Learn more about the use of early scientific advice, how to choose the best process and effectively prepare.
In Europe, a “scientific advice” (SA) refers to an early dialogue between a manufacturer, HTA bodies and/or regulators on initial evidence generation for relative effectiveness and cost effectiveness assessment. The SA and parallel scientific advice (PSA) processes are valuable in helping companies to develop evidence that demonstrates the value of their product, to gain detailed feedback on their evidence generation plans, to integrate cost-effectiveness considerations into health technology assessments (HTA) and to better understand the concerns and perspectives of HTA and/or regulatory decision makers.
Manufacturers must now also consider the impact of Brexit on existing SA processes. For example, while the UK National Institute for Health and Care Excellence (NICE) is a leader due to the potential applicability of its advice to over 20 countries, it will no longer be able to provide parallel advice with the European Medicines Agency (EMA) through the European Network for Heath Technology Assessment (EUnetHTA) and will have to develop a concurrent advice. We will discuss Brexit impacts and some other challenges manufacturers should prepare for in the future.
Join us to learn more about the processes of an early scientific advice, how to choose the best process and effectively prepare. We will provide insights on:
- The pros and cons of seeking scientific advice from regulatory and HTA bodies separately and/or in parallel.
- How to best time your SA request and build a comprehensive and effective dossier/briefing book.
- The impacts of Brexit on the NICE SA process.
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Presenters
Céline Taveau
Céline joined ICON in 2008. She is an experienced consultant with over 12 years of market access experience. Céline provides senior leadership for large projects on strategic market access and Health Technology Assessment (HTA)’s for pharmaceutical, vaccine and medical device companies. She has extensive experience with orphan drugs and has worked on projects for products in a number of oncology indications, immunology, cardiovascular, respiratory and infectiology. Her experience is wide, working on projects for market access strategies, systematic literature reviews, value proposition development, French HTA submissions and payer advisory boards. Céline holds a keen interest in orphan drugs and has presented at international conferences/workshops on this topic.
Emmanuel Lacharme
Emmanuel joined ICON in May 2020 as a senior consultant. Emmanuel is a pharmacist, with more than five years of professional experience in clinical practice, clinical trials, market access (HEOR/HEMA), scientific advice and health technology assessment. During his pharmacy residency, he worked in various Paris hospitals in clinical trials, ATU, medical device, purchase, and clinical pharmacy (psychiatry, neurology) departments. He spent six months at AGEPS (General Agency for Health Products & Equipment) managing the quality and logistic for distribution of health products for Paris hospitals. He worked one year at Novartis on market access, pricing and reimbursement in the oncology department. He also worked for one year at the HAS as a health technology assessment analyst in economic and clinical drug assessment. Lastly, he worked six months as technical leader in the scientific advice department at NICE.