The 10 Most Innovative Pharma and Biotech Solution Providers, 2020 September 2020 by Insights Success Media

VOL 09 | ISSUE 08 | 2020

The 10 Most Innovative

Pharma & Biotech

Solution Providers,

2020

FRONTAGE LABORATORIES

Solving the Most Complex Drug Discovery Challenges

Editor’s Desk

Pioneers of Pharma and Biotech

s the novel coronavirus continues to spread, scientists and researchers are working day and night to identify diagnostics, therapeutics and vaccines to help protect individuals and communities across the globe. Leaders within the biopharmaceutical industry are stepping ahead across the world to insure the safety of people and promising help is on the way. In the present condition of our society, bioanalytical tools and technologies are playing a crucial role to make it functional eﬀectively. But there are few technologies which are becoming trend and reducing spread of corona while helping business to stay open. These technologies are making society more resilient in the time of pandemic and may have a long-term impact beyond COVID-19.

Protecting the world in times of crisis

In its upcoming edition “The 10 Most Innovative Pharma and Biotech Solution Providers, 2020” Insights Success is bringing a list of pioneer/leading companies which vision to make the world a healthy & happy place to live by enhancing the quality of pharmaceutical & biotechnology products. The cover features Frontage Laboratories, is a value-added partner with a focus on solving its customers’ most signiﬁcant and complex drug discovery and development challenges. The organization’s scientiﬁc knowledge base, technical expertise and reputation for high quality services have been integral to its ability to enter into strong long-term strategic relationships and partnerships with its key customers. Frontage is closely monitoring the outbreak of COVID19 and

following guidance from the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and other public health and government agencies. “We are committed to ensuring the health, welfare and safety of our employees and to the best of our ability continues to the delivery of our services,” says the company. The edition features Metrendalytics as company of the month. Metrendalytics is a Pharmaceutical consulting services and software development company focused on helping pharma/biotech clinical operations and CRO’s laboratory operations centralize operational data for real-time use. The company utilizes cloud-based, scalable, modular, rapid development, and low-cost platforms which are analytics and visualization enabled. The key to success is its software combines existing internal and external data into a single platform allowing customers to gain efficiencies and make faster, more informed decisions. As a result, the firm helps transition a business from a process that is reactive to one that is more proactive. Also, while flipping the pages, don’t forget to go through the articles and CXOs written by our in-house editorial team and industry experts respectively.

08 FRONTAGE

LABORATORIES Solving the Most Complex Drug Discovery Challenges

22 3Scan

Digitizing Tissue in 3D

Company of The Month

METRENDALYTICS

Combining Knowledge and Technology to Bring EfďŹ ciency in Business

A Sweeping Wave of Big Data Innovation in the Pharmaceutical Industry

ClinCapture

Article

Pros & Cons Mobile Healthcare Applications: Treating People Anytime, Anywhere.

CMIC Inc.

Leading Treasure in Healthcare Industry Especially in Pharmaceutical Sector

Golden Helix

Helping Researchers and Clinicians Understand the Role of CNVs in Human Health and Disease

Janrain

Pioneering Digital Identity Solutions for the Healthcare Industry

Peachtree BioResearch Solutions

Determined to Deliver Flexible, Reliable and Scalable Clinical Development Services

44 ÂŽ

Triox Nano

Pioneers in point of care programmable medicine! presenting the next healthcare revolution!

Editor-in-Chief Pooja M. Bansal Managing Editor Anish Miller

Executive Editor

Assistant Editors

Rohit Chaturvedi

Jenny Fernandes Rohit Chaturvedi

Visualizer

Art & Design Director

Associate Designer

David King

Amol Kamble

Iresh Mathapati

Co-designer Kushagra Gupts

Senior Sales Manager

Business Development Manager

Kshitij S

Andy Mitter

Marketing Manager

Sales Executives

John Matthew

David, Kevin, Vishnu

Technical Head

Business Development Executives

Jacob Smile

Steve, Joe, Alan, Anup

Technical Specialist Aditya

Digital Marketing Manager Marry D'Souza

SME-SMO Executive Amol Wadekar

Research Analyst Frank Adams

Database Management Stella Andrew

Circulation Manager Robert Brown

Technology Consultant David Stokes

sales@insightssuccess.com September, 2020

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COVERSTORY

Song Li Founder

“

“Our commitment to investing in highly

trained and experienced scientists, stateof-the-art facilities and instrumentations, and a strong commitment to operational

excellence will allow us to deliver results that meet or exceed our customers' needs.”

- Song Li

FRONTAGE LABORATORIES

Solving the Most Complex Drug Discovery Challenges

rontage Laboratories, is a value-added partner with a focus on solving its customers' most significant and complex drug discovery and development challenges. The organization's scientific knowledge base, technical expertise and reputation for high quality services have been integral to its ability to enter into strong long-term strategic relationships and partnerships with its key customers. The company immensely gets benefited from having operations in both the United States and China (the two largest markets for CRO services in the world) and are well placed to capture growth opportunities in both markets. Frontage's “Two Countries, One System” approach is integral to its commitment to high quality standards. This approach assures the company's customers the same quality standards, operating procedures and systems in both China and the United States, whilst also providing its customers with a detailed and highly experienced understanding of the regulations and requirements for drug discovery and development in both countries. This approach enables Frontage Laboratories to be a partner of choice for companies with multinational requirements or companies that need support for parallel submissions with the US FDA and China FDA. In an Interview with Insights Success, Frontage Laboratories' spokesperson has shared many details, which has made the organization a true global leader. Below are the highlights of the interview; What led to the inception of Frontage Laboratories, Inc? Our origins date back to 2001 when our founder, Dr Song Li, set up a testing laboratory in Thorofare, New Jersey with an ambition to build a customer-focused organization to help pharmaceutical companies overcome their complex drug development challenges through an outsourced solution. Over the past 19 years Frontage Laboratories, Inc, has grown to one of the leading CRO's with over 850 employees in both North America and China. Describe Frontage Laboratories, Inc. and its cutting-edge services which address all the needs of its customers. Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies.

COVERSTORY

Drug Metabolism and Pharmacokinetics (“DMPK”) We offer standard and customized in vivo and in vitro DMPK services. This includes pharmacokinetic (“PK”) and pharmacodynamics (“PD”) studies throughout the development process. We also offer ADME studies. For the discovery phase, we also offer PK screening and characterization to enable structure optimization. We also offer metabolite identiﬁcation in different animal species, Metabolites in Safety Testing (“MIST”), drugdrug interaction, and radiolabeling studies.

Safety and toxicology We offer clients and extensive range of safety and toxicology services, including large animal testing, to our customers for the ﬁrst time. These services include non-GLP and GLP toxicology studies to support regulatory submissions such as INDs. Additional toxicological assessments include pathology, ophthalmology and cardiovascular studies. We also offer chronic toxicity and investigative toxicology studies, carcinogenicity studies and support for additional indications. We also assist with the development of safety and toxicology testing plans, mainly for the pre-clinical stage, with the goal of identifying the pharmacological and toxicological effects of drug candidates.

Bioanalytical Our bioanalytical services include non-GLP research based and GLP assays (both in vivo and in vitro) for small and large molecule drugs and biomarkers throughout the drug development process as well as immunogenicity and neutralizing antibody assessments. These assays support ﬁrst-in-human dose justiﬁcations and Investigational New Drug (“IND”) packages for pharmaceutical therapeutics. We provide method development and validation services in addition to sample analysis services to assess pharmacokinetics, immunogenicity and pharmacodynamics effect.

Chemistry, manufacturing and controls (CMC) Our portfolio of CMC services spans drug discovery to the post approval phase, including lead compound quantiﬁcation and analytical testing for the discovery phase, formulation development, GLP toxicology batch studies, release and product testing, stability testing, CTM and Good Manufacturing Practice (“GMP”) manufacturing, extractability and leachability studies and commercial product release following approval of an application.

Clinical Services With over 20 years' experience in the execution of comprehensive Phase I-IIa studies, the Frontage Clinical team collaborates closely with our clients to develop a unique approach to overcome the challenges of each study, while maximizing efﬁciency and mitigating risk. We leverage our best practices in study design and execution to advance investigative compounds to drug candidates. Located near NYC, we have access to one of the most diverse study populations and acclaimed medical professionals and facilities to help support each study.

Bioequivalence We provide bioequivalence (“BE”) and related services (such as medical writing and regulatory support) in China. Bioequivalence is the term used to assess the expected in vivo biological equivalence of two preparations of a drug. Bioequivalence is generally deﬁned as the absence of a signiﬁcant difference in the rate and extent of which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administrated at the same molar dose under similar conditions in an appropriately designed study. These services are currently provided by us in China from our facility in Zhengzhou, Henan, and 17 clinical research centers in our collaborating hospitals in China. Focus on product development on clients' needs then the services are one stop shop – list services in product development

COVERSTORY Give a detailed description of the featured person's inﬂuence over Frontage Laboratories, Inc. and the industry. Dr. Song Li founded Frontage Laboratories in 2001 with the ambition of building a client-focused organization to help solve the most complex drug development challenges. Prior to Frontage, Dr. Li held management positions at Great Valley Pharmaceuticals and Wyeth. During this time, he led numerous projects related to the development of pharmaceutical products. Dr. Li has authored more than 15 scientiﬁc publications spanning a wide range of topics, including chiral separations, drug-protein interactions, pharmacokinetics, and analytical chemistry. Importantly, Dr. Li has been the recipient of numerous awards, most recently Healthcare CEO award from Philadelphia Alliance for Capital and Technologies, Ernst & Young Entrepreneur of the Year Award, the “Realizing the American Dream” award from the Pennsylvania Welcoming Society, and the Outstanding 50 Asian Americans in Business Award from the AABDC. Dr. Li earned a Doctor of Philosophy degree in analytical chemistry from McGill University and a Bachelor of Science degree in chemistry from Zhengzhou University in China. What measures are you taking to prevent the outbreak of COVID-19, amongst your workforce? Frontage is closely monitoring the outbreak of COVID19 and following guidance from the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and other public health and government agencies. We are committed to ensuring the health, welfare and safety of our employees and to the best of our ability continue to the delivery of our services. Given the rapid spread of COVID-19 and its proximity to our communities, we have implemented the following measures, in which we believe are in the best interest of our workforce and operations, to minimize, as best as we can, the risk of our employees' exposure to COVID-19, and the likelihood of its spread to the members of our community while striving to maintain the continuity of our business operations. Ÿ

We have established an internal situation management committee and dedicated resources to

help our organization to navigate through the immediate challenges presented by the evolving COVID-19 outbreak. We have continuity plans in place to prepare for events as they occur and to meet the needs of employees and clients. We have instituted business travel restrictions that apply to our employees, contractors, suppliers and vendors. We have worked with our facilities teams to employ additional disinfecting and cleaning procedures in all facilities. Frontage has donated RMB 1M to Wuhan through Red Cross Society of Shanghai in order to support the prevention and control of novel coronavirus epidemic. This donation helped to purchase urgent medical supplies such as protective clothing, respirators, goggles and disinfectants, as well as supporting the construction of hospitals that used for the treatment of patients infected by novel coronavirus pneumonia in Wuhan and surrounding areas

To enable our delivery of services during this dynamic situation, we emphasize the need for open lines of communication about potential challenges as a result of the current COVID-19 outbreak. We encourage you to regularly connect with your respective contacts at Frontage. Is it possible to find a cure of COVID-19 virus by the end of the year? Many of our leading Pharmaceutical partners are committed to proactively developing anti-COVID-19 virus products. Frontage is honorably supporting several of these programs and clinical trials. We have seen extraordinary commitment from the industry as a whole and as a result we believe it is very possible to have new therapeutics available by the end of the year. As a leading laboratory and agrochemical services provider, what contribution has been made by you? We are a value-add partner with a focus on solving our customers' most significant and complex drug discovery and development challenges. Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to enter into strong long-term strategic relationships and partnerships with our key customers.

Over the years, Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and ﬁle regulatory submissions globally. Describe in detail about the work culture and the values that drive Frontage Laboratories, Inc. Our Purpose: To improve quality of life Our Vision: To be the preferred partner of life science leaders in product development Our Core Values Quality: We are committed to excellence in the results we achieve, and how we achieve them. Integrity: We believe in honesty, reliability and accountability in our words and behavior. Innovation: We employ new scientiﬁc approaches, technologies and processes to provide innovative solutions to challenging problems.

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“We believe this approach—where we are positioned as a value-add partner—differs from standard CROs, who focus on offering a variable-cost alternative to their customers' internal product development functions and support their customers on their routine work.” - Song Li

What are the future aspirations of Frontage Laboratories, Inc.? What strategies are you undertaking to achieve those goals? Frontage Laboratories will continue to grow its capacity and capabilities both organically and through mergers and acquisitions as appropriate. In just the last six months, the company has expanded its footprint in both North America and China, acquiring a majority share position of a CMC group in China and setting up new labs in both China and North America to accommodate growth in the CMC and Bioanalytical areas. Along the same lines, Frontage Laboratories will continue to look for opportunities that will enhance its end-to-end discovery and drug development services. What is your idea of Corporate Social Responsibility? Frontage engages in local community activities in order to promote its community commitment and value to the community. Our strategy is to establish partnerships with local non-proﬁt organizations (Autism, Breast cancer, any other signiﬁcant charity).

COVERSTORY How are you solving your customers' complex drug discovery challenges? Integrated CRO operating in a large and growing market and well positioned to capitalize on strong industry growth drivers, especially in China We provide integrated, scientifically-driven research, analytical and development services in the United States and China - the two largest pharmaceutical markets in the world. Our “Two Countries, One System” approach enables us to be a partner of choice for pharmaceutical companies with multinational requirements, which we believe could uniquely position us for the outsourcing demands from foreign companies entering China as well as Chinese pharmaceutical companies expanding into the United States. Proven ability to deliver value-add technical expertise because of our deep pool of talented scientists and world-class facilities and equipment We believe that we deliver high quality services through our focus on technical excellence, which enables us to understand and solve complex scientific challenges (such as challenges in drug formulation, data interpretation and bioanalysis). Our facilities and equipment enable us to deliver results that meet our customers' needs. Each of our facilities is equipped with state-of-the-art equipment, which includes over 80 mass spectrometers across our facilities and high-performance chromatography systems. We aim for our facilities and equipment to remain at the forefront of the global pharmaceutical research, analytical and development standards. Effective quality management systems and strong track record of regulatory inspections

We have a strong track record of successful regulatory inspections. Our facilities have successfully undergone inspections by the US FDA, NMPA and Health Canada on numerous occasions. In addition, our facilities have also been inspected by the US EPA, the US Drug Enforcement Agency (“DEA”), the World Health Organization (“WHO”) and the US Nuclear Regulatory Commission (“NRC”). None of these inspections have resulted in any materially adverse issues being identified. Highly experienced and professional management team Our highly skilled and experienced management team possesses extensive knowledge of the markets in which we operate. Most of our senior management team have experience with leading global pharmaceutical companies and an in-depth understanding of our markets and the requirements of our customers. Almost all members of our senior management team possess a scientific background with a PhD and/or MD in their relevant field. They also regularly contribute to peerreviewed industry publications and journals as well as present at national and international scientific conferences. Our deep pool of talented and highly qualified scientists is integral to our business. The majority of our scientists held advanced degrees, including PhDs, MDs or Master's degrees. In addition to being highly qualified, our scientists are regularly trained on new scientific and regulatory developments and frequently participate in academic activities. A number of our scientists have expertise across a range of disciplines, that enables them to perform and manage a wide variety of tasks across our various business units. This helps us provide flexibility in allocating resources to our customers and maximizes our productivity. We believe that the depth of our scientific knowledge base is a key strength and the foundation of our reputation and competitive position in our markets.

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Pharmaceutical services consulting and software

Jan Miotto President Metrendalytics

development company, focused on helping both pharma and CRO's

centralize operational data for real-time use.

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Company of The Month

METRENDALYTICS Combining Knowledge and Technology to Bring Efﬁciency in Business

etrendalytics was founded by scientists, for scientists. Our goal is to provide integrated solutions which provide a consolidated view of all of one's operational data—whatever the source—on one shared platform for faster interactive collaboration and client service with reduced risk. Metrendalytics recognizes that companies need a platform to create comprehensive efficiencies across project planning and execution with built-in analytic tools that are easy to implement, are highly customizable, and cost-effective. To enable this transformation journey to optimize “running the laboratory business” with technology requires innovative business solutions uniquely designed and customized around a company's specific business model and processes. Metrendalytics works to understand and build systems to meet the unique process needs of each company. Then we enhance the resultant process efficiency with corresponding operational dashboard views with automated data integration, aggregation, and signal detection in interactive visualizations, which allows for centralized views and remote monitoring of project performance in real-time. Reviewers are able to zero in on signals and trends that could affect operational performance and make smarter decisions sooner about how to deploy resources. This eliminates error prone, redundant entry and information update lag time associated with typical business management via various spreadsheets used for tracking of these activities which are a basis of vast inefficiencies. As a result, companies are essentially road blocked in the ability to unleash the power buried in their operational data. Metrendalytics' solutions have been presented at multiple pharma/biotech meetings and conferences over the years. Many of these presentations were from its customers. Most recently, it was featured in a Bioanalysis Zone article on how Metrendalytics' remote access solutions helped businesses continue and thrive through the Covid-19 pandemic.

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Extensive Service Offerings Metrendalytics is a Pharmaceutical consulting services and software development company focused on helping pharma/biotech clinical operations and CRO's laboratory operations centralize operational data for real-time use. The company utilizes cloud-based, scalable, modular, rapid development, and low-cost platforms which are analytics and visualization enabled. The key to success is its software combines existing internal and external data into a single platform allowing customers to gain efficiencies and make faster, more informed decisions. As a result, the firm helps transition a business from a process that is reactive to one that is more proactive. The laboratory tools and technologies in the bioanalytical laboratory have evolved and changed. However, leveraging real-time business data to make more informed decisions has seen limited progress. Further, additional time is required to manually create plots and metric reports to be used for analytics and process improvement initiatives. As a result, less time is available for analyzing data to improve business outcomes, customer service, and risk reduction. Metrendalytics' software integrates the information from existing software like Salesforce, Watson, NetSuite, etc and incorporates these into a suite of applications to centralize from proposal creation, award, and management of milestones and deliverables through QC, QA, and reporting. This provides a “one-stop-shop” for all critical business functions and data so that each stakeholder has what they need to efficiently complete their part. This means laboratory and management personnel can spend more time doing science and serving customers instead of chasing data and re-entering information. Passion and Expertise Jan Miotto, President of Metrendalytics, had a successful career in the drug development industry because of her ethics of hard work and wanting to make things better for the industry. This, along with a lifelong passion to learn and apply new technologies is what drives the success of Metrendalytics. She has assembled a group of like-minded successful individuals who work together with the goal of making customers successful. September 2020 | 19

Jan focuses on being authentic and bringing value every day and trying her best not to keep a fixed mindset in order to be able to explore new opportunities. Jan says, “If you wait for things to be perfect, you can miss opportunities.” She brings a mindset to never stop adapting. For Metrendalytics, experimentation has helped them reach a product-market fit. Driving Improvement by Knowing Your Customer Metrendalytics' culture is to really partner with its clients to help take them to the next level. “We work with our customers to understand their business, their pain points, and where they want to be in the future,” says Jan. Being knowledgeable in the industry allows the company to understand each client's specific situation and allowing it to be flexible to design the tools they need to be successful. The goal is to add value and transparency to all levels of the organization. Metrendalytics aims to improve the “life of the scientist in the laboratory” by providing tools to leverage already existing information. It helps mid-level managers drive improvement gains through automated capture of metrics and trends. It also provides senior-level executives up to the minute visibility to their entire portfolio to understand the current status of their projects and where action is needed to keep programs on track. By being more efficient with information, the company helps all levels of the organization perform better to help take time and cost out of the drug development process. Current Crisis and Future Opportunities Metrendalytics has always been at the forefront when it comes to how it uses the information to improve business results. It will continue to do so in the future. The recent Covid-19 pandemic has accelerated the adoption of cloud-based and remotely accessed information systems. The company will build on its past success in this area to develop new and expanded capabilities to meet the full-service needs of

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its customers. The company asserts “Our low cost, rapid development model also makes replacing some of the disconnected and more expensive “point solution” systems possible.” Metrendalytics continues to build a network of experienced, results-oriented subject matter experts in the laboratory, drug metabolism, and chemistry manufacturing and controls. This expanded knowledge base provides access to new markets and the opportunity to leverage its technology to benefit these areas. Socially Responsible Metrendalytics is active in Corporate Social Responsibility including philanthropy, environment conservation, diversity and labor practices, and volunteerism. As a company, Metrendalytics is diverse and designated as a femaleowned, minority business and some of its partners are also minority-based. It has donated time and resources to start-up groups and technology companies that share the same passion for data and using that data to build the next-generation laboratory or improving upon existing technology to help the day-today work life of the scientist. On Drug Development Challenges Drug development is a long and costly process typically requiring approximately 10 years and hundreds of millions of dollars. By developing solutions that reduce this time and cost, Metrendalytics not only saves money for customers but also helps get products to market faster. As a result, the public has access to potentially life-saving medications sooner. This in turn provides a revenue stream for the pharma company to reinvest in future drug development. For CROs, where the name of the game is efficiency and value, here again, Metrendalytics helps to improve both of these. The more efficient the resources are in a CRO, the more projects can be completed, which accelerates drug development as noted above. It also means better profitability and stability for the CRO. For both CROs and pharma biotech companies, the time saved translates to more focus on the actual work of drug development instead of time wasted collecting and managing information. That time saved can then channelled into value-added activities like quality control, assessment and impact analysis or actions or innovations to improve the outcome. Testimonials from Clients “Jan and her team at Metrendalytics collaborated with our www.insightssuccess.com

team at Alturas Analytics to create a total customized information management system that organizes and manages client information, data and resource management. The system has improved productivity, efficiency and compliance in our bioanalytical CRO. Thank you Metrendalytics!” -Shane Needham, Co-Founder and Chief Scientific Officer at Alturas Analytics, Inc. “Immunologix Labs is accelerating our bioanalytical service delivery to the technology forefront with the Metrendalytics initiative. The platform will be our primary driver for industry-leading efficiency, organization and client experience. It will provide the architecture to seamlessly ensure consistent, high-quality, on-time performance for our clients. We are very enthusiastic about our partnership with Jahanara (Jan) Miotto and the team at Metrendalytics" -Michael Anderson, President and Chief Executive Officer at Immunologix Laboratories “We are on an exciting journey with Metrendalytics in moving from a paper heavy lab to a paper-lite lab to a paperless lab, which will enhance the efficiency of the entire laboratory process, leading to a dramatic overall cost reduction in operations and a better way to work for everyone. Many thanks to Metrendalytics in bringing our vision into reality” -Luca C Matassa, VP and Head of Bioanalytical at QPS Laboratoriese operational data for real-time use”

September 2020 | 21

3Scan

Digitizing Tissue in 3D

edical science has made incredible advances in modern times. However, the ﬁeld of anatomic pathology has remained largely static since the 19th century. It is regarded as an artisanal practice – manual and qualitative with little attention given to automation or computation. In recent decades, though, pathology has shown immense growth potential, not only in its methods, but also in its role in the understanding, development, and diagnosis of disease. Diseases faced today are more complex and therapeutics potentially more precise, requiring more nuanced investigations and even better platform to explain the issues. Platforms developed in recent years through technological advancements have empowered the healthcare sector. 3Scan is amongst the prime examples of companies leading this push. The company’s 3D tissue imaging platform improves the comprehensiveness of investigations in the same way gene sequencing revolutionized genetics. The company believes that every biopsy, sample, or specimen should provide broad, spatially-indexed information to further medical innovation and improve clinical outcomes.

Todd Hu man CEO & Co-founder

This computer-aided technique further maps related microenvironment structures and produces detailed 3D representations of anatomical structures, and supports the emerging ﬁeld of computational pathology throughout the procedure.

It envisions a transformation of how scientists and doctors understand anatomy. 3Scan supports both translational medical research, and the biotechnology industry in its quest to create new diagnostics and novel therapies.

The Pursuit of Biotechnological Innovation Todd Huﬀman is the CEO and Co-Founder of 3Scan. Prior to joining the company, he worked for DARPA (Defense Advanced Research Projects Agency) on advanced technology development in post-disaster stabilization.

Detailed Representation of Anatomical Structures A San Francisco-based startup, 3Scan uses revolutionary technology that digitizes entire tissue samples through serial sectioning and simultaneous high-resolution image capture. The procedure enables them to compute metrics and apply mathematical models with a high degree of precision.

Todd’s background is in complex technology innovation, particularly in the domains of collection and organization of data. He has a deep interest in mapping the human brain. His scientific bent has driven the unceasing innovation efforts at 3Scan. Todd hopes to help digitize tissue samples in support of scientific discovery and the progress of biotechnology.

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A Revolutionary but Complex Idea Timing is the most essential factor when introducing a new product or an innovative idea. As a concept, 3Scan was specially designed for the pharmaceutical industry five years before the company was officially established. The time delay was to allow for the IT industry to lower prices on compute, transport, and storage technologies, as 3Scan’s techniques push the limits of what’s possible on data creation. The 3Scan robots can collect up to 50 terabytes per robot per day, so the trends in performance on processors, networking, and hard drives have only recently made 3Scan’s approach viable. The company has been developing its products in translational research and drug development scenarios. The pharmaceutical industry implements cutting edge technologies before the clinical markets due to lower regulatory barriers and more technology progressive workflow philosophies. Thus its focus is on being patient and thoughtful with product design to fit the evolution of underlying technology, application requirements, and market maturity. Automating and Digitizing Pathology Anatomic pathology is an antiquated discipline, filled with highly manual, time-intensive processes. 3Scan is automating the process of slicing and imaging; by removing the human hand, it speeds up tissue analysis 100-fold. The idea is to look at these tissue slides in the context of an entire organ. A 3D view of, for example, the microvasculature of a tumor helps in observing the effects and efficacy of drugs. This process takes days and while it can show the microanatomy of a cell, very little can be discovered about how that cell fits within the greater tissue structure.

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3D reconstruction of Murine brain vasculature modeled from 1,200 serial sections

3Scan, by contrast, is working on automating and digitizing the crosssection of tissue in its original structure, without the human factor to slow things down or introduce errors. The idea is to look at these tissue slices in the context of an entire organ. 3Scan is automating the process of slicing and imaging; by removing the human hand, it speeds up tissue analysis 100-fold.

We digitize whole tissue samples, through serial sectioning and simultaneous highresolution image capture, enabling us to compute metrics and apply mathematical models.

Many diseases manifest at the tissue and organ scale, so a conventional slide on a microscope may not provide the same insights that a full tissue analysis would. A 3D view of, for example, the microvasculature of a tumor helps in observing the effects and efficacy of drugs. Increasing the Predictive Value of Preclinical Studies 3Scan is a company that gives pathologists a cutting edge technological tool that focuses on increasing the predictive value of preclinical studies for clinical trials. In addition to this, 3Scan is removing sampling bias from the pathology workflow by automating the sectioning and imaging process using a robotic microscope. This ensures that every tissue sample is comprehensively digitized with its structural alignment intact. Moreover, 3Scan uses its proprietary software to interpret the image stack in three dimensions, providing spatial information that rivals radiology with light microscopy resolution. These features are unsurpassed and have elevated 3Scan to the status of an industry leader with its real-time solutions. Since its inception, the company has delivered end-to-end solutions with multiple experts from a diverse range of disciplines who are dedicated to empowering each piece of the value chain. Modernizing Pathology Workflows 3Scan is focused on tackling diseases that cannot be cured using conventional pathology workflows. The company is working to expand their assays into wider range of disorders and find more effective cures for disease.

September 2020 | 23

ClinCapture A Sweeping Wave of Big Data Innovation in the Pharmaceutical Industry

Few years ago, Mckinsey Global Institute estimated that the application of big-data strategies to improve decision making was capable of generating over $100 billion in value annually across the US health-care systems. This advanced decision making made possible by cloud technology, improved analytical methods was the next horizon of innovation on the block. Today, this change is sweeping across the healthcare landscape creating value and opening new territories for innovation. However, in order to benefit from this innovation it is important for companies to optimize this innovation and improve the efficacy of their current research methods and trials simultaneously. This innovation opens up a personalized array of solutions for patients supported by a wide array of tools for physicians, consumers, insurers and regulators. A large part of this innovation is the role of Big data and it is an opportunity unlike anything we have witnessed before. Earlier the data generated from clinical trials under controlled environment could be well documented. However, with the advent of cloud solutions, pharma companies can store data from various sources including patient care, retail stores and caregivers as well. Of course, all of this data must be HIPAA compliant. Applying this data effectively will allow pharmaceutical companies to get an insight into the industry to predict the rise of new patient needs and develop effective drugs to reach new patients and reach greater heights.

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Todd Weidley Scott Hu man CEO & Co-founder President & CEO

ClinCapture provides a powerful eClinical platform that enables sponsors and CROs to rapidly build and deploy studies, lower clinical trials costs, and streamline data capture processes. Oﬀering a host of private cloud solutions, ClinCapture’s technologies help advance the evaluation and development of drugs, biologics, and devices that demonstrate promise for the diagnosis and/or treatment of a wide range of diseases or medical conditions. By bringing greater eﬃciency and accuracy into clinical trials, ClinCapture serves the mantra, “Software that saves lives!” A vision - the Turning Point CEO Scott Weidley joined the ClinCapture team at a pivotal time in the company’s history. The company had recently built Electronic Data Capture (EDC) software, but was also a

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professional services business. Weidley saw the value of technology in the clinical trials space, and felt that customers were seeking solutions – not services. From this vision, the Captivate eClinical platform was born. “Scott is the Marc Benioﬀ of EDC,” Ale Gicqueau, ClinCapture founder, was quoted as saying at the time. History seems to be proving him right, as ClinCapture is now a leading provider of eClinical software solutions.

help advance the evaluation and development of drugs, biologics, and devices by bringing increased eﬃciency and accuracy into the clinical trials process, thereby allowing pharmaceutical, biotechnology, and diagnostic companies to bring products to the market faster and at a lower cost. Ultimately, these products may be lifesaving; this is the story behind the mantra of the company, “Software that saves lives!” ClinCapture’s customers are creating medical advancements, some of which may have life-saving applications.

A Leading Innovator From the beginning, ClinCapture has set out to be different than what the industry is used to. Its competitive and technologically-advanced product is setting new EDC industry standards, giving customers a higher quality, more affordable EDC alternative to established industry leaders. For example, Electronic Data Capture (EDC) with Medical Coding integrates a user-friendly interface that was built on the same modern framework as Facebook, Instagram, and Netflix and includes a free build tool, and free training and support. Additionally, it is HIPAA, CFR 21 Part 11, and GDPR compliant and the platform includes Electronic Clinical Outcomes Assessments (eCOA) / Patient Reported Outcomes (ePRO) as well as Randomization options for customers. The company has pushed the limits with both the brand and the product alike. It believes in providing innovative and high-quality Electronic Data Capture (EDC) product at a fraction of the cost of its leading competitors. Its eClinical solutions

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Our primary goal is to continue to provide our customers with the highest-quality eClinical solutions at the lowest price.

An Upcoming Bright Future There are two or three big companies in the eClinical space and ClinCapture is committed to being on top in terms of quality with these companies. It has stayed true to its brand and its highquality product, which is increasingly gaining popularity with clinical data managers in the industry. When asked about the future prospects of the company, Scott said, “From big 3 EDC to the gold standard in EDC? We are on our way!” He also added, “ClinCapture is growing at a high velocity as we continuously introduce new products. Our primary goal is to continue to provide our customers with the highest-quality eClinical solutions at the lowest price.” His statement highlights a rapid advancement in the industry. According to the Mckinsey Global Institute study, there are various segments in the pharmaceutical industry which are experiencing a rapid growth. One such segment is biopharmaceuticals. According to the study, the rates of growth for biopharmaceuticals is near 8% annually and it is almost double that of conventional pharmaceutical solutions. In order to tap the growing potential and demand in the pharmaceutical industry, ClinCapture adopts a simple approach to innovation. To summarize it, Scott said, “Data is what makes it work. We love our customers. We love data managers!”

September 2020 | 27

Mobile Healthcare Applications Treating People Anytime, Anywhere.

ealthcare is of prime importance to any and every individual. With pandemic times like these, monitoring the health has become necessary. Even though people take care of themselves with a set routine that they follow, they need to be reminded of it every now and then. This need of continuous healthcare has led to the invention of mobile healthcare applications. Every individual from 10 years of age has their own smart phone or any other smart device. This is the only thing that is always around and with people. It is easy with mobile healthcare apps to take care of one's health. There are applications that are free or paid depending on the requirement of the individual. Mobile healthcare makes it very convenient for people to get access to a doctor,

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whether it is an emergency or not. People do not have to wait in long lines or take prior appointments for getting themselves checked. Illness is never an expected thing. So to be prepared to face the worst is all a man can do. Even people who do not have any health conditions can use these apps to monitor their health and prevent any unexpected health hazards. There are several advantages of these mobile healthcare applications and are discussed below. Convenience and Control With smartphones and mobile apps, monitoring health

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Pros and Cons progress has become convenient and eďŹ&#x192;cient. The patients do not need to go to doctors to understand and maintain their health. There are thousands of apps to choose from.

of emergency or whenever needed. It is easy for the patient and the doctor to communicate through chats in these apps. Easy Access in Emergency Situations

Fewer Visits to Clinics A combined advantage to the medical practitioners as well as the patients is that the visits to the clinics are reduced. It helps the patients who cannot leave their homes to visit the doctors and also the hospitals can get rid of the crowded lines. There are numerous types of apps that people can use for diďŹ&#x20AC;erent conditions. There are medical reference apps that provide information on health conditions and help prevent diseases. There are telemedicine apps that provide remote health options. This type of app is in the booming stage.

In most countries, emergency services are lagging the ability to immediately locate the victim. Considering the fact that every individual has a smart device with them these days, it is bad that victims cannot be located on time. There are mobile phone towers and GPS technology, which can help locate the victims at the earliest. These mobile health apps allow easy access to the location of the injured. The emergency apps also provide widgets that can be placed on the home screen of the phones. Clicking on the widget, the victim can call an emergency service or their family member also.

24/7 Patient Monitoring

Reduced Healthcare Costs

Keeping patients under observation continuously is a challenge, especially for those who do not stay at the hospital. The wearables and mobile apps that serve the purpose of wearables are usually helpful in such situations. They keep a check on the patient vitals, blood pressure, heart rate, sleep quantity and quality, etc. Doctors can keep track of the patients' health and give immediate help in case

When the patients are properly educated of their health conditions and are in continuous communication with their doctor, they tend to take good care of themselves. There are also patients who cannot aďŹ&#x20AC;ord expensive OPD for small health issues. Such people can use the medical health apps. Studies even show that these apps reduce the cost of overall healthcare.

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September 2020 | 29

CMIC Inc. Leading Treasure in Healthcare Industry Especially in Pharmaceutical Sector

harmaceutical sector is blooming at subsequently than ever being imagined. And only few companies proved themselves worthy of it. Meet, a CMIC, Inc. leading CRO (Contract Research Organization) and a provider specialized in bioanalytical services, whose cutting-edge capabilities and sophisticated expertise in various aspects helped it achieve a greater stature in the business. Its bioanalytical services are in support of TK/PK/PD Biomarker studies for pre-clinical and clinical developments. It firmly focuses and holds expertise in bioanalytical method development, method validation/qualification and study sample analysis for small, large molecules and Oligonucleotide. The “CMIC” name originally stood for “Current Medical Information Center”, and the company remains committed to the advancement of medicines and healthcare revolution. As a strategic drug development partner, CMIC helps sponsors to overcome challenges in bioanalysis with expertise, rapid data turn-around-time, and high-quality customer services. The company states its core values intercepted through, W & 3C; Ÿ WELLBEING: Fully Live Every Moment Ÿ Challenge: Liberate opportunity by changing our vantage point Ÿ Change: Transform without seeking refuge in conventional wisdom Ÿ Communication: Proactively reach out to sponsors, people and society The Story behind CMIC CMIC Inc. originated from CMIC Group, which is the very first and largest Contract Research Organization (CRO) in Japan. Contract research organizations (CROs) have become an integral part of drug discovery and development to support sponsors research needs, expedite timelines and provide an extension of technical and scientific support. CMIC has worked with the top 10 global pharma companies and has been involved in and supported more than 80% of new drug development in Japan. CMIC, Inc. was established as a strategic cornerstone for CMIC Group’s North America growth. It has the vision to provide a solution service as “Pharmaceutical Value Creator” (PVC) that encompasses an entire value-chain of pharmaceutical companies. The company has been the top bioanalysis CRO in oligonucleotide therapeutics (Oligo) development for nearly a decade with strong proven expertise. It also offers 30+ years of experience in conventional & small molecule and are also significantly expanding its capabilities in large molecule and biomarker Bioanalysis. On account being different from other companies, it is leading bioanalysis CRO in oligonucleotide therapeutics (Oligo) as well as very flexible and agile with quick turn-around time on all services offered, which is not possible by large CROs. In addition, CMIC, Inc. together with the rest of CMIC Group has significant scientific publications and whitepapers and had been the integrated players f supporting various drug development efforts.

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Jenny Lin Chief Operating OfďŹ cer & Board Member

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September 2020 | 31

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“Our vision is to advance the innovation of products and solutions that will empower people worldwide to achieve greater health and well-being.”

A Glimpse into Jenny’s Life Jenny Lin, Chief Operating Officer and Board Member. She holds 26 years of executive/lab management experience in bioanalytical and analytical laboratory operations in support of drug discovery, pre-clinical and clinical drug development. Moreover, she is proficient in GLP, GMP, GCP, OECD, ICH and 21 CFR part 11 regulations and in business strategic planning and execution. Her expertise includes building organizational quality system, staff training, bioanalytical/analytical method development/validation, bioanalytical sample analysis, analytical development for CMC submission, chromatography purification, stability studies, reference standard certification, QC support for GMP manufacture. She has been also a selected member for Global Bioanalysis Consortium (GBC) making recommendations for global Bioanalysis harmonization. She serves as editorial board member for peer reviewed journal and chair for international conferences. Besides, she is an author and co-author for approximately 40 publications, white papers and presentations and is the inventor of 7 issued US patents. Jenny earned her BS in Analytical Chemistry at Peking University and her MS in Medicinal Chemistry at University of Connecticut. She is a member of the American Society of Mass Spectrometry (ASMS), American Association of Pharmaceutical Scientists (AAPS), American Chemical Society (ACS), National Association of Professional Woman (NAPW) and Global CRO Council (GCC). Future of CMIC CMIC and the CREED as corporate philosophy, consists of Wellbeing, Challenge, and Communication (W&3Cs). The company has been applying these items to continuously evolve itself in line with market changes, and will do so in the future. Moreover, by further expanding from the current “Pharmaceutical Value Creator” (PVC) business model, the company has an aspiration to become a “Personal Healthcare Value Creator” (PHVC) to contribute for and to address to the up-coming personalized medicine and individual patient quality of life.

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September 2020 | 33

Golden Helix

Helping Researchers and Clinicians Understand the Role of CNVs in Human Health and Disease

producing software which gives the power of analysis to researchers, supporting them through their analysis, and by providing them with genomic services when the need arises.

A Well-known Leader Back in 2013 with the objective of leading the business into genetic testing market, Andreas Scherer joined Golden Helix® as the President and CEO. While working for organizations like Netscape and AOL as a Global Vice President, Andreas gained much needed valuable insights in running world-wide businesses which require functional know-how in sales, marketing, product development, services and operations.

Golden Helix®takes pride in itself for creating software tools that are integrated and robust, but more importantly user-friendly and intuitive. The tools are specifically created in order to empower biologists, clinicians and other researchers to easily perform complex analyses and visualizations, eliminating the need to rely exclusively on bioinformatics experts or cobble together difficult to use, incompatible freeware. This way researchers can completely focus on their research instead of learning to be a programmer or waiting in line for bioinformaticians. The organizations’ support team is motivated by one mission—to make sure that the customers have a great experience with its software tools. From helping to import data, to bug detection, to finding technical resources, Golden Helix® is fully committed to provide its customers with the resources they need in order to complete their analysis in a world class manner and at a lightning fast pace.

ounded in 1998, Golden Helix® is a global bioinformatics firm. Since foundation, the organization has accumulated a significant customer base and is currently working with more than 350 organizations—with thousands of users leveraging the organizations’ various analytics products. From its early days till the present-day, GlaxoSmithKline has been the largest outside investor of Golden Helix.® Till date the organizations’ software has been referenced in more than 1000 publications. The customers of Golden Helix® fall into five primary categories: testing labs, hospitals, pharmaceutical companies, major research organizations and government organizations.

His educational background is centered around Computer Science in which he holds a PhD from the University of Hagen, Germany. Andreas has so far published more than twenty peer reviewed articles, authored books on Neural Networks, Intranets and Project Management. His latest book, “Be Fast Or Be Gone” was a prizewinner in 2012 Eric Hoﬀer Awards competition. In his private time, Andreas enjoys weightlifting throughout the year. In the winters, he likes to spend his times by skiing the mountains of Montana and in the summer, anyone can ﬁnd him on the golf course. Empowering End Users to Perform High-End Analytics Work ® Golden Helix’s main goals is to empower their end users to perform high end analytics work. This is achieved by

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However, the organization doesn’t stop only at support, it also offers comprehensive and personalized training sessions to help researchers jumpstart their research. Golden Helix® s’ Field Application Scientists and Engineers help researchers by taking them through workflows that are relevant to their specific research. Ground Breaking Products Golden Helix®has developed a powerful technology stack that supports a number of products in the genomics space, including the following: Ÿ VarSeq®: VarSeq is an intuitive, integrated software solution for tertiary analysis. With VarSeq you can automate your workflows and analyze variants for gene panels, exomes and whole genomes. Ÿ VS-CNV: Directly calls CNVs in target regions and avoids the cost and turn-around time of additional CMA

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‘‘

We provide a complete end-to-end solution for clinical labs and hospitals to analyze Next-Generation Sequencing data

‘‘

or MLPA testing. VSPipeline: Repeatable clinical workflows essential for CLIA and CAP certified analysis, creation of high throughput pipelines and access to curated annotation sources that are updated regularly. VSReports: With VSReports, you can easily convert the output of your tertiary analysis into a customized clinical report. After you’ve filtered down your imported variants, simply select variants to include in the report. VSWarehouse: A scalable, multi-project warehouse for NGS variant call sets, clinical reports and catalogs of variant assessments. SNP & Variation Suite™ (SVS): SNP & Variation Suite is a powerful analytic tool created specifically to empower biologists and other researchers to easily perform complex analyses and visualizations on genomic and phenotypic data. GenomeBrowse®: A powerful tool that delivers stunning visualizations of your genomic data that gives you the power to see what is occurring at each base pair in your samples.

A Diﬀerent Organization When it comes to client handling and providing support, Golden Helix® is a completely diﬀerent organization from its competitors mainly due to: Pervasiveness: The company has a strong competence building on-premises solutions for the life science space. To date, many labs, hospitals and government organizations prefer to control the IT environment over cloud solutions. However, as the clinical testing space goes mainstream, cloud deployment models are attractive for certain market

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Andreas Scherer President & CEO

® segments. Golden Helixs’ future development plans include a strategy to deploy the Golden Helix®stack in a way that customers can pick and choose their preferred deployment model: Ÿ On Premises: Currently, the main deployment mode for Golden Helix. This continues to be a highly desirable approach as hospitals and testing labs are concerned about hosting patient data outside their premises. Ÿ Cloud: Certain segments of the market have accepted cloud solutions as viable. The company is extending out technology stack in this direction. Ÿ Mix Deployment: For certain deployment scenarios a mixed approach is preferable. For example, in certain scenarios it could make sense to run the analysis and clinical reports pipeline on premises and store all the resulting data in a cloud hosted data warehouse. Ÿ Internationalization: The US has been a strong market for clinical testing and research analytics products and services. However, selected markets in Europe, Asia and Latin America, as well as Australia and the Middle East ® are increasingly important. Golden Helixs’ mid-term strategy is to increase its local presence in these markets either through partners or directly. ® Ÿ Preservation: Golden Helix has a strong customer base with a high renewal rate. Its high rate of customer satisfaction and the stickiness of its solution is one of the reasons why Golden Helix has been highly capital efﬁcient. The organization continues to focus on a highquality customer experience to encourage future renewals.

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Janrain Pioneering Digital Identity Solutions for the Healthcare Industry

ToddKaskade Jim Hu man

ounded in 2002, Janrain pioneered Customer Identity and Access Management (CIAM) and is widely recognized by industry analysts as a global CIAM leader. Janrain is the first choice of global enterprises for mission-critical CIAM, and the largest brands in the world trust Janrain to manage their most valuable assets: customer identities. The company’s identity capabilities include social and traditional login and registration, which includes single sign-on (SSO), customer profile data storage, and management, customer segments, customer insights and engagement solutions. Janrain reaches over 1.5 billion digital identities with over 3,400 commercial deployments, including Pfizer, Merck, Samsung, Whole Foods, Philips, McDonald’s and Dr Pepper. The Leader’s Perspective Jim Kaskade is the CEO of Janrain and leads the company’s strategy, worldwide operations and vision. He has helped enable the digital transformation of the healthcare industry to improve patient experience and data security.

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CEO & Co-founder

Jim is a seasoned entrepreneur with more than 31 years’ experience in complex enterprise technology. For 10 years, he worked as a startup CEO, leading companies from founding to acquisition. Jim has built multiple technology businesses in cloud computing, enterprise software, software as a service (SaaS), online and mobile digital media, online and mobile advertising, and semiconductors. Distinctive Services Janrain Identity Cloudis a CIAM solution that balances security, privacy, and compliance while providing the seamless, frictionless experience healthcare providers, patients and partners’ demand. It is also the ﬁrst choice in leading healthcare, biopharma and life sciences organizations. The platform enables the secure exchange of veriﬁed, third-party credential information and authorized access, to restricted information and assets. It also makes it easy for organizations to manage patients’ information and

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health care provider identities in compliance with regulatory requirements. With Janrain Identity Cloud, your organization and your users will benefit from the peace of mind that comes from knowing that the right people have access to the right content – all in a secure, friction-free, patient-focused environment. In addition, healthcare companies can leverage omnichannel access and robust data collection to create more engaging customer journeys that ensure these individuals remain satisfied and continue to build relationships with the company. Digital Transformation of Healthcare Pharmaceutical companies are working hard to keep pace with the disruptions brought about by digital technology and a shifting health care landscape. To overcome these challenges, companies must develop digital identity strategies for creating seamless, safe and compliant customer journeys. In 2010, Janrain began investing in the pharmaceutical category and now serves a majority of the top pharma companies globally, including Pfizer and Merck. Janrain is the only identity management provider to be HIPAA/HITECH certified. Its technology allows healthcare professionals and life science firms to gain actionable customer insights in a secure manner and streamline their customer interactions for improved patient experience. Industry Involvement

leading pharmaceutical companies and technology and service providers dedicated to making it faster and easier for healthcare professionals to connect with the life sciences industry. Align Biopharma has defined an identification and authentication standard that enables single sign-on for HCPs to access online content—including websites, portals, virtual events or webinars—directly from the life sciences companies. It is also defining the standards for consent and preference management so that there is consistency in how HCPs specify communication preferences with each company—an essential component for companies that do business in the EU and must comply with the General Data Protection Regulation (GDPR). When Janrain announced its joining with Align Biopharma, Jim, expressed,

“Our excitement around Align Biopharma is ﬁrst rooted in our passion to innovate in digital identity, but then also in our passion to collaborate and share those innovations with the identity industry. Janrain’s commitment to open standards began when we helped form the OpenID foundation. We’re very eager to contribute our pharma learning’s from over the past seven years and to help advance not only the HCP’s experiences but patients’ experiences and our client organizations’ experiences.” Aiming towards Future Goals Janrain envisions a future where patients and healthcare providers will move seamlessly and safely between their in-person visits, web and mobile properties and connected digital healthcare devices. The process combines security, privacy, marketing, data infrastructure, and application technologies to create simple and safe experiences that improve healthcare outcomes.

Our vision is to be the largest digital identity network in the world.

Janrain is a member of Align Biopharma™, an industry technology standards group that includes 23

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September 2020 | 39

Peachtree BioResearch Solutions Determined to Deliver Flexible, Reliable and Scalable Clinical Development Services

he challenges in the pharma industry continue to rise. Declining R&D productivity coupled with the need for increasingly complex head-to-head clinical trials to prove superiority have resulted in a signiﬁcant increase in clinical development expenditures. Pricing pressures have impacted return on investment.

Kristy Nichols Sharon Hilton

CEO

COO

attention the companies required and the experience of the operational teams provided were neither contingent on the size of a company’s pipeline nor the dollar amount of the services needed. It ensures that every company it works with receives ﬂexible, reliable, and scalable solutions coupled with undivided attention, thus, ensuring both program and overall company success.

The pressure on clinical research departments has never been so high. Timely completion and cost-efﬁciency are paramount to the projected return on investment. With limited internal resources, the reliance on contract research organizations (CRO) continues to grow. In 2008, the founders of Peachtree recognized this trend, but with a twist. Peachtree would invest in highly-experienced clinical research professionals with the requisite expertise in planning and executing clinical trials. Additionally, focusing on emerging to mid-sized companies, the founders believed the organization ﬁt well in an underserved market needing attention and solutions.

Peachtree is dedicated to delivering superior and customized clinical development services that enable its clients to complete their clinical projects in an efﬁcient and cost-eﬀective manner. Peachtree aims to build long-term relationships with its clients based on mutual trust, respect and integrity. Peachtree’s CEO, Kristy Nichols, mentions “Our goal? To be most admired for the commitment to our people, partnerships and performance.”

Peachtree is a full-service Clinical Research Organization (CRO) that specializes in providing clinical development services for emerging to mid-sized biotechnology, pharmaceutical and medical device companies. Peachtree was formed to ensure the balance between the level of

Identifying the customer needs, the company provides a wide range of solutions .Peachtree’s core services include study and clinical site feasibility, clinical project management, clinical monitoring and site management, medical monitoring, clinical data management, biostatistics,

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Delivering Superior Clinical Trial Support Services with Remarkable Agility

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clinical quality assurance, and medical writing. Dynamic Pillars Kristy Nichols, CEO, and Sharon Hilton, COO are the dynamic pillars of Peachtree. These astute individuals had a vision to create a company to support emerging to mid-sized sponsor companies that were underserved by existing CRO models. True to their passion, Peachtree was founded in the same year. Kristy has relevant experience of more than fifteen years in both medical device and pharmaceutical clinical development. Prior to creating Peachtree, Kristy served as a Global Director within Clinical Development for UCB, a Belgium based biopharmaceutical company focused on severe diseases in CNS and Immunology. Sharon is a consummate, seasoned professional motivated by challenge and rewarded through the seamless implementation of key corporate initiatives that aid profitability, productivity and quality. She has been acknowledged for vigorously managing multifaceted projects, applying stringent standards and rallying cross-functional team participation that serves to elevate marketplace status. Both with over 20 years of Sponsor and CRO-side experience had empirical knowledge of what the ideal CRO should be and set out to fill this void. Ahead of the Curve

bureaucracy, commonplace with larger vendors. The company recognizes that its people are its most valuable asset. Peachtree continues to evaluate and implement superior technologies in clinical study management and data management. Its experienced and highly capable clinical operations staff has been instrumental in performing every task and applying this experience to run clinical studies efficiently, costeffectively, and without sacrificing quality. Peachtree’s Clinical Operations senior management leaders individually have over 25 years of clinical development experience including the management of multiple global programs in numerous therapeutic areas. These leaders are empowered, allowing straight-forwardness, responsiveness and flexibility in decision making. COO, Sharon Hilton states, “Providing solutions, not problems to our clients is

We are the CRO that thinks and acts like a Sponsor.

paramount. Supporting our clinical operations teams, the company utilizes best-in-class study management, data management, and analysis tools.” Tackling Challenges with Determination, Achieving Sustainability with Excellence With global sponsor-side experience, Peachtree’s founders witnessed the frustrations of working with CROs that assigned personnel with limited experience, and were unable to provide solutions to study challenges as they arose. The opportunity was identified to build a solutions-oriented CRO that required experienced clinical operations professionals to successfully implement their clinical programs. Peachtree was fortunate to start with a highly-experienced staff assuming responsibility for over 25 ongoing clinical studies. This enabled the company to generate revenue from Day 1, and invest to improve in its processes and systems. Recognizing the need for sustainability and longterm growth, expansion of its client base was initially accomplished through networking and established industry contacts. It also recognized that each client has unique challenges and issues, and thus could not take a cookie-cutter approach to the business. Now, entering its 10th year of operation in 2018, Peachtree is experiencing phenomenal growth and expecting this to continue. The company believes that its reputation as ‘solution’ providers with a highlyexperienced staff, and continued success in managing clinical programs is the key to sustainability.

Peachtree is big enough to matter, but ﬂexible, scalable, and reliable enough to execute a complex clinical program without the multiple layers of

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September 2020 | 41

Triox Na

Pioneers in point of care programmable medicine! presenting th

n an interview with Insights Success, Triox Nano's management describes its impeccable journey to become the first biotech company to develop a modular programmed drug delivery platform. The company's revolutionary technology, termed S.M.A.R.T, an acronym for Stimuli Multi Adjusted Responsive Technology, or simply put “Programmable medicine” is based on combinations of DNA coding, DNA molecular machines and mesoporous nanoparticles. SMART offers the potential to add programming to almost any approved medicine that may in turn increase its efficacy exponentially. Prominent opinion leaders and investors had been funding TrioxNano's development to date including the European commission through the prestigious H2020 Horizon program. Competing with over 1500 companies TrioxNano's technology won a non diluting grant of roughly $2.5 million USD. TrioxNano's all inclusive patents are granted around the world . Many believe this breakthrough technology may lead the way to the next healthcare revolution! To create S.M.A.R.T Triox Nano had to first invent the modular hardware that will allow incorporation of many different medications, the software language which is based on DNA coding and the actual codes that will control the nano particle. The technology is expected to create a paradigm shift and highly impact human lives around the globe, transforming medicine from its current primitive analog state to a programmable digital modern era. S.M.A.R.T creates a vast field of programmable nanoparticles that can deliver their payload to target tissues based on the software code that is uploaded to them. The final commercialized product is expected to be supplied with a list of common software codes. The treating physician will decide which codes to use and will easily upload them to the modular nanoparticle that incorporates the relevant medication. The doctor will have the option to

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upload a mixture of several codes into the same treatment based on the patient's clinical and pathologic profile. Under the supervision of Joseph Farfara, Triox Nano's CEO, the company has progressed robustly in the last 3 years, broadening the type of medications that can be loaded into the platform, improving the capping characteristics and securing its IP with patents granted around the world. Below are the highlights of the interview: Can you explain to our readers what so exciting about Triox Nano work? Joseph Farfara, Triox Nano's CEO “By the year 2020, thousands of APIs (Active Pharmaceutical Ingredients) had been developed to treat different diseases, yet not even one efficient modular technology was developed to deliver them accurately to their target! The most efficient way to do this is use programming abilities so that each API can have tens of programs to direct it to different targets upon request. If you compare this to the car industry its like everyone has been developing thousands of types of engines without finding a way to connect them to the wheels yet. Current delivery methods, such as Injections or tablets deliver only a small percentage of their original doses to the tissues requiring treatment, and instead, most of the dose arrives to healthy tissue causing severe toxicity. Examples for our programing abilities include the TXN770 family of nanoparticles intended for the treatment of TNBC (Triple Negative Breast Cancer). TXN770 combines between a modular unit loaded with the chemotherapy doxorubicin, that is already approved for the treatment of TNBC and the ability to be programmed by a combination of different software codes that control its release according to common traits found in the patient's specific tumor such as high levels of Magnesium and high levels of ATP. Other programing options we are developing include high levels

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ano

he next healthcare revolution! of PD1, PARP and Nucleolin found to be high in subgroups of TNBC patients. This allows us to use the same modular particle that includes Doxorubicin and program it to react to different cancer traits. In parallel we have created other modular particle loaded with the chemotherapies Mitoxantrone and Docetaxel (that is approved already for TNBC) that can use the same software codes described above (Mg, ATP, PD1, PARP, Nucleolin). We are focusing on TNBC Triple Negative Breast Cancer to prove our technology's benefits but expect it to be relevant for many other indications. We offer specific licenses to the use of our S.M.A.R.T platform loaded with the client's APIs (active pharmaceutical ingredient). This is relevant for many types of companies, those who have a medication that is effective but proven to be too toxic to be used, or for medications that require high doses to be effective, or in cases patent cliff issues have to be avoided. Our standard license agreements includes milestone payments and royalties fees, we offer our services for a fee to develop the asset until completion of the of In Vitro phase, expecting the companies to complete the In Vivo Tox and clinical trials. What led to the inception of Triox Nano? Answer Dr. Roy Farfara CTO and founder of TrioxNano The inception of TrioxNano was at 2 AM after a long operation of a young kidney cancer patient. Our department was regularly accepting patients that other surgeons had given up on operating them due to the technical difficulties. We had the best techniques and technologies in Israel at the time (biologic glues, mannitol, hypothermia) we were taking out carefully tumor after tumor in the renal. We finished the surgery exhausted though we knew we did the best that can possibly be done. The patient kidney was not resected, we managed to take out all tumors and substantial bleeding avoided. Yet we understood that the patient ended

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Roy Farfara, MD Founder & CTO

September 2020 | 45

“Triox Nano’s technology offers a paradigm shift that will highly impact human lives, transforming medicine from an analog state to an exciting programmable digital modern era”

up having less than %20 of the original kidney parenchyma meaning he would most probably need dialysis in the near future. My grandfather Simon Farfara RIP who was an artisan taught me when I was a child that "The first step in every challenge is to find the best tools to complete it". Understanding that it is not possible that in the year 2013 we are trying to resect micron (one millionths of a meter) size cancer cells with centimeter size knifes while on the other hand treating with chemotherapy that is not specific enough thus causing substantial side effects. Being aware of the limitation of surgery (trying to resect micro meter size cancer cells with inch size knifes) and the limitations of non specific chemotherapies causing substantial toxicity made me understand at that moment that we are totally not using the right tools to achieve this goal, and set me out on this journey” Describe Triox Nano and its cutting-edge technology. Answer Dr. Ehud Saas head of biologic programming Interestingly computers have been incorporated into everyaspect of our lives except medicine. TrioxNano has developed and patented a programmable nano delivery platform that can carry different medications, including chemotherapies, to their target tissue. The technology uses nanoparticles based on DNA machinery. These amazing machines are made from single-stranded DNA and RNA and allow us to program a modular particle with almost infinite possibilities. Once completed, the technology will enable the treating physician to upload the relevant DNA module per individual patient and precise the administered treatment based on his specific cancer traits. It is estimated that more than 1000 approved medication can be delivered by this programmable system and at least 500 unique programmed modules can be uploaded to them. This adds up to about half a million different options of unique treatments (in the case that only one code is uploaded per particle), in the case a combination of three codes is loaded and estimated 125 billion treatment options are created. As a leading pharma and biotech solution providers, what contribution has been made by you? Answer by Dr. Ofer Nusbaum head of chemistry biology interface.

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TrioxNano is trying to create a paradigm shift in the way we treat disease. Programming is urgently need to enhance the treatment of patients. In the case of Cancer as an example, cancer cells develop different mutations in different organs of the same patient. On the other hand different cancer type share common pathways. For example the PD1 pathway is relevant for a small percentage of TNBC patients and larger percentage in many other cancer types, many are being treated with PD1 inhibitors. This translate into a need for modular programmed platform that can relate to common traits in different tumors and different mutation in the same patient. We believe we will be able to offer the world the first modular programmable nano delivery platform where the physician will be able to program the medicine he gives his patient, he will choose from a list of software codes that we will offer commercialy and upload it to an armantarium of medication he can choose from. Later on we plan to offer specific programming to less common cases that require specific softwares. Of note is that all the different chemotherapies are packed in the same modular nanoparticle. Describe in brief about the work culture and the values that drive Triox Nano. Joseph Farfara, Triox Nano's CEO TrioxNano is driven by a team of highly intelligent hard working open minded scientist. All our staff have hands on experience of years in the industry. We are roughly divided to chemists and biologists that are integrators able to bridge the gap between these two worlds. As an Israeli company we try to think out the box and “cut to chase” as much as possible basing our decision on sound science. What are the future aspirations of Triox Nano? What strategies are you undertaking to achieve those goals? Answer Dr. Roy Farfara CTO and founder of TrioxNano TrioxNano aspires to be the next Microsoft and IBM, on one hand creating "the operating system for computerized drug delivery" and on the other developing the hardware required to run the operation system and the code. We want to revolutionize the way patients are treated! To achieve this

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goal our strategies include a hybrid business model where we develop our own drug candidate TXN770 (as a proof of concept) for the treatment of TNBC but are actively persuing to cooperate with others to incorporate their APIs (Active Pharmaceutical Ingredients) into our modular computerized platform.

IP and an exponential increase in value. This cooperation will importantly beneﬁt humanity as thousands of medications can be improved which translate into improving human lifes!

How are you solving your customers' complex drug discovery challenges?

Joseph Farfara, Triox Nano's CEO

Answer Dr. Roy Farfara CTO and founder of TrioxNano By incorporating their APIs into TrioxNano's S.M.A.R.T platform, our partners may be able to increase eﬃcacy while using smaller doses, creating decreased toxicity, new

What is your idea of Corporate Social Responsibility?

The hebrew saying "KOL HAMEZIL NEFESH ACHAT KEILU HEZIL OLAM U MELO'O," meaning he who saves one life is considered to save the world entire. www.Smartriox.com Joseph@TrioxNano.com

“It is estimated that more than 1000 approved medication can be delivered by this programmable system and at least 500 unique programs can be uploaded to them. This adds up to about half a million different options of unique treatments (in the case that only one code is uploaded per particle), in the case a combination of three codes is loaded and estimated 125 billion treatment options are created."

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