Helen Pentikis

Dr. Helen Pentikis has held key positions within the pharmaceutical industry for over 15 years and has extensive expertise in regulatory and strategic drug development with a focus on pharmacokinetics (PK), pharmacodynamics (PD), and biopharmaceutics involving numerous therapeutic areas. Prior to forming SAJE Consulting, Dr. Pentikis served as Head, Clinical Pharmacology at AkaRx Inc., an emerging pharmaceutical company. Dr. Pentikis was responsible for all clinical pharmacology activities and management for the company’s lead oncology product. Dr. Pentikis’ work and position on the senior management team was instrumental in the $300M acquisition of AkaRx. Previously, Dr. Pentikis was Global Vice President, Pharmacokinetics and Pharmacodynamics at ICON plc (formerly GloboMax LLC) and was responsible for the scientific management of all PK and biostatistics teams. Dr. Pentikis was a Research Fellow in the Pharmacometrics section at Sanofi-Aventis where she successfully applied PK and PD principles to the design of Phase I-III studies and their interpretation. Dr. Pentikis was involved in several worldwide regulatory submissions in the areas of women’s health, allergy, and oncology supportive care.

Dr. Pentikis received a B.S. in Biology from Wake Forest University, and a Ph.D. in Pharmacology and Toxicology from the University of Maryland. Dr. Pentikis completed a Pharmacokinetics Fellowship at the FDA where she studied population PK and PD mixed effects modeling and in vitro drug metabolism using human liver microsomes.