Executive Director
Novartis Institutes for Biomedical Research
East Hanover, New Jersey
Heidi J. Einolf, Ph.D., is an Executive Director and Head of the Clinical PBPK group, Modeling and Simulation (M&S), Pharmacokinetic Sciences, Novartis, East Hanover, NJ. She earned her Ph.D. in biochemistry and molecular biology from Purdue University followed by a postdoctoral fellowship at Vanderbilt University, studying chemical carcinogenesis, DNA adduct formation and DNA polymerase fidelity. In 2000, she joined Novartis as a Laboratory Head in the area of in vitro enzyme DDI. In 2006, she became the US Head of the in vitro DDI group and was in this role for nearly a decade. Currently she leads the Clinical PBPK M&S group leveraging PBPK modeling to support clinical trial planning or waivers for DDI, organ impairment, and food effect studies, to define pediatric starting doses, and virtual bioequivalence modeling in support of drug formulation changes. In addition to her roles at Novartis, she was the company representative of the IQ Translational and ADME Sciences Leadership Group (TALG) for many years, contributing as a leader and active contributor to several IQ Working Groups. She is currently a PhRMA representative on the ICH M12 Expert Working Group to harmonize the conduct and interpretation of in vitro and in vivo DDI studies.
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Wednesday, October 19, 2022
9:00 AM – 9:30 AM ET