Integrated Scientific Advice

Early Multi-Stakeholder Engagement in Product Development Improving Patient Access in the US and EU

AMCP Nexus • October 16 • 2-5 PM

Scientific advice is gaining momentum around the world and many processes are evolving

Mapi offers Integrated Scientific Advice (ISA) training workshops and consulting services to support manufacturers in optimizing their product development programs to generate evidence that is relevant to regulators, HTA bodies, and payers for timely patient access.

A shift in the regulatory/HTA paradigm is occurring, driven by affordability concerns, efficacy-effectiveness gaps, patient centricity, and early access
to important medicines. The value of early integrated scientific advice is
to support navigating this paradigm shift, manage uncertainty and de-risk, manage evidence complexity in HTA submissions, and promote company collaboration to eliminate the “silo effect”. The most important reason for seeking integrated scientific advice is to provide support for timely access to innovative medicines.

Transformational medicines may be made available to patients up to 4 years earlier through the Early Access to Medicines Scheme (EAMS) in the UK, Compassionate Access programs or expanded access studies. Obtaining this designation will require integrated early dialogue between the regulatory authorities, payers, and HTA agencies to support these new changes to align the regulatory and HTA bodies earlier.

Today, we’ll discuss the considerations from the regulatory, payer, and HTA perspectives with respect to the overlap and synergies in the consideration of the definition of population, study design and comparators, outcomes, and subgroups. The importance of the value proposition is emphasized in the development of a robust briefing book to provide a framework to develop “value added” questions for the agencies. Additionally, the importance of patient involvement in these early engagements will be discussed to support early alignment of all stakeholders to optimize the clinical development plan and identify potential gaps.

Selected Presenters

  • Dr. Matthew Bending
  • Rory Graham
  • Manasee Shah

Dr. Matthew Bending

Director, Head of HTA, Strategy & Communication, Real World Strategy & Analytics, Mapi Group

Dr. Matthew Bending, a Director of Real World Strategy & Analytics, 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.

Rory Graham

Senior Director, EU Regulatory Services, Mapi Group

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.

Manasee Shah

Senior Research Manager, Real World Strategy & Analytics, Mapi Group

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.

 The Agenda

SESSION 1: Introductions and Background
Presenter: Dr. Matthew Bending, Mapi Group
SESSION 2: Realities of the US Market
SESSION 3: The US Regulatory Environment
Presenter: Rory Graham, Mapi Group
SESSION 4: Engaging Payers and Obtaining Advice in the US and EU
Presenter: Manasee Shah, Mapi Group
Coffee Break (Including snacks)

SESSION 5: Application of Advice in a Clinical Development Program
SESSION 6: Coverage Decision Making: Must Have vs. Nice to Have
SESSION 7: Workshop: Determining When and How to Obtain Advice
Presenter: Dr. Matthew Bending, Mapi Group
SESSION 6: Coverage Decision Making: Must Have vs. Nice to Have
SESSION 8: Workshop Readout and Q&A
Presenters: Dr. Matthew Bending, Mapi Group

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