= Members Only
Practical Application of Toxicology in Drug Development Speakers
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.
Ernie Harpur, PhD
Following periods of doctoral and post-doctoral 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 non-clinical 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 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 UK 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 non-clinical 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. Gerry Kenna is a drug safety safety consultant. He advises clients on how best to undertake the selection and development of drugs that have the least possible propensity to cause human adverse reactions. Gerry has particular expertise in drug induced liver injury. He is actively involved in several programs of research on the multiple contributory mechanisms by which this may arise (especially the roles played by metabolic bioactivation, biliary transporter inhibition and adaptive immune responses), on identification and use of improved safety biomarkers and on the development of physiologically based mathematical modelling of multiple data types which enhance human risk assessment. Previously, Gerry held leadership roles as a molecular toxicologist and preclinical Hepatic Target Organ Strategy Leader in AstraZeneca. Prior to this, he supported safety assessment and registration of agrochemicals in the Zeneca/Syngenta Central Toxicology Laboratory UK. Before joining industry, Gerry founded and led a research group which investigated the role played by metabolic bioactivation and adaptive immune responses in human adverse drug reactions at St. Mary’s Hospital Medical School, London UK, where he was a Senior Lecturer in Pharmacology. This was preceded by research positions at the Laboratory of Chemical Pharmacology, National Institutes of Health USA and the Liver Unit, King’s College Hospital, London UK. Dr. Kenna received a BSc in Biochemistry from the University of Leeds UK and a PhD in Biochemistry from the University of London UK. He has authored or co-authored >100 scientific publications and book chapters, is a Fellow of the British Toxicology Society and is a Committee member of the International Society for the Study of Xenobiotics.
Marc Pallardy, PharmD, PhD
Marc Pallardy, Pharm D 1982, PhD in Toxicology 1997 (University Paris-Sud), postdoctoral fellow 1987–1988 (Chemical Industry Institute of Toxicology, Dr Jack Dean), assistant professor 1988 (Department of Toxicology, Faculty of Pharmacy, University Paris-Sud). In 1997, Marc Pallardy was hired as a full professor and head of the Department of Toxicology (Faculty of Pharmacy, University of Paris-Sud).
He has been elected Dean of the Faculty of Pharmacy, University Paris-Sud (3500 students, 300 academic and research staff, 150 technicians and engineers, 60 administrative staff) in July 2015. Before, he was Vice-Dean and research director of the Faculty of Pharmacy (2000 to 2015) and director of the “Ecole doctorale” (PhD program) “Therapeutic innovation” (University Paris-Sud, 2006 to 2015). Since 2004: Director, master program “Toxicology and pharmacovigilance”, University Paris-Sud (25 students/year).
Pr Pallardy headed the INSERM laboratory UMR-S 996 “Cytokines, chemokines and immunopathology” from 2011 to 2015 (60 permanent and non-permanent personnel, 4 teams). Marc Pallardy is coordinating the IMI (Innovative Medecine Initiative) project ABIRISK (Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the Risk, 39 partners from academia and industry).
Marc Pallardy has been a member of the committee for marketing authorization of medicinal products (French agency for medicinal products), chairman of the preclinical working party (French agency for medicinal products), co-chairman of the gene therapy working party (French agency for medicinal products), and member of the clinical trials authorization and cellular therapy working party (French agency for medicinal products). He has been also a member of the safety working party at EMA.
Concerning its research activity, Marc Pallardy has 110 publications in international and national journals (104 indexed in Med-line), 47 Invited International conferences since 1991, 43 Invited National conferences since 1990, 39 Invited Seminars (International and National) since 1988, 23 Oral Communications in meetings (International and National) since 1989. He received the “Bo Holmstedt memorial award” in 2012 from EUROTOX. Marc Pallardy is a current associate editor for Toxicological Sciences. He has been and he is the PhD advisor of 29 PhD students since 1990.
Since 1987 his research has been in the field of Immunotoxicology. He was first interested by the mechanism of immunosuppression provoked by PAHs and then by pharmaceutical drugs. The latter being tested and evaluated in vivo and in vivo using standard tests published by the NTP with the aim to compare these data with the one obtained with chemicals. However, mechanistic studies were also conducted in particular with glucocorticoids and addressing the mechanisms of apoptosis induced on T-cells by these molecules. In these past, research activities were and are focused on the mechanism of chemical and drug-induced allergy. Projects were developed to address the question if chemical sensitizers provoking contact allergy could be perceived as danger signals by dendritic cells. Indeed, the team was pioneer in describing dendritic cells phenotype modifications by these molecules and also elucidating what signalling pathways were involved. This activity is now focused on the role of the Nrf2 transcription factor in contact allergy using both in vitro and in vivo models (Nrf2 ko mice). For drug allergy, the question addressed these past years is to understand how patients are immunized by protein-drug complexes. Using penicillin derivatives covalently bound to human serum albumin (HSA) as a prototype, we were able to identify naïve T-cells specific for benzylpenicillin. Research is now ongoing to identify what are the peptides from HSA haptenized with penicillin that are presented to T-lymphocytes and are immunodominant in term of being responsible for patient immunization to the drug.
Nigel Roome, Bsc, MSc, PhD
Dr. Nigel Roome has worked in the Pharmaceutical Industry for the last 30 years and currently is an independent expert in Toxicology and Toxicologic Pathology working with a variety of pharmaceutical companies, Non-Governmental Oganizations (NGOs) and consulting firms. He is also involved in teaching on several European and International programs. He is based in Versailles, France.
After his initial B.Sc. degree in Physiology and M.Sc. degree in Experimental Pathology and Toxicology, he completed his Ph.D. in Experimental Pathology at the University of London. After Post-Doctoral experience at the University of Marburg, he joined Synthelabo in 1984 as a Toxicological Pathologist with a speciality 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.
Jennifer Sims, PhD
Dr. Sims is the President of Integrated Biologix GmbH, Basel, Switzerland, a pharmaceutical consulting company located in Basel, Switzerland. Integrated Biologix focuses on providing translational PK-PD, safety assessment and regulatory strategies and for biological products and emerging technologies at all stages of product development. Specific product areas of expertise include protein therapeutics (including peptides, proteins, monoclonal antibodies, antibody-related products, bispecific products and novel protein scaffolds), biosimilars, therapeutic vaccines, cell/tissue and gene therapies, and xenotransplantation.
Dr. Sims has more than 25 years experience in small molecule and biological drug development, with experience in both the Health Authority and Industry sectors, with a major focus on biological products.
Prior to founding Integrated Biologix GmbH, Dr Sims was Head of Translational Sciences and Safety for Novartis Biologics Unit, and built and led a global group of 100 associates responsible for toxicology, pathology, preclinical and clinical bioanalytics (PK-PD and Immunogenicity), and preclinical/clinical PK-PD aspects of biologics development from target validation to life cycle management. Previous industry positions include Head Project Safety Assessment group at Novartis, Head of Toxicology for Biopharmaceuticals (AstraZeneca/MedImmune). Prior to joining the pharmaceutical industry, Dr Sims served for 12 years as a senior preclinical assessor with the UK MHRA and was the UK delegate to the CHMP Safety Working Party from 1995–1999.
Dr. Sims was a member of the first ICH S6 Expert Working Group and was the Industry Rapporteur for the more recent revised guidance in ICH S6 R(1). She was also a member of the ICH S8 (Immunotoxicity) and ICH M4(S) Common Technical Document-Safety Expert Working Group. She has participated as member/chair of British and European Pharmaceutical Industry Association (ABPI, EFPIA) preclinical expert groups and is a current member of, and has acted as the Chair of BioSAfe, a focused expert science committee within BIO which identifies key scientific and regulatory issues and developments related to the preclinical safety evaluation of biopharmaceutical products. Dr. Sims chaired the preclinical working group of the ABPI/BIA Early Stage Clinical Trials task force set up following the Tegenero incident, and which was instrumental in highlighting translational approaches to safety assessment embodied by the MABEL approach.
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.
Ian Taylor, Bsc, DIBT, CBiol, MRSB
Ian Taylor is Associate Director, Pathology at Envigo CRS Ltd., Eye. Dr. Taylor has worked in Toxicological Pathology for thirty years, joining Life Science Research at Eye (now Envigo) in 1986. Ian has performed the role of study pathologist in over 400 studies of varying types and duration in all the commonly used laboratory species including 18 carcinogenicity studies. In recent years, Ian has also traveled to China to conduct histopathological investigation of regulatory safety testing studies for JOINN Laboratories. As Associate Director, Ian is responsible for the scientific output of pathologists within the Pathology department and the peer review of pathology reports. He also has responsibility for the education and training of pathologists within the department. Ian is actively involved in the internal training and education programme for Study Directors in toxicology, and occasionally lectures on Toxicological Pathology on the University of Surrey Modular Training Programme in Applied Toxicology. Ian has a particular interest in the factors contributing to variability in the reporting of histopathology data from studies performed for submission to regulatory authorities. Ian gained a BSc (Hons) in Biological Sciences from Edinburgh Napier University, in 1984. In 1993 he gained the postgraduate qualification the Diplomate of the Institute of Biology in Toxicology (DIBT). He is a member of the Royal Society of Biology (CBiol, MRSB); the Society of Toxicologic Pathology; European Society of Toxicological Pathology; and the British Society of Toxicological Pathology. Ian is currently Chair of the Education Sub-Committee of the BSTP.
Robert Wallis, Bsc, PhD
30 years experience in safety pharmacology, including implementation of ICH S7A and S7B strategies. 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 non-clinical assays to detect drug-induced QT prolongation. Managed the development and implementation the Pfizer non-clinical testing strategy for detecting abuse potential liability. Co-chaired the Pfizer Cardiovascular Safety Advisory Council responsible for advising project teams on CV safety issues from early discovery to post-marketing. Co-chaired a working group established by Academy of Medical Sciences charged with identifying scientific gaps in the area of safety pharmacology. Former member of the Board of Directors of the Safety Pharmacology Society. Member of the Cardiovascular Research Consortium and co-author of white paper ‘Strategies to Replace the Clinical Thorough QT study’.
Management Experience: 30 years of management experience from managing discovery project teams to multiple departments. History of building effective teams with a sense of common purpose and shared responsibility.
Reputation for building a trusting relationship with staff at all levels of the organization and motivating colleagues to achieve their full potential, whilst at the same time making difficult decisions to enable groups to evolve in accordance with the changing work environment. Managed the integration of components of drug safety organizations arising from the Pfizer acquisition of Wyeth Pharmaceuticals. Currently working as an independent Safety Pharmacology Consultant.
Adam Woolley, MSc, DABT, FRCPath, CBiol, MSB, ERT, ATS
Adam is a senior toxicologist, with over 40 years’ experience in nonclinical development, of which nine years were spent in the pharmaceutical industry and 21 years in contract research, including the post of Director of Toxicology/Pathology at Quintiles, Scotland. He has broad experience in pharmaceutical development and the conduct and reporting toxicological reviews for a wide range of substances, including pharmaceuticals, agrochemicals, veterinary products, consumer products and medical devices. This has included submissions and presentations to various European authorities, such as the EMEA, MHRA, BfArm and the FDA.
Adam is certified as a toxicologist in both Europe (European Registered Toxicologist) and the USA (DABT), and is a Fellow of the Royal College of Pathologists and a Chartered Biologist; he is also a Fellow of the Academy of Toxicological Sciences. He has been involved in a number of training initiatives and has a published various papers and a textbook “A Guide to Practical Toxicology: evaluation, prediction and risk” (2nd edition, Taylor & Francis 2008) for which a 3rd edition is in preparation.
He is also a Fellow of the British Toxicology Society, and a member of The Organisation for Professionals in Regulatory Affairs (TOPRA) and the Society of Biology. He has been a Director on the Board of the American Board of Toxicology (currently European Liaison Officer to ABT) and Chair of the Registration Panel to the UK Register of Toxicologists. He is Chief examiner in toxicology for the Royal College of Pathologists and a regular presenter on the modular MSc course in toxicology at the University of Surrey.
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.