About Us
Helen S. Pentikis, Ph.D.
Founder and Chief Scientific Officer
hpentikis@SAJEConsultingLLC.com
Dr. 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.
Carol Braun Trapnell, M.D.
Founder and Chief Medical Officer ctrapnell@SAJEConsultingLLC.com
Dr. Trapnell has over 20 years of experience in drug development and clinical research in both the pharmaceutical industry and the Food and Drug Administration. Prior to founding SAJE Consulting, Dr. Trapnell served as Head, Clinical Research & Development for AkaRx, Inc., an emerging pharmaceutical company, where she was the project leader for the company’s lead hematology product. Her work and position on the senior management team was instrumental in the $300M acquisition of AkaRx, Inc. Dr. Trapnell previously served as Vice President, Clinical Research and Development at ICON plc (formerly GloboMax LLC), where she was responsible for overseeing and developing drug development programs for numerous pharmaceutical products for a wide array of clinical indications. Dr. Trapnell also served as a Medical Officer at the FDA where she was involved in regulatory review and research of drugs and therapeutic biologics. Dr. Trapnell’s expertise includes strategic planning of regulatory science and drug development programs, drug metabolism, drug-drug interactions and the use of PK/PD data to optimize drug development.
Dr. Trapnell holds Pharmacy (cum laude) and Doctor of Medicine degrees from The Ohio State University. Dr. Trapnell completed residency training at The Ohio State University Hospitals in Internal Medicine and fellowship training in Clinical Pharmacology in a joint Georgetown University/FDA program. Dr. Trapnell is a Diplomate of the American Board of Internal Medicine.