Rochelle, Virginia (May 16, 2018) – NDA Partners Chairman Carl Peck, MD, announced today that Yong Fan, MD, former Senior Product Quality Reviewer in the FDA Office of Tissues and Advanced Therapies (OTAT) and Biologist in the Division of Human Tissues at the Center for Biologics Evaluation and Research (CBER), has joined the firm as an Expert Consultant.
Dr. Fan is an expert regulatory scientist with 10 years of experience in regulatory strategy for somatic therapy products (pre-IND, IND, and BLA), medical device applications (IDE, 510(k), and PMA), and human tissue products including registration, donor eligibility determination, and cGTP. She has hands on experience developing Car-T cell, MSCs, tumor vaccines, viral specific T-cells, T-regs, TILs, and hematopoietic stem cells and graft engineering.
Prior to her FDA career, she served as Staff Scientist at the Cell Processing Section of the Department of Transfusion Medicine at the National Institute of Health and as Supervisor of Cellular Activities in the Gene Transfer Core Facility at the Memorial Sloan-Kettering Cancer Center.
“We are very pleased to welcome Dr. Fan to NDA Partners,” said Dr. Ellen Feigal, Manager of the Biologics Practice. “Her experience at FDA and knowledge of regulatory strategy for medical devices, human tissues, and cellular and gene therapy products makes her an outstanding resource for our clients in various stages of product development.”
Dr. Fan earned her medical degree from Jilin Medical College in Jilin, China and Master of Medicine from the Academy of Military Medical Sciences in Beijing, China. She completed her post-doctoral training in cancer immunotherapy, hematopoietic stem cell transplantation, and graft engineering research and translation at The New York Blood Center.
About NDA Partners
NDA Partners is a life sciences management consulting firm focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; 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, expert consulting, high-impact project teams, and management of client product development programs.
Earle Martin, Chief Executive Officer