JFIAC 2025: Roundtable 5

Early Access: AI-based monitoring of early access: a project at the scale of an ecosystem

This roundtable, moderated by Wassinia Zirar (APM International), will focus on the contribution of generative AI to improving the monitoring of data from early access, a valuable French specific feature for generating the first real-world data. Building on the DANTE pilot project conducted within the Filière, the speakers will explore the promises of automating real-world data collection, the associated regulatory challenges, and how this use case could help structure a sovereign and reproducible innovation ecosystem.

Moderator

Wassinia ZIRAR

Journalist and Editorial Coordinator for Events – APM International

Wassinia has been a journalist at the Agence de presse médicale (APM) for nearly 8 years, specialising in digital health topics and serving as APM’s editorial coordinator for “events”.

Speakers

Nicolas Ozan

Medical Director, Oncology and Haematology – 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.

Aurore GAIGNON

Health and Data Protection Lawyer – CNIL

Aurore worked as a lawyer specialising in health products law, both in advisory and litigation. She joined the health department of the Legal Support Directorate at CNIL in 2020 and works in particular on topics related to artificial intelligence in this sector.

Béatrice FIQUET

Medical Director, Onco-Haematology at Amgen

Béatrice studied medicine in Paris and is a former resident and chief resident at the Paris hospitals. Trained as a nephrologist, she worked at HEGP and joined the pharmaceutical industry in 2002 at Novartis, in the cardio-metabolism medical department. She joined Amgen in 2016 and has been Medical Director, Onco-Haemato since late 2019.

Lamia BOUDIAF

Director of Medical Affairs – MSD

A trained oncologist, Lamia has acquired solid experience in clinical development and medical affairs, as well as a strong understanding of access and commercial challenges, by holding various leadership positions—both in major pharmaceutical companies and in small biotechnology firms, at both national and global levels.

Lamia has in-depth knowledge of the drug development phases, having led various international clinical research and medical affairs programmes in oncology as well as in other therapeutic areas.

She has also led teams of varying sizes (3 to 150 people) as part of her roles as Medical Director in France and internationally, as well as in her role as Executive Director of the European office of PDL BioPharma. Lamia has also successfully led various structural and cultural transformations.