Vice President
Certara
Ann Arbor, Michigan
James R. Herman, PhD, DABT (1992-2022) is currently Vice President of Toxicology at Certara USA, leading a group of 10 toxicologists providing strategic, operational, and tactical consulting services to small and large pharmaceutical companies worldwide. Previously, he was President of the consulting group Integrated Nonclinical Development Solutions, Inc (INDS) that was aquired by Certara in 2022. Prior to establishing INDS in 2007, he spent almost 20 years at Pfizer and its predecessor in Ann Arbor (Parke Davis) in various scientific and managerial roles within the toxicology group. Jim has significant experience in serving on multidisciplinary drug development teams for small molecules and biologics in several therapeutic areas. He has also served as study director for exploratory and GLP toxicology studies. Jim has extensive experience in the regulatory toxicology field in all 3 regions (US, EU, and Japan), and has authored and/or critically reviewed over 200 nonclinical portions of IND and NDA/MAA submissions, including sections required for Investigator Brochures, impurity qualification, and product labeling. He made signficant contributions to the development of the first-in-class drugs Cognex (tacrine), Neurontin (gabapentin), Rezulin (troglitazone), Nexletol (bempedoic acid), Onfi (clobazam), and the blockbuster drugs Lipitor (atorvastatin) and Lyrica (pregabalin).
Impurity/Degradation Products: Time to Move Beyond Standard ICHQ3 Qualification Studies?
Tuesday, October 24, 2023
12:30 PM – 1:30 PM ET