Dr. Mendicino’s extensive experience in CMC regulatory, regulatory strategy, development strategy, and diligence make him a valuable resource to our clients developing cell and gene therapies, gene editing, regenerative medicine, tissue engineering, and xenotransplantation products.
WASHINGTON (PRWEB)
September 13, 2022
NDA Partners’ General Manager, Eric Fish, announced today that Michael Mendicino, PhD, a highly regarded subject matter expert in cell and gene therapies and related platform technologies, has joined the company as an affiliated Expert Consultant.
Dr. Mendicino serves as a Chief Consultant and advisor for companies on CMC/CMC regulatory, regulatory strategy, development strategy, and diligence in the fields of cell and gene therapies, gene editing, regenerative medicine, tissue engineering, and xenotransplantation.
Dr. Mendicino was formerly an FDA Commissioner’s Fellow and CMC Reviewer in the Office of Cell, Tissue & Gene Therapies (now Office of Tissues and Advanced Therapies) in the Center for Biologics Evaluation and Research (CBER). In this role, he was responsible for reviewing regulatory submissions for biologics and devices, participated in determining product jurisdiction within CBER, and led/co-led special projects assessing INDs across product areas. He also previously worked at four biotech companies in the cell and gene therapies area for companies at different stages of product and clinical development.
According to Dr. Ellen Feigal, Manager of NDA Partners’ biologics practice, “Dr. Mendicino’s extensive experience in CMC regulatory, regulatory strategy, development strategy, and diligence make him a valuable resource to our clients developing cell and gene therapies, gene editing, regenerative medicine, tissue engineering, and xenotransplantation products. We are pleased to welcome him to NDA Partners.”
Dr. Mendicino is an accomplished leader in cell and gene therapies, and supports numerous professional organizations in the cell and gene therapies area. He has served as co-chair of the Alliance for Regenerative Medicine (ARM) Science and Technology Committee and is the current Chair of the CMC Regulatory Task Force, he is a representative on the International Society for Cellular Therapy (ISCT) Legal & Regulatory Affairs Committee, and is a co-founder and Board Member of the Standards Coordinating Body (SCB). He has authored in excess of 22 publications and book chapters including Nature Biotechnology, Cell Stem Cell, Cytotherapy, Circulation, Journal of Clinical Investigation, and Journal of Immunology, in addition to presenting at numerous international conferences.
Dr. Mendicino received his doctorate degree in immunology and bachelor’s degree in medical genetics and molecular biology from the University of Toronto. He operates his own independent consulting firm and his relationship with NDA Partners is non-exclusive.
About NDA Partners
NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.
Contact
Eric Fish, General Manager
Office: 540-738-2550
FishEric@ndapartners.com
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