Jim Herman, Ph.D.
Jim has more than 34 years’ experience managing the nonclinical development of novel pharmaceuticals from discovery through successful registration. Currently, Jim is Vice President of Toxicology at Certara USA, leading a group of 9 toxicologists providing strategic, operational, and tactical consulting services to small and large pharmaceutical companies worldwide. Previously, he was President of Integrated Nonclinical Development Solutions, Inc (INDS). Prior to establishing INDS, he spent 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, and am well-versed in study design, execution, and reporting. He also has significant 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 and product labeling. He was involved significantly in 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). Jim has also has experience as a nonclinical consultant in the National Institutes of Health’s Blueprint Neurotherapeutics Network.