Integrated Scientific Advice

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

Expert Roundtable & Workshop

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

The value of early engagement from regulatory, payer, HTA, and industry perspectives was the subject of a recent roundtable hosted by Mapi. Experts from Mapi, Debiopharm, and across the industry provided 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
  • Rory Graham BPharm MBA
  • 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.

Rory Graham BPharm MBA

Senior Director, Regulatory Affairs, Europe & International Region, Mapi

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 affairs 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.

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.

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Mapi recently convened an afternoon workshop and roundtable gathering together speakers and participants from a number of stakeholder groups to discuss the importance of integrated regulatory and HTA scientific advice. To download a PDF summary of the event, please complete the following form.