Michael J. Fossler, Jr is Executive Consultant and Vice-President, Strategic Consulting at Cytel. He received PharmD (1992) and PhD (1995) degrees from the Univ of Maryland. From 1995 to 2000, Dr. Fossler was employed by the FDA as a clinical pharmacology reviewer in the Div of Metabolic and Endocrine Drug Products.  In 1998, he was promoted to Senior Reviewer and joined the Pharmacometrics group at FDA, where he was responsible for reviewing and performing population PK/PD analyses. He left the Agency in 2000 and joined the Clinical Pharmacokinetics Group at DuPont Pharmaceuticals, where he had major responsibility for PK/PD analyses in the cardiovascular and anti-inflammatory areas. In November, 2001, he joined GlaxoSmithKline, where he continued to work in the cardiovascular area, and eventually headed a group of nine pharmacometrics scientists. He left GSK in 2015 to join Trevena Inc, a late-stage small biotech company, where he led clinical pharmacology, clinical development, biostatistics, programming and data management.  He assumed his present role at Cytel in April 2022, where he provides strategic consulting services in the areas of clinical pharmacology and pharmacometrics. Dr. Fossler is a Fellow of the American Foundation for Pharmaceutical Education, a Fellow of the American College of Clinical Pharmacology, a past President of the College and is an Honorary Regent and former Councilor to the President.  He holds an adjunct faculty appointment at the Univ of North Texas where he teaches in the school’s Pharmacometrics program. He has been quoted in the media (Wall St. Journal, NPR) on issues related to medicines and drug development.

Craig Hendrix, MD, has been a Member of ACCP since 2018 and became a Fellow in 2019. He has served the society in various capacities, including current service as Treasurer and the Executive Committee since September 2024 and as a member of the Board of Regents since 2020. He currently chairs the Conflict of Interest Work Group and previously chaired the Credentials Committee (2021-2022), Special Interest Group Task Force (2022-2023) and Finance Committee (2022-2024). He was a Faculty Speaker and/or Symposia leader at the ACCP Annual Meeting in 2016, 2017, 2019, 2023 and 2024 as well as serving several years as an Abstract Reviewer. He received the ACCP Distinguished Investigator Award in 2018. 

Dr. Hendrix is currently Professor Emeritus at the Johns Hopkins Univ and Senior Scientist at Oak Crest Institute of Science in Monrovia, CA. In 30 years on the Hopkins medical school faculty, he served the past decade as the Wellcome Professor and Director, Div of Clinical Pharmacology (2015-2025), Director of the Hopkins T32-funded Clinical Pharmacology Training Program and Director of their outpatient Phase I Drug Development Unit. He obtained his baccalaureate degree at MIT and doctorate in medicine at Georgetown Univ after which he went to The Johns Hopkins Hosp for housestaff and fellowship training in internal medicine, infectious diseases and clinical pharmacology. He served 13 years in the US Air Force, including deployment for Desert Storm. 

His primary research focus is the clinical pharmacology of HIV pre-exposure prophylaxis and he has served as Principal Investigator of over 120 phase I clinical studies and principal pharmacologist for over 80 multi-center clinical trials. He has also served on a National Academy of Medicine Advisory Panel, the CDC Board of Scientific Counselors and several FDA Advisory Committees. He is the current Chairman of the American Board of Clinical Pharmacology. 

Dr. Manjunath Pai is Professor and Chair of Clinical Pharmacy, and Co-Director of the Pharmacokinetics Core at the Univ of Michigan. His research focus is optimal drug dose selection in specific populations such as patients with obesity and abnormal kidney function. His group repurposes existing CT scans to generate body composition and imaging biomarkers predictive of clinical pharmacology, an approach coined as “pharmacomorphomics”. He earned his PharmD from the Univ of Texas Health Sciences Ctr in San Antonio, Texas, a residency at Bassett Healthcare in Cooperstown, New York and a pharmacokinetics fellowship at the Univ of Illinois at Chicago. Dr. Pai has received multiple honors for his scientific contributions including the Russell R. Miller Award for sustained and outstanding contributions to the clinical pharmacology literature.

Dr Suneet Shukla is a Director (Clinical Pharmacology) at Boehringer Ingelheim Pharmaceuticals, USA where he leads global Clinical Pharmacology programs in oncology, inflammation, and cardio renal metabolism therapeutic areas for both large and small molecules.

Dr Suneet Shukla is a pharmacist by educational training with a Ph.D. in molecular pharmacology studying drug transporters, their role in fungal infections and drug resistance. After graduation, he continued to pursue his research interest in drug transporters for over 10 years at the National Cancer Institute (NCI), NIH where he completed his postdoctoral training in the Laboratory of Cell Biology and was later appointed as Staff Scientist. He then joined US Food and Drug Administration and has worked in the Offices of New Drug Products, Generic Drugs and Clinical Pharmacology and acted as ophthalmology team lead where his responsibilities included the review of INDs, NDAs, ANDAs, and other regulatory submissions from a biopharmaceutics, bioequivalence and clinical pharmacology perspective.

Suneet has published several highly cited research and review articles, received patents, and awards from NIH and FDA. He has served on panels evaluating research grants submitted to NIH and FDA, mentored several undergraduate, graduate, and post-doctoral trainees. He is currently serving as member of American College of Clinical Pharmacology Public Policy Committee and has served as the lead instructor of the medical pharmacology course at the Foundation for Advanced Education in the Sciences (FAES) Graduate School, NIH.