Michael J. Fossler is Executive Consultant and Vice-President, Strategic Consulting at Cytel. He received the Pharm. D. (1992) and Ph. D. (1995) degrees from the University of Maryland. From 1995 to 2000, Dr. Fossler was employed by the FDA as a clinical pharmacology reviewer in the Division 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 Councilor to the current President.  He holds an adjunct faculty appointment at the University 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 University 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, Division 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 University after which he went to The Johns Hopkins Hospital 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. 

Myong-Jin (MJ) Kim serves as a director of Division of Therapeutic Performance II, Office of Research and Standards, Office of Generic Drugs, CDER, US FDA. MJ leads the group that leverages expertise in clinical pharmacology, formulation science, and human subject protection to conduct research that ensures therapeutic equivalence of generic versions of oral drug products, and to develop product-specific guidances for generic drug developers. She recently served as the FDA Deputy Topic Lead for the ICH Expert Working Group on M13: Bioequivalence for Immediate Release Solid Oral Dosage Forms.

MJ is currently serving as the Secretary of the American College of Clinical Pharmacology (ACCP), Member of the Board of Regents, and the chair of the Inclusivity, Diversity and Equity Committee within the ACCP. Her other ACCP volunteer efforts include serving as a member of the Strategic Planning Committee, Publication Committee, Annual Meeting Program Committee, and Honors and Awards Committee with the ACCP. She is the recipient of the FDA Outstanding Inter-Center Scientific Collaboration Award, CDER Center Director’s Special Citation, CDER Special Recognition Award and FDA Outstanding Service Award. MJ is on the editorial boards of Journal of Clinical Pharmacology and Clinical Pharmacology & Therapeutics. Lastly, she is    the recipient of the American Society for Clinical Pharmacology and Therapeutics Mentor Award for serving in a mentoring role and making a significant impact in the career of her mentees.

MJ graduated from Georgia Institute of Technology in Atlanta, GA, with a Bachelor of Science in chemistry. Subsequently, she received a Doctor of Pharmacy from the Temple University School of Pharmacy in Philadelphia, PA and completed her postdoctoral training in Clinical Pharmacology at Bassett Healthcare in Cooperstown, NY.

Dr. Manjunath Pai is Professor and Chair of Clinical Pharmacy, and Co-Director of the Pharmacokinetics Core at the University 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 University of Texas Health Sciences Center in San Antonio, Texas, a residency at Bassett Healthcare in Cooperstown, New York, and a pharmacokinetics fellowship at the University 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.