Michelle Combs

Dr. Combs serves as the Vice President of Data Management and Biometrics, one of the largest and most experienced groups in the industry. In this role she is responsible for modeling and simulation, protocol development, data programming, biostatistics, pharmacokinetics, and medical writing. Dr. Combs has successfully harmonized global processes from legacy companies and sites to deliver consistency of data and to ensure the highest level of scientific excellence across all client programs.

Dr. Combs has over 20 years’ experience in clinical development and has done extensive research in a variety of areas, with publications and presentations on topics focusing in safety, tolerability, pharmacokinetics, and efficacy of new compounds and formulations. Dr. Combs has specialized in early clinical research for the past 17 years, giving her in-depth expertise in the scientific and logistical challenges faced by clients. She is currently focused on the automation of data delivery and innovative study designs, including adaptive trials, to accelerate drug development.

Dr. Combs joined MDS Harris in 1997 and held positions of increasing responsibility in biostatistics and pharmacokinetics before leading the Global Clinical Pharmacology Sciences department at MDS Pharma Services.

Previously in her career, Dr. Combs was a member of the research team at the University of Iowa Clinical Trials Data Management Center, where she participated in the planning, analysis, and interpretation of several Phase III clinical trials. Dr. Combs holds an M.S. and Ph.D. in Biostatistics from the University of Iowa, as well as a B.S. in Mathematics and Statistics from the University of Nebraska at Kearney.