Developing gene and cell-based medicinal products (referred to as “Advanced therapy medicinal products” in Europe) still represents huge challenges. At the same time, these breakthrough therapies bring hope for filling unmet medical needs and curing life-threatening diseases. Knowledge of the European regulatory framework for ATMPs and their main development hurdles is crucial, especially for academics & sponsors based outside the European Union.
Key learning objectives:
- EU regulatory framework for ATMPs
- Main CMC (Chemistry Manufacturing and Control), NC (Non-Clinical) and C (Clinical) challenges during ATMP development
- Introduction to an integrative approach for ATMP development
G. Narayanan, Vice President, Disruptive Biologics and E. Sabbah-Petrover, PhD., Associate Director at VCLS, will share their experience of ATMP development and their assessment at national and European levels. M. Deneux, PhD., Senior Director, Regulatory Science, Drugs & Biologics at VCLS will moderate the session.
Gopalan Narayanan, Vice-President Disruptive Biologics
He provides advice and guidance on the global development and regulatory strategy for ATMPs and complex disruptive biologics based on substantial experience in the field as previous medicines regulator in Europe.
Emmanuelle Sabbah-Petrover, Associate Director Complex Biologics
Emmanuelle manages projects involving Advanced Therapy Medicinal Products (ATMP) especially gene therapy; from Non-Clinical to Clinical development phases, both in Europe & US.