Race Against the Clock: Bringing New Cell and Gene Therapies to Market

9:00 AM - 9:55 AM, Monday, June 8, 2020 ・ Track Atlantic
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Four gene therapies have been approved by FDA and we’re expecting many more in the coming years. By 2020, FDA expects more than 200 cell and gene therapy applications per year totaling more than 800 active applications. By 2025, FDA expects approvals for cell and gene therapy products will rise to 10-20 per year, however these programs are expected to seek approval beyond just in the United States.

The increasing number of programs in development provide both opportunities and challenges as regulatory frameworks must continue adapt to the rapidly advancing science. This session will explore the regulatory requirements and pathways to approval and provide insight from industry experts taking new approaches to bring much needed treatments to patients.
Sponsored By
Senior Director, Science and Regulatory Affairs
Biotechnology Innovation Organization
Director, Office of Tissues and Advanced Therapies
Senior Director, Quality Systems, Regulatory Affairs, Compliance Officer, ISO Management Representative
Fujifilm Irvine Scientific
Global Head, Regulatory Policy and Intelligence
Gilead Sciences
Associate Director, Global Regulatory Affairs, Regenerative Medicines and Advanced Therapies, CAR-T and Microbiome
Janssen Research and Development