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WEDNESDAY, APRIL 24 - Preconference Workshops | Wednesday, April 24, 2019

Continental Breakfast
Medical Affairs Strategies for an Effective Product Launch

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 harmonize all levels of your medical and commercial groups is crucial for a successful product launch.

  • Create a medical strategic and tactical launch plan that aligns with your organization’s business objectives
  • Establish a meaningful scientific communication platform to communicate and differentiate the medical and scientific value clearly
  • Develop a comprehensive and actionable stakeholder (KOLs, clinicians, payers, advocacy groups, policy makers, etc.) engagement plan in a compliant way
  • Set a clear strategy for data generation activities by identifying unmet medical needs and insights from stakeholders
  • Leverage medical information to educate healthcare practitioners

*This session contains a 30-minute networking break.

Randall E. Kaye, M.D., Chief Medical Officer, CLICK THERAPEUTICS
Diya Lahiri, Executive Vice President, Global Business Lead, MEDISTRAVA
Matt Lewis, Global Chief Data and Analytics Officer, MEDISTRAVA
The Right Person, at the Right Time, With the Right Message — An Exercise in Precision KOL Identification

This interactive workshop is designed for all attendees to design and develop an algorithm, that will serve as the basis on which to build a personalized database reflective of each attendee’s KOL territorial management needs. The “Strategic Opinion Leader Identification” or SOLID process is structured to use those quantitative variables, determined by each attendee, to align with their specific therapeutic area, geography, product life cycle, available economic resources, and more. With the completed algorithm, attendees will be able to identify the right person, at the right time, with the right message and do so in a way that will optimize results.

  • An interactive workshop — computers will be required
  • Identify 8-12 quantitative variables that align with each attendees’ territorial management needs
  • Design and develop a weighing scale based on the strategic business direction of the attendees respective company
  • Each attendee will build their own database in the time provided
  • Change the way your company looks at strategic opinion leader identification — a SOLID approach

*This session contains a 30-minute networking break.

Duke Dickerson, Ph.D., M.Sc., MBA, Regional Medical Director, Orphan and Rare Diseases, HORIZON PHARMA
Bill Maltas, Medical Science Liaison, CIRCASSIA
Marty Perz, Immunotherapy Sales Specialist, DENDREON
Workshop A Concludes
Workshop B Concludes
Luncheon (For PM Workshop Attendees Only)
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

*This session contains a 30-minute networking break.

Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW
Leadership in Medical Affairs: Tactics, Insights and Guidance From the World’s Best

Whether starting out as an MSL or leading an entire team, we can all recognize amazing leaders. At the same time, however, the qualities that define these leaders and their success can often be elusive and challenging to master. Lucky for us, there are masters who have shared their genius in the form of TED talks. With so many of these talks directly applicable to medical affairs success, this is the ultimate TED for MED-ical affairs.

  • Learn skills and insights on topics from motivation and happiness to lying and body language
  • Collaboratively engage to apply lessons from some of the world’s foremost experts in leadership
  • Develop ways to immediately incorporate TED’s greatest minds into your role
  • Shape and polish your performance for success in your current role and the role you’re building toward

*This session contains a 30-minute networking break.

Ryan Case, Ph.D., Director, U.S. Medical Affairs, NEURODERM
Stacy Martin Conner, Pharm.D., MBA, Field Director, Medical Science Liaisons - Women's Health, ABBVIE
Michael W. Ravotti, DHSc, PA-C, Senior Associate Director CDMA, Field-Based Medicine Respiratory MSLs, BOEHRINGER INGELHEIM
Workshop C Concludes
Workshop D Concludes
THURSDAY, APRIL 25 - Main Conference, Day One | Thursday, April 25, 2019
Main Conference Registration & Continental Breakfast
Chairperson's Opening Remarks
The Benefits of Early Medical Affairs Involvement in Launch Preparations
  • Examine increased responsibilities Medical Affairs has assumed over the last decade and how Medical plays a leading role in the pre-launch phase
  • Understand the importance of evidence generation throughout product life cycle and how Medical Affairs is uniquely positioned to leverage evidence to advance clinical practice and improve patient outcomes
  • Discuss how early Medical Affairs involvement, including early engagement of HCPs, payers, and patient organizations, plays a critical role in successful launch
Jing L. Marantz, M.D., Ph.D., Senior Vice President, Head of Medical Affairs, ALNYLAM
Marissa Nolan, Ph.D., CMPP, Vice President, Group Scientific Director, LOCKWOOD GROUP
Panel: The Medical Affairs Dilemma - Considerations for Building a Medical Affairs Group That Is Fit-for-Purpose
  • Develop a framework for building a fit-for-purpose medical affairs organization, considering corporate needs and the existing healthcare environment
  • Highlight methods, roles, and responsibilities of larger pharmaceutical and biotechnology medical affairs teams and how and when they can be replicated within different models
  • Assign cross-functional work streams to MA team members that can be efficiently executed
  • Pinpoint communication channel issues that arise in large medical affairs teams and increase collaboration between field MSL and in-house teams
Dan Hennessy, Ph.D., M.S., MBA, Vice President, Field Medical Affairs, EMD SERONO
Randall E. Kaye, M.D., Chief Medical Officer, CLICK THERAPEUTICS
Terri L. Phillips, M.D., Vice President and Head of Global Medical Affairs, MERZ
Beate Stych, M.D., Vice President, Head, Medical Affairs, REGENERON PHARMACEUTICALS
Leverage Online Discussion Platforms for Optimal Stakeholder Engagement
  • Identify the logistical and resource barries to domestic and global stakeholder engagement
  • Learn about innovative communication solutions that leading organizations utilize to overcome these challenges
  • Discuss how to use these solutions to deliver improved engagement outcomes while maintaining regulatory compliance
Networking Break
THURSDAY, APRIL 25 - Tracked Sessions, Day One | Thursday, April 25, 2019
Medical Affairs Executive Strategy
MSL Best Practices
Track Chair Opening Remarks

Poushali Mukherjea, Ph.D., Executive Director, Medical Affairs, BRISTOL-MYERS SQUIBB
Track Chair Opening Remarks
Davida J. White, M.D., Head, U.S. Medical Affairs, INDIVIOR
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 from a case study and discuss best practices for utilizing technology to elevate customer interactions
Terri L. Phillips, M.D., Vice President and Head of Global Medical Affairs, MERZ
How to Gather and Optimally Manage Clinical and Field Insights to Help Shape Your Medical Strategy

  • Review the importance of insights and share novel ways to gather field insights in an intuitive manner
  • Discuss the value of applying influence analytics to uncover insights, determine implications and priorities, and drive action for impact
  • Explore ways to define metrics that track the frequency and quality of the feedback reported by team members and the ultimate outcome
Kevin Appareti, Senior Director, Global Medical Science Liaison, PHILIPS HEALTHCARE
Creation of a Global Medical Affairs Function Alongside Existing Regional and Local Medical Affairs Organizations

  • Understand the context and process that drives the transformation
  • Meet existing needs while planning for the future state of the organization
  • Assure that the organization and infrastructure support the needs of multiple key stakeholders
  • Develop aligned tactical plans that have clear roles/responsibilities and timelines
Howard Rutman, M.D., Vice President, Medical Affairs, DAIICHI SANKYO
Panel: The MSL Archetypes: Satisfaction, Retention and Development

  • Analyze and identify the main archetypes of MSLs
  • Highlight what drives and satisfies different types of MSLs and discuss tips on finding satisfaction as an MSL (e.g., big pharma versus small biotech; team projects versus individual development; science versus operations)
  • Discuss how identifying the archetypes amongst your team can lead to better camaraderie and employee retention
Ryan Case, Ph.D., Director, U.S. Medical Affairs, NEURODERM
Stacy Martin Conner, Pharm.D., MBA, Field Director, Medical Science Liaisons - Women's Health, ABBVIE
Michael W. Ravotti, DHSc, PA-C, Senior Associate Director CDMA, Field-Based Medicine Respiratory MSLs, BOEHRINGER INGELHEIM
Take a Patient-Centric Approach to Medical Affairs Engagement

  • Improve outreach with detailed, multifaceted profiling that quickly identifies the right influencers and patient populations for your medical engagement.
  • Optimize scientific engagements with real-time, online predictive data as well as offline analytics support to radically improved results at significantly greater speed
  • Deliver field-level intelligence on competitor engagements to help you prioritize and compliantly improve the impact of outreach efforts
Pamela Morris, Director, Key Accounts, KOMODO HEALTH
Building a Field Medical Team From the Ground Up and Their Evolution Through the Growth Curve

  • Establish key priorities and build the infrastructure as you go
  • Determine the ideal headcount for your field team pre- and post-product launches
  • Discuss how the size of a company and the number of products in a portfolio and pipeline should affect the configuration of MSL teams
  • Ensure field activities are aligned to business objectives throughout growth trajectory
Sandra Petralia, Ph.D., Principal Medical Science Liaison, CLOVIS ONCOLOGY
Sagar Shah, Pharm.D., Senior Director and Head, Field Medical Affairs, AKCEA THERAPEUTICS
Networking Break
Design a Frictionless Research Grants Program That Maximizes Patient Outcomes

  • Identify pain points in current processes
  • Streamline workflow by incorporating dynamic approval, automated processes, concurrent versus sequential reviews and more
  • Determine planning considerations for transparent reporting
  • Embrace best practices from leading grantmakers

Rob Livada, Vice President, Solution Architecture, CYBERGRANTS
Panel: How to Set up Compliance Firewalls That Balance SOPs With Practical Needs

  • Review the history of events that have lead companies to develop the compliance framework they have today
  • Understand the origins, what has guided this framework and gain an overview of the legal perspective
  • Learn how to work collaboratively, semi-autonomously or purely independently of other departments based on the culture at your organization
David Jacobs, Assistant General Counsel, Commercial Brands, DAIICHI SANKYO
Teresa Kelton, J.D., Pharm.D., MPH, Senior Director, R&D Counsel, ALEXION PHARMACEUTICALS
7 Novel Ways to Wow HCPs: A Look at Wildly Creative Digital Platforms in Medical Affairs

  • Review emerging technology trends in digital content delivery and consumption
  • Experience how pharma companies can use virtual reality (VR), augmented reality (AR), Artificial Intelligence (AI), virtual worlds, and more
  • Develop spectacular and customized content that inspires and delights your customers
Michael Banks, M.D., Managing Director, BESTMSLS
Use Data Mining Techniques to Enhance Customer Engagement

  • Explore different avenues and technologies that can allow MSL teams to profile and segment customer channels to support customer engagement
  • Leverage external databases to identify discrepancies across therapeutic areas and extrapolate data for medical affairs needs
  • Use these insights to develop enhanced resources for MSLs to engage their customer base
Duke Dickerson, Ph.D., M.Sc., MBA, Regional Medical Director, Orphan and Rare Diseases, HORIZON PHARMA
Bill Maltas, Medical Science Liaison, CIRCASSIA
Marty Perz, Immunotherapy Sales Specialist, DENDREON
Cocktail Reception
Day One Concludes
FRIDAY, APRIL 26 - Main Conference, Day Two | Friday, April 26, 2019
Medical Affairs Executive Strategy
Medical Affairs Executive Strategy
MSL Best Practices
Continental Breakfast
Track Chair Recap of Day One

Poushali Mukherjea, Ph.D., Executive Director, Medical Affairs, BRISTOL-MYERS SQUIBB
Track Chair Recap of Day One

Davida J. White, M.D., Head, U.S. Medical Affairs, INDIVIOR
Case Study: Engage Patients Via Social Media in Compliance With International Guidance and Regulations

  • Navigate the jurisdictional restrictions that slow down patient engagement via social media
  • Examine the risks associated with responsibility for what goes on with user-generated content and the lack of detailed regulatory guidance
  • Outline practical considerations including pharmacovigilance, monitoring, content solicitation, access to information, and getting better at data security
Dan Zavodnick, Senior Associate General Counsel, KEDRION BIOPHARMA
Meaningful Metrics and a Qualitative Approach to Measuring MSL Activities

  • Consider the potential difference in value of KOL interactions at a congress versus their office versus offsite meetings
  • Determine which interaction and activity provides more quality and relationship heightening
  • Explore how to incorporate measures indicative of the quality of an activity, especially those that result in actions from KOLs
Monica Arora Sukhatme, Pharm.D., Head of U.S. Medical Affairs, NANOBIOTIX
Establish a Centralized and Consolidated Training Hub to Ensure Global Alignment and Understanding of Value-Based Healthcare

  • 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
Terry Babb, Pharm.D., Senior Director and Head, Global Medical Strategy and Training, TAKEDA PHARMACEUTICALS
The Evolving Role of the Medical Science Liaison in a Patient-Centric Healthcare Landscape

  • Appreciate the patient as the primary stakeholder and recognize the need to hear their voice
  • Determine the potential roles of the medical science liaison in this new landscape
  • Explore how the medical science liaison demonstrates value to both internal and external stakeholders

If you are interested in leading this session, please contact Michael Williams at

Networking Break
Best Practices for Establishing Investigator Grant Fair Market Value for Investigator Sponsored Studies

  • Assess ISS grant costing through protocol interpretation
  • Expedite contracting by applying FMV benchmarks and budgeting strategies
  • Gain financial intelligence by identifying the key drivers within an ISS investigator grant
  • Provide insurance that their budgets are audit-ready
Mike Jozefowicz, Associate Director, Consultative Services, IQVIA TECHNOLOGIES
How to Ensure Compliant Communications During Scientific Exchange and Off-Label Data Dissemination

  • Explore the difference between solicited and unsolicited requests
  • Understand why medical affairs needs compliance training
  • Develop techniques to provide accurate and balanced off-label data in a compliant manner
  • Examine the difference between scientific exchange and promotion
Jacqueline S. Armani, O.D., FAAO, Medical Science Liaison, ALCON
Real-World Evidence and Medical Affairs

  • Discuss the evolution of real-world evidence (RWE) and patient-reported outcomes (PROs) from postmarketing safety surveillance to therapeutic effectiveness
  • Consider opportunities and challenges relating to RWE, PROs and the FDA
  • Understand the strategic role for medical affairs in generating and communicating RWE to all stakeholders
Archie Stone, Ph.D., Vice President, Medical Affairs, ALCRESTA THERAPEUTICS
The Payer Problem: Team Deployment Strategies for Navigation of Confrontational Reimbursement Environments

  • Discuss the analytics that can be used to determine regions and team composition in order to overcome reimbursement barriers
  • Describe how best to approach differing payer environments in a changing landscape
  • Convey the best way to measure and present the value of payer interactions
Colville Brown, M.D., Executive Medical Director, INNOCOLL PHARMACEUTICALS
Develop a Comprehensive Publication Plan Aligned With Corporate Strategy and Product Life Cycle

  • Construct working relationships with clinical development (R&D), biostatistics, pharmacology, HEOR, epidemiology, etc., to manage data generation and analysis
  • Prioritize certain data sets/types in the publication plan aligned with the product life cycle
  • Understand the importance of publication timing, authorship and journal selection
  • Conducting effective scientific steering committees with external and internal experts to create bidirectional feedback that uncovers data gaps and to develop forward-thinking areas of scientific/clinical interest
  • Ensure that the publication plan is integrated to the Medical Affairs field team strategy and tactics, as well as being flexible enough to address competitive intelligence feedback
Joseph Chiao, M.D., Medical Director, Therapeutic Area Head, CSL BEHRING
Streamline Efficiencies and Improve Techniques to Build and Run Advisory Boards

  • Learn how to manage your brand by prioritizing markets and considering their similarities and differences
  • Discuss key areas of strategic planning necessary to make decisions on the scope and reach of your advisory boards
  • Explore the tactical implementation of advisory board management before, during and after each meeting
  • Review the involvement of key internal and external decision makers necessary to optimize the advisory board
Matthew M. Goodwin, Pharm.D., MBA, Director, Medical Affairs, ARSANIS
Track Chair Closing Remarks

Poushali Mukherjea, Ph.D., Executive Director, Medical Affairs, BRISTOL-MYERS SQUIBB
Track Chair Closing Remarks

Davida J. White, M.D., Head, U.S. Medical Affairs, INDIVIOR
Conference Concludes

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