Biopharma (includes Biologics)

Advanced Therapy - What Is It?

Monday, September 14, 2020

12:00 PM – 1:30 PM EDT

Moderator(s)

Kirsten Messmer, PhD, RAC

Principal Regulatory Affairs Specialist
PPD

Slides

Speaker(s)

Kamali G. Chance, PhD, MPH, RAC

Chief Regulatory Office, BioSciences Corporation
BioSciences Corporation
Tobias Fleischmann, Dr. rer. nat., Dipl. Biol.

Prinicpal Regulatory Affairs Specialist
PPD

Slides
Ana Hidalgo-Simon, MD, PhD

European Medicines Agency

Advanced therapies, including gene and cell therapy as well as tissue engineered products, have emerged as a rapidly growing sector of innovative therapies for many serious and life-threatening diseases. However, due to their complexity special regulatory considerations need to be taken into account during product development to allow for the development of a safe and effective product. Additionally, in the European Union, clinical trials involving genetically modified organisms may need additional reviews/approvals at a national level which should be built into the strategic development plan.

The session provides an overview of regulatory requirements for advanced therapies in the European Union and the United States. This session also covers expedited pathways and opportunities to interact with regulators to aid a successful development program.

Learning Objectives:

Understand the regulatory requirements, pathways and agency interaction opportunities in the EU and the US
Define potential challenges due to additional GMO approval requirements for clinical trials in EU countries
Identify regulatory support options to optimize development strategy