= Members Only
Toxicology for Industrial and Regulatory Scientists
Alys Bradley, BSc, BVSc, MAnimSc, DipRCPath, FRIPH, MRCVS, FRCPath, FIATP
Alys Bradley attained an Honours degree in Zoology from Manchester University, and a Masters Degree in Applied Veterinary Parasitology from Liverpool School of Tropical Medicine. She then held research posts at the Liverpool School of Tropical Medicine and Liverpool University department of Pathology, in the field of monoclonal antibody development and refinement. She gained her Degree in Veterinary Medicine from Liverpool University in 1994 and following a year working for the Ministry of Agriculture, joined the Pathology Department of Edinburgh University as HBLB lecturer in Neuropathology. She was recruited to the Pathology Department of Charles River Edinburgh in 1998 and appointed Director of Pathology in 2005. Alys is actively involved in training pathologists and is Chair of the Board of Examiners for the UK Veterinary Pathology boards regulated by the Royal College of Pathologists. Her specialist interests are nonhuman primate pathology, rabbit pathology, and neuropathology of all species. She is Treasurer of the British Society of Toxicological Pathology, a member of the Society of Toxicologic Pathology Special Interest Groups for Neuropathology and Environmental Toxicology, Associate Editor for the Journal Toxicologic Pathology, and serves on the International Harmonisation of Nomenclature and Diagnostic Criteria (INHAND) GESC and Working Groups for the Nervous and Haematopoietic Systems, and the Society of Toxicologic Pathology Working Group for Best Practices in Nervous System sampling.
Peter JM Clements, BSc, BVM&S, PhD, DipRCPath, MRCVS, FRCPath
Peter Clements is a Director of Pathology, Safety Assessment at GlaxoSmithKline. He graduated from Edinburgh University in Pathological Sciences and Veterinary Medicine, and was awarded a PhD in molecular pathology/genetics from the Institute of Ophthalmology, London. Following a postdoctoral position at Cambridge Vet School, he started his 19-year pharmaceutical industry career at Pfizer, followed by Roche and GSK and was awarded MRCPath in Veterinary Pathology in 2006, gaining FRCPath in 2008. He is a member of the InHAND Cardiovascular organ working group, chairs the Nonclinical Cardiovascular Safety Panel at GSK and leads GSK’s representation on the NC3Rs InPulse Crack-It challenge to deliver a mature human pluripotent stem cell-derived cardiomyocyte platform. His current responsibilities also include discovery pathology and project-aligned regulatory and investigative toxicologic pathology, supporting drug candidates into and through clinical development, and leading safety assessment interactions with Discovery colleagues, particularly in the neuroscience therapeutic area. He is also a member of the IMI eTOX project, working primarily on pathology ontologies. Interests include cardiovascular pathobiology, the generation of integrated ‘functional and structural’ datasets in drug development, to enhance the detection and understanding of cardiovascular toxicology and its clinical implications and also ophthalmic pathology. He has presented and co-authored papers on cardiovascular pathology/biomarkers, integrated cardiovascular safety assessment and written a book chapter on xenobiotic-induced inflammation.
Adam Hargreaves, BVSc, MRCVS, DipRCPath, FRCPath, DiplACVP
Adam is an independent veterinary and toxicologic histopathology consultant with over 12 years experience in pharmaceutical drug discovery and development. He previously worked at the Central Toxicology Laboratory, followed by a number of years at Astrazeneca. He is currently the Managing Director of PathCelerate Ltd., a small CRO offering bespoke support to both small and large pharmaceutical companies. Adam has interests in preclinical and translational pharmaceutical efficacy/safety assessment, toxicologic endocrinology and cardiology, oncology, pharmacodynamic modeling, target identification and validation, early-stage compound selection, IMPD/IND documentation and FDA, EMA and PMDA submission/interaction.
Kevin McDorman, DVM, PhD, DACVP
Kevin joined Charles River in 2008 as the Director of Pathology for the Reno, Nevada facility and is currently the Executive Director of Global Pathology and Charles River Pathology Associates (PAI) headquartered in Frederick, Maryland, USA. Prior to joining Charles River, Kevin spent four years as a Veterinary Pathologist at Amgen and two years as a Scientist/Pathologist at Genentech where he held various positions in both research and development sciences. While at Amgen and Genentech, Kevin was active in drug development team activities and contributed to several journal publications, scientific presentations and regulatory submissions. Kevin is a veterinarian (DVM), has specialty training in Anatomic and Toxicologic Pathology, and earned an advanced degree in Toxicology (PhD) at the University of North Carolina at Chapel Hill, where he studied chemical carcinogenesis with the Environmental Carcinogenesis Division of the United States Environmental Protection Agency. He has been a Diplomate of the American College of Veterinary Pathologists (ACVP) since 1999. He is active in allied professional societies and has served as chair and/or member on numerous committees, working groups, and scientific sessions for the ACVP and the Society of Toxicologic Pathology (STP).
Vasanthi Mowat, BVSc, MVSc, MRCVS, FRCPath
Vasanthi Mowat is Director of Pathology at Huntingdon Life Sciences, where she manages the Histology, Necropsy, Pathology and Special Pathology Services Units. She has 24 years experience as a pathologist and has worked at CROs in Britain and France. She joined Huntingdon Life Sciences in April 2006 and was appointed as Director of Pathology in February 2008. She is a member of the INHAND Cardiovascular working Group of the Society of Toxicological Pathologists. She graduated as a vet in India, where she also gained a Master’s degree in Veterinary Pathology. After moving to the UK she passed the statutory exams of the Royal College of Veterinary Surgeons and subsequently the Royal College of Pathologists to gain the MRCVS and MRCPath qualifications respectively. She was awarded the FRCPath in 2004. She has co-authored publications and posters and presented talks on procedural and background findings in a variety of species. She has published several papers on induced and background lesions, and co-authored a book on toxicological pathology.
Marlon Rebelatto, DVM, PhD, DACVP
Dr. Rebelatto received his Doctor of Veterinary Medicine degree from the Federal University of Santa Maria, Brazil. He received a Master’s Degree in Epidemiology and Public Health and a PhD in Immunology from Purdue University, USA. He did a residency in Veterinary Pathology at Purdue University and became a Diplomate of the American College of Veterinary Pathology in 2002. Dr. Rebelatto worked for 7 years at MPI Research (a Contract Research Organization), as a Principal Pathologist evaluating pathology in toxicity studies, including studies in rats, mice, dogs, monkeys, and pigs, with a variety of small and large molecules as well as medical devices. At MPI Research, he also served as the Director of Immunotoxicology, developing and validating the methods to assess the immunotoxicity of compounds, and interpreting the results from the immunotoxicity and pathology assessment of the immune system. In 2009, Dr. Rebelatto joined MedImmune (a Member of the AstraZeneca group), where he participates in many aspects of drug development, including target identification and validation, animal model development, efficacy study read-out, immunohistochemical-based assays, cell-based assays, preclinical and clinical trial biomarker development, evaluation (as study or peer review pathologist) of toxicity studies and tissue cross-reactivity studies, companion diagnostic development, and regulatory submissions.
Kenneth Schafer, DVM, PhD, DACVP, FIATP
Ken Schafer received his DVM in 1991 and his PhD in Veterinary Pathobiology in 1998, both from Purdue University. The thesis work for his PhD was performed at Lovelace Respiratory Research Institute in Albuquerque, NM. Ken has been engaged in toxicologic pathology for 17 years at Wyeth Research, Lilly Research Laboratories, and Vet Path Services. Ken is the past Secretary/Treasurer of the STP and recently took on the role of the STP President starting in June of 2015. Ken also served as chair of the STP’s Scientific and Regulatory Policy Committee. Ken has an interest in ocular and otic pathology and has co-authored four book chapters on these topics.