Gerald Fetterly, Jr.

Dr. Fetterly is the Director of Clinical Pharmacology and Pharmcometrics at Pfizer (Cambridage, MA). Prior to moving to Pfizer, Dr. Fetterly was the Senior Director and Head of Clinical Pharmacology at Sage Therapeutics. Prior to moving to Sage Therapeutics, Dr. Fetterly was the Vice President responsible for Clinical Pharmacology & Regulatory Affairs at Athenex. Prior to moving to Athenex, Dr. Fetterly was the Director of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Core Resource at Roswell Park Comprehensive Cancer Center. Dr. Fetterly has research experience at Cognigen where he performed population PK/PD modeling among other projects, and provided consulting services for both industry and academia to assess the impact of patient factors that are sources of variability not only in PK but also in the PK/PD relationships for both efficacy and safety, mainly for oncology and neuropharmacology drugs. At Cognigen, he led and managed interdepartmental projects in Clinical Pharmacology, provided sparse sampling designs for clinical pharmacology trials, provided clinical pharmacology services for regulatory strategy during Advisory Board and Sponsor/FDA meetings, was a reviewer for the non-clinical and clinical pharmacology development sections of various INDs and NDAs, and was also a consultant in the interpretation of preclinical data and extrapolation of implications for human clinical development utilizing PK/PD modeling approaches. He has over fifteen years of experience with successful regulatory submissions for INDs, Dossiers and NDAs across the globe and formulating dose selection through all phases of the oncology drug development process.