Dr. Stein has demonstrated time and again that strong competence, commitment, and indeed, her pioneering spirit are part of her personality and ethic.
(PRWEB) July 18, 2014
NDA Partners LLC congratulates Premier Expert consultant Kathryn Stein, PhD as the recipient of the distinguished Bard College John and Samuel Bard Award in Medicine and Science. Dr. Stein was presented with the award during the college’s one-hundred and fifty-fourth Commencement ceremony held on May 23. The award is named after two 18th century physicians, father and son, whose descendant, John Bard, was the founder of Bard College. It honors scientists whose achievements demonstrate the breadth of concern and depth of commitment that characterized these pioneer physicians.
“There is no surprise here, that Kathryn is the recipient of this prestigious award,” said Carl Peck, MD, founder and Chairman of NDA Partners. “She has demonstrated time and again that strong competence, commitment, and indeed, her pioneering spirit are part of her personality and ethic.”
Dr. Stein is a former Director of the Division of Monoclonal Antibodies at the US Food & Drug Administration (FDA). During her tenure at the agency, she was a leader in developing policies to regulate polysaccharide-protein conjugate vaccines, monoclonal antibodies and other recombinant DNA-derived products. Dr. Stein was lead or co-author on all of the guidance documents published by the FDA with respect to monoclonal antibodies and a co-author of the FDA guidance on comparability. She led the FDA efforts to develop guidance for plant-made pharmaceuticals and was responsible for bringing USDA into the process so that a joint FDA-USDA guidance document could be developed and issued (2002). Dr. Stein was one of the approving officials for the Haemophilus influenza type b (Hib) vaccines for routine use in infants. She was a member of the review committee of the first approved monoclonal antibody, OKT3™, and one of the approving officials for the subsequent 15 monoclonal antibodies approved through the first half of 2002. These products include abciximab, rituximab, palivizumab, trastuzumab, infliximab, and alemtuzumab.
In 2002, Dr. Stein left the FDA to join MacroGenics where she was responsible for establishing the Product Development and Regulatory Affairs, Project Management, Quality and Manufacturing departments. She currently serves the company on a part-time basis as Senior Vice President.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of approximately 40 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, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.