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.

Joan Korth-Bradley is a Distinguished Scientist at Vivpro and was previously a Senior Director of Clinical Pharmacology at Pfizer Inc. She received her BScPhm from the University of Toronto, her PharmD from the University of Minnesota and her PhD from the University of Texas at Austin. She also completed a residency in hospital pharmacy at the Ottawa General Hospital and a post-PharmD fellowship in pediatric clinical pharmacy at the University of Texas at Austin/Brackenridge Hospital, Austin. She serves on the editorial board of the Clinical Pharmacology and Therapeutics, Journal of Clinical and Translational Science, and The Journal of Clinical Pharmacology. Joan also serves as a peer reviewer for several other clinical therapeutics and pharmacology journals. In addition, she has served as a leader in the American Association of Pharmaceutical Scientists (CPTR Section), American College of Clinical Pharmacy (PK PRN, Industrial Pharmacy PRN), the American College of Clinical Pharmacology (Regent), and the American Society of Clinical Pharmacology and Therapeutics (TPM Network). Her work includes participating as a member of multi-disciplinary development teams working in rare diseases, including hemophilia and growth hormone deficiency. Previously, she supported anti-infectives and anti-inflammatories as well as life-cycle management activities and market support for a variety of products. Her current research interests are the application of modeling and simulation of pharmacokinetic and pharmacodynamic data in drug development of hemophilia replacement products as well as for drugs in children and other special populations.