JFIAC 2024: Round Table 1

Round Table 1: Can real-world data support early access?

How can the reuse of health data generated in routine practice provide higher quality patient follow-up data, including after early access has ended? How can early access data help us demonstrate the adoption of innovation as well as equity of access?

Speakers

Marianne Duperray

Director of Recommendations and Medicines at the National Cancer Institute

At the Institute since 2007 and currently in charge of the Recommendations and Medicines Department, which produces clinical practice guidelines on cancer management strategies, reference frameworks and tools for general practitioners, expertise in the field of shortages and the prevention and management of adverse effects of anticancer drugs, as well as all content for patients and their families as part of the Cancer Info collection. A horizon scanning initiative has also been developed within the department since 2019.

Nathalie Varoqueaux

Executive Medical Director at Amgen France

Nathalie Varoqueaux MD PhD is the Medical Director of Amgen France.

A specialist in hematology, she holds a PhD in Science from Paris VI Pierre and Marie Curie University in cellular and molecular biology.

She has held various senior positions in several pharmaceutical companies, such as Roche, Alexion, and AstraZeneca, in medical affairs, business development, and pharmacovigilance.

N. Varoqueaux is also Vice-President of ARIIS, Vice-President of the Research and Innovation Commission of LEEM, and a board member of FIAC.

Nicolas Ozan

Medical Director of Oncology and Hematology at AstraZeneca France

After practicing clinically, Nicolas joined the pharmaceutical industry in various medical roles across different companies, covering immuno-oncology, cell therapy, and targeted therapies, among others.

Camille Thomassin

Head of the Real-World Data Coordination Unit at the DEAI department of the HAS

Camille Thomassin, Doctor of Pharmacy, has been the Head of the Real-World Data Coordination Unit at the FRENCH NATIONAL AUTHORITY FOR HEALTH (HAS) since October 2022. The mission of this unit is, among others, to: coordinate the implementation and monitoring of post-listing studies for reimbursement, as well as the collection of data within the framework of early access for medicines. Previously, until 2017, Camille Thomassin was a benefit/risk assessor at the NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS. Then, from 2017 to 2022, she reviewed dossiers for the Transparency Commission regarding the reimbursement of medicines and coordinated the production of scientific opinions and international activities at the HAS, in anticipation of the implementation of the European regulation on health technology assessment.

Pierre Demolis

Vice Chair of SAWP at the European Medicines Agency

Laure Guéroult Accolas

Founder and Director of Patients en Réseau

Philippe Bonnard

Medical Director of Oncology at MSD France