Mike Fossler

About Mike Fossler

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 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 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 and was on the faculty of the University of California’s American Course on Drug Development and Regulatory Science from 20••••24. He has been quoted by major media (WSJ,NPR) on issues related to medicines and clinical development.

Experience

1. Executive Consultant Vice-president, Strategic Consulting

   Cytel

   Apr 2022 — Present

Education

• University of Maryland Baltimore

  Ph.D., Pharmaceutics

  1987 — 1995

• University of Maryland Baltimore County

  B.A., Biological Sciences

  1981 — 1986

• University of Maryland Baltimore

  Pharm.D., Pharmacy

  1986 — 1992

Skills

• U.s. Food and Drug Administration (Fda)
• Clinical Development
• Lifesciences
• Oncology
• CRO
• Regulatory Submissions
• Life Sciences
• Pharmacokinetics
• Pharmacodynamics
• Clinical Study Design
• Bayesian Analysis
• Pharmacology
• Pharmaceutics
• Drug Discovery
• R
• Pk/Pd
• Pharmaceutical Industry
• Fda
• Sas
• CRO Management
• Bayesian Statistics
• Pharmacometrics
• Clinical Research
• Clinical Pharmacology
• Drug Development
• Clinical Trials
• Biomarkers
• Strategic Partnerships