Regulators' strategies for managing the surge in cell and gene therapies

Featuring:

Michael Rosu-Myles, PhD, Executive Director, Health Canada

Josephine Lembong, PhD, Senior Manager, Science and Industry Affairs, Alliance for Regenerative Medicine

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Currently, there are more than 2,000 cell and gene therapies in clinical trials worldwide. With a goal of ensuring that safe and quality products are approved for use by patients, regulators determine whether these innovative therapies move from the lab to market.

In this interview, Michael Rosu-Myles, PhD, Executive Director, Health Canada, and Josephine Lembong, PhD, Senior Manager, Science and Industry Affairs, Alliance for Regenerative Medicine, provide listeners with an exclusive look at how regulators are preparing for an increased number of applications for cell and gene therapy products in the years to come. 

Our guests discuss how Health Canada, the U.S. Food and Drug Administration and European Medicines Agency have created new regulatory frameworks and offices to enhance their ability to review cell and gene therapy submissions. Listeners will learn how companies that are planning a submission can prepare to work successfully with regulators, whether regulators consider the potential price tags of these therapies, and how patients benefit from regulators’ work. 

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