31 October 2016  •  13:00-17:30

Expert Roundtable: Integrated Scientific Advice

Developing an Integrated Regulatory & HTA Strategy to Demonstrate and Communicate Value to Multiple Stakeholders

Vienna, Austria

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

Join Mapi’s upcoming roundtable on the value of early engagement from regulatory, payer, HTA, and industry perspectives. Experts from Mapi, Debiopharm, and across the industry will provide an overview of European and US processes, as well as their experience with the NICE, G-BA, HAS, FDA and EMA scientific advice processes.

Selected Presenters

  • Dr. Chris Chesters PhD
  • Nathalie Gilmore MSc
  • Dr. Sabine Latour MD
  • Dr. Matthew Bending PhD, MSc
  • Carina Righetti MSc
  • Mary Speagle BSc
  • Caroline Delaitre-Bonnin

Dr. Chris Chesters PhD

Technical Advisor and Technical Analyst, NICE

Dr. Chris Chesters is involved in a range of scientific advice projects, which include attending parallel scientific advice with other HTAs and regulatory agencies, as well as delivering educational seminars. Previously, Chris worked in both the NICE Technology Appraisals Programme, and the NICE Medical Technologies Evaluation Programme. Prior to joining NICE, he worked at a healthcare consultancy, where he worked on market access projects. Chris graduated with a Master’s degree in Biological Chemistry from the University of Sheffield and completed a PhD in Biochemistry at the University of Manchester.

Nathalie Gilmore MSc

National Scientific Advice & Innovation Office Coordinator, MHRA

In 2001, Ms. Gilmore received a BSc in Genetics from the University of Glasgow, and an MSc in Science, Culture, and the Environment from the University of London, in 2004. She worked for the Society for Endocrinology’s editorial team, studied Periodical Journalism in Liverpool, and in 2005, she began working with the MHRA as a medical writer. With her regulatory knowledge and extensive experience communicating complex information to the public, she took over as National Scientific Advice Coordinator in 2013.

Dr. Sabine Latour MD

Global Market Access Director, Debiopharm

Dr. Sabine Latour is a physician with diverse pharmaceutical experience through her work for major pharma, medical device companies, and start-ups. Specializing in value identification, as well as clinical and economic evidence generation, Dr. Latour earned her medical degree and completed courses in Pharmaceutical Medicine and Health Economics. She leads international, strategic discussions with regulatory and reimbursement authorities, and payer bodies, both individually, with country HTA entities (GBA, NICE, TLV, AIFA, HAS), and also through joint scientific council with EMA and HTA entities.

Dr. Matthew Bending PhD, MSc

Director, Mapi Real World Strategy & Analytics

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.

Carina Righetti MSc

Associate Director, Mapi Real World Strategy & Analytics - UK

Carina Righetti is an experienced health economist with seven years working in consultancy, the pharmaceutical industry, and for Health Technology Assessment (HTA) bodies. Carina provides senior leadership for projects on strategic market access and HTAs for pharmaceutical, vaccine, and medical device companies. Carina has worked on projects in oncology, immunology, cardiovascular, and transplantation. Her wide experience includes working on projects for UK HTA submissions, value proposition development, economic models, payer advisory boards, global value dossiers, and market access strategies.

Mary Speagle BSc

Executive Director, Mapi Regulatory Services

Mary Speagle’s broad experience includes combination products, medical devices, biologics, pharmaceuticals, natural health products, reimbursement, and international regulatory affairs. At Mapi, she oversees a team providing regulatory consulting services for pharmaceuticals, biologics, natural health products, cosmetics, food, and new substances. Mary is a member of Regulatory Affairs Professionals Society, Canadian Association of Professional Regulatory Affairs, Consumer Health Products Canada, Canada’s Medical Device Technology Companies Association, and the Canadian Cosmetic, Toiletry and Fragrance Association.

Caroline Delaitre-Bonnin

Director, Real World Strategy & Analytics

Ms. Delaitre took over as Director of Market Access in 2009, and since then, she has been primarily focused on projects in health policy, health technology assessment, and public health programs assessment, including due diligences for mergers, acquisitions, and licensing. She began her career with R&D Pharmaceutical Affairs in 1999, and since 2001, she has led the Department of Regulatory Consulting. Ms. Delaitre teaches “Master in Law and Management of Health” as part of Paris XI University, and “Medicinal Products: Production, Regulatory and Quality” at Tours University (France) School of Pharmacy.

Discussion points include:

Regulatory & HTA Scientific Advice Processes
  • Regulatory Strategies for Early Scientific Advice: FDA & EMA Scientific Advice, PRIME & Adaptive pathways link to scientific advice
  • EMA-HTA parallel scientific advice
  • MHRA-NICE joint Scientific Advice
  • NICE Scientific Advice
  • Standard SA, advice for SMEs, recent developments in NICE SA options
  • HAS Scientific Advice
Key Considerations– Regulatory & HTA/Payer Perspective
  • Trial design [PICOS] – focus on endpoints:
  • Discussion on endpoints and the academic value Meaningful
    • Clinical value
    • Real world value
    • Differentiation
  • 1° vs. 2°
    • How to decide
    • How to make the best use
  • How endpoints can translate into indication
    • Validated
    • Novel
    • Academic
    • Language
    • Validation of global language
  • Marketing Impact
    • Indication
    • Data in label
  • Selecting comparators for access: Panel discussion? choice of comparator; views from the regulator(s), the payor(s), the prescriber, the patient – can they agree?
  • Early economic value considerations
  • Case study (hypothetical case study of common pitfalls where SA would have been helpful)
Experience of Early Scientific Advice from the Industry Perspective
Discussion Panel
Topics include:
  • Regulatory Strategies for Early Scientific Advice: FDA & EMA Scientific Advice, PRIME & Adaptive Pathways Link to Scientific Advice
  • EMA-HTA Parallel Scientific Advice
  • MHRA-NICE Joint Scientific Advice
  • NICE Scientific Advice
  • Standard SA, Advice for SMEs, Recent Developments in NICE SA Options
  • HAS Scientific Advice
Question & Answer

An open forum for attendees to ask presenters questions about regulatory and joint scientific advice issues concerning the future of the industry.

Registration

The Venue

Wolke 21, Saturn Tower, Sky Lobby

Leonard-Bernstein-Straße 10
1220 Wien, Austria

Tel: +43 1 2639873