Former Director of FDA Division of Biostatistics, Gregory Campbell, PhD, joins NDA Partners as Expert Consultant

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NDA Partners Chairman Carl Peck, MD, announced today that Gregory Campbell, PhD, a highly-respected biostatistician with 20 years of service as former Director of the FDA Division of Biostatistics in the Center for Devices and Radiological Health (CDRH), responsible for the pre-market review of medical devices, statistical and clinical trial design, research and policy, has joined the firm as an Expert Consultant.

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Dr. Campbell’s knowledge and expertise of biostatistics and Bayesian adaptive clinical study design at FDA and NIH will greatly benefit our clients in the early-stage drug development process. We are pleased to have him on the NDA Partners team.

NDA Partners Chairman Carl Peck, MD, announced today that Gregory Campbell, PhD, a highly-respected biostatistician with 20 years of service as former Director of the FDA Division of Biostatistics in the Center for Devices and Radiological Health (CDRH), responsible for the pre-market review of medical devices, statistical and clinical trial design, research and policy, has joined the firm as an Expert Consultant. Prior to joining the FDA, Dr. Campbell was Chief, Analytical Biometrics Section, Acting Chief, Laboratory of Statistical and Mathematical Methodology, Chief, Statistical Methodology Section, Research Mathematical Statistician, and tenured research scientist at the National Institutes of Health (NIH).

Dr. Campbell has been the innovative leader of numerous FDA committees including the Guidance on Principles of Study Design for Medical Device Premarket Clinical Investigations, Guidance on the Use of Bayesian Statistics for Medical Device Clinical Trials, and Draft Guidance on Adaptive Designs for Medical Device Clinical Studies.

“Dr. Campbell’s expertise in biostatistics and Bayesian adaptive clinical study design will greatly benefit our clients in the early-stage drug development process. He is a welcome addition to our team of Expert Consultants and we are very pleased that he has joined NDA Partners,” said Dr. Peck.

Dr. Campbell earned his PhD and MS in Statistics from Florida State University, a MS in Mathematics from Michigan State University, and his BS in Mathematics from the University of Dayton. He was the driving force in the establishment of a new section on Medical Devices and Diagnostics in the American Statistical Association and currently serves as an Associate Editor of "Statistics in Biopharmaceutical Research".

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 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 virtual product development teams.

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Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle(at)ndapartners(dot)com

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Earle Martin
NDA Partners LLC
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