Cook Myosite Blog

Webinar: Lessons Learned from RMAT Submission, Denial, and Successful Resubmission

Posted by Cook MyoSite on Sep 14, 2021 11:48:51 AM
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In this webinar, originally presented via RegMedNet on April 15th, 2021, the Regulatory experts at Cook MyoSite walk attendees through the company's experience applying for the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, receiving an initial rejection, and reapplying to successfully obtain the designation.



About the Webinar

A successful strategy for obtaining the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation requires a strong understanding of the FDA/CBER defined designation criteria and potential pitfalls. Equally important to the RMAT strategy is understanding how/if/when regulatory flexibility applies, including GMP challenges to overcome and understanding of the effect of potential government agency interactions. Attendees will gain a better understanding of the possible outcomes from RMAT designation requests, be better positioned to determine if a clinical indication is ready for request of RMAT designation, understand how they can use RMAT designation to expedite clinical development and explore additional avenues for product development.



Stephen Westover, Directory of Regulatory Affairs

Stephen Westover is the Director of Regulatory Affairs at Cook MyoSite Incorporated, where he is the point of contact with health authorities for the clinical investigation and eventual commercial licensing of cellular therapy products and oversees the regulatory interactions and submissions to health authorities including the Food and Drug Administration (FDA), Health Canada, and European competent authorities. Stephen is a certified manager of quality and operational excellence through the American Society of Quality (ASQ) and is certified in RAC Drugs through the Regulatory Affairs Professionals Society (RAPS).

Brett Snyder, Regulatory Affairs Manager

Brett Snyder started at Cook MyoSite in January 2010 in the QA department, moved into Compliance, and finally into Regulatory Affairs. In her tenure at MyoSite, Brett has helped grow systems to fit cGMPs throughout the organization, helped regulatory move from paper submissions to electronic submissions, and is putting systems in place for the department to become an industry leading group. Brett is a certified quality auditor (CQE) through the American Society of Quality (ASQ) and certified as a regulatory affair professional (RAC) through RAPS.

Topics: regenerative medicine, clinical development, clinical trials, regulatory