8h45: Wellcoming participants

9h15: Opening session

?‍⚖️ 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.

9:30 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

9:50 The Regulation of ATMPs in the USA: What Differences with the EU?
? Erika Lietzan, Full Professor, Missouri University

10:10 The Reality of the Regulatory Framework for ATMPs
? Heloise Mignot EMA

10h30 Discussion and break

11:00 How can competition law regulate mergers in biotech companies producing ATMPs?
? Clotilde Fortier, Full Professor, Directress of Credimi, UBE

11:20 CRISPR and GMO Regulation: Navigating the Intersection of Biotechnology, Public Health, and Legal Frameworks
? Alessandro Nato, Postdoctoral Researcher Università di Teramo & Luiss Roma

?‍⚖️ Chair: Olivier Debarge, Full Professor, President of AEDEP ??

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

14:00 What legal liability arises in case of ATMP failure?
? Valérie Siranyan, Full Professor, Université Lyon 1 Claude Bernard – AEDEP

14:20 Manufacturing ATMPs and cross-border travel of cells: what challenges?
? Tamara Hervey, Full Professor, City Univ. London ??
? Mirko Dukovic, Postdoctoral Researcher ?? / Hertie School ??

14:40 Discussion

15:00 Development of the ATMP market: risk or opportunity for consumer law?
? Guillaume Rousset, Full Professor, Director of CRDMS, Université Lyon 3 Jean Moulin 

15:20 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 Panthéon-Assas – Honorary President of 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.

9:00 From innovation to patient rights: navigating informed consent and patient protection for ATMPs
? Laura Kadile, Assistant Professor, University of Riga ??

9:20 ATMPs and their challenges, the perspective of an industry representative (Gilead)
? Pierre Sinet, Industrial Pharmacist ??

9:40 Discussion

10:00 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 3 Paul Sabatier – CERPOP & IRDES – AEDEP 

10:40 Discussion and break

11:00 Misuse of ATMPs: genetic doping? Myth or reality?
? Cécile Chaussard, Associate Professor with HDR, UBE ??
? Claire Sourzat, Associate Professor, UBE ??

11:30 Discussion and Lunch

?‍⚖️ Chair: Olivier Debarge, Full Professor, President of AEDEP ??

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

14:00 Round Table 1: IP and patentability (cells, DNA, biosimilars)

? Stéphane Oudin, PhD, Industrial Property Attorneys

? Matthieu Dhenne, PhD, Lawyer, Member of the Paris Bar

14:30 Round Table 2: Financing access / reimbursing innovations – economic sustainability

? Valérie Paris, Economist, OECD

? Rémi Pellet, Full Professor, Université Paris Cité – Paris 5 – vice President of AFDS

⚖️ Blanka Bartos, Doctor of Law

15:00 Round Table 3: The patient pathway

⚖️ Maxence Cormier, Associate Lecturer, Lawyer – AFDS

? Pierre Sinet, Gilead

? Amélie Cransac, Assistant Professor and Hospital Pharmacist, UBE CHU Dijon