MASS 2017 -- West

STRATEGIC SUMMIT

WEST

MEDICAL AFFAIRS

Manage Medical Affairs, Communication, Information and Research Collaborations to Strategically Position Your Organization in the Marketplace

SEPTEMBER 25–27, 2017 | WYNDHAM SAN DIEGO BAYSIDE | SAN DIEGO, CA

FOUR TRACKS | ONE LOCATION | ALL ACCESS MEDICAL AFFAIRS EXECUTIVE STRATEGY

65+ Expert Speakers

Brandi Howard, Vice President, Global Clinical Development and Medical Affairs, EVOFEM

MSL BEST PRACTICES

RESEARCH COLLABORATION AND INVESTIGATORINITIATED TRIALS

MEDICAL INFORMATION AND CALL CENTER MANAGEMENT

Dominick Albano, Vice President, Global Medical Information, PFIZER

Ryan Arnold, Vice President, Head of Medical Affairs, SAGE THERAPEUTICS

Christopher Bess, Associate Director, UCBCares, UCB

Fernando Blanco, Ph.D., Senior Medical Science Liaison, SHIRE

Arthur Chan, Ph.D., MBA, Head, MSL Capabilities, Development and Training, NOVARTIS

Noam Frey, M.D., MBA, Vice

Hoyee Leong, Ph.D., Director, Global Medical Information, Oncology, Global Medical Affairs, ABBVIE

Leslie Meltzer, Vice President, Head of Medical Affairs, KERYX BIOPHARMACEUTICALS

Avni Patel, Pharm.D., Associate Director, Global Medical Affairs, Medical Information, INTERCEPT PHARMACEUTICALS

Manijeh Pouliot, Pharm.D., BCPS, Regional Medical Liaison, Diabetes Medical Unit, SANOFI U.S.

Kathleen Ritz, Director, Lead Medical Contact for Europe and Asia Pacific Regions, BRISTOLMYERS SQUIBB

David Tworek, Regional Director, Medical Affairs, LUNDBECK

¨¨ Field Medical Affairs in IITs: Leveraging Risk-Tolerance Models to Featuring Ensure Compliant and Strategic KOL Engagements Presentations, ¨¨ PANEL: Explore Different Models for Managing Medical Affairs Panel Discussions Activities in Co-Promotion Agreements, Strategic Alliances and Acquisitions and Case Studies, ¨¨ Centralize Scientific Content Creation for Improved Quality, Speed Including: and Reduced Cost ASSOCIATION CONFERENCE PARTNER

SPONSORS

President, Medical Affairs, JAZZ PHARMACEUTICALS

Richard Haubrich, M.D., Senior Director,

HIV Medical Affairs, GILEAD SCIENCES

Alan Wright, M.D., MPH, Chief Medical Officer, ROCHE DIAGNOSTICS

¨¨ Foster Collaboration Between U.S. and Global Medical Affairs ¨¨ Implement Quality Assurance (QA) Process of Medical Information Database ¨¨ PANEL: Drive Alignment and Improve Dialogue Across Medical and Commercial Functions to Create a Unified Brand Strategy ¨¨ Build an Agile Medical Affairs Group That is Able to Evolve and Transition as the Company Changes

For more information, visit www.exl-mass.com/west

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Dear Colleague,

WHO SHOULD ATTEND

The Medical Affairs Strategic Summit (MASS) West will cover all of your educational needs through in-depth sessions, case studies, and panels divulging best practices in enhancing medical communication with internal and external stakeholders. As a professional in this space, we understand that communicating scientific and medical information to internal and external stakeholders is a key facet to your everyday task and responsibilities. MASS West 2017 will allow you to choose your own adventure and tailor your educational experience to your immediate needs.

This conference is designed for representatives from pharmaceutical, biotechnology, and medical device organizations with responsibilities in the following areas: ✓✓ Medical Affairs/Field Medical Affairs

✓✓ Compliance/Legal

✓✓ Clinical/Scientific Affairs

✓✓ Medical Information

✓✓ Medical Science Liaisons

✓✓ Patient Communication

Digital health technologies have come a long way and can be leveraged to analyze big data to generate scientific insights. Medical affairs professionals have deep product and scientific knowledge and are best positioned to be a strategic, customer-facing partner responsible for the education and communication of a company’s product ahead of a product launch. The biggest challenge lies in streamlining your communications and data sources across an organization to create unified messaging to your core customers that is both innovative and scientifically sound.

✓✓ Medical Strategy/Communications

✓✓ Quality Assurance

✓✓ Medical/Clinical Operations

✓✓ Scientific Engagements

✓✓ Clinical Project Management

✓✓ Patient Education

✓✓ Key Opinion Leadership/Thought Leadership/ Opinion Leader Relationships

✓✓ Call Center Management

The Medical Affairs Executive Strategy track will feature insights on developing agile medical functions that have the ability to adapt as the company grows, learn how to work in a strategic alliance, and leverage technological innovations to reduce costs.

✓✓ Health Economics and Outcomes Research

The MSL Best Practices tracks will provide attendees with a successful blue print for building a field team from the ground up, effective training and onboarding practices, and insights into navigating the regulatory landscape.

✓✓ Investigator-Initiated Studies (IIS)

In the Investigator-Initiated Trials and Research Collaborations, you’ll learn skills to navigate the changes in ICH E6 that will impact IITs, from both a sponsor and investigator perspective; apply field medical affairs in IITs by leveraging risk-tolerance models to ensure compliant and strategic KOL engagements; prevent non-compliance in Investigator-Initiated Trials and understand the auxiliary steps to take when non-compliant; and ultimately select and execute worthwhile Investigator-Initiated Trials or research collaborations that meet your organizational needs.

In the Medical Information and Call Center Management track, you’ll gain best practices in advancing patient and provider access to relevant information in order to enable current, evidence-based, and scientifically accurate medical information exchange; streamlining discourse between field medical and internal medical teams to translate validated medical information; and heightening medical information operations through leveraged technology and call center optimization.

The Medical Affairs Strategic Summit West serves as your educational platform to establish internal alliances across organizational silos while aligning your organization with external stakeholders to strategically position yourself in the marketplace. This year, we’re happy to provide you, our attendees, with: ¡¡

Medical Information and Call Center Management (Brand-New Track)

¡¡

Forty brand-new speakers

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Fifty never-before-seen presentations

¡¡

Leadership representation from biotechs, mid-sized and large life science companies

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Innovative technology platforms

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Insights on tailoring global strategies to regional affiliate needs

¡¡

Governance of medical activities in strategic alliances and post-acquisition

We look forward to seeing you in San Diego!

Sincerely,

Mercy Lister Conference Production Director MASS Series Production Team

Zohaib Sheikh

Senior Conference Director MASS Series Production Team

✓✓ Investigator-Initiated Research (IIR) ✓✓ Investigator-Initiated Trials (IIT) ✓✓ Investigator-Sponsored Trials (IST) ✓✓ Research and Development

✓✓ Medical Communication ✓✓ Patient Services ✓✓ Research Collaborations ✓✓ Research Grants ✓✓ Clinical Outcomes and Publications ✓✓ Regulatory Affairs

 VENUE WYNDHAM SAN DIEGO BAYSIDE 1355 North Harbor Drive San Diego, CA 92101

To make reservations, please call (619) 232-3861 or the Wyndham 1-800 number at 1-800-996-3426 and request the negotiated rate for ExL’s The Medical Affairs Strategic Summit (MASS) West. You may also make reservations online using the following weblink: http://bit.ly/2qjTUjV. The group rate is available until September 5, 2017. Please book your room early, as rooms available at this rate are limited. *ExL Events is not a affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

Do you want to spread the word about your organization’s solutions and services to potential clients attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact Eric Morrin, Senior Business Development Manager, at 212-400-6228 or emorrin@exlevents.com.

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SEPTEMBER 25, 2017 PRE-CONFERENCE WORKSHOPS

SEPTEMBER 26, 2017 MAIN CONFERENCE DAY ONE

8:00

Continental Breakfast

9:15

WORKSHOP A: BUILDING A MEDICAL AFFAIRS LAUNCH POWERHOUSE

PLENARY SESSIONS

Across the core launch phases, medical affairs teams play a critical role in preparing the market for a successful product launch. Developing a compliant, strategic launch plan through high-impact scientific activities that harmonizes all levels of your medical and commercial groups is crucial for a successful product launch. gg Create a medical strategic and tactical launch plan that aligns with your organization’s business objectives gg Develop a meaningful scientific communication platform to communicate and differentiate the medical and scientific value clearly gg Develop a comprehensive and actionable stakeholder (KOLs, clinicians, payers, advocacy groups, policy makers, etc.) engagement plan in a compliant way gg Set clear strategy for data generation activities through identifying unmet medical needs and insights from stakeholders gg Leverage medical information to educate healthcare practitioners

Ramin Farhood, Pharm.D., MBA, Vice President, Head of Global Medical Affairs, AVEXIS

WORKSHOP B: DEVELOP YOUR MEDICAL INFORMATION CONTACT CENTER MANAGEMENT GAME PLAN

This three-hour workshop will provide a window into developing your Medical Information Contact Center Management game plan, Service Delivery Implementation as well as Customer Engagement and Satisfaction. Learn operational best practices leveraged from the Contact Center Industry to turn your traditional internal Medical Information call center into a progressive, global, Medical Information Contact Center supporting phone, electronic, and digital channels. Topics include: gg Contact Center Management gg Metrics to Measure gg Engagement Quality Oversight gg Performance Management – Internal Teams or External Suppliers gg Globalization and Market Alignment

Kathleen Ritz, Director, Lead Medical Contact for Europe and Asia Pacific Regions, BRISTOL-MYERS SQUIBB

*This sessions contains a 30-minute networking break

7:30

Main Conference Registration and Continental Breakfast

8:30

CHAIRPERSON’S KEYNOTE ADDRESS: REVOLUTIONIZE MEDICAL AFFAIRS TO MEET THE NEEDS OF THE EVOLVING HEALTHCARE LANDSCAPE gg

Alan Wright, M.D., MPH, Chief Medical Officer, ROCHE DIAGNOSTICS

8:45

Regulatory bodies recognize the value of truthful and non-misleading scientific or medical publications on unapproved new uses of a product. However, the major challenges with off-label communications are being able to provide accurate scientific data and protecting the patient, all while extending the market for a particular product. gg Explore the distinction between solicited and unsolicited queries and discuss regulatory expectations for medical affairs teams gg Clarify how to provide scientific research and medical findings that are clearly non-promotional gg Develop tools and techniques to provide ethical, accurate and balanced off-label data while adding patient value in a compliant manner

Davida J. White, M.D., Global Medical Affairs Director of MSL Training and Development, ALCON

*This sessions contains a 30-minute networking break

Reimagine insight creation as a systemic process Use data to drive targeted information collection and support planning and execution across the product lifecycle ggEngage to build community consensus around specific objectives gg

Tony Page, CEO, VOXX ANALYTICS

9:15

PANEL: DRIVE ALIGNMENT AND IMPROVE DIALOGUE ACROSS MEDICAL AND COMMERCIAL FUNCTIONS TO CREATE A UNIFIED BRAND STRATEGY

Compare and contrast the motivations and objectives for medical and commercial functions Examine some common pitfalls that lead to communication challenges between the two groups ggHear perspectives from both sides of the organization regarding how to successfully work together toward the creation of an effective brand strategy Vimal Patel, Senior Director, Customer Engagement, SUNPHARMA gg gg

12.15 Luncheon WORKSHOP C: ENSURE COMPLIANT COMMUNICATIONS DURING SCIENTIFIC EXCHANGE AND OFF-LABEL DATA DISSEMINATION

GATHER INSIGHTS TO INFLUENCE AND ACHIEVE BUSINESS OBJECTIVES gg

*This sessions contains a 30-minute networking break

1:30

Review the growing number of key external stakeholders and their impact on the life science industry Develop processes that will put your organization in a position to meet the needs of the marketplace ggHighlight the need for better collaboration within medical functions ggUnderstand the opportunity for medical groups to firmly position themselves as the strategic partner for internal and customer-facing communications gg

WORKSHOP D: EXAMINE HOW TO OPTIMIZE THE APPROACH TO THE ICH E6 (GCP) ADDENDUM IN INVESTIGATOR-INITIATED TRIALS

The addendum to ICH E6 was finalized at the end of 2016 and has already been implemented in the EU (14 June 2017). The ICH E6 changes were intended to bring more effective and efficient processes to sponsors running clinical trials, but most sponsor organizations are still struggling to get to grips with the changes and impact, and have not yet evaluated the impact on IIT where the investigator assumes the sponsor responsibilities. This presentation will go beyond the usual scope of assessing the potential and benefits of an IIT, and it will address the risk for the company and the investigator (sponsor) of IIT. gg Walk through the changes in ICH E6 that will impact IIT, from both a sponsor and investigator perspective gg Provide a basic template to address the changes with recommendations for the investigator gg Examine the site to ensure the ability to meet the ICH E6 standard

Alan Wright, M.D., MPH, Chief Medical Officer, ROCHE DIAGNOSTICS Julio Casoy, M.D., Senior Vice President, Medical Affairs, TURING PHARMACEUTICALS

10:00

TAKE A LOOK AT MODERN AND EMERGING VENUES FOR ENGAGING STAKEHOLDERS AND REMOVING COMMUNICATIONS BARRIERS Discover trends and tips to maximize program results through digital avenues Examine key examples of recent innovations within varying size programs ggLeverage online discussion platforms to optimize program outcomes gg gg

Lance Hill, CEO, WITHIN3 10:30

Networking Break

MEDIA PARTNERS

A.W. Lawton, SME, TRANSCELERATE; Lecturer, STANFORD UNIVERSITY; Former Global Head of Data Management, BOEHRINGER INGELHEIM

*This sessions contains a 30-minute networking break

4:30

Workshops Concludes

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SEPTEMBER 26, 2017 - MAIN CONFERENCE DAY ONE TRACK SESSIONS MEDICAL AFFAIRS EXECUTIVE STRATEGY

RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS

MSL BEST PRACTICES

MEDICAL INFORMATION AND CALL CENTER MANAGEMENT

11:00 Track Chair’s Opening Remarks

Track Chair’s Opening Remarks

Track Chair’s Opening Remarks

Track Chair’s Opening Remarks

11:15

Keynote: Build an Agile Medical Affairs Group that is Able to Evolve and Transition as the Company Changes

Keynote: Enhance MSL Capabilities at Various Stages of the Product Lifecycle: Optimizing Tactics, Tools and Communications

Keynote: Explore Industry Perspectives in Collaborative Research

Keynote: Reflect on the Future of Medical Information as a Value-Added Function in the Industry

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Shaheen Kaplan, Pharm.D., M.Ed, MBA, Vice President, Medical Affairs, ADAMAS PHARMACEUTICALS

Highlight methods, roles, and responsibilities of larger pharmaceutical and biotechnology medical affairs teams and how and when they can be replicated within a smaller model gg Assign cross-functional work streams to MA team members that can be efficiently executed gg Pinpoint communication channel issues that arise in large medical affairs teams and increase collaboration between field MSL and in-house teams

Ryan Arnold, Vice President, Head of Medical Affairs, SAGE THERAPEUTICS

12:00 Develop Value- and Outcomes-Based KPIs By Conducting External Assessments of Medical Affairs

Assess opinion leaders’ medical and clinical scientific views of disease states and treatment profiles by specialty, region, and classification of opinion leader gg Leverage third-party research to assess the attitudes of key opinion leaders toward your company and the perceived value of your MSLs compared to key-competitor field teams gg Determine OL need-segments and quantify MSL’s ability to meet those needs gg Track opinion leader decision making over time and understand drivers of value gg

David Tworek, M.S., MBA, Regional Director, Medical Affairs, LUNDBECK

Explore the use of social media and news outlets to help familiarize your team with a disease state gg Apply the appropriate analytics to identify and map key opinion leaders by territory gg Conduct publication SWOT analyses to prepare for a product launch gg Understand how the role of an MSL changes so that they are best positioned to make an impact post-launch

Fernando Blanco, Ph.D., Senior Medical Science Liaison, SHIRE

Identify the critical considerations when comparing research opportunities gg Examine basic, yet often overlooked components needed for collaborative research success gg Define best practices in collaborative research gg

Noam Frey, M.D., MBA, Vice President, Medical Affairs, JAZZ PHARMACEUTICALS

James Fratantonio Pharm.D., Manager, Medical Information, ALKERMES

Stimulate discussion and debate about the future practice of medical information gg Name three factors that are imperative to MI utilization gg Identify at least one potential consequence of the accelerated pace of technological change gg Become aware of the Medical Information Code of Practice gg

Dominick Albano, Vice President, Global Medical Information, PFIZER

Arthur Chan, Ph.D., MBA, Head, MSL Capabilities, Development and Training, NOVARTIS

Design and Build a New Medical Science Liaison Examine Criteria to Determine When to Start an Team: Solving Challenges and Maximizing Value Investigator-Sponsored Trial

Maximize the Use of the Medical Information Team

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Consider the various options for developing a team given identified resources gg Define core MSL functions and how they may change given the organizational evolution gg Examine the MSL role and skill sets required to successfully address current and future organizational needs

Consider tactics and how to engage stakeholders from the start gg Propose risk mitigation strategies when launching pipeline programs gg

Sara So, M.S., Senior Manager, Scientific Alliances, SEATTLE GENETICS

Tammy Coberly, Pharm.D., Executive Director, Medical Science Liaisons, HELSINN THERAPEUTICS

Gary Kaplan, M.A., Vice President, Medical Affairs Research, CLINICAL SCORE

Compose your medical information team of highly talented individuals who are capable of wearing multiple hats within the medical affairs department, including responding to unsolicited medical inquiries, content creation (e.g., standard response letters, slide decks), congress planning/ execution, library/literature services, and promotional review gg Avoid redundancy, maximize efficiency and productivity within the medical affairs department through successful Medical Information team operations, regardless of company size or resources gg Set the stage for a high-functioning team that is valued cross-functionally and within the medical affairs department

Colleen Tholen, Associate Manager, Medical Information, AVANIR PHARMACEUTICALS

12:45 Luncheon 1:45

Explore the Use of Technology and Innovative Communication Channels to Engage Physicians and KOLs

Look at new tools and channels that can be used to engage KOLs in a non-traditional way gg Understand the use of web-based collaborative communities as a discussion forum that is independent, but supported by industry gg Leverage this engagement to generate awareness during clinical development and to discuss emerging news regarding specific disease states gg

Examine the Various Skill Sets Required to Be a Successful MSL in Different Therapeutic Areas Gain an overview of the basic challenges facing specific therapeutic areas gg Outline the skill sets required to overcome these challenges gg Review strategies and best practices for delivering the most value to your organization gg

David Tworek, M.S., MBA, Regional Director, Medical Affairs, LUNDBECK

Consider Drug Supply from an IST Perspective

Examine key factors to consider when supply is precommercialization gg Manage vendors through effective shopping and realistic timelines gg Review how proactive internal processes can avoid potential problems gg Consider infrastructure that allows for flexibility in the face of inevitable change gg

Sarah Henry, Senior Clinical Project Manager, KARYOPHARM THERAPEUTICS, INC.

Dannis Chang, Pharm.D., Strategic Program Lead - Business Innovations, U.S. Medical Affairs, GENENTECH

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Implement Quality Assurance (QA) Process of Medical Information Database

Recognize the need for QA of medical information inquires and responses in the database gg Discuss common medical information reports for analysis and metrics gg Analyze the QA process, categories, severity, and resolutions gg Determine the best practices for medical information personnel training and documentation based on QA results gg

Avni Patel, Pharm.D., Associate Director, Global Medical Affairs, Medical Information, INTERCEPT PHARMACEUTICALS

WEST

WEST

MEDICAL AFFAIRS EXECUTIVE STRATEGY 2:30

Panel: How Technology-Leveraged Continuous Learning Yields Better Clinical and Scientific Outcomes

Characterize the need to provide effective learner-driven training to benefit “point of learning” performance support gg Evaluate technology tactics which make micro-learning effective for overall knowledge retention gg Understand how micro-learning works in the context of an innovative continuous learning approach gg Share best practices for deploying accessible training for MSLs/CRAs and review case study summaries gg

Michael W. Young, Vice President Strategic Accounts, SCIENCEMEDIA

MSL BEST PRACTICES The MSL at the Epicenter of the Field Intelligence Radar

Highlight the value of MSLs as the first signal detector for changes in the marketplace gg Define competitive intelligence in the framework of MSL team activities gg Leverage relationships with HCPs to gain a better understanding of the competitive landscape gg Discuss appropriate intelligence-gathering tools and tips for MSLs in the field gg

Lynn Bass, Director, Medical Science Liaisons (Americas), SANTEN

RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS Field Medical Affairs in IITs: Leveraging RiskTolerance Models to Ensure Compliant and Strategic KOL Engagements

Align Communication Resources Across Field and Internal Medical Affairs

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Understand the complexity of regulatory oversight on Investigator-Initiated Trials through landmark cases that helped shape the regulatory arena gg Leverage knowledge of risk-tolerance models to compliantly align field medical teams in the setting of investigator-initiated studies gg Foster discussions and share best practices on the role of institutional compliance training and pre-emptive riskmitigation strategies to ensure a successful IIT program

Networking Break

3:45

Navigate Medical Affairs in the World of Alliance Explore the Use of Intelligence Reporting as a Field Partnerships and Co-Promotions Metric

Examine What Factors Can Improve the Likelihood of a Successful IIT

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Review the different types of alliances and partnerships Establish a model to manage medical affairs through the alliance gg Discuss the various challenges with respect to compliance, thought leader initiatives and organizational structures gg Build trust with your alliance partners and minimize the overlap of team members from the same function on every project workstream

Poushali Mukherjea, Ph.D., Executive Director, Medical Affairs, BRISTOL-MYERS SQUIBB

4:30

Panel: Explore Different Models for Managing Medical Affairs Activities in Co-Promotion Agreements, Strategic Alliances and Acquisitions

Review the different kinds of scenarios that require you to partner with another organization gg Analyze the impact of this arrangement on the development and execution of medical activities gg Determine what sort of arrangement best serves your business needs gg Hear case examples and shared learnings from real-world scenarios from experiences gg

Poushali Mukherjea, Executive Director, Global Medical Affairs, BRISTOL-MYERS SQUIBB Sarah Guadagno, Ph.D., Vice President, Medical Affairs, Communications and Information, ZS PHARMA

5:15

Networking Reception

6:15

Day One Concludes

Discuss some of the challenges of leveraging CRMs to extract field insights in an intuitive manner gg Review the different types of intelligence collected gg Develop a process to collect field intelligence, tier it based on importance/urgency, and report it up the management chain accordingly gg Use this process as a metric that tracks the frequency and quality of the feedback reported by team members gg

Review key goals for the investigator and pharmaceutical company to define an IIT structure that meets both parties’ needs gg Build a structured foundation for the collaboration to ensure successful product-knowledge expansion

Diane Hanna, Senior Regional Medical Liaison, SANOFI; Director of Clinical Research, MODERN DERMATOLOGY

Kristin C. Ryan, Pharm.D., Field Director, Medical Science Liaisons, ASTELLAS

James Fratantonio, Pharm.D., Manager, Medical Information, ALKERMES

Examine a Pharmaceutical Company’s Perspective in Finding Medical Information Online

Review reputable sources of online medical information Manage inaccurate and outdated online medical information gg Provide mechanisms to update online medical information to external websites gg Respond to customers who have incorrect medical information gg gg

Matt Bryant, Associate Director, Medical Affairs, THERAVANCE BIOPHARMA

Continuing Development Programs to Facilitate Connections Between Field-Based Medical Affairs Professionals to Home Office Colleagues

Develop an Efficient Process for Fair-Market Value Analysis of Budgets for Investigatorsponsored Trials

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Allow for knowledge exchange and awareness between the field and home offices in order to strengthen medical affairs department and personal development gg Hear a multitude of ways to create and engage crossfunctional teams within medical affairs gg Learn about a rotation program for MSLs that exposes them to various medical affairs roles gg Establish the value of MSLs in the eyes of home-office colleagues

Identify the need for resource development Engage the team in preparation of new internal initiatives and data dissemination gg Educate and review new materials for external stakeholder communication gg

Fernando Blanco, Ph.D., Senior Medical Science Liaison, SHIRE

3:15

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MEDICAL INFORMATION AND CALL CENTER MANAGEMENT

Learn how to develop a process to analyze IST budgets for fair-market value working closely with compliance gg Determine company position on invoice-ables, milestone payments and overhead allowance gg Assess whether outsourcing (within company or externally) is appropriate for your IST program

Elizabeth Mena, Associate Director, Medical Sciences, PHARMACYCLICS LLC

Brandi Howard, Vice President, Global Clinical Development and Medical Affairs, EVOFEM

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Panel: Develop Innovative Mediums to Provide Patients With Digestible Medical Information

Develop engaging material that complements standard response documents and further patient understanding gg Expand medical communication with HCPs and patients to include social media and online chats gg Review regulations to ensure compliant communication through new mediums and channels gg

Hoyee Leong, Ph.D., Director, Global Medical Information, Oncology, Global Medical Affairs, ABBVIE Dominick Albano, Vice President, Global Medical Information, PFIZER Colleen Tholen, Associate Manager, Medical Information, AVANIR PHARMACEUTICALS

WEST

SEPTEMBER 27, 2017 - MAIN CONFERENCE DAY TWO TRACK SESSIONS MEDICAL AFFAIRS EXECUTIVE STRATEGY 8:00

Continental Breakfast

8:45

Track Chair’s Recap of Day One

9:00

Medical Affairs Strategies in Managed Care: Out Assess the Career Path of an MSL gg Identify reasons why scientific professionals seek the MSL of the Box and Into the Conversation

Shaheen Kaplan, Pharm.D., M.Ed, MBA, Vice President, Medical Affairs, ADAMAS PHARMACEUTICALS

Conduct an analysis of competitive products Focus efforts on differentiating your product gg Leverage existing structures and key relationships gg Learn how to effectively communicate your value story in a managed care setting gg gg

Harry Kovelman, M.D., Vice President, Medical Affairs, PACIRA PHARMACEUTICALS

Track Chair’s Recap of Day One

David Tworek, M.S., MBA, Regional Director, Medical Affairs, LUNDBECK

position Highlight the importance of show individual value to the team and organization and demonstrate how to excel in the MSL role gg Evaluate longer-term career opportunities for the MSL, within the role and a company gg Analyze alternative opportunities for the MSL seeking other options gg

Vicki L. Fisher, RN, Director, Medical Affairs Operations and Training, JAZZ PHARMACEUTICALS

9:45

RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS

MSL BEST PRACTICES

Track Chair’s Recap of Day One

Fernando Blanco, Ph.D., Senior Medical Science Liaison, SHIRE

requests from sponsor-Investigators Ensure effective oversight of the trial to ensure the written agreement is followed gg Identify strategies and leverage MSLs to mitigate and remedy non-compliance gg

Cultivate Synergies in Scientific Communications and Medical Information Services to Provide Useful Resources to Cancer Patients and Healthcare Professionals

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Sarah Jarvis, Associate Principal, Medical Affairs Consulting Lead, ZS ASSOCIATES

Review benefits and challenges of global content centralization gg Consider technology enablers to promote content reuse gg Review strategies for global medical content success gg

Rebecca Weingard, Director, Medical Affairs, BRISTOLMYERS SQUIBB COMPANY

Successfully Integrate a Quality Component into Investigator-Initiated Trials

David Freilich, Senior Medical Science Liaison and Senior Team Trainer, IMPAX PHARMACEUTICALS

James Fratantonio Pharm.D., Manager, Medical Information, ALKERMES

Kathryn Shantz, Operations Leader, Medical Evidence & Observational Research, ASTRAZENECA

Explore the Career Growth Prospects and Challenges for MSLs

Examine the MSL career trajectory and their possible defined career path gg Consider potential alternative careers MSLs can transition to gg Navigate the relationship between compensation levels and therapeutic areas

Track Chair’s Recap of Day One

Prevent Non-Compliance and Steps to Take When Case Study: Centralize Scientific Content It Occurs in Investigator-Initiated Trials Creation for Improved Quality, Speed and gg Create an established group that evaluates research Reduced Cost

Analysis of Field Medical Growth and Industry Trends

Explore the latest analyses on the continued growth of field medical across the industry, especially in specialty therapy areas gg Review the drivers and current perceptions across the industry that are fueling this growth gg Outline the implications and future needs of medical affairs organizations to meet these industry trends

MEDICAL INFORMATION AND CALL CENTER MANAGEMENT

Develop a strategy for an IIT program supporting the therapeutic area and/or research objectives gg Review compliance with global requirements gg Create a checklist to promote efficiency and maintain compliance with regulations

John Schenkel, Grant Manager, Global Medical Grants and Research Collaborations, PFIZER

William Soliman, Ph.D., MPhil, M.A., U.S. and Global Medical Director, Rare Diseases, Hepatology/Gastroenterology, RETROPHIN Davida J. White, M.D., Global Medical Affairs Director of MSL Training and Development, ALCON

Review SOPs/processes for Information Specialists Implement efficient legal, medical and regulatory (LMR) review processes for accurate and timely dissemination of up-to-date disease state education and patient support information gg Review Effective CI surveillance of trends in the “Engineered T cell Marketplace,” including FAQs and other useful resources to educate cancer patients and healthcare professionals gg gg

Joe Petroziello, Senior Director/Head of Scientific Communications, JUNO THERAPEUTICS, INC.

10:30 Networking Break 11:00

Closing the Loop: Pulling Through Field Insights to Medical Strategy

Soft Skills Needed for Impactful KOL Engagement

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Describe a field insights model Discuss tactics used to facilitate real-time discussions of insights between MSLs and product leads gg Identify ways to encourage MSLs to share relevant, focused and timely field insights gg Examine how cross-functional teams utilize field insights to shape their initiatives gg

Deborah Hails, Director, Hematology MSLs, US Medical Affairs, SHIRE

11:45

Foster Collaboration Between U.S. and Global Medical Affairs gg

Describe the value-add of integrated dialogue between U.S. and global medical affairs in the development and execution of medical affairs strategies and operating plans

Adapt your style in order to work more effectively with various KOLs gg Build and maintain reapport with top KOLs gg Develop engaging presentation skills for the target audience gg Learn how to get on a personal level with your KOLs for long term relationships

Georgea Pasedis, Pharm.D., Senior Medical Science Liaison, SHIRE

Partnering from Within to Build the Best Team gg

Discuss the value of continuous exchange of ideas, debate and sharing of feedback as critical in building a new MSL team at a small company

Navigate the Investigator-Initiated Trials Process Succeed through Collaboration by Integrating From a Site Perspective Frontline Operations from Different gg Understand site stakeholders, in addition to the principal Organizations investigator, through case studies Establish clear expectation of deliverables to avoid delays gg Review universal opportunities for improvement gg Foster partnerships to optimize IITs gg

Joseph Cosico, Director, Clinical Research Operations, CEDARS-SINAI MEDICAL CENTER

Create an integrated call center via collaborative knowledge transfer gg Understand the steps and processes to ensure sustained and consistent consumer support across different portfolios gg Examine examples of a successful integration plan gg

Stéphanie Vézina, Pharm.D., Director, Medical Customer Interface (MCI), PFIZER

Optimize the Advancement of an Investigational Drug from Pre-clinical to Clinical Trials Through Research Collaborations

Improve the Health Literacy of Medical Information Response Letters

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Identify internal and external factors that hamper the transition of an investigational drug from the non-clinical to first in human clinical trial phase

F o r m o r e i n f o r m a t i o n , v i s i t w w w. e x l - m a s s . c o m / w e s t

gg

Understand the current medical information landscape Engage the four steps to better communication

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MEDICAL AFFAIRS EXECUTIVE STRATEGY Discuss strategies and approaches for facilitating increased collaboration between global medical affairs and the U.S. affiliate gg Outline innovative approaches for communicating the U.S. medical affairs cross-functionality perspective to the global teams, with an emphasis on gathering field insights gg Provide scenarios/case discussions for troubleshooting collaboration challenges between U.S. and global teams gg

Leslie Meltzer, Vice President, Head of Medical Affairs, KERYX BIOPHARMACEUTICALS

MSL BEST PRACTICES Explain the value of leveraging past experiences of new colleagues to more practically train and onboard gg Review the “power of the small” in testing new systems, operations and approaches for smoother and more satisfying implementation gg

Chris Robertson, Pharm.D., Director, Medical Affairs Operations and Training, DERMIRA Andrew Smith, Ph.D., Senior Director, National Head of MSLs, DERMIRA

RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS Apply strategic initiatives and resources that promote immersive deep dive, protocol design optimization, and seamless project team and project management gg Design and apply benchmarking parameters to evaluate success of initiative selected gg

MEDICAL INFORMATION AND CALL CENTER MANAGEMENT gg

Provide the optimal HCP experience through response letter transformation

Hoyee Leong, Ph.D., Director, Global Medical Information, Oncology, Global Medical Affairs, ABBVIE

Nanette Hock, Clinical Research Scientist, Translational Development, CELGENE

12:30 Luncheon 1:30

Strategic Considerations for Developing Phase 3b/4 Study Portfolios Including Clinical Cohort (Real-World) Data

Review Phase 3 study portfolio and identify data gaps with prioritization gg Phase 4 studies: develop and manage InvestigatorSponsored and collaborative studies to address data gaps gg Collaborate with investigators and research networks to ensure access to relevant data sources gg

Richard Haubrich, M.D., Senior Director, HIV Medical Affairs, GILEAD SCIENCES

2:15

Outline current methods of data dissemination and inherent challenges with traditional methods gg Identify new digital options that have proven to be valuable solutions to age-old problems gg Discuss the methodology to managing digital engagement projects gg

Aaron Shaw, RN-BSN, Medical Director, Medical Science Liaison Team, PACIRA PHARMACEUTICALS

Examine Investigator-Initiated Clinical Trials Industry Considerations to Ensure You Organization Truly Understands What the Researcher is Doing

Know the criteria that suggest the researcher is likely to conduct a quality study balance the legal and ethical impact of support to the researcher gg Understand the consequences of non-compliance or fraud gg

Harvey Arbit, Pharm.D., Professor, UNIVERSITY OF MINNESOTA COLLEGE OF PHARMACY

Case Study: Innovative Approaches to Engaging Bridging the Gap Between MSL Field and Officeand Collaborating With Patient Advocacy Groups Based Medical Affairs Teams gg Implement a structure that will capture global MSL insights, While Working With a Limited Budget

Discuss FDA and the Drug Approval Process in the U.S. to Outline the Various Steps, Timelines and Milestones in Research Collaborations

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Consider the end goals and motivations for patient groups gg Identify opportunities to support these organizations as an alternative to direct funding gg Create objectives that are mutually beneficial and measure the ROI of these activities as a means to grow these relationships

Pauline Bianchi, Senior Director, Medical Affairs— Pulmonology, VERACYTE

3:00

Case Study: A Value-Based Approach to PriceLimiting Solutions Such as Virtual Reality

Case Study: How to Develop and Sustain HighPerformance Promotional Review Committee Teams Employ universal onboarding/training guidelines for PRC members gg Accommodate multiple communication channels gg Maintain consistency and prevent mixed messages from multiple teams that would confuse ad agencies gg Standardize PRC processes across drugs/devices and indications to improve effectiveness of PRC review gg

Jay H. Mashburn, Ph.D., R.Ph, PMP, Senior Manager, Medical Affairs—Aesthetic and Corrective, GALDERMA

3:45

Track Chair Closing Remarks

4:00

Summit Concludes

Shaheen Kaplan, Pharm.D., M.Ed, MBA, Vice President, Medical Affairs, ADAMAS PHARMACEUTICALS

Case Study: Component Authoring in Medical Information

Implement systems and processes that enable authoring smaller components of content that can be systematically combined to create broader pieces of medical information gg Describe the rationale used to decide to move to this new approach to creating and managing content globally gg Discuss successes and challenges in our approach gg Highlight some early results from our experience gg

Michael Rocco, Director, Business Planning and Communication-Americas, PFIZER

Dive Deep Into Strategies That Elevate the Customer Experience

Kasmin Delgado, Medical Science Liaison, VALEANT PHARMACEUTICALS

Uncover best practices to effectively interact with increasingly engaged customers to ensure added value and increased customer satisfaction gg Leverage innovation to elevate the customer experience and increase the impact provided to a variety of customers gg Build a foundation for a new approach to customer service excellence through culture shifts Christopher Bess, Associate Director, UCBCares, UCB

Forge Strategic Partnerships With Your Medical Information Group to Develop Meaningful Relationships With Thought Leaders

Panel: Overcome Barriers Throughout the Investigator Initiated Trials Grant Cycle

Divulge Practices to Move Into the Medical Information Space as a Clinical Pharmacist

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ensure alignment in resource utilization, and identify unmet needs across various regions gg Demonstrate the value of MSL insights and strong partnerships between field and office-based medical affairs teams to effectively develop and deliver strategic medical and educational materials and tools gg Engage in the ability to connect MSLs across the globe with each other and within office-based medical affairs functions in a manner that promotes unity, collaboration, and integration

Discuss most common trial structures to understand what sponsors must go through to get an FDA-approved drug to market gg Review compassionate use and the “Right to Try” in the United States

gg

Anisha Bhagat, Pharm.D., Manager, Global Medical Affairs, INTERCEPT PHARMACEUTICALS

Explore different data sources and channels to increase your knowledge base of a therapeutic area gg Highlight the importance of a collaborative relationship between MSL and medical information groups gg Leverage these materials to connect with KOLs

Manijeh Pouliot, Pharm.D., BCPS, Regional Medical Liaison, Diabetes Medical Unit, SANOFI U.S.

Track Chair Closing Remarks

David Tworek, M.S., MBA, Regional Director, Medical Affairs, LUNDBECK

Define high quality IIT study characteristics Differentiate various parties’ interests in high quality IITs gg Describe any signals of barriers to high quality IIT studies gg Explain various strategies for overcoming these barriers

Jeff Braziunas, PhD, Sr. Medical Science Liaison, Oncology, ASTELLAS Eric Mortenson, PhD, Medical Science Liaison, Oncology, BRISTOL MEYERS SQUIBB Axel Grothey, MD, Chair, ACADEMIC AND COMMUNITY CANCER RESEARCH UNITED (ACCRU) Fawn Hangge, Program Manager, ACADEMIC AND COMMUNITY CANCER RESEARCH UNITED (ACCRU) Christy Gilchrist, PhD, Director of Research, HSHS ST. VINCENT HOSPITAL CANCER RESEARCH INSTITUTE

Track Chair Closing Remarks

Fernando Blanco, Ph.D., Senior Medical Science Liaison, SHIRE

F o r m o r e i n f o r m a t i o n , v i s i t w w w. e x l - m a s s . c o m / w e s t

Describe opportunities and challenges faced by clinical pharmacists interested in transitioning into the pharmaceutical industry gg Highlight advantages individuals with prior patient-care experience bring to medical affairs teams gg Identify areas of support needed by clinically-trained pharmacists to excel within medical affairs

Joal Mayor, Pharm.D., Associate Manager, Medical Information, SEATTLE GENETICS

Track Chair Closing Remarks

James Fratantonio Pharm.D., Manager, Medical Information, ALKERMES

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