a healthcare option to their patients. Powered by IntElligo®, Elligo’s advanced technology platform, including ResearchConnectSM for feasibility and patient recruitment, we provide flexible and agile multi-therapeutic and geographic reach, enabling access to a spectrum of physicians and patients. Elligo delivers your complete solution for research and commercialization success: • Patients are given the opportunity to participate in clinical research as care for their condition under the supervision of their trusted physician. • Physicians are able to focus on patient care while offering cutting-edge treatment to patients through performing clinical research within their existing practice. • Sponsors receive full and secure remote monitoring capabilities while accessing data from a diversified patient pool. • Our System of Accelerated Research (SOAR®) is a transformative model that enables decentralized trials while adhering to all required regulatory processes and accelerating the overall research process, ensuring quality and integrity, and focusing on the patient. • ResearchConnectSM establishes secure data connections at the healthcare practice to facilitate direct access to patient population analytics and insights, not only creating data products for determining the deep protocol feasibilities that dictate enrollment, but ongoing process improvements through trending performance reports and a platform for data staging and sharing.

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Elligo Health Research, a healthcare-enabling research organization, uses electronic health records and the trusted patient and physician relationship to ensure all patients have access to clinical research as a care option. Powered by our Goes Direct® approach and novel IntElligo® Research Stack clinical technology, our team provides access to the best healthcare experts, patients, and research technologies. We engage physicians and patients who otherwise would not participate in clinical research and accelerate the development of new pharmaceutical, biotechnology, and medical device and diagnostic products. Learn more at elligodirect.com.

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Elligo Health Research 11612 Bee Cave Road, Bldg. 1, Ste. 150 Austin, TX 78738 +1-512-580-4633

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TRANSFORMATIVE INNOVATION ANCHORED IN TRUTH

Our culture encourages creativity and inventiveness, generating recognition as a Best Place to Work. • A leading-edge mindset led to our development of one of the first Internet-based data entry and clinical research support platforms, Advantage eClinical. This platform allowed us to launch an important therapeutic trial during a pandemic in three days from receipt of the study protocol. • We remain at the forefront using the science of omics in researching vaccines and therapeutics.

Our name, Emmes, means truth in Hebrew. We were founded by a statistician who believed that combining solid statistical design with a deep understanding of the disease or condition would shed light on the world’s important human health problems.

We connect with scientists around the world to make a difference in human health. Our focus on innovation extends to our employees, who are valued contributors and idea generators. From the start, we’ve invested in the health and well-being of our staff and our community. It’s why we’ve been recognized as a family-friendly workplace and good corporate citizen; it’s why we’ve been chosen as a Best Place to Work. It’s the reason our people think of Emmes as a place where they can make a difference. Where they are viewed as trusted partners by our clients. And where their creativity and inventiveness are recognized.

Projects are never identical, and neither are their solutions. We have built a reputation over the past 40+ years for innovative study designs and sound execution that save time and resources. • Our understanding of science led us to develop an entirely new pediatric scoring algorithm for liver transplantation. Adopted by the United Network for Organ Sharing, this tool now gives children a fair chance to receive available organs. • We pioneered a new way to use central statistical monitoring for the FDA, uncovering data anomalies undetected by existing site monitoring practice. • Out-of-the-box thinking produced a Bayesian platform trial that allows product evaluation over multiple cancer types and treatments. • Creative design and execution of one study resulted in the first FDA approval of a device using artificial intelligence to diagnose disease.

“At Emmes, we question the ordinary and create the extraordinary. We challenge assumptions and remain teachable to ensure a deep understanding of a problem – before we offer solutions.” – Dr. Anne Lindblad, President and Chief Executive Officer

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We collaborate with our clients to produce valued, trusted scientific research. Our team members at Emmes are passionate about making a difference in the quality of human health, and we have supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world.

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Our Advantage eClinical platform has dramatically accelerated the time it takes to initiate studies.

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We have built successful partnerships with scientists in Sierra Leone and all around the world.

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“As the industry evolves and the competitive environment changes, our ERG team continues to advance innovative strategic approaches to improve and diversify our comprehensive clinical service.” – Lori T. Wright, President and Chief Executive Officer, Evolution Research Group, LLC.

Evolution Research Group

IMPROVING THE QUALITY AND DELIVERY OF COMPLEX, SPECIALIZED CLINICAL TRIALS ERG maintains its leadership status by uniquely combining expertise in technology, science and medicine to enhance clinical site performance.

has increased the requirement for early phase studies to deliver specialized data collected from healthy volunteers as well as patient populations. Historically, these needs were met by sponsors utilizing significant resources to identify, engage and manage a mixture of academic sites and independent investigators.

Simplifying Complexities Early stage clinical trial execution is complex and has been considered inefficient by internal and external stakeholders. Yet, over the past decade, the pharma industry’s need for expedited delivery of decision-making data

ERG was among the first in the industry to develop an organizational structure and business model to specifically meet these evolving needs and simplify the sponsor interface. A portfolio of centrally managed, purpose built clinical research units enables ERG to provide the geographic reach required to identify study participants. Centrally managed state-ofthe-art technology, training and quality oversight enable ERG to deliver industry leading execution across all sites, while also supporting specialized capabilities at individual units.

Envisioning Solutions ERG was founded in 2014 by industry veterans with three decades of clinical research experience. The management team, led by President and Chief Executive Officer, Lori T. Wright, shared a common vision for positioning ERG where few non-academic clinical research units existed– to dedicate world class investigators enabled by cutting edge technology and experienced research staffs to the investigation of early drug candidates in support of Phase 1 decision making. All provided to Sponsors via a single point of contact.

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Embracing Innovation

ERG continues to both develop and invest in new methodology and technology to identify diverse patient populations and execute research protocols which require specialized assessments (e.g., imaging, cognition testing, EEG/qEEG, PSG, surgical and laboratory procedures).

ERG believes technology serves to improve performance. With cloud-based infrastructure, ERG ensures scalable computing power and storage. Critical to the current and ongoing technological improvements, ERG provides the highest levels of security and regulatory compliance. The company built a remote platform which enables centralized, remote management of portfolio sites, including cloud-based clinical trial management system, an online training platform, enhanced security cameras, advanced recruitment techniques including mobile application referrals, social media integration and a collaborative telephone system.

With its disciplined approach to growth through acquisition, ERG identifies and acquires sites where the principal investigator delivers consistent results, maintains tremendous access to diversified patient populations, and seeks to continue their work. ERG’s hub and spoke structure was implemented to expand the catchment area and patient access, while exploring how best to expand to satellite locations.

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By adopting emerging technologies, ERG remains at the forefront of virtual engagement. ERG offers clients a hybrid model which includes remote monitoring visit platform, remote visits/telemedicine, home visits, electronic regulatory documents, and electronic source. Ensuring the needs of each patient population and nuances of individual study designs, ERG balances technology with quality as they evaluate and implement the systems and corresponding policies.

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ERG enjoys a proven track record of executing complex inpatient and outpatient clinical research trials in specialized populations and healthy volunteers across all age groups. ERG’s expertise includes psychiatric and neurological disorders (CNS), non-CNS indications, and early phase drug development.

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GLOBAL SPECIALIZED LEADERSHIP IN ORPHAN DRUG DEVELOPMENT AND PHARMACOVIGILANCE

Ergomed is a UK listed company that provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fastgrowing, services business includes an industry leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, a full range of high-quality contract research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR.

infrastructure, and systems has ensured that it is a market leader, offering highly effective and compliant solutions to all its clients. Together in full engagement with Automation Anywhere and DataRobot, PrimeVigilance is leveraging a portfolio of technologies to achieve a state-of-the-art pharmacovigilance services.

Due to Ergomed’s size, the CRO can handle global trials, but is still small enough to be agile and creative. This attitude, in combination with Ergomed’s unique Site Management services, makes the CRO extremely suitable for complex clinical trials, with a strong focus on rare diseases and oncology.

Ergomed plc acquired PSR Orphan Expert in 2017, a dedicated orphan drug division with significant experience in neurological indications including neuromuscular and neurodegenerative diseases. Ergomed and PSR have been experts in translating challenging and complex protocols into successful clinical trials for over 20 years. Ergomed/PSR’s unique expertise has helped us support over 100 clinical trials and observational studies in rare and ultra-rare indications. We understand the challenges faced during orphan drug development and how important the patient and their families’ experiences are to keep them engaged in potentially life-changing trials. Ergomed/PSR’s input to delivering new treatments, our Orphan Toolkit, Site Support Model, Patient Engagement Officer, and Patient Organization Advisory Board demonstrate our dedication and passion for the rare diseases business and at the patient level. In addition, Ergomed is providing drug safety services through PrimeVigilance for an ongoing

For small biotech-companies, Ergomed can offer a full array of services during the clinical development phase: from EMA/FDA regulatory consultancy all the way through to market access and reimbursement. Ergomed strengthens its global services offering with the acquisition of Ashfield Pharmacovigilance, a US pharmacovigilance services provider, from UDG Healthcare in January. Providing significant US pharmacovigilance presence and access to a genuinely global offering for customers. PrimeVigilance’s strong history of investment in technology,

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US clinical trial to assess the effect of a rheumatoid arthritis treatment on patients with severe COVID-19 infection. The ability of Ergomed to support the rapid initiation of clinical trials and establishment of appropriate safety monitoring will be critical to providing new treatments which may improve outcomes for patients. The focus on patients is central to everything at Ergomed. During the year, the company has recruited a leading patient advocate to the team to ensure that every protocol is reviewed with patient and their family in mind and that appropriate patient concierge services are offered to reduce the study burden for patients and their families. This approach and Ergomed’s ability to be agile and creative, has been very instrumental during the COVIDpandemic. Where other CRO’s have seen up to 80% of their studies put on hold, Ergomed has been able to continue the majority of its studies by implementing remote technologies and home-care services very quickly and efficiently. This patient-engagement role also focuses on developing relationships with patient advocacy organizations in support of this, PSR – the rare disease focused division of Ergomed – has formed a Patient Organization Representative Board that discusses key challenges in the development of orphan drugs and can be consulted for individual orphan drug trials.

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Ergomed plc is part of the AIM market of the London Stock Exchange and trades under the symbol “ERGO”.

Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing, profitable services business includes an industry leading suite of specialist pharmacovigilance (PV) solutions, a full range of high-quality contract research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR.

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PHARMALEX – CONFIDENCE BEYOND COMPLIANCE OUR TECHNOLOGY-ENABLED CONSULTING SERVICES EMPOWER OUR EXPERTS TO MAKE BETTER DECISIONS IN ORDER TO DRIVE EFFICIENCY GAINS Beyond knowledgeable PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries. We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval/maintenance postlaunch activities. Our experts use technologyenabled solutions to support you through the entire product lifecycle. We deliver exceptional results – going above and beyond the standard to deliver tailor-made solutions worldwide. PharmaLex has over 1000 employees across 33 offices in 21 countries. Our diversity provides a distinct advantage in an era when innovation, flexibility and creativity are key to competitiveness.

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Beyond innovative Automation, Artificial Intelligence (AI) and machine learning are revolutionizing many industries, helping enable increased productivity, improved quality and enhancing return on investment. At PharmaLex we combine our extensive global experience and deep understanding of pharmaceutical lifecycle processes with the development of our cloudbased platform for life sciences automation alongside key partnerships with leading technology vendors. Through our technology-enabled services we are helping our customers to adopt and take advantage of innovative technologies to drive efficiency gains within their own operations. Helping the pharmaceutical industry to move away from relying on established, but increasingly outdated, systems and methodologies that were efficient many years ago, yet now prove to be a limiting factor in innovation and growth.

D E V E L O P M E N T

It’s also the fact that we genuinely like what we do and the people we work with. That is why we scale our solutions on your specific situation. From smaller organizations to multi-layered, multinational companies – all our clients are high priority. We take your business above and beyond.

Most pharmaceutical companies have the raw ingredients at their fingertips – mass volumes of valuable historical data that can be analyzed to predict future outcomes. At PharmaLex we have the technology, know-how and experience to take these raw ingredients and realize real, immediate and lasting benefits for our customers – we call this Knowledge. Accelerated.

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Beyond trusted Expanding on our core business, we’ve built a trusted network of colleagues – PharmaLex Partnerships – unlike anything else in our industry. Our business model is beyond proven, with over 90% of our revenue from satisfied repeat customers. It is the powerful combination of ‘big picture’ thinking and targeted problem-solving that sets us apart.

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PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries. We have the capacity to scale to meet the demands of our clients and individual programs whilst ensuring a personal professional service which is at the very core of our client values.

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MASTER YOUR DATA MAXIMIZE CONTROL OVER YOUR CLINICAL TRIAL WITH A BETTER UNDERSTANDING OF YOUR DATA

Small and mid-size biopharmaceutical companies don’t have the budgets and resources to control their clinical trials that the large companies do. With most costs generally increasing; data has become cheaper. As has been said for a more than a decade, “We are in a data driven world.” Randomized controlled clinical trials sponsored by biopharmaceutical companies are a costly undertaking. Patient recruitment targets remain the biggest hurdle, compounded by the increasing complexity of study protocols and regulatory compliance. These factors driving the cost and success of clinical trials from phase I to IV can be managed more efficiently and economically by mastering your clinical trial data. It is a matter of using leverage rather than working harder or increasing budgets, or as often is the case, both. Data are generated for the lifecycle of a clinical trial. Collecting and managing these data in near real-time enable sponsors of clinical trials to make better-informed decisions. This control increases the probability of success while keeping clinical trials within budgets.

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Quartesian utilizes its Confero analytics, Powered by Spotfire®, to produce rich graphical dashboards that inform clinical trial sponsors regarding the performance of clinical research sites and which sites might require more attention. Quartesian is experienced with implementing direct data capture technology, which reduces or eliminates source data verification. Higher quality data can be captured while reducing costly visits by clinical study monitors. The clinical trials industry is exploring virtual and near virtual trials to overcome pandemic-induced challenges. Such trials may require visits by research coordinators to patients’ homes rather than patients making scheduled visits to investigator sites and clinical data will likely be captured from mobile devices and wearable technologies. Quartesian has developed tools to extract, translate and load data from these different devices and integrate these data for analysis and reporting for regulatory submissions.

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Decentralization, streaming of data in real-time and data interoperability are the waves of future for clinical trials. Quartesian has positioned itself to deploy the optimum mix of commercial off-the-shelf eClinical technology and proprietary solutions to provide turnkey data services. This efficient and flexible combination enables sponsors to rapidly make better informed decisions and keep budgets in line which increases the probability of success by facilitating patient retainment, regulatory compliance and quality data.

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Quartesian LLC was formed in January 2003 to provide customized, insightful data to organizations performing clinical studies. Our full technical expertise pairs with our industry experience to provide clinical data services — quickly, efficiently, and at a competitive cost — no matter the size of your business or the phase of your study.

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SubjectWell risk-free patient recruitment DRAMATICALLY DECREASING TIME TO LAST PATIENT IN (LPI) WHILE ONLY CHARGING FOR PATIENTS WHO RANDOMIZE. SubjectWell is the largest risk-free clinical trials marketplace for patient recruitment. With most people unaware of the benefits of clinical trials or how to get involved, SubjectWell looks to raise awareness of clinical research in the general population and provide patients more choice and easy access to innovative treatment options.

highlight clinical trial benefits and then following up with telephone-based prescreening, SubjectWell delivers qualified referrals that traditional, study-specific recruitment methods miss. This high-touch approach delivers referrals who randomize at three to five times the rate of other sources, speeding up the process by referring qualified patients for studies in only days, helping researchers dramatically decrease time to last patient in (LPI). And, as the only risk-free pricing model in the industry, SubjectWell’s clients only pay for patients who randomize, with no additional fees, sign-up charges or hidden costs.

SubjectWell’s model is simple, yet it addresses the widespread industry pain point -- the costs and time associated with patient recruitment. SubjectWell’s non-study-specific online advertising runs on tens of thousands of general interest websites around the clock, introducing the idea of clinical research to people when they’re not actively thinking about their condition. Once they’re registered, SubjectWell contacts these patients to screen them against criteria for multiple studies at once until the right fit is found. By using these broad education campaigns to

SubjectWell’s unique capabilities and innovative patient recruitment strategy complement traditional recruitment methods, and can be put to work for a wide-range of studies completely risk-free for sponsors.

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SubjectWell, the risk-free clinical trials marketplace for patient recruitment, raises awareness of clinical research in the general population and provides patients more choice and easy access to innovative treatment options.

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SYMBIO, LLC

Complex Dermatology Clinical Trial Nuances Simplified: Rely on Experience AS THE TOP GLOBAL NICHE CRO SPECIALIZING IN DERMATOLOGY, SYMBIO HAS SIMPLIFIED THE JOURNEY OF SUCCESSFUL DERMATOLOGY PRODUCTS FROM FORMULATION THROUGH FINAL APPROVAL. Skin. Everyone has it. Dermatology clinical trials are different and success in Dermatology requires decades of experience. How are they different? Dermatology clinical trials on average run much faster than industry. Some published averages of Phase 3 trials have a duration of 1000 days, whereas the average Symbio Dermatology Phase 3 trials duration is 580 days. Symbio leverages experience in Dermatology and utilizes efficiencies and staff accustomed to the pace to streamline the process. Fail to plan; plan to fail. A common perception is that CROs under budget to secure a study. Some investigation into this has suggested that CRO revenue is 70% contracted costs + 30% scope changes. This could be either intentional or because the CRO does not fully understand what is required. With the benefit of experience, Symbio is able to generate a superior plan for Dermatology clinical trials and on average Symbio invoices 96% of the contracted budget and does not rely on scope changes. This means the initial plan is accurate based on experience. Dermatology assessments are easy. Sure, maybe Dermatology assessments seem easy to someone who is not an expert in Dermatology, but it is this thinking that, unfortunately for too many Sponsors recently who have invested heavily in Phase 3 Dermatology trials, and for the potential patients who would have

benefited from that approved drug, has resulted in recent failed Phase 3 Dermatology trials. Investigator selection and training are key, particularly where subjective assessments are primary endpoints. Symbio has decades of metrics on Investigators who not only enroll well for fast paced Dermatology clinical trials, but as paramount, Symbio maintains metrics on Data Quality to equip Sponsors with knowledge for proper site selection. Symbio also has proven methods to train Investigators on proper assessments to maximize the potential of a successful trial.

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Dermatology clinical trials require indication expertise to be successful. The ultimate goal is a fast, masterfully managed clinical trial in an effort to provide approved products based on top quality data for patients suffering so many Dermatology indications around the world. Many Sponsors have selected Symbio as their preferred CRO and also awarded Women’s Health and Ophthalmology trials which have led to successful products approved by FDA that are currently marketed.

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Symbio is a niche CRO specializing in Dermatology with offices in the US and Europe. Since 2002, Symbio has conducted over 140 clinical Phase 1-4, POC, and Device trials in Dermatology and has been part of 50 FDA approvals with many more pending. Applying trial management expertise, Symbio has also enjoyed much success in Women’s Health and Ophthalmology. With core CRO services in house including Project Management, Medical Monitoring, Site Monitoring, Data Management, Statistics and Medical Writing, and the Formulation and Manufacturing talents at Symbio’s wholly owned subsidiary, Dow Development Laboratories, Symbio is the only global CRO specializing in Dermatology from Formulation through clinical trials, through final approval.

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Symphony Clinical Research Decentralized and Hybrid Trials: Here and Now! BRINGING CLINICAL TRIAL VISITS DIRECTLY TO PATIENTS AT HOME SINCE 2003. Symphony Clinical Research is the industry leader in taking clinical trial visits directly to patients in their homes, offices, schools, on vacation, or other convenient locations. Traditionally, clinical trials require patients to travel to the clinical research site, where they often face long wait times to receive services. Up to 86% of traditional clinical trials fail, largely due to a lack of enrollment and retention, caused by the travel and time burdens placed on study participants [1]. Symphony’s services are instrumental in minimizing the travel and time burdens typically associated with participation in a clinical research study.

comply with industry standards including International Conference on Harmonization (ICH)/Good Clinical Practices (GCP), privacy regulations, dangerous goods standards, and other national and local regulations. Symphony services have been used in 27 studies that resulted in FDA or EMA approvals. Most recently, the FDA publicly encouraged the pharmaceutical industry to move to a decentralized clinical trial model, defined as studies executed through telemedicine, mobile or local healthcare providers or other innovative practices that vary from the traditional clinical research model [2]. Symphony services align closely with current trends to decentralized, hybrid and virtual trials models. Symphony helps pharmaceutical companies modernize their clinical research trials to increase patient enrollment and retention – allowing them to get new drugs to market more quickly – to those patients who need them so desperately.

Symphony has worked with nine (9) of the top 10 biopharmaceutical companies across the globe in all phases and therapeutic areas of clinical research studies. Symphony services are provided on five (5) continents and are especially beneficial for immobile patient populations, rare disease studies and pediatric patient groups. Symphony services allow clinical research studies to include participants located in remote geographies not near clinical research sites and can increase patient diversity, since recruitment isn’t constrained by a patient’s physical location. From recording vital signs, collecting and processing lab specimens, reviewing patient diaries to conducting in-home study drug infusions, Symphony clinicians meet the highest clinical standards. Symphony services

References: 1. Hale, C. (2019, February 4). New MIT Study Puts Clinical Research Success Rate at 14 Percent. Retrieved from https://www.centerwatch.com. 2. Clinical Trials Transformation Initiative. Decentralized Clinical Trials. Published September 2018.https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials. (The CTTI is a partnership established by the FDA and Duke University)

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Symphony Clinical Research® is the global leader in providing alternatesite and in-home clinical trial services to study subjects across the globe. By making study participation convenient, our services improve retention, accelerate enrollment and increase compliance, while lessening the burden on study patients and your trial sites. Symphony is headquartered in Vernon Hills, Illinois and has a second location in Gdansk, Poland.

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ECLINICAL SOLUTIONS

BUILT BY CLINICAL FOR CLINICAL YOUR PERFECT FIT PLATFORM TO SIMPLIFY CLINICAL CONTENT MANAGEMENT AND OVERSIGHT When your document processes and data across the study life cycle are in one place, your operations become flexible, efficient, and cost-effective. Collaborate with team members and organizations for all documentation, review, and oversight with Trial Interactive. The 21 CFR part 11 compliant platform delivers an author-to-archive experience that simplifies and automates essential processes. That means comprehensive solutions for clinical document management, site selection, site activation, learning management, eISF, compliance training, quality, and more, that connect seamlessly with your eTMF for easy indexing.

compliance risks. For over a decade, Sponsors and CROs powered by Trial Interactive have passed inspections and delivered new therapies to patients. Additionally, we have enabled faster timelines, leaving more time to assure quality, completeness, and overall excellence. With Trial Interactive, you can be up and running in weeks, alleviating the pain of complex implementations while affording time for your important work. Our support continues when you go live. We provide dedicated project managers, a 24/7, global, multilingual service desk, and on-demand expertise for needs that emerge during your clinical trial.

Trial Interactive places key processes in the palm of your hands with mobile content management, eTMF, and site monitoring solutions for document scanning, coding, and CRA reconciliation. Get the information you need in one click to manage your study with our mobile-first CTMS. Additionally, TMF services complement the platform, allowing teams to scale resources and access TMF subject matter experts to establish best practices.

As part of our community, it is our mission to make sure you are heard. We maintain a transparent platform roadmap and many ways to communicate your pain points and feedback, so you can share ideas to improve the platform and see your requests come to life. If you want to become a more influential contributor to the future of eClinical technology, you can join our customer engagement program.

When choosing an eClinical partner, you want peace of mind. In clinical product development, that means passing inspections by reducing

Straighten your path to product approvals. From author-to-archive, we know how.

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TransPerfect transperfect-life-sciences Study teams worldwide are adapting to rapid change with centralized and remote processes. Since TransPerfect created the Trial Interactive eClinical platform, it has been our mission to straighten the path for product approvals with paperless, remote solutions. With thousands of active studies and millions of documents processed, Trial Interactive has become the preferred platform for Sponsors, CROs, and Sites around the world.

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WCG DELIVERING TRANSFORMATIONAL SOLUTIONS THAT STIMULATE GROWTH, FOSTER COMPLIANCE AND MAXIMIZE EFFICIENCY FOR THOSE WHO PERFORM CLINICAL TRIALS. Always Moving Forward with a Pioneer Spirit WCG is the powerful engine of the Clinical Trials industry, purpose-built to support biopharmaceutical sponsors, CROs, research sites, and patients in the development of life-changing therapies. We strive to consistently provide specialized service and partnership to these stakeholders, and are committed to facilitating their collaboration inside the clinical trials ecosystem. Built on a 50-year legacy of ethical review, and a foundation of best-in-class services companies, WCG has grown to what is today a suite of capabilities and technologies that deliver transformational solutions to stimulate growth, foster compliance, and maximize speed and efficiency for those who perform clinical trials, while ensuring the risks of progress never outweigh the value of human life.

Unique Within the Industry WCG occupies a distinctive space in the industry, offering unparalleled solutions driven by comprehensive, proprietary data; scientific and analytical insights; and integrated execution. WCG’s proprietary Knowledge Base™ is the data collection and decision platform designed to provide real-time data and insights into global clinical trials, and help customers make better, more informed decisions— in real time.

Catalyst to the Clinical Trial Ecosystem Historically, there has not been a single facilitator of conversations between all stakeholders within the industry: sponsors and CROs, sites, and patients. WCG is the catalyst for this essential intersection of perspectives, serving these stakeholders to prompt innovation. In fact, we routinely host events that bring these groups together to drive the conversations that power progress.

Unrivaled Depth — Two Divisions WCG serves the marketplace via two divisions, and unrivaled depth in clinical expertise that informs our offering: • WCG Ethical Review– Independent Review Board services designed to maximize patient protections in pursuit of clinical discovery • WCG Clinical Services– designed to systematically maximize the critical inflection points that drive trial success

Ethical Review Division WCG is the acknowledged industry leader and the gold standard in ethical and regulatory review – with years of experience and trusted relationships among stakeholders. Our mission continues undiminished: improve the efficiency, protection, and speed delivered by solutions in ethical compliance, biosafety, and research management.

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• Study Planning and Site Optimization WCG significantly reduces study startup time by accelerating the time from protocol finalization to site identification and activation using processes, expertise, technology, and informatics. • Patient Engagement WCG optimizes recruitment, enrollment, and retention results by identifying patient candidates to clinical sites and simultaneously eliminating site burden by providing the necessary resources, services, and technologies that support patient assessments and meet program goals. • Scientific & Regulatory WCG streamlines safety and pharmacovigilance operations, allowing sponsors/CROs faster access to safety data via automation technology; and offers industry-leading statistical and committee management to ensure the development of research programs with scientific rigor and statistical validity. • Market Intelligence and Insights WCG’s independent publishing and benchmarking group provides a suite of industry-leading publications, benchmarking services, custom research capabilities, and live and virtual conferences and webinars.

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WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two divisions – the industry’s first central IRB – WIRB-Copernicus IRB, and first clinical services organization (CSO) – WCG enables biopharmaceutical companies, CROs, and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protection.

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CONTRIBUTING FOR THE GREATER GOOD STEVE GENS MSOD, MANAGING PARTNER AND FOUNDER, GENS & ASSOCIATES INC.

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In the summer of 2005, I founded Gens & Associates Inc., a virtual consulting firm that serves the global Life Sciences industry. The office consisted of a folding table, chair, laptop and cell phone in a spare room of my home. Today it is a leading independent boutique management and organizational consultancy that provides advisory consulting services and a world-renowned regulatory benchmark serving over 100 Life Sciences organizations annually. The company’s mission is to help all stakeholders in the regulatory eco-system accelerate global transformation, increase efficiency and organizational agility to shorten approvals of effective new drugs and contribute to medicine affordability. We do this through strategic leadership, enhancing industry standards, collaboration, and providing deep insights derived from our highly respected research platform, to identify the most effective investments for improved outcomes.

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Allen Hamilton, where the firm’s obsession with “bring the best thinking to every client situation” was focused on insights that produce the greatest impact. Today, our most successful client engagements and benchmark studies have one thing in common – diverse teams that are highly collaborative, curious, and value “group thinking” to find the best solutions. This is a cultural statement as we strongly believe there is a direct connection between culture and successful innovation.

The question of “what is innovation” is a good one, with many different expressions and viewpoints. For me, it is more a mindset of “what is possible” and the intentional collaboration with your community “for the greater good.” Innovation takes curiosity, experimentation, and the pursuit of excellence.

Use data strategically and tactically Within a year of starting Gens and Associates, we began contributing toward the “greater good” of industry in a meaningful way by conducting a pro-bono, large-scale study of new technologies applied to the R&D process, and adoption of global submission standards from the International Committee of Harmonization (ICH). This provided “actionable” insights that each participant could immediately use in their operations and for long-term planning. We attracted 37 out of the top 50 largest biopharmaceuticals (by revenue) in our first study, and were quickly requested to “keep the research going” as it provided considerable value for the community.

Diverse experiences and the right culture provide more innovation possibilities I worked for several great companies that formed the basis of what we do today, from start-ups to long standing industry leaders. As a junior business systems analyst at Waterford Crystal/Wedgewood China, I merged the company’s financial and inventory systems. This was quite challenging; but it was the quality craftmanship and dedication to excellence in arguably the world’s best crystal that left a lasting impression on me.

While this differentiated us from the large, better-known consultancies, it was the strategic use of this benchmark data that would eventually help shape the regulatory transformation that exists in most organizations today that got us excited. 35 studies later and the core belief to “share widely” what you learn “with no strings attached” has made all the difference. Our 100 + clients regularly use this knowledge to inform their strategy, make the right investments, understand key trends and how their organization compares to others.

A decade at Janssen Pharmaceutical, a division of Johnson & Johnson, during a time of medicine innovation and exponential growth taught me the value of diversified thinking, risk-taking, the impact of technology innovation and leveraging the best in teams to collectively contribute. This was accentuated during my tenure as an executive at Booz

Utilize and support your community Sponsors, software/service providers, and health authorities all benefit from our studies. We take great responsibility to continuously improve so “everybody gets better.” Our goal is to enhance the performance of both industry and its’ providers, resulting in better information for patients and health authorities.

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We regularly tap into our community so the entire regulatory ecosystem can improve. For example, in the fall of 2015, we harnessed the perspective of 31 companies via global design sessions to create a “World Class Regulatory Information Management” standard that is the basis of our performance benchmark today. By facilitating this global “group-think,” we were able to provide valuable “actionable” information. Again, the entire community collectively improves. Golden Age of Innovation While most of the technology innovation in the last 20 years revolved around transactional systems and global collaboration, it is rapidly shifting to artificial intelligence, natural language processing, and robotics which will accelerate new drug submissions, patient empowerment, and global knowledge sharing. For regulatory organizations, we will see significant progress with regulatory intelligence and health authority interaction automation, reduction of cycle time in variation/label management, and the implementation of data standards over the next five years. Our role is to use the benchmarking platform to understand where organizations are having success in their innovation initiatives, the latest fads not worthy of investments, and learnings from experimentation. For those with an entrepreneurial spirit, I recommend spending time to reflect on what type of impact you would like to have, and how it would be valuable for your particular community. After a good mountain bike ride one fall afternoon, it occurred to me that my organization and assets were the entire Life Sciences community. How I would connect to the community and collaborate with them freed my thinking to always operate towards “what is possible for the greater good.”

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AS A RESEARCH COMMUNITY, WE MUST EMBRACE INNOVATION TO BRING BETTER TREATMENTS TO PEOPLE FASTER. DR. ANNE LINDBLAD, PRESIDENT AND CEO OF EMMES

Imagine a world where we could ask questions and discover answers as part of the day-to-day work flow of patient care. Imagine a world where someone with a newly diagnosed condition could be quickly triaged and receive the optimal therapeutic approach. Despite the fact that streamlined clinical research is not part of mainstream practice, there are signs of changes – changes that could signal a positive trend. Some stem from technological developments, while others relate to a shift in responsibility. For example, patient-based research that eliminates or reduces the need for physician visits is occurring in some settings through the use of wearables and electronic patient-reported outcomes. These approaches can be effective in low-risk studies with proper attention to privacy, confidentiality and a virtual informed consent process. Increasing the research mindset in our approach to patient care is of little value unless we can assimilate and manage the vast amount of information from our studies – and build it into the decision-making process. Artificial Intelligence (AI) is one answer, giving us a powerful platform to extend our ability to synthesize and interpret data. Increasing interoperability between and among medical health data systems will further extend our ability to access and combine large amounts of data, minimizing the need for de nova or repetitive data collection. The omics revolution, too, will build our understanding of disease to target potential preventative or therapeutic agents. If we’re able to collect data in a standardized and repeatable fashion – with full sharing – AI could assist in creating predictive models and searching for “best match” candidates. Thinking differently can make a world of difference in the care and treatment of patients. As a biostatistician and clinical trialist, I believe that scientific rigor, elimination of bias, and minimization of variability are the research drivers that lead us to truth. Thinking differently should not mean sacrificing these principles.

401 N. Washington St, #700 Rockville, MD 20850 United States +1-301-251-1161 info@emmes.com

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I BELIEVE TECHNOLOGY WILL HELP US CONQUER THE THREE PRIMARY TMF CHALLENGES – TIMELINESS, QUALITY AND COMPLETENESS. KAREN ROY, CHIEF STRATEGIC OFFICER, PHLEXGLOBAL

On joining Phlexglobal in 2007, and becoming immersed in the trial master file (TMF) space, I didn’t imagine that something that seemed to get so little focus (a TMF was really just a paper archive) could turn into such an innovative space. When I started, an eTMF was broadly an unknown apart from a few of the biggest Pharmaceutical companies, and the systems they used were disparate, with personalised TMF structures and limited remote access, if any. Roll forward 13 years and the world has completely changed. The first key innovation has to be the TMF Reference Model (TMF RM), of which I was honoured to be a founder, and which I continue to chair today. The TMF RM was driven out of a problem – there was no standardisation of the structure of TMFs, and today we have global adoption of the TMF RM as a standard – an industry driven initiative to standardize the content, naming and structure of Trial Master Files. This facilitated the world-wide adoption of eTMF technology, specifically cloud based to allow for remote access. The importance of the TMF has also been dramatically enhanced – especially by the MHRA who announced in 2011 that if a TMF did not meet the required standards, a critical finding could be issued. Every time a company runs a trial, it is mandated to have a TMF for documents that tells the story of the trial, and now the Regulators have a sharp eye on TMFs too. TMF processing and quality control has, until now, been a very manual process. The innovation we currently find ourselves surrounded by is machine learning and artificial intelligence. Our automation technology can auto index study documents and check their quality. This means that people can free themselves from repetitive, timeconsuming manual effort and focus their experience and knowledge on more critical study and compliance related tasks – a game changer for our industry. So where do we go from here? I believe technology will help us conquer the three primary TMF challenges – timeliness, quality and completeness. Data flows between systems coupled with automation will allow us, at the press of a button, to understand the compliance of our TMFs, and will direct the TMF owner’s attention to where it is most needed. Whilst the Pharmaceutical industry has been historically slow at adopting new technologies such as electronic signatures, it is clearly seeking the transformational benefits of new technologies such as AI. From first-hand experience among customers and industry peers, I believe that we are firmly in the midst of digital evolution. Global Headquarters Mandeville House 62, the Broadway, Amersham Bucks HP7 0HJ, United Kingdom +1-149-472-0420 info@phlexglobal.com Phlexglobal

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PATIENT-CENTRICITY AND TRIAL CONTINUITY IN TIMES OF CRISIS NICKI NORRIS, CEO, SYMPHONY CLINICAL RESEARCH

service—the convenience for patients eliminating the time and travel burdens, leads to higher overall satisfaction, increased retention and quicker enrollment. In addition, bringing trial visits directly to patients reduces the burden on trial sites, and may even reduce the overall cost of a trial. This year, we learned that one of our crucial offerings is that of a “plan B” to keep clinical trials active during a crisis. Many clinical trial sites were forced to shut down or delay their studies due to high numbers of COVID-19 cases and patients being anxious, or unable to travel to study sites during quarantine. By bringing a nurse directly to the patient, it reduces human contact in a typical study visit while protecting critical study drug administration visits or data/sample collection visits. In fact, we were able to do just that for one program we were contracted with, comprised of four (4) global studies evaluating the long-term safety and effectiveness of a study drug on a rare inherited disease that impacts the kidneys and other vital organs. For this program, we were already contracted to perform in-home visits including 24-hour urine collection, study drug administration via subcutaneous injection, body systems assessments, blood draw, and vital sign collection. Initially, we were contracted for later visits in the overall timeline of the studies. When the pandemic hit, we were able to accelerate our timelines and perform visits as quickly as three (3) days from the initial request. Because of our flexibility, no doses were missed from the start of the COVID-19 pandemic. Going forward, it will be important to integrate innovations like remote visits in all clinical trials, not only for the inherent benefit of patientcentric trial strategies, but also as a trial continuity tactic in times of emergency. In my opinion, all protocols, Informed Consent language and EC/IRB approvals should be written to allow for the flexibility of remote visits. By already being contracted for in-home visits, services can be enacted immediately without having to go through proposal timelines, contracting, and study-startup during a crisis.

This year, we’ve seen first-hand how important flexibility and innovation can be to keep a clinical trial running during times of crisis. In fact, the pandemic forced many pharmaceutical companies, CROs and study sites to rush to integrate study innovations in order to keep their studies active. Due to the COVID-19 crisis, study site costs increased 30% with much of the increase stemming from sites being forced to quickly adopt remote monitoring strategies. A Global Medidata survey of 1,000 investigator sites revealed that nearly 45% of respondents had switched study participants from in-clinic visits to virtual/telemedicine visits. This tells me that being ahead of the curve on new innovations in clinical research is not only important for business development, but it can be vital to business continuity.

Symphony Clinical Research 700 Deerpath Drive Vernon Hills IL 60061 United States +1-866-333-1550 info@symphonyclinicalresearch.com SymphonyCR Symphony Clinical Research

As the CEO of a patient-centric business bringing trial visits directly to patients in their home, there are many benefits of using our innovative

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WHAT THE POWER OF CONNECTED DATA CAN DO FOR CLINICAL TRIALS? SUDEEP PATTNAIK, FOUNDER & CEO, THOUGHTSPHERE

The pharmaceutical industry is responsible for countless innovations, and yet it is notoriously labor-intensive and expensive to bring these about. On average, pharmaceutical companies spend around $2.6 billion and five to seven years getting a single drug to market. And so ThoughtSphere has asked the question: How do we use the data available to increase the speed of decision-making, to make it faster for drugs to reach the patients who need them, and to add to the bottom line of all stakeholders? For us, the answer has been to stitch together the data to give our clients what they need: better clinical trial monitoring and risk management, better information for the FDA, and better explanations for the patient as to what the risks and benefits are for a particular study. The next-generation technology stack that is able to do that is already here: AI, machine learning, IoT, and so on. As a technology innovator, I’m particularly fascinated by this process. By connecting data to identify problems remotely and by using modern technologies to actively look for signals and patterns, the pharmaceutical industry could be massively different in the future. At ThoughtSphere, we’re building toward a model where everything can be analyzed in real-time and where we can anticipate and work on challenges instead of waiting for them to happen and then reacting.

The remote monitoring and offerings that ThoughtSphere provides are ushering in this change to make a significant difference for the future, but none of this is particularly easy to achieve. The sheer number of stakeholders involved in clinical trials means a high number of obstacles, and with the rise of telemedicine and e-consent, there comes the issue of data privacy and security, which we take very seriously and build our offerings upon. I see, for example, a future where a patient can use social media to learn about the clinical trials available, and the risks and benefits of each of those studies before they join—and of course, from their own device. They’ll also be able to provide e-consent because even getting to the doctor to provide consent is another way the entire process gets slowed down. To bring about a future of decentralized trials, a future of a hybrid approach that speeds the process, two main things are needed:

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cooperation among all stakeholders; and sustained innovation. The objective should be to get safe drugs to market as quickly as possible, but without connected data, it’s like you’re building a house without a blueprint. ThoughtSphere is working to draft those blueprints in order to disrupt the industry and add value where it’s needed most.

ThoughtSphere 2445 Augustine Dr. Suite 150 Santa Clara California 95054 United States +1-916-622-6444 Thought_Sphere thoughtsphere-inc

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WHY BEING THE DUMBEST GUY IN THE ROOM CAN BE HELPFUL BOB BEAN, PRESIDENT AND CEO, TRANSNETYX I have spent the last 20 years helping build a genetic testing company. We have been on the forefront of high throughput/low price testing and have automated all of it through generations of tech development. We lead our industry segment and are building some remarkable new products as we grow. Interestingly I have spent these 20 years being the dumbest guy in the room. Surrounded by individuals who are well educated in Biomedical Engineering, IT, Molecular Genetics, Chemistry and Finance has been quite an education. The reality that I have made any contribution is my biggest surprise. I have two degrees in Music, zero scientific knowledge, and was not required to take a math class after Algebra II, so I didn’t. From a technical perspective I offer little or no value. However, it turns out the role I have played is more of a conductor. Being a musical conductor is a blend of motivation, real time diagnosis, inspiration, conflict resolution (musically and personally), correction, and most importantly, listening. I learned to stand in the back of a room and listen to the “outcome”. For instruments, the oboe and the cello sound beautiful together, but they must be balanced. How the audience hears the harmony and the blends comes into play as well. The same can be said for voices. If the audience is hearing too much alto, there needs to be a correction. Getting thirty, hard-working, volunteer Altos to “pipe down” without them walking out is a bit of an art. This has been my experience in the world of high throughput genetic testing. The most elegant automation and efficient robots in the world do not mean a thing if the customer is not being served. Often in the world of extreme technical proficiency, it is not only helpful for the CEO to be a generalist, it’s critical. I have seen many scientific businesses struggle because the inventor fell in love with their discovery and then tried to find the market for it. Great businesses meet market needs and satisfy customers, even if it means the core technology of their business has to change. Our original technology never made it into production. If we had not switched to a commercially available option, we would not be in business today. I remember those conversations and how personally invested one of our folks was. How they fought for the novel technology even when failure was obvious. Being unaware of every technical aspect at that time was a blessing. When serving the customer comes first, the work boils down into a few simple playground rules. It makes complex and intricate things easy to understand. It helps you ask questions that keep priorities simple and clear. Most of the time being a C student is not good. But I have found that it’s the one thing that made it possible for me to keep my job.

8110 Cordova Rd Suite 119 Cordova TN 38016 United States geneticservices@transnetyx.com +1-888-321-2113 Transnetyx

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BUILDING THE NEXT GENERATION OF CLINICAL TRIALS MARK HANLEY, CEO, VIRTRIAL

Modernizing the clinical trials industry has long been a vision I’ve held. During more than a decade of leading the largest network of clinical trial sites, I’ve seen first-hand the challenges of recruitment and retention in clinical trials, which has afforded me the opportunity to envision new solutions for existing challenges. The undeniable results of incorporating technology into traditional processes across other industries has demonstrated a need to adopt modern solutions in clinical research. By incorporating thoughtfully designed technology into the process we can enable increased speed to market while significantly reducing the cost. The introduction of telemedicine platforms to offset some clinical trial visits with virtual visits has been only lightly considered these past few years, but not implemented due to the perceived risk to patient safety and quality data collection outside of a brick and mortar clinic. Due to COVID-19, however, what was once perceived as risk is now the exact risk mitigation strategy and the resulting necessity for alternative solutions that enable trials to continue has accelerated telemedicine’s adoption. Fortunately, the needs of patients and sites are generally aligned – efficiency, convenience, and safety are key for both groups, and I anticipate its adoption will continue after the pandemic. For the industry to successfully evolve, clinical research sites must understand they’re in the midst of a transition, and that they’re not only critical in facilitating the adoption of technology, but also in helping patients navigate through this transition as well. Sites will remain the center of trials even as the new normal adopts hybrid decentralized clinical trial (DCT) protocols. CROs and sponsors will need to recognize where a site is on its digital journey and recognize that some sites will need more time to adopt new systems than others. The support and guidance of these CROs and sponsors will be critical in making this transition seamless and in determining the speed of adoption based on their inclusion of DCT elements within study protocols. Virtual site monitoring will also become pervasive over the next several years. An enhancement to remote site monitoring, virtual site monitoring enables zero-touch Clinical Research Associate (CRA) visits through the use of wearable, eyeglass technology worn by a site coordinator. The technology transmits a live HD-video stream over a secure platform to the laptop of a remote CRA. This innovative approach to site monitoring frees CRA’s from the burden of travel and enables sponsors and CROs to complete zero-touch site selection (SSV), site initiation (SIV), interim monitoring (IMV), and close-out visits (COV). When all involved parties are aligned and working collaboratively with these and other new technology options, the benefits of improved agility and decreased patient burden will move trials forward much quicker – a long term win for the industry and the patient population at large. VirTrial 7047 E. Greenway Pkwy. Suite 190 Scottsdale, AZ 85254 Scottsdale AZ 85254 United States info@virtrial.com +1-480-462-2222 virtrial virtrialapp

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LEADERSHIP IN THE TIME OF A PANDEMIC DONALD A. DEIESO, PHD, CHAIRMAN & CEO, WCG

While some in the clinical trial arena are reacting desperately to the changing landscape, the best leaders are finding what works and prioritizing it. They are using the COVID-19 moment to improve and remembering what really counts. “This is a moment in which doing what works must become a priority.” I spoke these words in April 2020 in an interview for Clinical Leader. The quote came in response to a question about the reaction of those in the clinical trial space and the impact the COVID-19 pandemic has had on their professional world. But how do we know what works in the time of a pandemic, let alone prioritize it? There are no guidebooks, no reference material for what to do and what not to do. From my position as chairman and CEO of WCG, I see a frantic search to find anything that works in the quest to protect patient participants. Yet this is a time when true leaders are emerging in the clinical trial arena. They recognize that communication is everything. Take biopharmaceutical sponsors, for example. Leaders of those organizations are closely monitoring their clinical trial sites. If a site does not have staff available to communicate with patients, the sponsor should be willing to help the site gain access to a HIPAA-covered clinical service provider. The best leaders are using this moment to improve – now and for the future state of the industry. The clinical trial ecosystem of sponsors, clinical research organizations (CROs), sites, and patients is depending on leadership to take it forward. Clinical trials will never be conducted the way they were pre-pandemic. It is unlikely that brick-and-mortar clinical trial model – with patients visiting sites – will ever come back to prior levels. True leaders recognize that many of the changes we are making now to accommodate the pandemic will most certainly become the norm. And they are planning accordingly. COVID-19 is not merely a speed bump to get over. We are being taken to a new plateau where we will have to play by a different set of rules. The interim solutions being implemented today will give way to more durable systems that capitalize on the innovation this moment has required; more structured applications that will be implemented and configured with other systems. Opportunities exist for CROs that their leaders must identify and react to. For instance, clinical research associate shortages exist in part because they are being pulled to local hospitals and sites to assist with COVID-related priorities. We are now seeing that the nature of their jobs can be tempered by having them successfully perform site visits remotely via Telehealth. Finally, the best leaders know that some things should never change – namely, the passion for improving the clinical trial process and doing what’s right for patients, no matter what. The human-centric approach to problem solving is more important than ever.

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CONSIDER THESE TWO LEADERSHIP LESSONS FOR CLINICAL TRIAL SUCCESS JILL JOHNSTON, PRESIDENT, STUDY PLANNING AND SITE OPTIMIZATION DIVISION, WCG Flexibility and attitude are key factors. As the investigational landscape begins to open up against the backdrop of COVID-19, it’s doubly important to lead by example – and know why you do what you do. Leadership does not come easy even during the best of times, let alone during an unprecedented pandemic that has upended the clinical trial space. Yet unwavering, calm and decisive action is needed now more than ever. As president of the Study Planning and Site Optimization Division at WCG’s Clinical Services Organization, I see every day what it takes to successfully navigate the clinical trial landscape. Back before COVID-19 emerged, our industry faced many challenges. While many of those complexities remain, we’re now facing issues we never imagined or considered. As we deal with the aftermath of shutting down or pausing activity in the first half of 2019, key stakeholders in the clinical trial space are trying to figure out how to re-engage, especially now that recovery is commencing. The key is flexibility. Leaders who are flexible typically come out of a crisis with their organization relatively unscathed and on the right path. It’s time to drill down on current trials and look at ways to minimize interruptions as regions around the country recover. Investigational sites should examine each of their trials. Look for potential trouble spots to address now, before trials resume. Don’t wait to identify problems once you turn a study back on. Think through the different pieces now.

Leadership and attitude are not something to be turned on just in the middle of a crisis. They apply every day to the business we are in. When I start each workday, I think about getting life-saving drugs to patients as quickly as possible. As the day unfolds, my thought process naturally turns to the nitty gritty of clinical operation efficiency, which is how I help the sites reduce the time it takes to enroll patients into trials. But doing right by patients is always on my mind. This is why I am committed to helping sponsors and sites reduce the time and cost of the clinical study start-up process.

In addition to flexibility, attitude is critical. An organization defined by positivity even in the midst of a crisis is better suited to navigate the trouble spots. A positive attitude starts from the top. These are not easy times, but people with the right mindset can do incredible things to speed up the clinical trial process. And now is the time for teams to innovate, adapt, and lead to the future.

Because I know patients depend on it.

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CHAPTER 7