Gerald Fetterly

Biography

Jerry is a leader in the field of Clinical Pharmacology and drug development. As Director of Clinical Pharmacology, he brings to Athenex 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. Before joining Athenex, Jerry was the Director of the Pharmacokinetics and Pharmacodynamics Core Resource at Roswell Park Cancer Institute, where he led a multidisciplinary translational and bioanalytical team supporting preclinical and clinical testing, as well as IND submissions for cytotoxic and targeted oncology drugs. Prior to his work at Roswell Park, Jerry developed expertise in population PK/PD modeling at Cognigen, where he acted as a consultant for commercial and academic clients in pharmacokinetics and the PK/PD relationships for efficacy and safety. His analyses led to the successful dose selection for cytotoxic drugs including Yondelis®, novel formulations of paclitaxel, and targeted therapy in the fields of mTOR, VEGF, and immunomodulation. During his work at Roswell Park and Cognigen, Jerry led interdepartmental projects that provided clinical pharmacology services for regulatory strategy, and assisted in the interpretation of preclinical data and extrapolation of the implications for human clinical development. Early in his career, Jerry worked at the FDA as a clinical pharmacology and biopharmaceutics reviewer of IND and NDA regulatory submissions. Jerry obtained his PhD in the Pharmaceutical Sciences from the University at Buffalo where he focused on developing novel delivery systems and PK/PD models for paclitaxel that led to optimal dose selection.

Research Interest

 Cancer