Philip Lavin, Ph.D, FASA, FRAPS

Phil has 40 years of experience serving as an expert consultant with core expertise in biostatistics (all aspects of study design and analyses inclusive of endpoint construction/validation, sample size calculation, modeling (prognostic, predictive), randomization designs, interim monitoring, bayesian modeling, adaptive designs, meta analyses, survival analyses, longitudinal models, iDMC service), regulatory affairs (21 CFR 312, 21 CFR 812, 505(b)(1-2), PAS, generics, biosimilars), agency representation (FDA, CMS, EMA), strategic consulting (program planning, creative solutions), investor decision making, legal support (research, depositions, testimony); lead biostatistician for 80 NDA, BLA, GRAS, PMA, de novo, and HDE approvals/clearances; served on multiple FDA panels since 1983 as a Special Government Employee through 2015, he was first person to be an elected Fellow of the American Statistical Association and Regulatory Affairs Professional Society. Phil is a graduate of the University of Rochester (AB, Math), and Brown University (PhD, Applied Mathematics).