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

9:00 AM - 9:55 AM (PDT), Monday, June 8, 2020
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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
Moderator
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Senior Director, Science and Regulatory Affairs
Biotechnology Innovation Organization
Speakers
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Director, Office of Tissues and Advanced Therapies
FDA
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Corporate Compliance & Quality Officer
Fujifilm Irvine Scientific
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Senior Director, Science and Regulatory Affairs
Biotechnology Innovation Organization
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Global Head, Regulatory Policy and Intelligence
Gilead Sciences
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Associate Director, Global Regulatory Affairs, Regenerative Medicines and Advanced Therapies, CAR-T and Microbiome
Janssen Research and Development