Donald Klein, PhD

Regulatory Expert

Dr. Klein is a regulatory, scientific CMC Expert with 23 years (1995 – 2017) of experience as a Senior Review Chemist of new drugs in CDER/FDA where he received upon retirement the FDA Distinguished Career Service Award (2017) from the FDA Commissioner. While at the FDA, Don significantly contributed to developing FDA policies for pharmaceutical packaging, comparability protocols, and drug master files. With respect to post-approval changes, his last 12 years were dedicated to the CDER CMC post-marketing division. In addition, Don worked with fellow FDA experts and Industry to resolve drug shortage issues from 2005 to 2017. Prior to starting a Consulting Company (7/2019) with his wife Lynda Taskett, Dr. Klein was a CMC Consultant at parexel (9/2017 – 6/2019). In his professional career he has either reviewed or drafted applications in the following therapeutic areas: Oncology, AIDs, Neurology, Psychiatric, Metabolic/Endocrine, Dermatology, Pulmonary, Analgesic, Radiopharmaceutical; and OTC. Combining his FDA and consulting career, Don has completed 41 NDAs – NDA RSs and 131 original INDs. As a Consultant he has directed Clients through 5 F2F pre-IND meetings and 4 pre-NDA meetings.

Don has been an invited speaker at AAPS, PDA, and RAPS Conferences and had presented several internal training seminars (1999 – 2017) to the FDA Staff. He received a B.S. in Chemistry from Allegheny College (1982) and a Ph.D. in Synthetic Organic Chemistry from Emory University (1988).