Barbara von Beust, Dr. med. vet., PhD, DACVP, ECVCP
Dr. von Beust is a Swiss veterinarian who is board certified in veterinary clinical pathology and specialized in laboratory medicine. She received her PhD from Washington State University in veterinary cell-mediated immunology research (with a strong emphasis on molecular biology techniques). She is an experienced laboratory manager with a profound understanding of Good Laboratory Practice guidelines (as required by regulatory agencies) and their implementation in a real life setting. Based on her insights gained from planning, directing and monitoring numerous preclinical safety studies, she pursues high professional standards in clinical laboratory data analysis, interpretation and reporting. She has authored and peer reviewed numerous clinical pathology reports and assisted in the audits of clinical pathology laboratories in several leading European CRO’s.
Dr. von Beust is an expert in hematology and bone marrow data analysis, the interpretation of acute phase response parameters, and the scientific evaluation of cell-mediated specific immune responses (including cytokine profiles). As an invited guest lecturer at the university of Berne she had a chance to communicate and teach her comprehensive knowledge of the hemo- and lymphopoetic system. As one of the very few European veterinary clinical pathologists with significant experience in the pharmaceutical industry she is an active member of the regulatory affairs committee of the American Society of Veterinary Clinical Pathology. This allows her to maintain and further develop a strong professional network with her North American peers. Regular contacts and co-authorship of Best Practices publications allow her to be at the cutting edge of new developments in the global field of clinical pathology in preclinical safety and drug development.
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Brad Bolon, DVM, MS, PhD, DACVP, DABT, FATS, FIATP
Dr. Bolon is an experienced pathologist (toxicologic neuropathology) with special interest in genetically engineered and developing animals. He has written or co-authored over 200 articles and book chapters, has edited or co-edited 4 books, and is a frequent invited speaker at national and international meetings on mouse pathology.
Dr. Bolon has B.S., D.V.M. and M.S. degrees from the University of Missouri, “enjoyed” an anatomic pathology residency (1986-1989) at the University of Florida, and obtained a Ph.D. (1993) from Duke University while completing postdoctoral training at the Chemical Industry Institute of Toxicology. He was employed by Pathology Associates International as associate director of the Molecular and Immunopathology Division (1993-1994) and later as staff pathologist at the National Center for Toxicological Research (1994-1996) before moving to Wyeth-Ayerst Research (1996-1997) as a senior scientist.
Dr. Bolon served as an experimental pathologist at Amgen (1997 to 2004) responsible for evaluating engineered rodents and the efficacy of novel biopharmaceuticals. He subsequently founded an experimental pathology consulting practice (GEMpath, for “Genetically Engineered Mouse Pathology”), working there from 2004 to 2011. Dr. Bolon worked for a time as an associate professor at The Ohio State University College of Veterinary Medicine (2011-2015), after which he returned to re-launch GEMpath (2015 to date). Dr. Bolon is a Diplomate of both the American College of Veterinary Pathologists (ACVP, anatomic pathology; 1991) and American Board of Toxicology (ABT; 1996, re-certified 2001, 2006, 2011, 2016) and is a Fellow of both the Academy of Toxicological Sciences (ATS; 2011) and the International Academy of Toxicologic Pathology (IATP; 2007).
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Maurice Cary, DVM, PhD, DACVP
Expert in regulatory nonclinical anatomic histopathology, drug safety assessment and outsourcing
Dr. Cary is a recognized expert in histopathology with a +30 year track record in preclinical development and safety assessment of pharmaceuticals/ biopharmaceuticals and medical devices, as well as +15 years of business and consulting experience. Dr. Cary has handled implementation of nonclinical programs, including problem solving/development issues, Expert Report preparation, regulatory documentation preparation for numerous projects (100s of studies) performed in Europe, USA and Asia involving biologics or NCEs. Somewhat unusual for a pathologist, he is also experienced in outsourcing as he was Head of Outsourcing (toxicology) in Europe for Novartis (Switzerland). This has led to his special interest in optimizing the performance and reporting of preclinical safety/risk assessment studies. Dr. Cary is the author of the chapter, “Contract Research Organizations” in the book, “Pharmaceutical Toxicology in Practice: A Guide for Non-Clinical Development” (John Wiley & Sons, Inc.).
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Johan Forsell, PhD, MSc
Dr. Forsell is a Swedish senior research scientist with more than 10 years of experience in nonclinical drug safety development in therapeutic areas such as diabetes, haemophilia, inflammation and cancer. His knowledge and solid foundation in toxicologic pathology and histology combined with special emphasis in investigative studies gives him a unique skill set valuable to both discovery and non-clinical activities. Specifically, his key expertise includes development of therapeutic antibodies, tissue cross reactivity and biodistribution studies, immunohistochemistry and in situ hybridization techniques, and local tolerance studies. Dr. Forsell has functioned as study director/monitor and project pathologist on numerous non-clinical studies/projects, including managing the design, conduct and interpretation of state-of-the-art GLP studies, as well as preparing reports and documentation for European and American authorities. His experience includes working on inter-disciplinary teams with researchers and contract research organizations in Europe and the USA. Dr. Forsell has also skillfully supervised and trained laboratory staff/students in histology, pathology related techniques and various microscope techniques.
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Monique Wells, VMD, MS, DACVP, DECVP, DABT, Eurotox-registered toxicologist
Dr. Wells has worked for the chemical (Chevron), pharmaceutical (Rhône-Poulenc Rorer; currently Sanofi-Aventis) and cosmetics (L’Oréal) industries in the U.S. and in France prior to entering consulting in 2002. She has extensive experience in preparing expert reports and regulatory documentation for companies in North America, Europe and Asia. Her most recent first-author journal publications feature the investigation of vascular lesions of the skin in subcutaneous toxicity studies performed in rats. Dr. Wells is the author of the chapter, ”Data Analysis, Report Writing and Regulatory Documentation” in Pharmaceutical Toxicology in Practice: A Guide for Non-Clinical Development (John Wiley & Sons, Inc, 2011).
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