ROCHELLE, Va., May 29, 2019 /PRNewswire-PRWeb/ -- NDA Partners Chairman Carl Peck, MD,
Dr. Fairweather was formerly Acting Director of the Division of Biometrics (CDER), Associate Director of the Office of Epidemiology & Biostatistics (CDER), Group Leader of the Statistical Evaluation Branch, and Mathematical Statistician. As Chief of the Statistical Application & Research Branch, he provided support to CDER and to the Center for Biologics Evaluation and Research (CBER) for clinical trial evaluation for safety and efficacy of anti-viral drugs, biologicals, animal tumorigenicity testing, bioequivalence, epidemiology, and compendial standards. Prior to his FDA career, Dr. Fairweather served as a Statistician in the Biometrics Branch of the National Heart and Lung Institute, National Institutes of Health.
Dr. Fairweather is an expert in clinical and preclinical study design and analysis, methodological research in statistics, pharmacokinetics, bioavailability and bioequivalence, CMC, stability studies, animal safety studies, and carcinogenicity studies.
"Dr. Fairweather's expertise in clinical and preclinical study design and analysis, pharmacokinetics, bioavailability and bioequivalence, in addition to his extensive career at FDA in CDER, will greatly benefit our clients in the early-stage drug development process," said Dr. Peck. "We are very pleased to welcome him to NDA Partners."
Dr. Fairweather earned a doctorate in biomathematics (biostatistics) from the University of Washington and a master's degree in industrial engineering and operations research (statistics) from Cornell University. He has served on numerous data and safety monitoring boards, as a referee for the National Academy of Sciences/National Research Council, and has been designated as an "Expert Regulatory Statistician" by the FDA.
About NDA Partners NDA Partners is a life sciences management consulting and contract development organization (CDO) 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; 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, expert consulting, high-impact project teams, and contract management of client product development programs.
Contact Earle Martin, Chief Executive Officer Office: 540-738-2550 MartinEarle(at)ndapartners(dot)com
SOURCE NDA Partners, LLC
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