Opportunities for Regulatory Convergence in Cell and Gene Therapy

Disparate requirements from one country to the next, from pre-clinical tests to manufacturing, make it difficult for developers to efficiently ensure patients across borders have access to therapies, particularly to rare disease patients whose numbers in any one geography may be very small. Representatives from the US Food and Drug Administration, European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency will discuss areas where regulators can and are cooperate on common standards, and what next steps are being envisioned to improve equitable access to critical CGT medicines.

Chair:
Jessie Hanrahan, Ph.D., Chief Regulatory Officer, AavantiBio

Speakers:
Patrick Celis, Ph.D., Lead Scientific Officer, ATMP Office, European Medicines Agency (EMA)
Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA)
Yoshiaki Maruyama, Ph.D., Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA)