Frank’s has 40+ years of experience in designing clinical trials in all therapeutic areas across pharmaceutical, vaccines, and consumer products. His experience in running clinical operations, various clinical research functions, clinical safety as well as 20+ years leading biostatistics and epidemiology functions has given him a diverse and in-depth view of many aspects of clinical research covering hundreds of development programs. In addition to a long history of interaction with regulatory agencies in the US, Canada, Europe and Japan on development projects, Frank served on three expert working groups (E1, E9, E10), for the International Conference on Harmonization (ICH) and has personally presented at FDA advisory committee meetings. He is a Fellow and past president of the Society for Clinical Trials and a Fellow of the American Statistical Association. This background and experience gives him the ability to design an individual trial, a group of trials, or an entire development program.