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Convergence, Communication and Commercialization, The Cornerstones In Emerging Regulatory Trends
At the recently concluded 25th annual meeting of the American Society for Gene and Cell Therapy (ASGCT), Dr. Peter Marks, Director, Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration and Dr. Ana Hidalgo-Simon, Head of Advanced Therapies, European Medicines Agency took part in a Fireside chat titled “State of the Field: Emerging Regulatory Trends”. The session was aimed at creating greater awareness about how the two main regulatory agencies (USFDA and EMA) are gearing to regulate the field of cell and gene therapy. In the freewheeling conversation the speakers shared their insights on various aspects ranging from importance of public-private partnerships, lessons learned from COVID-19 to the role of innovative trial design and primary biomarkers in accelerated development of gene therapies.
Role of Public-Private Partnerships In Cell And Gene Therapies