= Members Only
Practical Application of Toxicology in Drug Development Speakers
Following completion of a PhD at UCL in 2001, Dr. Chambers undertook a Postdoctoral Position at Columbia University, New York, where she worked to elucidate the pharmaco-toxicological profile of galectin-3 and paclitaxel in the treatment of Polycystic Kidney Disease (PKD). Following three years in she joined the MHRA where she now holds the post of Senior Non-clinical Assessor. During Dr. Chamber’s eight years as an Assessor she assessed > 500 applications in line with ICH/ CHMP/OECD scientific guidelines. These assessments have encompassed toxicology studies supporting numerous therapeutic areas for drugs administered via all routes of administration all of which must be critically analysed to determine relevance to the clinical situation. In this role, she has also developed a working knowledge of environmental toxicology and the nonclinical requirements to support clinical trials, requiring specific understanding of how the current regulations apply to each specific product.
Gary J. Chellman, PhD, DABT
Gary earned his PhD in toxicology from the University of Rochester in 1984, followed by postdoctoral training at the Chemical Industry Institute of Toxicology. Over the next 20+ years Gary has worked in pharmaceutical toxicology, with specialty in reproductive toxicology. From 1986–1996, he was employed by Syntex Pharmaceuticals where he advanced to Department Head of Reproductive Toxicology. For the next three years, he was Director of Toxicology at Sanofi Pharmaceuticals. Gary joined Sierra Biomedical (now Charles River Laboratories) in 1999, as Vice President of Toxicology. Since 2003, he has been the Program Director for Developmental and Reproductive Toxicology, specializing in the design, conduct and interpretation of nonhuman primate reproductive toxicology studies. Gary is a diplomat of the American Board of Toxicology and a member of the Society of Toxicology, the American College of Toxicology, and the Teratology Society. He has authored/co-authored numerous publications in reproductive toxicology, most recently related to optimizing these studies in nonhuman primates to support biopharmaceutical drug development.
John obtained his first degree in Zoology from the University of Wales in 1975 before undertaking research, on liver pathology, for which he was awarded a PhD in 1978. He then joined the British Industrial Biological Research Association (BIBRA), at Carshalton in the UK, as an experimental pathologist and head of the electron microscopy unit. He left BIBRA in 1983 to join the Pathology Department of ICI Central Toxicology Laboratory in Cheshire, United Kingdom. He obtained a diploma of the Royal College of Pathologists (RCPath) in Toxicology in 1987 and passed the examination to become a member of the RCPath in 1988, and was elected a Fellow in 1997. He was chairman of the Specialty Advisory Committee for Toxicology for the RCPath from 2002–2005, and was Chair of the Panel of Examiners for the Toxicology Specialty of the RCPath from 2006–2012 and he remains an examiner for the College.
He was a science–reviewing member of ECETOC’s LRI on Carcinogenicity from 2000–2006 and he sat on the UK Food Standard Agency’s Committee on Toxicity from 2006–2012. He was President of the British Society of Toxicological Pathologists from 2002–2004 and was appointed an Honorary Fellow of the British Society of Toxicology in 2008. He was a visiting lecturer, and then made an Emeritus Professor in the Faculty of Faculty of Health and Medical Sciences at the University of Surrey in 2010 and was elected as an Honorary Fellow of the BSTP in the same year. In 2011 he was made an Honorary Fellow of the Latin American Society of Toxicologic Pathologists and became a Fellow of the International Academy of Toxicologic Pathology in September 2012.
Prof Foster has published over 150 research papers, review articles, and book chapters in toxicological pathology, and was the Editor-in-Chief of the journal, Toxicologic Pathology, from 2008–2013. Following 20 years working on the development of agrochemicals and industrial chemicals, at ICI, Zeneca and finally Syngenta’s Central Toxicology Laboratory, he joined AstraZeneca Pharmaceuticals in 2001 specializing in the development of oncology targeting drugs. He retired in 2013 as a Senior Principal Pathologist and Deputy Director of Pathology. He has recently been elected as Vice President of the International Academy of Toxicologic Pathology and is currently an independent consultant pathologist working for Regulatory Science Associates and for himself in an independent consultancy company called ToxPath Sciences Ltd.
Ernie Harpur, PhD
Following periods of doctoral and postdoctoral research in toxicology, Ernie spent 13 years engaged in teaching and research in academia where his research interests centered on investigations of mechanisms of toxicity and the relationship between pharmacokinetics and toxicity. Ernie subsequently gained 21 years of operational and managerial experience in nonclinical safety evaluation within pharmaceutical industry based in Europe and the USA. He transitioned from Head of General and Investigative Toxicology, through Senior Director of Toxicology and Scientific Director of a development site to Global Head of Scientific Affairs and Regulatory Standards within Drug Safety Assessment in Sanofi-Aventis. Since leaving industry in 2010, Ernie has held an honorary position in the Institute of Cellular Medicine at Newcastle University UK and engaged in various scientific advisory roles. He has served as Scientific Meetings Secretary of the British Toxicology Society (BTS) and has also contributed to EUROTOX as President and Chair of several committees. He is a Fellow of the BTS, a Fellow of the RSB, a Fellow of the Academy of Toxicological Sciences, and an honorary member of EUROTOX. He has served on several expert committees, including the Safety, Efficacy and Adverse Reactions Committee of the UK Committee on Safety of Medicines. He has had leadership roles in a number of scientific consortia on both sides of the Atlantic serving as Chair of the Washington, DC based ILSI Health and Environmental Sciences Institute (HESI) Renal Biomarkers Committee (now Scientific Advisor to this committee) and Vice Chair of the ILSI HESI Emerging Issues Committee, as a member of the Advisory Committee of the Predictive Safety Testing Consortium of the Critical Path Institute and as Chair of the Scientific Advisory Board of the UK public private partnership, Stem Cells for Safer Medicines. Currently, he is President of the BTS and Vice Chair of the Board of Trustees and Executive Committee of ILSI HESI. He has published more than 90 journal articles, reviews, and book chapters and is a member of the editorial boards of several toxicology journals.
Kenneth L. Hastings, DrPH, DABT, ATS
Dr. Hastings joined the US Food and Drug Administration (FDA) in 1991 as a pharmacology/toxicology reviewer in the Division of Antiviral Drug Products, where he was involved in review and approval of several drugs for the treatment of HIV/AIDS. In 1997, Dr. Hastings was appointed Pharmacology/Toxicology Supervisor in the Division of Special Pathogen and Immunologic Drug Products, where he was involved in review of several marketing applications for drugs to treat tuberculosis, malaria, serious bacterial and fungal diseases, and for use in transplant medicine. In 2003, Dr. Hastings was appointed Associate Director for Pharmacology and Toxicology in the Office of New Drugs. In this position, he served as tertiary reviewer for various review divisions. Dr. Hastings served on many committees and working groups while in government service, including several guidance committees (immunotoxicology, safe start dose, nonclinical studies for pediatric clinical trials, phototoxicity, metabolites in safety testing, biologic counterterrorism, and phospholipidosis). Dr. Hastings was lead CDER representative for the ICCVAM validation of the murine local lymph node assay, acting director of the International Regulatory Issues Staff in the Office of Regulatory Affairs, acting FDA safety coordinator for ICH, and lead FDA negotiator for ICH S8.
He has served in several professional societies, including the American Board of Toxicology (Past President), the American College of Toxicology (Past President), the Society of Toxicology (Past President of the Immunotoxicology Specialty Section), board member of the Biotechnology Industry Organization BioSafe Leadership Team, and past Co-Chair of the Nonclinical Special Interest Community of the Drug Information Association. Dr. Hastings is a Fellow in the Academy of Toxicological Sciences. Dr. Hastings received his Doctor of Public Health degree from the University of North Carolina, School of Public Health in 1987, where he completed his doctoral research at the Chemical Industry Institute of Toxicology.
Dr. Hastings served as a Peace Corps volunteer in Fiji, where he was a special assistant to the Permanent Secretary for Health. Following this, he completed a postdoctoral fellowship and was then appointed Research Associate in the Pharmacology/Toxicology Research Laboratory, Department of Anesthesiology, University of Arizona prior to his position at FDA/CDER.
From 2007 to 2014, Dr. Hastings was Associate Vice President for Regulatory Policy, Sanofi. His responsibilities included serving as in-house advisor to corporate management on drug development regulatory policy, primarily concerning USFDA and ICH. He served as corporate liaison with numerous scientific and industrial groups, including PhRMA and BioSafe. Dr. Hastings is currently an independent consultant.
A. Wallace Hayes, PhD, DABT, FATS, FIBiol, FACFE, ERT
Dr. Hayes is a toxicologist with over 35 years of experience in industry and academics. He holds degrees from Auburn University (PhD and MS) and Emory University (AB). Dr. Hayes was a NSF predoctoral fellow at Auburn University, a NIH individual postdoctoral fellow at the Vanderbilt University School of Medicine, a NATO Senior Scientist at the Central Veterinary Laboratory in Weybridge, England and held a NIH Research Career Development Award. Dr. Hayes has held tenured Professorships at the University of Alabama, the University of Mississippi Medical Center and Wake Forest University School of Medicine. Dr. Hayes has served on committees and expert panels for the National Academy of Sciences, the National Institutes of Health, the Environmental Protection Agency and the Department of Defense. Dr. Hayes has served on a number of GRAS Expert Panels. He currently serves on the US FDA Food Advisory Committee. Dr. Hayes has authored more than 230 peer reviewed publications, is the editor of Hayes’ Principles and Methods of Toxicology, 6th edition, Human and Experimental Toxicology, Cutaneous and Ocular Toxicology; and co-editor of the Target Organ Toxicity Series. Dr. Hayes is the Editor-in-Chief, Food and Chemical Toxicology. Dr. Hayes is a past Secretary-General of IUTOX (two terms), past treasurer and board member of the American Board of Toxicology, a past president of the American College of Toxicology, the Toxicology Education Foundation, and the Academy of Toxicological Sciences and a past member of the council of the Society of Toxicology. Dr. Hayes is a diplomate of the American Board of Toxicology, the Academy of Toxicological Sciences, the American Board of Forensic Medicine, and the American Board of Forensic Examiners. He is a Fellow of the Academy of Toxicological Sciences, the Institute of Biology (UK), the American College of Forensic Examiners and the American College of Nutrition. Dr. Hayes is a registered toxicologist in the European Union (ERT) and a certified nutrition specialist (food safety). Dr. Hayes was honored by the Society of Toxicology in 2006 with the Society’s Merit Award, by the Mid-Atlantic Society of Toxicology with its Ambassador Award in 2012, by the American College of Toxicology in 2012 with its Distinguished Scientist Award and by the International Dose-Response Society in 2013 with its Outstanding Leadership Award. Dr. Hayes was named a Distinguished Fellow by the American College of Toxicology in 2013.
Matthew Jacobsen, Bsc, Msc, VetMB, MRCVS DipACVP
Matt studied Marine Biology and Parasitology at the University of Wales in Bangor UKb in the early 1980s, obtaining Bsc and Msc degrees. He was employed abstracting journals at the Commonwealth Agricultural Bureau International, before returning to university to study Veterinary Medicine at Cambridge (Ba medical Sciences Tripos and VetMB). Following a period as a veterinarian in small animal practice, he undertook an anatomic pathology residency at Cornell University in the USA, obtaining board certification with the American College of Veterinary Pathologists in 2000. Matt returned to the UK and was a senior and then Chief pathologist at Syngenta’s Central Toxicology Laboratory where he supported a wide range of regulatory toxicology and investigative toxicology studies for Syngenta agrochemicals, with the lab also acting as a CRO for pharma. He took a particular interest in neurotoxicity and developmental neurotoxicity studies. Matt then joined the Safety Assessment Department of AstraZeneca at Alderley Park as a senior pathologist, supporting oncology, infection and respiratory and Inflammation (RIA) therapy areas. He was then appointed Director of the clinical pathology and biomarker group in the UK which provided support for routine preclinical toxicology studies, as well as Phase I clinical trials in man. Having managed the biomarker group at AstraZeneca for a number of years, Matt remained at AZ, where he was interim Global Head of Pathology, Head of European Pathology, and is currently Director and lead of Regulatory Toxicological Pathology. Throughout this period he remained an active project pathologist, with an emphasis on antimicrobials, Oncology and RIA.
George Johnson, PhD
Dr. George Johnson is an Associate Professor in the Institute of Life Science at Swansea University, UK. George obtained his PhD degree in Swansea 2006, under supervision of Professor Jim Parry, and since then has developed a great interest in the statistical approaches and underlying mechanisms that support points of departure (PoD) for genetic toxicity. This expertise has lead George to being a Steering Member of the International Life Science Institute—Health and Environmental Science Institute (ILSI-HESI) Genetic Toxicology Technical Committee (GTTC), as well as being co-Chair of the GTTC ‘Quantitative Workgroup’. His work includes improving the quantitative use of genetic toxicity data for human-health risk-assessment (Johnson et al., 2014, EMM), and he links this to his great interest in replacing, reducing and refining (3Rs) the use of animals in research.
His current projects include a joint GTTC, RIVM, Swansea, Health Canada collaboration that is funded through Health Canada’s chemical management programme (Prof. Paul White as PI) as well as collaborations on the effect of background mutation frequencies on PoDs with US-FDA-NCTR (Cao et al., 2014, EMM); assessing genetic toxicity profiles of drug candidates with the Drugs for Neglected Disease Initiative; in vitro to in vivo correlations with the National Institute for Public Health and the Environment (RIMV, Netherlands) and Astra Zeneca; the International Workshop on Genetic Toxicology Quantitative Workgroup 2013; developing and testing high-throughput high-content flow cytometry based genetic toxicology assays with GSK, Gentronix, Litron, and Hoffman-La-Roche; developing a multiplex in vitro system for detection of carcinogens with the National Centre for 3Rs of animal testing (NC3R) and GE Healthcare; along with being involved in numerous projects with the DNA Damage group in Swansea University, and recently initiating his own group on Quantitative Genetic Toxicology.
George has experience in teaching Genetic Toxicology at BSc, MSc, PhD and CPD levels, and he has also run workshops on this topic at international conferences, along with running one on the assessment of genetic toxicity data sets at the European Chemicals Agency (ECHA). Recent accolades include becoming a Fellow of the Higher Education Academy (FHEA), a British Registered Toxicologist (BRT) and he won the European Environmental Mutagen Society (EEMS) Young Scientist Award 2014.
David Jones, Bsc, Msc, EurBiol, CBiol, MRSB, MTOPRA, European Registered Toxicologist
After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London, whom I joined in 1996. My current role principally involves assessing nonclinical data for Clinical Trial Applications, both non-biological and biological. A further aspect of my job is to offer regulatory advice to companies on behalf of the MHRA or the EU’s Committee for Human Medicinal Products (CHMP). I am one of the UK’s accredited nonclinical experts to support the CHMP and am the UK representative on the EU’s Safety Working Party (SWP). I represented the EU in the ICH revision of the M3 Guideline and on the new ICH S10 Guideline. I am now EU Rapporteur on the new ICH S11 (Juvenile Animal Studies) guideline and the Q&A document for ICH S3 (Toxicokinetics). I work closely with the NC3Rs and represent the MHRA on a Governmental body dealing with animal welfare. I am also a guest lecturer at the University of Surrey, the University of Wales, and the University of Leicester and a frequent presenter at conferences around the world.
Gerry Kenna, PhD, FBTS
Dr. Kenna is Pharmaceutical Director of the Safer Medicines Trust, which is an independent UK charity. In this role, he is focused on developing and gaining regulatory acceptance of human biology-based methods that can improve human safety assessment of drugs and other chemicals. Currently he is also a member of the TRISTAN consortium, which is funded via the EU Innovative Medicines Initiative’s Horizon 2020 program and will validate translational imaging methods for use in drug safety assessment; and a member of the Board of Trustees of the Evidence Based Toxicology Collaboration www.ebtox.org. In addition, he is an independent Drug Safety Consultant who advises clients in pharmaceutical and biotech companies on how best to select and develop efficacious and safe new drugs, and to validate new predictive safety methods and strategies. Previously, he held scientific leadership roles as a toxicologist in the pharmaceutical and agrochemical industries (at AstraZeneca, Syngenta and Zeneca). These were preceded by academic faculty positions (at Imperial College School of Medicine, London, UK; National Institutes of Health, MD USA; King’s College Hospital Medical School, London, UK and the National Institute for Medical Research, London, UK), in which he led research teams that explored mechanisms underlying human adverse drug reactions. He has authored or co-authored >100 peer reviewed scientific publications, is a member of the International Society for the Study of Xenobiotics and a Fellow of the British Toxicology Society. He received a BSc Hons in Biochemistry from the University of Leeds UK and a PhD in Biochemistry from the University of London, UK.
Ian Kimber, University of Manchester
Dr. Ian Kimber is currently Professor of Toxicology in the Faculty of Biology, Medicine and Health at the University of Manchester. He also served as Associate Dean for Business Development from 2009–2016. He has previously held academic positions in cancer biology and immunology, and senior positions in a number of companies (ICI, Zeneca, AstraZeneca and Syngenta). He has broad research interests at the interface between toxicology and immunology, with a particular focus on immunotoxicity, allergy and inflammation. He also has interests in skin biology and toxicology, risk assessment, hazard characterisation, Adverse Outcome Pathways, and the development of alternative approaches to safety assessment.
Professor Kimber holds, and has held, a variety of positions on national and international expert and scientific advisory committees. Currently these include the following: Member UK Medicines and Healthcare products Regulatory Agency (MHRA) Devices Expert Advisory Committee, Programme Advisor Food Standards Agency Food Allergy and Intolerance Research Programme, member Scientific Advisory Board National Institute for Biological Standards and Control, member MRC Translational Research Group, and Council member Laboratory Animal Science Association. Professor Kimber was previously: Deputy Chair of the MRC Physiological Medicine and Infection Board (2001-2003), President of the British Toxicology Society (2012–2014), and Chairman of the Board of the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) (2008–2013).
Vasanthi Mowat is EU Director of Pathology at Envigo. She joined Envigo in April 2006 and was appointed as Director of Pathology in February 2008. She has over 25 years’ experience as a toxicological pathologist and has worked at CROs in Britain and France.
She graduated as a vet in Bangalore, India, where she also gained a Master’s degree in Veterinary Pathology. She was awarded the FRCPath in 2004. She has published and presented on procedural and background findings in a variety of species and study types at international meetings and conferences.
Nigel Roome, MSc, PhD
Dr. Nigel Roome has worked in the Pharmaceutical Industry for more than the last 30 years and currently is an independent expert in Toxicology and Toxicologic Pathology working with a variety of pharmaceutical companies, Non-Governmental Organizations (NGOs) and consulting firms on scientific problem solving, dossier preparation, due diligences and interactions with regulatory agencies. He is also involved in teaching on several European and International programs. He is based in Versailles, France.
After his initial BSc degree in Physiology and MSc degree in Experimental Pathology and Toxicology, he completed his PhD in Experimental Pathology at the University of London. After Postdoctoral experience at the University of Marburg, he joined Synthelabo in 1984 as a Toxicological Pathologist with a specialty in Electron Microscopy. Since then he has held a variety of positions within the companies which now constitute Sanofi (including Head of Pathology, Head of Scientific Projects for Drug Safety and Global Scientific Coordination for the Safety Aspects of Development Projects). Most recently, he held a position within Sanofi R&D as a Global Scientific Advisor with responsibility for the overview of the scientific content and conformity of Regulatory Submissions and responses to questions from Agencies on safety issues and risk assessment as well as a role for evaluation of drug safety aspects of external opportunities and collaborations with both Governmental and Academic Institutions.
Per Sjöberg, PhD
Per Sjöberg has a PhD in Pharmaceutical Sciences (Toxicology) from the Swedish University of Agricultural Sciences in Uppsala. The list of publications include more than 20 original papers relating mainly to testicular toxicity and drug disposition and the use of the microdialysis technique for characterization of the disposition of unbound drug in the circulation and in body tissues.
Per started his professional career in 1978 with the WHO Collaborating Centre for International Drug Monitoring in Uppsala and followed that with various positions at the former Department of Drugs, National Board of Health and Welfare, also in Uppsala, between 1980 and 1990.
After working nine months as a preclinical reviewer at the Therapeutic Goods Administration of the Department of Community Services and Health, Canberra, Australia he became the Head of Pharmacology and Toxicology at Medical Products Agency in Uppsala. He was a member of the management group of the agency from 1990 until January 2000 and from 1994 until January 2000 he headed the Scientific Quality Review Group within the agency.
Per was a member of the Committee of Proproprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) and Chairman of its Safety Working Party (SWP) between 1995 and 2000. During this time he was involved in a number of ICH safety topics and acted as rapporteur for the ICH multidisciplinary M3 Guidance and as rapporteur for more than 20 EU Marketing Authorization Applications.
After leaving the Medical Products Agency in 2000, Per and two colleagues set up EUREDA KB—European Regulatory and Drug Development Services—a consultancy firm with its core business in nonclinical and clinical development with location in Uppsala.
Andy Spencer, BVMS, MRCVS, PhD, FRCPath, DipECVP
Dr. Andy Spencer has 40 years experience as a veterinary pathologist, 37 of which have been spent as a toxicological pathologist in Pharmaceutical Companies or Contract Research Organisations (CROs).
After graduating as a veterinarian from Glasgow Veterinary School he completed a PhD in the same school in glomerular changes in renal diseases of dogs. From 1978–1983 he worked in a UK CRO (Inveresk—Now Charles River) before moving to Pfizer’s Centre de Recherche in Amboise, France. In 1985 he moved back to UK to head up anatomical pathology section of the Sterling Winthrop Research Centre where he developed immunohistochemistry and electron microscopy and well as routine histopathology services and expertise. In addition to regulatory toxicology studies, significant time was spent on investigative programmes. For 25 years the centre was a part of global drug safety research for a succession of pharmaceutical companies (Sterling Winthrop, Sanofi, Sanofi-synthelabo, Sanofi-aventis) before being sold to a CRO (Covance) in 2010. Until 2009, Andy was head of pathology while for the following 5 years he headed up the Molecular and Cellular Toxicology group. At the beginning of this year, Andy became an independent consultant in toxicological pathology.
For over 15 years Andy served on numerous global drug development teams within Sanofi companies as the representative of Toxicology. At Covance he acted as an external pathology consultant to a large global pharmaceutical company for the preclinical development of a novel treatment for Alzheimer’s disease. For 30 years at the Alnwick site he was also Named Veterinary Surgeon under the Animals in Scientific Procedures Act.
Andy has been an active member of the British Society of Toxicological Pathologists since its inception, serving as treasurer for 12 years. In addition, he was an examiner for the Royal College of Pathologists in laboratory animal pathology for 20 years and has more than 30 scientific publications, including being co-author on the recent INHAND monograph on the histopathology of the gastrointestinal tract, salivary glands and pancreas in rats and mice.
Robert Wallis, Bsc, PhD
Rob is currently working as an independent Safety Pharmacology Consultant having worked for over 30 years in the pharmaceutical industry. Rob trained as a pharmacologist and led a number of drug discovery projects at Pfizer. Later in his career he joined the drug safety organization to lead the Global Safety Pharmacology group where he was responsible for the implementation of ICH S7A and S7B guidance. Rob has a world reputation in the area of drug-induced QT prolongation/nonclinical cardiovascular safety and invited to present at numerous scientific conferences, member of the ICH E14 Q&A Technical Group. Presented to the FDA on nonclinical assays to detect drug-induced QT prolongation. He managed the development and implementation the Pfizer nonclinical testing strategy for detecting abuse potential liability. He also Co-chaired the Pfizer Cardiovascular Safety Advisory Council responsible for advising project teams on CV safety issues from early discovery to post-marketing. He is a former member of the Board of Directors of the Safety Pharmacology Society and is an active member of the society. Latterly Rob was a member of the Cardiovascular Research Consortium and co-author of white paper ‘Strategies to Replace the Clinical Thorough QT study’.
Rob’s consultancy work is primarily focussed on developing risk management strategies for findings observed in safety pharmacology studies.
Malcolm J. York, PhD
Malcolm York is the Director of UK Clinical Pathology at GlaxoSmithKline R&D. The unit provides expert evaluations in Clinical Chemistry, Haematology, Urinalysis and protein biomarker measurements, supporting primarily preclinical investigative and regulatory studies.
He is a member of the Association of Clinical Biochemists, a Fellow of the Institute of Biomedical Sciences and also a Diplomate of the Royal College of Pathologists. Additionally he is a member of the UK Association for Comparative Clinical Pathology and has held Secretary and Training Officer roles in the past. More recently he was the Co-Chair of the ILSI HESI Biomarker Subcommittee Troponins Working Group. He has co-authored a number of publications with colleagues from the pharmaceutical industry and academia, in the areas of biomarker assessment of cardiac, renal and hepatic toxicities. Additionally he has just provided an updated chapter on Clinical Pathology for publication in the second edition of ‘A Comprehensive Guide to Toxicology in Nonclinical Drug Development’ ed A. Faqi in October 2016.