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

Gregory Campbell, PhD

Practice Area Focus

  • Devices
  • Combination Products
  • Diagnostics
  • Medical Imaging

Biography

Dr. Gregory Campbell joined NDA Partners as an Expert Consultant in 2016. He is an experienced statistician with 20 years of service as Director of the FDA Division of Biostatistics, responsible for pre-market review of medical device studies in statistical and clinical trial research.

Prior to joining FDA, Dr. Campbell was Chief, Analytical Biometrics Section, NIH; Acting Chief, Laboratory of Statistical and Mathematical Methodology, NIH; Chief, Statistical Methodology Section, NIH; Research Mathematical Statistician, NIH; and Senior Staff Fellow, NIH.

He has been the leader of several 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Premarket Clinical Investigations, Guidance on the Use of Bayesian Statistics for Medical Device Clinical Trials, and Draft Guidance on Adaptive Designs for Medical Device Clinical Studies.