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Integrated Scientific Advice Workshop & Roundtable 2017: Early Multi-Stakeholder Engagement in Product Development: Improving Patient Access in the US and EU

October 16, 2017 @ 13:45 - 18:30 UTC+0

Event Name:

Integrated Scientific Advice Workshop & Roundtable 2017: Early Multi-Stakeholder Engagement in Product Development: Improving Patient Access in the US and EU

Event Date & Time:

October 16 @ 14:00 - 17:00

Event Location:

Pecos 1 Room, Gaylord Texan Hotel & Convention Center, Grapevine, Texas

Event Description:

Join Mapi's experts for this workshop and roundtable to learn how to utilize early multi-stakeholder advice to speed patient access to new treatments.

We will also be hosting a 5:00 pm reception you may wish to attend after joining us for this workshop, or as a stand-alone event if unable to attend the actual workshop event. If either of those options appeals to you, please RSVP to attend either or both events via form submission now - limited seats/space remains, don't delay!

Event Agenda: Featured Presenters & Presentations: 

Featured Presenters & Presentations -

Topic Speaker Time
Registration/reception None 1:30 pm
Introductions and background Matthew Bending, RWSA, Mapi 2:00 pm
The current US environment Jonathan Watanabe, UCSD -    Expert Guest Speaker 2:10 pm
The US regulatory environment Rory Graham, Regulatory Affairs, EU & International, Mapi 2:30 pm
Engaging stakeholders and obtaining advice in the US and EU Manasee Shah, RWSA, Mapi 2:50 pm
Break None 3:10 pm
Application of advice in a clinical development program Fanta Waterman, Industry Expert 3:20 pm
Coverage decision making: must have vs. nice to have David L. Clark, Ventegra, Inc. 3:40 pm
Leveraging early multi-stakeholder advice to support innovative contracting and patient access Michael Pace, ICON plc 4:00 pm
Roundtable and Q&A: determining when and how to obtain advice Matthew Bending, RWSA, Mapi 4:20 pm
Reception [None] 5:00 pm


Registration/reception - 1:30 pm

Introductions and Background presented by Dr. Matthew Bending - Director, Head of HTA, Strategy & Communication - Real World Strategy & Analytics, Mapi Group - 2:00 pm

  • Dr. Matthew Bending is a health economist with 10+ years of consulting experience. He heads projects for HTA submissions, scientific advice, market access, literature reviews, economic modeling, payer advisory boards, and global value dossiers. Before joining Mapi, Dr. Bending was a Senior Consultant for York Health Economics Consortium. He earned a PhD in Health Sciences from the University of York; his thesis explored the use of HTA in international reimbursement decision-making. He has an MSc and BSc (Hon.) in Economics from the University of Warwick.

The Current US Environment presented by Dr. Jonathan H. Watanabe, Pharm.D., M.S., Ph.D. BCGP - Associate Professor of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, The University of California, San Diego (UCSD) - 2:10–2:30

  • Professor Jonathan Watanabe is a clinical consultant at the San Diego Program of All-inclusive Care for the Elderly (PACE) Clinic in San Ysidro, CA and the Villa Pomerado Skilled Nursing Facility in Poway, CA. He trains students, post-docs, and practitioners in multiple disciplines in clinical research and post-acute care. He is also an investigator on the Health Resources and Services Administration-funded San Diego Geriatrics Workforce Enhancement Program Grant. Dr. Watanabe was the inaugural recipient of the University of Washington/Allergan Health Economics and Outcomes Research Fellowship. He is a Board Certified Geriatric Pharmacist (BCGP).

The US Regulatory Environment presented by Rory Graham - Senior Director, EU Regulatory Services, Mapi Group - 2:15 pm

  • Mr. Graham has facilitated numerous aspects of drug and medical device development during his 25-year career in the pharmaceutical, biotechnology and device industries. Mr. Graham has held senior positions in the area of regulatory a airs in companies in Europe and Asia-Pacific. He has arranged and directly participated in meetings with many global agencies including FDA, EMA, PMDA, TGA and European National Agencies. He has experience in various therapeutic areas including CNS, Oncology, Hematology, Immunology, Diabetes, Analgesia and Wound-Care. He has achieved orphan designations for pharmaceutical products in the EU, US and Australia. Mr. Graham leads a talented team of regulatory professionals that produce client-specific regulatory and development strategies, as well as solutions for global and local market needs.
  • Presentation Description/Key Discussion Points -
    • High-level review of FDA Advice processes
    • Comparison to international regulatory advice processes
    • Potential for co-ordination with payer advice

Engaging stakeholders and obtaining advice in the US and EU presented by Manasee Shah - Senior Research Manager, Real World Strategy & Analytics, Mapi Group - 2:35 pm

  • Manasee V. Shah, MPH, joined Mapi in 2016 and has extensive experience in the areas of health economics, outcomes research, and US market access issues. Prior to joining Mapi, she worked for a US-based market access consultancy, providing strategic advice regarding drugs in a number of therapeutic areas, including pain management, mental health, ophthalmology, and orphan indications. She has experience in conducting market research engagements, creating and implementing HEOR strategy plans, and designing and implementing real-world studies. Ms. Shah holds a Bachelor of Arts degree in economics from Northwestern University and a Master of Public Health degree from the Department of Health Management and Policy of the School of Public Health at the University of Michigan where she is also a part-time lecturer.
  • Presentation Description/Key Discussion Points -
    • Discuss the value of engaging stakeholders to obtain early scientific advice with a  focus on de-risking clinical development programs
    • Compare and contrast scientific advice engagements in the EU (formal) versus US (informal) and how formal advice can be utilized in the U
    • Share how early multi-stakeholder advice can increase patient access

Break - 2:55 pm

Application of advice in a clinical development program presented by Fanta Waterman - Industry Expert - 3:15 pm

  • Fanta completed an MPH and PhD in Public Health at Temple University and a 1-year postdoc with the University of Kentucky College of Public Health in Public Health Systems and Services Research, funded by the Robert Wood Johnson Foundation. Fanta taught as an adjunct Associate Professor within the City University of New York’s Community College System from 2008 until 2013. Fanta has more than 10 years of experience in Clinical Development, COA/PRO, HEOR and Global Market Access., including consulting with KantarHealth and increasing leadership positions in pharma with Pfizer, Genentech/Roche, Boehringer Ingelheim and Avanir.
  • Presentation Description/Key Discussion Points -
    • Cross-functional collaboration between Medical, Market Access, Clinical Development and Regulatory departments to develop efficient and strategic programs for regulatory approval and commercialization
    • Executing US clinical programs with a global value proposition in mind

Coverage Decision-Making: Must Have vs. Nice to Have presented by Dave Clark - Chief Development Officer, Ventegra, Inc. - 3:35 pm

  • David Clark has been involved in managed care pharmacy and evidence base critical appraisal for more than 20 years.  His currently the Chief Development Officer for Ventegra, Inc. His previous experience includes President, VisumRx, LLC, President, RegenceRx, Senior Vice President Health Care Services, Regence Blue Cross Blue Shield, and Director Pharmacy Services, Intermountain Health Care. During his career he has been honored to serve as President and Chair of the Board for the Academy of Managed Care Pharmacy and has been appointed to serve on two federal committees, the Effective Health Care Stakeholder Group, Agency for Agency for Healthcare Research and Quality (AHRQ) and the State Pharmaceutical Assistance Transition Commission, Department of Health and Human Services (HHS). He was also selected to serve as a member of the Blue Cross Blue Shield Association National Council of Physician Executives. He received both his Bachelor of Science Pharmacy degree and his Masters of Business Administration from the University of Utah in Salt Lake City, Utah.
  • Presentation Description/Key Learning Objectives/Discussion Points -
    • Understand the issues facing payers when making coverage decisions
    • Discuss how payers may make different coverage decisions based on the same evidence
    • Share how evidence documenting value might increase early patient access

Leveraging Early, Multi-Stakeholder Advice to Support Innovative Contracting and Patient Access presented by Michael C. Pace, MBA - Senior Principal, Head of Boston Office, ICON Pricing & Market Access - 3:55 pm

  • Mike has more than 20 years of operational executive experience within global biopharmaceutical firms and digital health start-up ventures, leading market access strategy, payer and specialty pharmacy account management, contracting, business development, sales and operations functions. In these roles, he and his team launched and enabled market access for dozens of products in the US, across specialty, primary care and orphan conditions, including leading blockbuster brands in the areas of neurology, oncology, cardiology, allergy and ophthalmology. At EMD Serono, he pioneered the outcomes-based contracting effort that led to the first outcomes-based agreement on a specialty medication with a health plan, followed by the first outcomes-based agreement with a pharmacy benefit manager in the United States.
  • Presentation Description -
    • Launching a new drug and achieving/maintaining desired levels of patient access often requires a compromise between the manufacturer and payer’s objectives, priorities and timelines. While ensuring patient access to new drugs is an objective for both parties, payers also need to make certain that new therapies comply with budgetary constraints and that any associated risks of uncertainty are minimised. In this context, contracting represents mutually valuable agreements that address the needs of both the manufacturer and the payer. Traditional contracting agreements have focused purely on price negotiations and generally are discussed subsequent to regulatory approval. These simple agreements such as, price discounting/rebates, caps and free goods, in themselves are not novel; however, their combination or inclusion in the context of a more complex agreement can be considered in the design of innovative contracting agreements. When designing a contract, the aim is to find a cohesive solution that meets the needs of the payer while still achieving manufacturer objectives. Sometimes, “traditional” contracting and “payer engagement” is not sufficient to achieve this compromise, necessitating the adoption of more advanced, and sometimes complex, innovative contracting agreements (ICAs). Perceptions of innovative contracting and the use of outcomes-based agreements vary across markets. In Italy, where infrastructure for data collection is broadly available, payers are accustomed to outcomes-based contracts. In the US, outcomes-based contracting has been less common – though it is gaining traction and expected to play an increasing role in the future. Participants will gain a deeper understanding of the changing contracting landscape and to learn ways to leverage new and innovative approaches to improve the commercial success of your biopharmaceutical products.
  • Presentation description/key insights to be explored/discussion points:
    • Discover how informing innovative contracting through early engagement with key stakeholders benefits commercial market entry and outcomes
    • Learn why traditional contracting approaches and post-marketing payer engagement may not be enough to address the needs of both payers and pharma manufacturers
    • Hear about current trends and anticipated innovations, including the use of outcomes-based agreements
    • Understand the key contracting issues manufacturers should be considering today to optimise the commercial product success.

Roundtable and Q&A: Determining when and how to obtain advice presented by Dr. Matthew Bending - Director, Head of HTA, Strategy & Communication - Real World Strategy & Analytics, Mapi Group  - 4:15 pm

Post-Workshop Reception in the Pecos 2 Room @ Gaylord Texan Hotel & Convention Center - 5:00 pm - 6:30 pm

Register to attend this event for FREE now:


Questions? Contact Mapi Group:


Other Relevant Sources of Insight/Expertise:

  • Join Mapi’s experts for an Integrated Scientific Advice (ISA) Roundtable & Workshop in Glasgow, Scotland on Monday, November 6, 2017! Reserve your seat now in order to receive our event’s updated details via email upon availability: https://mapigroup.com/workshop/isa-glasgow-2017/
  • Subscribe to Mapi's RWSA Blog for relevant industry insights, news stories, service team announcements - and more!
  • Learn about Mapi's RWSA services


October 16, 2017
13:45 - 18:30
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