👨‍⚖️ Chair: Isabelle Poirot-Mazères, Full Professor, President of AFDS, Université Toulouse Capitole 🇫🇷

🎯 Objective: Explore the specificities of the regulatory framework in Europe and compare with other regions. Discuss the necessary adjustments and challenges related to international regulation.

The contributions of the pharmaceutical package in the field of ATMPs: between the new definition of gene therapy medicinal products and regulatory sandboxes?
🎓 Mathieu Guerriaud, Full Professor, UBE – AEDEP, EAHL, CREDIMI 🇫🇷

The Regulation of ATMPs in the USA: What Differences with the EU?
🎓 Erika Lietzan, Full Professor, Missouri University 🇺🇸

The Reality of the Regulatory Framework for ATMPs
🏥 EMA (to be confirmed) 🇪🇺

How can competition law regulate mergers in biotech companies producing ATMPs?
🎓 Clotilde Fortier, Full Professor, UBE 🇫🇷

Orphan ATMPs: what changes are expected with the European reform?
🎓 Alessandro Nato, Postdoctoral Researcher, Luiss Roma 🇮🇹
🎓 Luca Golisano, PhD candidate, Luiss Roma 🇮🇹

👨‍⚖️ Chair: Eric Loquin, Professor Emeritus, UBE 🇫🇷

🎯 Objective: Identify specific legal challenges related to ATMPs: liability of actors, regulation of cross-border circuits, tensions between commercial logic and ethical principles.

What legal liability arises in case of ATMP failure?
🎓 Valérie Siranyan, Full Professor, Lyon 1 University – AEDEP 🇫🇷

Manufacturing ATMPs and cross-border travel of cells: what challenges?
🎓 Tamara Hervey, Full Professor, City Univ. London 🇬🇧
🎓 Mirko Dukovic, Postdoctoral Researcher 🇲🇪 / Hertie School 🇩🇪

Private marketing or consumer law?
🎓 Guillaume Rousset, Associate Professor with HDR, CRDMS, Université Lyon 3 🇫🇷

The non-commercialisation of human body elements (SoHO) and ATMPs
🎓 Isabelle Moine-Dupuis, Associate Professor with HDR, Dijon 🇫🇷
🩸 Jean-Baptiste Thibert, Director of EFS Rennes 🇫🇷

👨‍⚖️ Chair: Didier Truchet, Professor Emeritus, Université Paris 2 – AFDS 🇫🇷

🎯 Objective: Examine the consequences of ATMPs on patients’ rights (consent, access, prioritisation) and analyse how these therapies are perceived in society, including beyond the healthcare sphere.

Is informed consent adapted to innovative therapies?
🎓 Laura Kadile, Assistant Professor, University of Riga 🇱🇻

Patient discrimination and prioritisation: when ATMPs arrive too late
🎓 Speaker: to be confirmed

ATMPs and their challenges, the perspective of an industry representative (Gilead)
💼 Pierre Sinet, Industrial Pharmacist 🇫🇷

Misuse of ATMPs: genetic doping? Myth or reality?
🎓 Cécile Chaussard, Associate Professor with HDR, UBE 🇫🇷
🎓 Claire Sourzat, Associate Professor, UBE 🇫🇷

Perception of ATMPs among patients affected by chronic myeloid leukemia
🎓 Marie Mathieu, Sociologist, Postdoctoral Researcher at Cermes3 🇫🇷

🎯 Objective: Debate the protection of innovation, funding models for ATMPs, and the practical conditions for equitable access for patients.

Hospital accessibility of ATMPs in France: cross-analysis of consumption data and the regulatory framework
🎓 Blandine Juillard-Condat, Assistant Professor and Hospital Pharmacist, Université de Toulouse – CERPOP & IRDES 🇫🇷

Round Table 1: IP and patentability (cells, DNA, biosimilars)

💼 Stéphane Oudin, PhD, Industrial Property Attorneys 🇫🇷

💼 Matthieu Dhenne, PhD, Lawyer, Member of the Paris Bar 🇫🇷

💼 An industry representative (to be announced)

Round Table 2: Financing access / reimbursing innovations – economic sustainability

📈 Valérie Paris, Economist, OECD 🇫🇷

🎓 Rémi Pellet, Full Professor, Paris 5 – AFDS 🇫🇷

🏛 Jean-Patrick Sales (subject to confirmation) 🇫🇷

⚖️ Blanka Bartos, Doctor of Law 🇭🇺

Round Table 3: The patient pathway

⚖️ Maxence Cormier, Associate Lecturer, Lawyer – AFDS 🇫🇷

💼 Pierre Sinet, Gilead 🇫🇷

🏥 Grand Est Regional Health Agency (subject to confirmation) 🇫🇷

🏥 Amélie Cransac, Assistant Professor and Hospital Pharmacist, UBE CHU Dijon 🇫🇷