Cell and gene therapies are progressing through clinical trials and driving towards commercialization at a rapid pace. As a result, regulatory agencies have had to pivot quickly to provide guidance to support the pace of development.
Based on extensive experience supporting early-stage and clinical-stage companies through the drug development and approval process, the webinar will provide critical guidance for navigating regulatory requirements to accelerate the commercialization process and get much-needed therapies to patients sooner.
Monica M. Commerford, Ph.D., is the Head of Regulatory Affairs, Viral Vector Services at Thermo Fisher Scientific in Cambridge, Mass. She previously worked as a Microbiologist and Consumer Safety Officer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. She is an expert in the microbial control, product quality microbiology, and sterility assurance of Investigational New Drug Applications and Biological License Applications submitted to CDER and performed pre-license inspections of biological product manufacturing facilities. In addition, she has participated in writing policies and a draft guidance document. Dr. Commerford earned her B.S. in Biochemistry and Molecular Biology from Michigan State University and her Ph.D. in Microbiology and Molecular Genetics from Harvard University. In addition to her regulatory experience, she was also a Sallie Rosen Kaplan post-doctoral research fellow in the Laboratory of Molecular Biology at the National Institutes of Health.
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