Model-Based Drug Development (MBDD) 101: A Primer on MBDD and Its Benefits

N. Seth Berry, PharmD, Director, Clinical PK/PD and Modeling & Simulation, Quintiles Innovation

Dr. Berry is Director of Clinical Pharmacokinetic / Pharmacodynamic (PK/PD) Modeling and Simulation in the Quintiles Innovation Group. He has a PharmD from the University of Missouri-Kansas City, School of Pharmacy, a 2-year Post-Doctoral PK/PD Fellowship with the University of North Carolina, and a 2-year Pharmacometrics Fellowship with the Center for Drug Development Science, Georgetown University (now at the University of California – San Francisco).

Since joining Quintiles in 2004, Dr. Berry has focused on Model-Based Drug Development, with an emphasis in population PK/PD modeling and simulation. Dr. Berry has performed population PK/PD meta-analyses for regulatory submission labeling requirements and conducted clinical trial simulations for optimizing study design. Dr. Berry has numerous publications and presentations in the pharmacometrics discipline, while also mentoring PK/PD Fellows, providing workshops, and training seminars. Dr. Berry is a high performance computing expert with strong backgrounds in NONMEM®, S-Plus®, and R.

Russell Reeve, PhD, Senior Strategic Biostatistics Director, Quintiles

Dr. Reeve earned his B.S. in Mathematics from Utah State University, M.S. in Operations Research from Rensselaer Polytechnic Institute, and Ph.D. in Statistics from Virginia Polytechnic Institute and State University. Dr. Reeve has taught graduate statistics courses at University of Rochester and Memphis State University, and is currently an adjunct faculty in Analytics and North Carolina State University, and has previously been adjunct in Clinical Research at Campbell University.

Dr Reeve has broad industry experience. While at Syntex and Chiron, Dr. Reeve became involved in clinical modeling and simulation, designing a randomized concentration-controlled trial with Bayesian updating of the doses. While at Chiron, Dr. Reeve worked on a number of biologics agents and vaccines, such as interferon-a, vaccines for HCV, HPV, and influenza, as well as in vitro diagnostics based on ligand-binding and bDNA technologies. At Pharsight, Dr. Reeve was responsible for the scientific development of modeling and simulation software (WinNonlin, WinNonMix, and Trial Simulator), and managing the scientific advisory boards in these areas.

Dr. Reeve has since worked in the CRO industry, supporting more than 100 studies from Phase I through Phase IV. Dr. Reeve has published and has expertise in model-based drug development, including CATD and population modeling, has a patent in the field of metabolomics, and has been a leader in adaptive trial design and execution. He currently supports development of MBDD capabilities at Quintiles, is on the Quintiles Adaptive Trial Board, manages the Innovation MBDD Advisory Board, and consults with clients on development and trial design strategies.