Overview

Gender

male

Dr. Gerald J. Fetterly is an Associate Professor of Oncology and the Director of the Pharmacokinetics and Pharmacodynamics Core Resource in the Department of Medicine at Roswell Park Cancer Institute. He is a clinical pharmacologist/pharmacokineticist who received his doctoral degree in Pharmaceutical Sciences from the University at Buffalo in 2000, where he has also been an Adjunct Assistant Professor since 2008.

He possesses considerable expertise in developing oncology agents and the liposomal encapsulation of drugs. Specifically, his doctoral work and subsequent publications focused on an extensive assay development and comparison of the PK/PD relationships of various anticancer drugs, such as liposomal paclitaxel, trabectedin, and mTOR inhibitors.

He has developed both preclinical and clinical PK/PD models to characterize the temporal relationship between the PK of the drug in relation to the time course of neutropenia and transaminase elevation.

Prior to joining Roswell Park Cancer Institute, he worked at Cognigen to further his expertise in population PK/PD modeling to provide consulting services for both industry and academia to assess the impact of patient factors that are sources of variability in not only pharmacokinetics but also 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, reviewed the non-clinical as well as clinical pharmacology development sections of various INDs and NDAs, as well as assisted in the interpretation of preclinical data and extrapolation of implications for human clinical development utilizing PK/PD modeling approaches. From 2000-2002, he was a clinical pharmacology and biopharmaceutics reviewer at the FDA.

The experience of working with the agency has allowed him to supply insight to industry about the necessary components for a successful IND and NDA submission, along with guiding dose selection during the drug development process.