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Agenda

Workshop Day | Tuesday, April 14, 2020
Option 1
Option 2
9:00AM
Workshop A - Establish an Integrated Approach to Managing Medical Information and Medical Communications to Leverage Insights and Deliver Value to Patients

In the age of empowered consumers, medical affairs groups can play a central role in informing data needs and ensuring the delivery of relevant medical information and impactful communications that address the needs of patients.

  • Cultivate synergies in scientific communications and medical information services to provide useful resources to patients and healthcare professionals
  • Centralize scientific content creation for improved quality, speed, and reduced cost
  • Identify the need for resource development and align communication resources across field and internal medical affairs

Lai H Jen, M.D., Executive Director, Oncology Global Medical Affairs, Head and Neck, Melanoma, and Hematology, Merck
Workshop B - The Ever Elusive Balance of Quantity vs. Quality in MSL Goals and Metrics
  • Outline what the key activities or goals of MSLs should be in this ever changing role
  • Review how we measure the success of those goals and ultimately the MSL
  • Discuss whether metrics are the same as goals and how to balance quantity versus quality
  • Determine what a valuable or ‘quality’ interaction should be and whether different types of events or activities should be weighted differently
Christine Chatas, Director, Medical Liaisons, ALEXION
12:00PM
Lunch
1:00PM
Workshop C - The Challenges and Opportunities in Disseminating Medical Information: Do We Need a Redesign of the Role of Medical Affairs in Ensuring Compliant and Effective HCP Interactions?

While the role of pharmaceutical companies to provide accurate scientific information to HCPs and the global medical community is well established, regulatory and compliance oversight continue. Pharmaceutical companies must take into account a range of regulatory and enforcement statutes as well as actions taken by various government agencies with overlapping authority and often differing enforcement perspectives. The Medical Affairs function is being called upon to take a more proactive approach in helping to develop and implement policies regarding medical communication with both the external medical community as well as internal stakeholders (including Commercial, R&D, HEOR). This presentation will review the basic provisions of the FDCA as regulatory guidances issued by the FDA and actions taken by the Office of the Inspector General (OIG) in enforcing the False Claims Act
(FCA) and the Anti-Kickback statute, among others, and discuss the need for a new paradigm relating to the role of Medical Affairs.

  • Understand the evolution of the current enforcement environment
  • Discuss the interpretation and importance of FDA guidance documents including the FDA Reprint Guidance, the Draft Guidance on Unsolicited Requests for Off-Label Information, Drug and Medical Device Manufacturers Communications with Payers and Formulary Committees, and Medical Product Communications Consistent with FDA-Required Labeling
  • Identify areas of concern for FDA and OIG as revealed through enforcement letters and Corporate Integrity Agreements (CIAs) as affecting company policies
  • Craft new policies to respond to current and future enforcement initiatives
Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW
Workshop D - Examine How to Best Develop Your IIT Team and Processes To Ensure Effective Management And Contracting

When developing an IIT program, how you align your resources, staff the team, and develop your processes can greatly affect how quickly you can finalize any contracting necessary to support IIT trials. This workshop will discuss two overarching areas that affect contracting: 1) Processes such as IIT portals and hands-off IIT submission processes versus relationship-based models; 2) Staffing such as fully insourced IIT teams, outsourced or IIT teams staffed by Flexible Staffing providers, and IIT teams with set contracts.

  • Weigh the pros and cons of the different types of submission processes that pharmaceutical companies use to support their IIT program and discuss how they are looked at by a site contract and budget team
  • Review different staffing models and why companies may choose to use a specific model for their IIT program
  • Discuss how the different models may affect your contracting timelines
Jay T. Alkam, Esq., Contracts Manager, Global Medical Operations, Allergan
4:00PM
Workshop Day Ends
Tracked Sessions | Workshop Day | Tuesday, April 14, 2020
9:00AM
KOL Engagement Seminar Opening Remarks
9:15AM
Future Proofing your Medical Affairs Organization and your KTL Engagement Strategy
  • Building an internal Key Thought Leader (KTL) Community of Practice.
  • Aligning Business Strategy and Objectives to drive Medical Affairs and KTL Program
  • Developing a Standardized Policy that provides Guidelines for KTL Engagement Strategy
  • Delivering strategic guidance, leverage clinical, scientific, and economic knowledge to drive meaningful innovations
Kevin Appareti, Senior Director, Global Medical Science Liaison, Philips Healthcare
10:00AM
MSL As the Valued and Credible Asset to the Payer and Provider Community
  • Address key takeaways of building basic relationships
  • The importance of the following up and following through strategy
  • Understand “what you do” vs. “what you can do” and where your KOL can collaborate within your organization
Howard Berkowitz, Respiratory and Immunology, MSL, U.S. Field-Based Medical Affairs, Sanofi Genzyme
10:30AM
Break
11:00AM
Case Study: Following the Journey Fellowship to KOL
  • Follow the progression of up-and-coming fellows through an integration with your organization
  • Create a continuum in the career of a physician to build a KOL story
Ann Roen, Director, Professional Relations and Customer Insights, Medtronic
12:00PM
Lunch
1:00PM
Discover Tactics to Enhance Communication Between Medical and Commercial Teams
  • Discuss how to begin breaking down silos within the industry for higher efficiency and stronger bonds
  • Assess obstacles and hesitancies in communication and discuss methods for overcoming them
  • Define clear objectives for legal and other departments to ensure smooth process flows
  • Work compliantly in the same space with supporting teams to increase efficiency
Christopher Alfieri, Thought Leader Liaison, EMD Serono
2:00PM
Effectively Tier Thought Leaders to Determine the Fair Market Value of Payments
  • Select a range of metrics and criteria for developing a stratification model for KOL segmentation
  • Identify thought leaders based on level of experience and recognition
  • Craft compliant processes to collect and evaluate data in order to determine regional and international fair market value rates
2:45PM
Break
3:15PM
Leverage Regional Influencers to Drive Meaningful Engagement with Local Communities
  • Identify unmet medical education needs for 5 target stakeholder groups
  • Prioritize medical education needs and align with cross-functional business strategy
  • Define medical education strategy and validate through an Advisory Board
Rita Zambelas, Associate Director, Amicus Therapeutics
4:00PM
A Compliance Perspective on Effective Advisory Board/Consulting Arrangement Execution
  • Consider the legal and regulatory risks involved
  • Explore the need for compliance monitoring in advisory boards
  • Discuss the difference in perspectives between medical and commercial groups
5:00PM
Closing Remarks
5:30PM
Conclusion of Seminar
Main Conference Day 1 | Wednesday, April 15, 2020
Strategy
Operations & Tech
MSL
IIT
9:15AM
Keynote Presentation: The Role of Medical Affairs from Prelaunch to Launch
  • Provide an overview of crucial activities during the prelaunch period
  • Use clinical narratives and supporting evidence to develop a strong scientific platform
  • Gain valuable input from the different disciplines to develop a scientific lexicon for a brand that is consistent and aligned across various stakeholder groups
12:00PM
Lunch
1:00PM
The Benefits of Engagement from the Medical Affairs Team Early in the Product Lifecycle
  • Examine the increased responsibilities medical has taken over in the last decade and how they should be playing a leading role in the pre-launch phase
  • Understand how the success of engaging payers, generating costs and leveraging the patient journey is all predicated on how early medical is involved
  • Hear how to collaborate with clinical development and take an integrated approach to generate clinical evidence
Barry Lubarsky, Executive Director, Medical Affairs Strategy, Alkermes
Case Study: Use Real World Evidence to Support Medical Affairs Operations
  • Discuss how to generate RWE with limited resources through product registries, outside investigators, partnerships, and demonstration projects
  • Discover how patient-generated data can assist in serving various stakeholder objectives
  • Understand the strategic role for medical affairs in generating and communicating RWE to all stakeholders
Jill Massey, Senior Vice President, Medical Affairs, Melinta Therapeutics
Case Study: Utilize Unbranded Scientific Exchange Programs to Ensure Effective Decision-Making
  • Discuss how your team can proactively engage customers through unbranded exchange programs
  • Ensure that you are clearly separating scientific exchange from promotional messaging
  • Use scientific and data-driven information to help HCPs make informed patient-care decisions
Jasmine Correy, Medical Science Liaison, Sanofi
Best Practices for Proposing an IIT Program and Preparing a Study Proposal
  • Strategies for identifying the best funding opportunities
  • Assess the stage in which you should start your IIT program
  • Write a compelling and successful budget justification
1:30PM
Panel – Launch Planning for Various Organizations Sizes and Scenarios
  • Examine the increased responsibilities medical has taken over in the last decade and how they should be playing a leading role in the pre-launch phase
  • Understand how the success of engaging payers, generating costs and leveraging the patient journey is all predicated on how early medical is involved
  • Hear how to collaborate with clinical development and take an integrated approach to generate clinical evidence
Yurek Paprocki, MD, MBA, Medical Lead Director, Novo Nordisk
Establish the Value of Medical Affairs to Ensure Proactive Collaboration and Alignment with Functional Partners
  • Discuss how to bridge the gap when working a highly matrixed organization between preclinical, clinical operations, and medical affairs
  • Develop a culture of collaboration with open communications within cross-functional teams to allow for efficient channel management and rapid bidirectional information flow
  • Consider the types of personality traits that can be beneficial when building out a new team
  • Explore how to proactively manage your team’s career and continue their development
Use Data Mining Techniques to Enhance Customer Engagement
  • How analytics drive your outreach strategy
  • Segment customer base and target them using data analytics
Dan Hennessy, Vice President Field Medical Affairs, EMD Serono
Ariel Katz, CEO, H1 Insights
Key Strategies for your Internal Investigator Initiated Study Operations
  • Understand all specifications needed for your proposal
  • Learn how to streamline your proposal submission process throughout your company
  • Close the gap between what is submitted vs. what your internal review committee needs
Steven Zhang, Vice President, Medical Affairs, Kala Pharmaceuticals
2:00PM
Establishing a Medical Affairs Organization in a Start-up Environment
  • Discuss key considerations when designing and growing a medical affairs organization in a small-company environment
  • Compare and contrast medical affairs responsibilities in a small-company or start-up environment vs. larger or more established organizations
  • Do Less with More
Establish a Centralized and Consolidated Training Hub to Ensure Global Alignment and Understanding of Value-Based Healthcar
  • Understand how the value discussion has evolved over time as a requirement by external stakeholders and learn the impact that both clinical and economic information can have for KOLs, payers, and healthcare systems
  • Identify the most impactful outcomes data and resources used by value-based health decision-makers to make informed decisions
  • Discuss the different models that field medical organizations leverage to address the value discussion externally
Panel: How Medical Affairs Can Help Prepare the Market for a New Drug Launch
  • Review how Medical Affairs (including Field Medical) can support market readiness in terms of external stakeholder engagement
Tommy Brock, Senior MSL, United Therapeutics
Luchy Hidalgo, M.D., Independent Consultant
Tonya L. Johnson, Pharm.D., Director, Global Medical Excellence, Allergan
Alan Polnariev, MSL, Ferring Pharmaceutical
Josh Yoder, Ph.D, Medical Science Liaison, uniQure
Best Practices for Negotiating Contracts to Improve Study Start-Up
  • Understand the motivations behind co-development deals and strategic alliances
  • Clearly communicate research areas of interest from the start to align expectations
  • Map out a plan to effectively manage the submission, review, and management of all IIT proposals and streamline operations
Michael Martineau, Senior Manager, Externally Sponsored Research, Ipsen
2:30PM
Break
3:00PM
Patient Centric Framework as a foundation for Medical Affairs Strategy and Operational Effectiveness
  • Patient Wellbeing is the key to healthcare sustainability
  • Medical Affairs has a leadership role in defining target patient segments for industry innovation and defining value for the patient
  • Patient centricity should be an anchor for planning and executing Medical Affairs activities
Stanislav Glezer, Vice President, Global Medical Affairs – Diabetes Care, BD
Panel – Optimize Customer Engagement Through Use of Innovative Technology
  • Discuss changes in the role of Medical Affairs in interacting with the next generation of healthcare providers and their patients
  • Leverage the virtual reality (VR) tool and apps to enhance clinical education and training
  • Learn and discuss best practices for utilizing technology to elevate customer interactions
Panel: Communication Strategies: A guide to meaningful conversations with HCPs, KOLs, patients, colleagues and other stakeholders
  • How do we generate good/valuable insights?
  • How do you bring value and focus of company to KOLs?
  • How to bring back insights/information that provide guidance on publications, educational modules, and developing strategies moving forward?
  • Technology, challenges (online/social versus in-person) technology you are leveraging
  • How to capture and report them?
Tonya L. Johnson, Pharm.D., Director, Global Medical Excellence, Allergan
Sheila Komara, Senior MSL, Mallinckrodt
Panel: Best Execution Practices for IITs in Different Therapeutic Areas
3:45PM
How to Best Leverage Social Media and the Digital Ecosystem in Patient Recruitment
  • Examine the use of social media in patient recruitment
  • Review what is and is not working in partnerships between patient social networks and pharmaceutical companies and CROs
  • Discuss key elements of a social media community dedicated to aiding patient recruitment

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