Bio: Dr. Brock has been actively involved with the toxicology community for about 43 years. In his current role, he provides pharmacology and toxicology advice to sponsors in the pharmaceutical, chemical, and consumer product industries. His research interest is the hepatic effects of xenobiotics and is an Adjunct Assistant Professor at UNC-Chapel Hill, School of Pharmacy, where he serves on PhD committees and assists in directing graduate research into the mechanisms of drug-induced liver toxicity.  

Dr. Brock is a Diplomate of ABT (1987) and a Fellow of ATS (2004). He served twice on the Board of Directors for ATS, serving as President during his first term.  He also served on the ABT Board of Directors, ultimately becoming President of ABT. Dr. Brock was the 2017 recipient of ACT’s Service Award and the 2024 recipient of the ATS Mildred Christian Career Achievement Award. He serves in leadership roles in ACT and has served in various committee within SOT.

He is the founder and organizer of the Advanced Comprehensive Toxicology course (ACT) that prepares candidates for the ABT examination and is an organizer and lecturer in study director training courses in the US, China and India since 2010. He has served as a member or chairperson of several national and international toxicology organizations including the USP, NTP, ILSI-HESI, WEEL, ECETOC and IPEC committees among others. He has been an invited speaker for the Committee on Toxicology, the National Research Council, IPEC, DIA, toxicity standard setting organizations and university toxicology programs.

Abstract: Over the last 20+ years, study directors are being requested to serve multiple roles during the conduct of a nonclinical study. Less time is made available for formal training of a study director with greater reliance on others that have longer-term experience. Often this leads to issues that arise during the study that has the potential to compromise the outcome. During this presentation, multiple case examples from a study monitor perspective will be described that are not often encountered during a study with recommendations for resolution. The case studies will be presented in a format that will allow audience participation.