NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Yong Fan, MD

Practice Area Focus

  • Cell Therapy
  • Devices
  • Biologics
  • Development Strategy
  • Quality Assurance
  • GMP Audits
  • CMC

Biography

Dr. Yong Fan joined NDA Partners as an Expert Consultant in 2018. Dr. Fan was formerly a Senior Reviewer in the FDA Office of Tissues and Advanced Therapies (OTAT) and a Biologist in the Division of Human Tissues at the Center for Biologics Evaluation and Research (CBER). She 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.

Prior to her FDA career, Dr. Fan served as Staff Scientist in the National Institute of Health’s Cell Processing Section and as Laboratory Supervisor at the Memorial Sloan-Kettering Cancer Center in the Gene Transfer Core Facility.