The Illustrated Dictionary of Toxicologic Pathology and Safety Science (PDF)

Robert Spaet obtained his BS and MS degrees in Zoology from Eastern Illinois University (1971, 1973). He began his career as a Sr. Research Technician at the Franklin McClean Memorial Research Institute, University of Chicago, before joining GD Searle Laboratories in Skokie, IL as a Parapathologist (1973-76). He became a Research and Teaching Assistant at the University of Oklahoma Health Sciences Center in Oklahoma City, OK, and completed the coursework towards a PhD in Anatomic and Experimental Pathology (1975-77) before joining Ciba-Geigy Pharmaceuticals in June 1977 as a Scientist II in Pathology, Preclinical Safety. He also completed his oral and written exams for PhD degree in Anatomic Pathology at University of Medicine and Dentistry of New Jersey, Newark, NJ (UMDNJ), in 1984 while working for CIBA. His core training and expertise lies in toxicologic pathology within the framework of drug safety evaluation. He has also had full time experience as a Study Director and is certified as a Diplomate, American Board of Toxicology. He has written many scientific papers in the field of toxicology and toxicologic pathology and holds full membership in several prominent professional societies including the Society of Toxicologic Pathologists (US and Europe), Society of Toxicology, American College of Toxicology, and is a member of the Roundtable of Toxicology Consultants. Robert has 35+ years of experience in toxicologic pathology and regulatory toxicology. During his tenure with CIBA and Novartis (merger of CIBA and Sandoz), he held a series of positions of increasing responsibility to eventually become Director, Translational Sciences, Preclinical Safety, Department of Pathology. His professional experience was broadened as an Exchange Scientist with CIBA in Basel, Switzerland (1987-88). Among other professional activities, he participated in the team teaching of Pathology in the School of Allied Health Sciences at UMDNJ for a number of years. Since 1986 he served as an International Project Team Preclinical Safety representative for a number of compounds in development, including several successfully marketed (blockbuster) pharmaceuticals. Within this capacity he has authored extensive safety summaries in support of IND/NDA/CTX drug submissions and represented the company as a preclinical safety expert before regulatory agencies such as the FDA and EMEA. Post-retirement, Robert continues to remain active in toxicologic pathology and non-clinical safety having established a consultancy RSPathologics, LLC. He is also a member of several high-profile groups including the Society of Toxicologic Pathology's Science and Regulatory Policy Committee, the STP Membership Committee, and the European Society of Toxicologic Pathology Committee on Future Technologies in Toxicologic Pathology.

Zbigniew W. Wojcinski, D.V.M, D.V.Sc., DACVP, DABT is Principal and Co-Founder of Drug Development Preclinical Services, LLC, and has 30 years' experience in drug development. Dr. Wojcinski received his undergraduate degree (B.Sc.) in Zoology at the University of Toronto and his D.V.M. and D.V.Sc. (Pathology) from the Ontario Veterinary College, University of Guelph. He is a certified Diplomate of the American Board of Toxicology and a Diplomate of the American College of Veterinary Pathologists. He is also recognized as a Specialist in Veterinary Pathology by the Canadian Veterinary Medical Association. Dr. Wojcinski gained experience in drug development and toxicologic pathology with Parke-Davis\Warner-Lambert and Pfizer Global Research and Development over 22 years and then Fulcrum Pharma Developments, Inc. for 3¿ years. In 2011, he co-founded Drug Development Preclinical Services, LLC. He has extensive experience as Study Pathologist and Review Pathologist for acute, repeated dose subchronic and chronic oral and intravenous studies, including 5 carcinogenicity studies. Throughout his career, he has managed successful cross-functional drug development teams in CNS, Metabolic Diseases and Dermatology therapeutic areas. As Therapeutic Area Leader for Dermatology at Pfizer, Dr. Wojcinski was responsible for development and implementation of the safety and risk management strategies in this new therapeutic area at Pfizer. He has also been directly involved in the preparation of pre-IND documents, Nonclinical Safety Assessments for IND/IMPD/NDA/MAA, Investigator's Brochures and labeling (USPI, SmPC) negotiations in CNS, anti-infective, and/or dermatology therapeutic areas. Dr. Wojcinski has had numerous interactions with regulatory agencies in the US, Europe, Canada and Australia for compounds at various stages of development. Most notably, Dr. Wojcinski was the toxicology representative throughout the entire development of the CNS drug, Lyrica®, which is now marketed worldwide. He has also provided pathology consultation and histopathology peer review on several projects in various therapeutic areas, including respiratory infections, dermatitis, and ophthalmic disease. Dr. Wojcinski has authored/co-authored numerous scientific manuscripts and 4 book chapters.

Philip Bentley is 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 USA with responsibility for Investigative Toxicology; Drug Metabolism; Drug Metabolism and Toxicology; Preclinical Safety Europe; Drug Metabolism and Pharmacokinetics; Toxicology/Pathology USA; Preclinical Safety USA 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 IND's. 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 and working on global projects. He has authored more than 80 scientific publications, has lectured in toxicology at the University of Basel for more than 30 years, and is a past President of the European Society of Biochemical Pharmacology and the Swiss Society of Toxicology. He was a member of the PhRMA/IQ Preclinical Leadership (DruSafe) Committee for 16 years, a member of the advisory board of the PSTC Biomarker consortium and a member of the expert working group for revision of the ICH S2 guidance on genotoxicity testing and the PhRMA expert group on genotoxic impurities.