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2017 Agenda

MONDAY, APRIL 9, 2018 - Pre-Conference Workshops | Monday, April 9, 2018
Workshop A
Workshop B
8:00AM
Continental Breakfast
9:15AM
WORKSHOP A: BUILDING A MEDICAL AFFAIRS LAUNCH POWERHOUSE
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.
  • Create a medical strategic and tactical launch plan that aligns with your organization’s business objective
  • Develop 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 clear strategy for data generation activities through identifying unmet medical needs and insights from stakeholder
  • Leverage medical information to educate healthcare practitioners
*This session contains a 30-minute networking break
Ramin Farhood, Pharm.D., MBA, Vice President, Head of Global Medical Affairs, AVEXIS
WORKSHOP B: THE ROLE OF AN MSL ACROSS THE DIFFERENT PHASES OF A PRODUCT’S LIFE CYCLE
Depending on the therapeutic complexity and specific product being developed, there can be a range of activities in which an MSL can engage. This workshop will identify key activities across product life cycles that will help inform your organization of valuable field insights and prepare your team for market introduction.
  • Understand the MSL role as part of global medical affairs, in clinical trials, and during the FDA pre-approval phase
  • Design your annual operating plan to prioritize activities and develop a strategy to work within budget constraints
  • Understand what interactions are permissible with sales and marketing
  • Explore best practices for MSLs in pharmaceutical and medical device industries and examine some key differences
  • IIT Spotlight: Review the various types, functions, and interactions with clinical affairs; protocol submissions; and how MSLs can help solve current unmet needs
  • Patient Advocacy Integration
*This session contains a 30-minute networking break
Luchy Hidalgo, M.D., Senior Medical Science Liaison — Nephrology/Transplant, HANSA MEDICAL
12:15PM
Luncheon
1:30PM
WORKSHOP C: ENSURE COMPLIANT COMMUNICATIONS DURING SCIENTIFIC EXCHANGE AND OFF-LABEL DATA DISSEMINATION
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.
  • Explore the distinction between solicited and unsolicited queries and discuss regulatory expectations for medical affairs teams
  • Clarify how to provide scientific research and medical findings that are clearly non-promotional
  • Develop tools and techniques to provide ethical, accurate and balanced off-label data, while adding patient value in a compliant manner
*This session contains a 30-minute networking break
Davida White, Head, Medical Excellence and Education, INDIVIOR
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 timeline
*This session contains a 30-minute networking break
Earl Knight, Esq., Director, Contracting Sponsored Program Services, PURDUE UNIVERSITY
TUESDAY, APRIL 10, 2018 - DAY 1 PLENARY SESSIONS | Tuesday, April 10, 2018
7:30AM
Main Conference Registration and Continental Breakfast
8:30AM
CHAIRPERSON’S OPENING REMARKS
Kirk V. Shepard, M.D., Senior Vice President, Head of Global Medical Affairs OBG, EISAI
8:45AM
THE ROLE OF MEDICAL AFFAIRS FROM PRELAUNCH TO LAUNCH
Kirk V. Shepard, M.D., Senior Vice President, Head of Global Medical Affairs OBG, EISAI
9:30AM
Panel Discussion PANEL: EXPLORE DIFFERENT OPERATING MODELS FOR MEDICAL AFFAIRS GROUPS AND DISCUSS HOW AN ORGANIZATIONAL STRUCTURE CAN IMPACT THE EFFECTIVENESS OF YOUR ACTIVITIES
Panelists:

Ruth du Moulin, Ph.D., Vice President, Medical Affairs, Head of Medical Communications, TAKEDA ONCOLOGY
Tehseen Salimi, Head of Medical Affairs — Primary Care and Women’s Health, MERCK
Kirk V. Shepard, M.D., Senior Vice President, Head of Global Medical Affairs OBG, EISAI
Alan Wright, M.D., MPH, Chief Medical Officer, ROCHE DIAGNOSTICS

10:15AM
LEVERAGING ONLINE DISCUSSION PLATFORMS FOR OPTIMAL STAKEHOLDER ENGAGEMENT
Lance Hill, CEO, WITHIN3
10:45AM
Networking Break
TUESDAY, APRIL 10, 2018 - DAY 1 TRACKED SESSIONS | Tuesday, April 10, 2018
MEDICAL AFFAIRS EXECUTIVE STRATEGY
MSL BEST PRACTICES
RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS
11:30AM
Track Chair’s Opening Remarks
Jason Bradt, Executive Medical Director, Oncology, Americas Medical Affairs, Consultant, ASTELLAS PHARMA
Track Chair’s Opening Remarks
Davida White, Head, Medical Excellence and Education, INDIVIOR
Track Chair’s Opening Remarks
Shailesh Chavan, M.D., Vice President Clinical Research, Drug Safety and Medical Affairs, BIOTEST PHARMACEUTICALS
11:45AM
CASE STUDY: How to Develop a Cutting Edge Medical Plan That Is Tailored to the Needs of Your Organization
Ruth du Moulin, Ph.D., Vice President, Medical Affairs, Head of Medical Communications, TAKEDA ONCOLOGY
The Smartest and Most Effective MSL Teams Need Innovative Training and Tools
Arthur Chan, Ph.D., MBA, Head, MSL Capabilities, Development and Training, NOVARTIS
Best Practices for Managing Investigator-Sponsored Research Across Strategic Alliances
Mary Voehl Hirsch, M.Sc., Senior Director, Investigator-Sponsored Trials, SANOFI
12:30PM
Luncheon
1:30PM
Navigate Medical Affairs in the World of Alliance Partnerships and Co-Promotions
Poushali Mukherjea, Executive Director, Global Medical Affairs, BRISTOL-MYERS SQUIBB
Medical Affairs and Emotional Intelligence: Not a Contradiction
Bryan N. Bischel, Ph.D., MBA, Senior Director, U.S. Field Medical Affairs, NOTAL VISION
The Perils and Pitfalls of Clinical Research Collaborations
Cynthia K. Barbitsch, Pharm.D., Director/Team Leader, Clinical and Research Collaborations, External Medical Communications, PFIZER
2:15PM
PANEL: Explore Different Models for Managing Medical Affairs Activities in Co-Promotion Agreements, Strategic Alliances and Acquisitions
Poushali Mukherjea, Executive Director, Global Medical Affairs, BRISTOL-MYERS SQUIBB
Effective Strategies for Keeping Your Field Team Engaged
Davida White, Head, Medical Excellence and Education, INDIVIOR
PANEL: Strategic Considerations for Converting an IIT to a Research Collaboration
Jennifer J. Gaskin, CCRP, CMQ-OE, Director, Investigator Sponsored Trials, KARYOPHARM THERAPEUTICS
3:00PM
Technology as a Clinical Coach: Real World Engagement
Michael W. Young, Vice President Strategic Accounts, SCIENCEMEDIA
Case Study The Difficulties of Launching a Product, Even If It Is a Groundbreaking Treatment
Alison McReynolds, Ph.D., Director, Medical Science Liaisons — Sleep, Medical Affairs, JAZZ PHARMACEUTICALS
Establish an Efficient and Compliant Process for Assessing the Fair Market Value (FMV) of IIT Budgets
Kelly Wimble Loughner, Senior Associate Director, Site Enablement, BOEHRINGER INGELHEIM
3:45PM
Networking Break
4:15PM
Patient-Centricity in Rare Diseases: Opportunities for Real- World Evidence
Sonal Bhatia, M.D., Vice President, North America Medical Lead, Rare Disease, PFIZER
In-House Versus Contract MSL Teams – What is the Best Fit for Your Organization?
If you are interested in leading this session, please contact Eric Morrin at emorrin@exlevents.com or 212-400-6228.
Reconcile Your Data and Evidence Needs With Internal Stakeholder Expectations When Evaluating IITs
Joe Kishel, Pharm.D., MBA, BCPS-ID, Team Lead (East), ID Research Scientific Directors, Global Center for Scientific Affairs, MERCK RESEARCH LABS
5:00PM
The World Is Flat: Enhancing Collaboration Between U.S., Global, and Regional Medical Affairs Teams
Robert Wright, Pharm.D., Senior Director, Strategic Planning and Transversal Scientific Projects, Global Medical Affairs — Diabetes, SANOFI
PANEL: Effective Strategies and Models for Managing Contract MSL Teams
Jay Elliott, Ph.D., Regional Deputy Director, Medical Science Liaisons, BAYER HEALTHCARE
Ensure the Timeline for an IIT Meets the Needs of a Product and Clinicians in the Field
Peter Shaw, MBBS., DRCOG, Senior Director, Medical Affairs — Orthopaedics, FERRING PHARMACEUTICALS
5:45PM
Cocktail Reception
6:45PM
Day One Concludes
WEDNESDAY, APRIL 11 , 2018 - DAY 2 TRACKED SESSIONS | Wednesday, April 11, 2018
MEDICAL AFFAIRS EXECUTIVE STRATEGY
MSL BEST PRACTICES
RESEARCH COLLABORATION AND INVESTIGATOR-INITIATED TRIALS
8:00AM
Continental Breakfast
8:30AM
Track Chair’s Recap of Day One
Jason Bradt, Executive Medical Director, Oncology, Americas Medical Affairs, Consultant, ASTELLAS PHARMA
Track Chair’s Recap of Day One
Davida White, Head, Medical Excellence and Education, INDIVIOR
Track Chair’s Recap of Day One
Shailesh Chavan, M.D., Vice President Clinical Research, Drug Safety and Medical Affairs, BIOTEST PHARMACEUTICALS
8:45AM
The Role of Medical Affairs in a Fast-Paced, Innovative and Engaged Space
Eric Pierre Guenin, Pharm.D., Ph.D., R.Ph., Director of Medical Affairs, RECKITT BENCKISER
Effective Strategies for Collaboration With Medical Affairs When Executing Field Medical Activities
Riju Ray, Ph.D., U.S. Medical Affairs Lead, GLAXOSMITHKLINE
Best Practices for Managing a Single Versus Multicenter Investigator-Sponsored Clinical Studies
If you are interested in leading this session, please contact Eric Morrin at emorrin@exlevents.com or 212-400-6228.
9:30AM
Professional Development in Medical Communications: What It Takes to Bring You and the Industry to the Next Level
Dheepa Chari, Senior Director/Team Leader, Global Medical Communications, Oncology, PFIZER
Optimizing Field Intelligence: Getting the Right Information to the Right People at the Right Time
Jay Elliott, Ph.D., Regional Deputy Director, Medical Science Liaisons, BAYER HEALTHCARE
Effective Strategies to Increase Sponsor and Site Collaboration During Investigator-Sponsored Studies
Earl Knight, Esq., Director, Contracting Sponsored Program Services, PURDUE UNIVERSITY
10:15AM
Networking Break
10:45AM
Strategies for Medical Affairs to Work Effectively With Commercial to Navigate the Compliance Landscape
Leslie Meltzer, Vice President, Head of Medical Affairs, KERYX BIOPHARMACEUTICALS
The Role of MSLs in Today’s Payer and Reimbursement Landscape
Usman Iqbal, Senior Director, Medical and HEOR, TREVENA
Best Practices for Managing Large-Scale Global and Multicenter Investigator-Sponsored Trials With Limited Resources and Funding
Jennifer J. Gaskin, CCRP, CMQ-OE, Director, Investigator Sponsored Trials, KARYOPHARM THERAPEUTICS
11:30AM
Effectively Demonstrate the Value of Investigator-Sponsored Research to Internal Leadership
Jason Bradt, Executive Medical Director, Oncology, Americas Medical Affairs, Consultant, ASTELLAS PHARMA
The Use of Data Analytics in Medical Affairs
Scott McConnell, Pharm.D., Senior Director, Medical Affairs, ALKERMES
Develop a Focused Field Strategy That Ties Into Your Overall Medical Brand Plan
Michael Steidle, Pharm.D., MBA, National Director, Medical Science Liaison Team, MELINTA THERAPEUTICS
12:15PM
Luncheon
WEDNESDAY, APRIL 11 , 2018 - DAY 2 PLENARY SESSIONS | Wednesday, April 11, 2018
INDUSTRY SPOTLIGHT:
THE EVOLVING ROLE OF MEDICAL AFFAIRS, MSLS AND INVESTIGATOR-INITIATED TRIALS IN THE MEDICAL DEVICE AND PHARMACEUTICAL INDUSTRY
1:15PM
NEW PRODUCT DEVELOPMENT
2:15PM
PANEL: EXPLORE HOW THE ROLE AND IMPACT OF MEDICAL AFFAIRS HAS EVOLVED AT MEDICAL DEVICE AND PHARMACEUTICAL COMPANIES
Idal Beer, Vice President, Medical Affairs, Medication Management Solutions Office of Science, Medicine and Technology, BD MEDICAL
Marianne Gill, Vice President Medical Affairs, BD MEDICAL
Mark Hunter, Manager, Medical Affairs, BD MEDICAL
3:15PM
Summit Concludes

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