Using Early Scientific Advice in Drug Development: Opportunities and Challenges

Life Sciences, Pharmaceutical Regulation, Medical Device, Commercialization & HEOR, Medical Device Safety and Regulation,
  • Thursday, September 10, 2020 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

In Europe, “scientific advice” (SA) refers to an early dialogue between a manufacturer, health technology assessment (HTA) bodies and/or regulators on initial evidence generation for relative effectiveness and cost effectiveness assessments. 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.

Manufactures 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 concurrent advice.

Join this webinar to hear experts discuss Brexit impacts and some other challenges manufacturers should prepare for in the future.

Speakers

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Celine Taveau, Principal, Global HTA, Health Economics, Reimbursement and Outcomes, ICON plc

Céline Taveau joined ICON in 2008. She is an experienced consultant with over 12 years of market access experience. Taveau 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. Taveau holds a keen interest in orphan drugs and has presented at international conferences/workshops on this topic.

Message Presenter
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Emmanuel Lacharme, Senior Consultant, Global HTA, Health Economics, Reimbursement and Outcomes, ICON plc

Emmanuel Lacharme joined ICON in May 2020 as a senior consultant. Lacharme 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 worked one year at Novartis on market access, pricing and reimbursement in the oncology department. Lacharme 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.

Message Presenter

Who Should Attend?

This program is intended for professionals from pharmaceutical, biotech and medical device companies involved in:

  • Health Technology assessment (HTA)
  • Health Economics & Outcomes Research (HEOR)
  • Marketing
  • Market Access,Pricing & Reimbursement
  • Medical Affairs
  • Regulatory Affairs
  • Pharmacovigilance & Risk Management

What You Will Learn

Join this webinar to learn more about the processes of early scientific advice. Featured speakers 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 SA requests and build a comprehensive and effective dossier/briefing book
  • The impacts of Brexit on the NICE SA process

Xtalks Partner

ICON

ICON plc is a global provider of outsourced development and commercialization services to pharmaceutical, biotechnology, medical device, and government and public health organisations. The company specializes in the strategic development, management and analysis of programs that support clinical development. With headquarters in Dublin, Ireland, ICON currently operates from 97 locations in 38 countries and has approximately 13,380 employees. Further information is available at ICONplc.com.

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