Experienced leader in the field of biopharmaceutics and formulation and drug product development, pharmacokinetics, and PBPK and IVIVC modeling as related to clinical, formulation development and CMC regulatory applications. In depth knowledge of absorption, biopharmaceutics and pharmacokinetics and their implications in drug delivery and formulation development decisions for both conventional and solubilizing technologies. Experienced in leading cross-functional drug product development and innovation teams and leading new technology initiatives in the field. Extensive experience with development of enabled formulation and application of in vitro, in silico and in vivo tools to drive the biopharmaceutical evaluation of oral formulations throughout development phases from FIH formulation selection to late stage and life-cycle management including Regulatory Agency interactions, NDA filing and setting of clinically relevant specifications. Key contributor to several NDAs including BELSOMRA, ZEPATIER and PREVYMIS. Authored/co-authored more than 85 manuscripts/book chapters and more than 90 conference abstracts/podium presentations in several national/international meetings in the fields of biopharmaceutics, PBPK modeling, formulation development and drug delivery. Elected as a Fellow of the American Association of Pharmaceutical Scientists in 2017.

Specialties: Biopharmaceutics, Modeling & Simulation, Formulation Development, Oral Peptide Delivery, Pharmacokinetics, Absorption Modeling, Biorelevant Dissolution, Clinically Relevant Specifications, PBPK modeling, IVIVR, IVIVC, GastroPlus, Simcyp, Phoenix/WinNonlin, Drug Delivery, Solubilization, CMC.