Toxicologic Pathology : An Atlas

Over the past few decades, there has been an exponential growth of interest in the field of toxicologic pathology, a critical field in safety science, particularly as related to its impact on nonclinical safety in global drug development and care of the environment. Photomicrographic examples of selected nonproliferative and proliferative lesions are necessary to complement the written narratives in textbooks on toxicologic pathology. Toxicologic Pathology: An Atlas fits that need with input provided by top experts in the field. It will become a valuable reference, not only for toxicologic pathologists, but also for a wide variety of nonclinical safety scientists, especially in the pharmaceutical and biotech industries.

This book provides illustrations and descriptions of commonly observed findings in toxicologic pathology (i.e., over 1100 photomicrographic examples). These illustrations add visual context to the terms and descriptions commonly used in the field. The illustrations and accompanying descriptions were prepared and peer reviewed by editors and contributors who are known experts in toxicologic pathology, toxicology, and drug development. The Atlas is designed to be practical, easy to use and written with the hope that it will become a reliable "go-to" reference that will be of interest to students and nonscientists (e.g., individuals serving on animal care and use committees) as a key, single source to understanding terminology and visualizing tissue changes described by toxicologic pathologists.

Dr. Pritam S. Sahota studied for his Veterinary Medicine (BVSc) and Veterinary Pathology (MVSc and PhD) degrees at Punjab Agricultural University in India (1976). He is a Diplomate of the American Board of Toxicology. After completing his PhD, he immigrated to the USA in 1976 and worked for Dawson Research Corporation in Orlando, Florida, for ten years (1976–86) with increasing responsibilities as Toxicologic Pathologist, Senior Toxicologic Pathologist, and Scientific Director. While working briefly for Dynamac Corporation in Research Triangle Park, North Carolina (1986–87), Dr. Sahota conducted retrospective scientific audits on 23 NTP carcinogenicity studies and participated in discussions with the representatives of NTP, FDA, and EPA to summarize the results of scientific audits of approximately 200 carcinogenicity studies. In 1987, Dr. Sahota joined Ciba-Geigy Pharmaceuticals in Summit, New Jersey, as Head/Manager of Pathologists and helped establish Pathology Peer Review, Scheduling, and Quality Control systems. He continued to work primarily in this position with increasing responsibilities in Ciba-Geigy and then Novartis Pharmaceuticals (resulting from the Ciba/Sandoz merger in 1997) up to 2000, when he became Head of Pathology (Director? Executive Director: 2000–12, East Hanover, NJ). In addition to his pathology responsibilities, Dr. Sahota also served as International Project Team Representative for several marketed drugs, including an antihypertensive blockbuster, Diovan, where he successfully defended the company’s position with the FDA and various International Regulatory Authorities. During 2010–12, he successfully led the following Global Preclinical Safety initiatives at Novartis: Patient Centricity, Cardiotoxicity, Ocular Toxicity, and evaluation of rodent carcinogenicity potential based on short-term toxicity and genotoxicity studies to minimize delays in regulatory submissions. Dr. Sahota also held an adjunct academic appointment as an Assistant Professor in the University of Medicine and Dentistry of New Jersey, Newark, New Jersey, for approximately eight years. In 2013 and 2018, he co-edited as Lead Editor the First and Second Editions of the book entitled "Toxicologic Pathology, Nonclinical Safety Assessment" (CRC Press). In 2019, Dr. Sahota co-edited as Lead Editor "The Illustrated Dictionary of Toxicologic Pathology and Safety Science" (CRC Press), which was considered one of the 100 Best Pharmaceutical Books of All Time (Book Authority). Finally, Dr. Sahota, as Lead Editor, published Current Topics in Nonclinical Drug Development Volume-1 (2020) and Road to Greatness (2022).

Zbigniew W. Wojcinski is President of Toxicology & Pathology Consulting, LLC, in Hillsborough, North Carolina, and has over 40 years’ experience in pharmaceutical drug development. Dr. Wojcinski received his undergraduate degree (B.Sc.) in Zoology from the University of Toronto and his D.V.M. and D.V.Sc. (Pathology) degrees 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 and a Fellow of the International Academy of Toxicologic Pathology. Dr. Wojcinski gained experience in drug development and toxicologic pathology during his 22-year tenure with Parke-Davis\Warner-Lambert and Pfizer Global Research and Development, and then 3½ years with Fulcrum Pharma Developments, Inc. In 2011, he founded Drug Development Pathology Services, LLC in Ann Arbor, Michigan, and subsequently grew the organization into Drug Development Preclinical Services, LLC to provide toxicology, pathology, and drug metabolism and pharmacokinetic services. Dr. Wojcinski has extensive experience as a Study Director, Study Pathologist, and Review Pathologist for numerous acute and repeated dose toxicity studies, including carcinogenicity studies. Throughout his career, he has managed successful cross-functional drug development teams in CNS, Metabolic Diseases, and Dermatology therapeutic areas. Dr. Wojcinski has 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. He has had numerous interactions with regulatory agencies in the US, Europe, Canada, and Australia for compounds at various stages of development. He has also provided pathology consultation and histopathology peer review on several projects in various therapeutic areas, including respiratory infections, dermatitis, oncology, ophthalmic disease, women’s health, and rare diseases, and served on Pathology Working Groups. Dr. Wojcinski is a full member of numerous professional societies, including the American College of Veterinary Pathologists, Society of Toxicologic Pathologists, Society of Toxicology, American College of Toxicology, American Veterinary Medical Association, Canadian Veterinary Medical Association, Canadian Association of Veterinary Pathologists, Regulatory Affairs Professionals Society, and Roundtable of Toxicology Consultants. He has served as President of the Dermal Toxicity Specialty Section of the Society of Toxicology, Chair of the Society of Toxicologic Pathology Recruitment Subcommittee, Editor of The Scope for the Society of Toxicologic Pathology, member of the Society of Toxicologic Pathology International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) committee, Editor for the Toxicologic Pathology Forum of the Society of Toxicologic Pathology, and member of the Editorial Board for the Society of Toxicologic Pathology journal. Dr. Wojcinski has lectured at the Ontario Veterinary College and the University of Maryland and authored/co-authored numerous scientific reports, manuscripts, and book chapters. He is Co-Editor for the following books: "The Illustrated Dictionary of Toxicologic Pathology & Safety Science" (published in 2019); "Current Topics in Nonclinical Drug Development, Volume 1" (published in 2021); "Guideposts for Veterinary Professionals" (published in 2021); "Road to Greatness" (published in 2022); "Toxicologic Pathology: A Primer" (published in 2024); "Current Topics in Nonclinical Drug Development, Volume 2" (published in 2024); "Toxicologic Pathology, Nonclinical Safety Assessment, 3rd Edition" (published in 2025); and "Current Topics in Nonclinical Drug Development, Volume 3" (due to be published in 2025).

Robert H. Spaet’s expertise lies in toxicologic pathology in drug safety assessment, with 45+ years’ experience in the field. He is accredited by the International Academy of Toxicologic Pathology and is certified as a Diplomate, American Board of Toxicology (1989–2025). He obtained his BS and MS degrees in Zoology from Eastern Illinois University and began his career as a Sr. Research Technician at the Franklin McClean Memorial Research Institute, University of Chicago, before joining GD Searle Laboratories as a Parapathologist. He became a Research/Teaching Assistant at the University of Oklahoma Health Sciences Center and completed coursework toward a PhD in Anatomic and Experimental Pathology before joining Ciba-Geigy Pharmaceuticals as a Scientist II in Pathology, Preclinical Safety. He also completed his oral and written exams for a PhD in Anatomic Pathology at the University of Medicine and Dentistry of New Jersey while working for CIBA. Robert 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 Pathology (US [Silver Member/Silver & Bronze Most Valuable Contributor] and Europe), Society of Toxicology, American College of Toxicology, and is a member of the Roundtable of Toxicology Consultants. While at CIBA/Novartis, he held a series of positions of increasing responsibility to eventually become Director, Translational Sciences, Novartis Institutes for Biomedical Research, Dept of Pathology. His professional experience was broadened as an Exchange Pathologist with CIBA in Basel, Switzerland (1987,1988). He served as International Project Team Preclinical Safety representative for several compounds in development, including two successfully marketed (blockbuster) 2nd and 3rd generation bisphosphonates developed to ameliorate bone loss, Aredia® and Zometa®. In this capacity he authored extensive safety summaries in support of IND/NDA/CTX drug submissions and represented the company as a preclinical safety expert before the FDA and EMEA. For these successes, he was awarded The President’s Distinguished Scientist Citation and The President’s Distinguished Fellow Award. Among other professional activities, he participated in the team teaching of Toxicologic Pathology as an Adjunct Professor in the School of Allied Health Sciences at the UMDNJ from 1999 to 2006. Post-retirement, Robert remains active in toxicologic pathology and nonclinical safety, having established a consultancy, RSPathologics, LLC, in 2013. He co-edited The Illustrated Dictionary of Toxicologic Pathology and Safety Science (May ‘19, CRC Press), which was considered the first of its kind published work in the non-clinical safety community. Within a year and a half of publication, the book ranked #5 among the top 100 pharmaceutical texts of all time by BookAuthority https:// bookauthority. org/ about. He recently completed co-editing Toxicologic Pathology: A Primer (March ‘24, CRC Press). He has been a member of several high-profile groups, including the Society of Toxicologic Pathology’s Science and Regulatory Policy Committee, the STP Membership, Fundraising (Co-Chair) and Tox/Path Forum (Chair) Committees, and the European Society of Toxicologic Pathology Committee on the role/impact of AI and Deep Learning in Toxicologic Pathology.

Dr. Jerry F. Hardisty was the Chief Executive Officer of Experimental Pathology Laboratories, Inc. (EPL®). He currently serves as a Senior Pathologist and consultant at EPL. He graduated from Iowa State University College of Veterinary Medicine and received his pathology training in the U.S. Army Preceptorship Program. He joined EPL as a staff pathologist in 1976. He has been a Diplomate of the American College of Veterinary Pathologists since 1976 and in 2015 was recognized as a Distinguished Member of the ACVP. Dr. Hardisty served as an Adjunct Assistant Professor with the North Carolina State University College of Veterinary Medicine. In 2005, he was awarded the Stange Award for Meritorious Service by the College of Veterinary Medicine at Iowa State University. Dr. Hardisty has worked with the NCI/NTP Carcinogenesis Testing Program closely for over 30 years. He has participated in the publication and presentation of significant results of the NCI/NTP Pathology Quality Assessment Program and of several specific carcinogenesis bioassay tests. He has coauthored several publications in experimental pathology, pathology quality assessment, and pathology peer review. He has served on the Editorial Board for Toxicologic Sciences, Toxicologic Pathology, and Experimental and Toxicologic Pathology. He specializes in the conduct of Pathology Peer Review of subchronic and carcinogenicity nonclinical toxicology studies. He was a co-editor for the First and Second Editions of the book entitled "Toxicologic Pathology, Nonclinical Safety Assessment" (CRC Press). He has organized and chaired Pathology Working Groups and Scientific Advisory Panels in the US, Japan, and Europe. Dr. Hardisty has been active in the Society of Toxicologic Pathologists (STP) as member of Executive Committee (1994–1998), Standard Systematized Nomenclature and Diagnostic Criteria Committee (SSNDC) (1984–2000), liaison with the American College of Toxicology (1998–2000), as President-Elect (199–1999), President (1999–2000) and as Past-President (2001–2002). He also served as the chair of the STP nominating and fundraising committees. In 2011, he received the Society of Toxicologic Pathology Achievement Award. He is a member of the International Academy of Toxicologic Pathologists (IATP) and served as the North American Director of the IATP. While President of the STP, he was involved in starting the ACT/STP Pathology for non-Pathologist course and the annual NTP pathology symposium presented at the annual American College of Toxicology (ACT) meeting. He has worked as an ad hoc member of the program committee for several years and is a member of the 2010 ACT program committee. In 2010, he received the American College of Toxicology Service Award. He was elected to the ACT council in 2011 and has served as chair of the Education Committee. Dr. Hardisty continues to support interaction between the ACT and STP through CE courses and symposia at the annual meetings of both organizations.

Gregory Argentieri received a BS and an MS degree in Biology from William Paterson University. He was Senior Electron Microscopy and Digital Imaging Laboratory Manager with 33 years of proven team management skills and diverse technical experience supporting pharmaceutical research and development in the medical and industrial fields at Sandoz and Novartis Pharmaceuticals Corp., E. Hanover, New Jersey. He is an Electron Microscopist certified by the Microscopy Society of America, with extensive experience in light and electron microscopy, image analysis, and other related techniques in medical, biological, and material sciences. Throughout his long career, he has been recognized by senior managers and peers for quality work in a high-pressure environment. Mr. Argentieri also taught Graduate and Undergraduate scanning and Transmission electron microscopy / lecture and lab, as an adjunct professor at William Paterson College. He was a contributor to the New York Microscopy Society newsletter. Mr. Argentieri’s ongoing contributions include serving as Illustrations Editor for the following books: The Illustrated Dictionary of Toxicologic Pathology & Safety Science" (published in 2019); "Current Topics in Nonclinical Drug Development, Volume 1" (published in 2021); "Toxicologic Pathology: An Atlas" (target publication 2023); and "Current Topics in Nonclinical Drug Development, Volume 2" (target publication 2023).