Overcoming the Challenges of Establishing Expanded Access Programs in Europe

Early access programs (EAP) provide unauthorized medicinal products prior to marketing authorization and commercial launch for life-threatening, chronically or seriously debilitating diseases, which can not be treated satisfactorily by an authorized medicinal product. Legislation is mostly at the national level, and practical aspects such as conduct, sponsorship, permission to charge for the medicinal product, and data collection frequently differ per country. Organizers must also consider differing national medical practices and standards of care.

This poster aims to review current status and challenges associated with mechanisms governing the provision of unlicensed pharmaceutical compounds in areas of high unmet need outside of clinical trials and provides recommendations for avoiding common pitfalls based on review of actual case studies in selected markets.

Carole Jones, Director, Market Access; Jean-Luc Béjot, Senior Medical Director; Emmanuel Prades, Director, Clinical Operations; Daniel Muscionico, Chief Operating Officer; Adeline Darchy, Clinical Project Manager; Voisin Consulting Life Sciences.

May 2017 - 22nd Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research

Carole Jones, B.Sc., M.B.A, Director, Market Access

Carole has specialized in the field of Market Access and has an extensive track record of working directly with NICE and NIHR on Health Technology Assessments and policy development in the UK. Carole has close working relationships with several Clinical Commissioning Groups in England, G-BA, HAS and the Centers for Medicare & Medicaid Services in the U.S. which provides an intimate perspective of the changing customer and the future implications for the commissioning of pharmaceutical products. Carole works closely with our clients to ensure an aligned and integrated clinical program and commercialization strategy.

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Jean-Luc Bejot Senior Medical Director

Jean-Luc Béjot, MD, MBA, has over 29 years of international experience in clinical development and in medical affairs in the life science industries. His main experience and expertise lie in early stage (phases I and II) clinical development, and he has been exposed at various depth to many steps of the medicinal products life cycle (medicinal chemistry, pre-clinical, clinical, marketing, licensing).

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Emmanuel has significant experience in the management of international clinical studies (pre, post-market. Device/feature validation, research studies) from protocol writing to report.

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Daniel Muscionico, Pharm.D., MBA Chief Operating Officer

Daniel has accumulated over 20 years of management experience, with Profit & Loss responsibility, in the life science industry, specializing in financial services, risk management and information security. He is also a senior lecturer in the fields of healthcare economics and public health at the Institute of Global Health, Geneva Faculty of Medicine, where he earned his Doctor of Pharmacy degree.

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