Pritam S. Sahota, Global ToxPath LLC, Kennewick, Washington, USA, has extensive experience in toxicologic pathology and drug development within the framework of nonclinical safety assessment of pharmaceuticals. Dr. Sahota was previously Executive Director and Head of Pathology, Preclinical Safety, at Novartis Pharmaceuticals, East Hanover, New Jersey. He obtained his veterinary medicine (BVSc) and veterinary pathology degrees (MSc and PhD) from Punjab Agricultural University, India. He is a diplomate of the American Board of Toxicology. After receiving his PhD in 1976, he started working as a toxicologic pathologist at Dawson Research Corporation (DRC), Orlando, Florida, a contract research organization involved in the preclinical safety evaluation of drugs and chemicals. At DRC, he received increasing responsibility over the next 10 years (toxicologic pathologist, senior toxicologic pathologist, and scientific director). As a scientific director, he was responsible for the scientific aspects of pathology as well as toxicology at DRC. While working briefly for Dynamac Corporation, Research Triangle Park, North Carolina (1986–1987), he conducted retrospective scientific audits of 23 NTP carcinogenicity studies and participated in discussions with the representatives of NTP, FDA, and EPA to review the results of scientific audits of over 200 NTP carcinogenicity studies. In 1987, he joined Ciba-Geigy Pharmaceuticals in New Jersey as Head/Manager of pathologists in preclinical safety and was also responsible for establishing pathology peer review, quality control, and scheduling systems. He continued to work primarily in this position with increasing responsibilities at Ciba-Geigy and then Novartis Pharmaceuticals (after Ciba-Sandoz merger in 1997) to become director and eventually Executive Director and Head of pathology. During this time, he also served as an international project team representative for a number of successfully marketed CNS, immunosuppression, diabetes, and cardiovascular drugs, including Diovan, which eventually became one of the 15 all-time, best-selling prescription drugs. He also held an adjunct academic appointment of Assistant Professor at the University of Medicine and Dentistry, New Jersey, for 8 years. He successfully led several global preclinical safety initiatives at Novartis, including patient centricity, review of best practices in cardiotoxicity and ocular toxicity, as well as evaluation of rodent carcinogenicity potential based on noncarcinogenicity data to minimize future delays in regulatory submissions. Since retirement from Novartis Pharmaceuticals in 2012, Dr Sahota has been the President of Global ToxPath LLC located in Kennewick, WA, USA (Toxicologic Pathology Consultancy). As lead editor, he published the following books with CRC Press/Taylor & Francis: (1) Toxicologic Pathology: Nonclinical Safety Assessment (First Edition, 2013); (2) Toxicologic Pathology: Nonclinical Safety Assessment (Second Edition, 2018); (3) The Illustrated Dictionary of Toxicologic Pathology and Safety Science (First Edition, 2019); (4) CT-NCDD: Volume 1 (due to be published in 2020); (5) Road to Greatness (due to be published in 2020); (6) Toxicologic Pathology: A Primer (due to be published in 2021); and (7) Toxicologic Pathology: An Atlas (due to be published in 2022). Philip Bentley is a principal consultant at Toxicodynamix International LLC. He studied biochemistry at the University of Hull, UK, graduating with a BSc in 1970 and a PhD in 1974. He had postdoctoral fellowships at the Universities of Basel, Switzerland, and Mainz, Germany. His postdoctoral research centered upon formation and inactivation of reactive metabolites and the enzymes involved in the metabolism of foreign compounds. In 1979, he joined the Investigative Toxicology group (known as Cell Biology) in the Toxicology Department of Ciba-Geigy, Basel, Switzerland, and remained with the company, later Novartis, until 2014. In these 35 years, he held various management positions in Europe and the United States with responsibility for Investigative Toxicology; Drug Metabolism; Drug Metabolism and Toxicology; Preclinical Safety Europe; Drug Metabolism and Pharmacokinetics; Toxicology/Pathology United States; Preclinical Safety United States; and Global Preclinical Safety. In these positions, he contributed to the registration of more than 45 marketed drug products and the preparation of several hundred investigational new drugs (INDs). He has vast experience in the areas of drug metabolism and disposition, toxicology/ pathology, genetic toxicology, pharmacokinetics/toxicokinetics, and all aspects of investigative toxicology. He is well grounded in biochemistry, cell biology, molecular biology, and pharmacology with the ability to integrate data from the different preclinical disciplines to enable translation to determine the clinical relevance of the findings. He is very familiar with global drug registration requirements
