PATDD 2023 Agenda / Speakers

Practical Application of Toxicology in Drug Development September 11th – October 09th, 2023 Speakers

Overview of Drug Discovery and Development- Ruth Roberts, Apconix

Professor Ruth A Roberts, PhD, ATS, FBTS, ERT, FRSB, FRCPath. A co-founder of ApconiX, Ruth has 25 years of experience in leading roles in drug safety within large pharma. Ruth is also Chair and Director of Drug Discovery at The University of Birmingham, UK and was previously Global Head of Regulatory Safety at AstraZeneca. With over 140 publications in peer-reviewed journals, she is former president of the British Toxicology Society, former president of EUROTOX, former secretary to SOT and President of the Academy of Toxicological Sciences. Ruth was the recipient of the SOT Achievement award in 2002, the EUROTOX Bo Holmstedt Award in 2009 and the SOT Founders award in 2018 for outstanding leadership in toxicology. Ruth is an established science professional bringing rigorous expert thinking to toxicology, drug discovery and drug development.

Pharmacology & Safety Pharmacology- Rob Wallis, Safety Pharmacology Consultant

Rob is a pharmacologist by training with expertise in drug discovery and development. He has more than 30 years industry experience as head of Safety pharmacology at Pfizer with a world-wide reputation in the area of drug-induced QT prolongation/non-clinical cardiovascular safety. He has presented at many scientific conferences and at the FDA and is a member of the ICH E14 Q&A Technical Group. He is a former member of the Board of Directors of the Safety Pharmacology Society.

DMPK and ADME, Concepts and Technologies - Kunal Taskar, GSK

Pathology - Vasanthi Mowat, Labcorp

Vasanthi Mowat completed her veterinary degree and her Master’s degree in Veterinary Pathology in Bangalore, India. She has over 30 years’ experience as a toxicological pathologist and has worked at CROs in Britain and France. She joined Covance (formerly Envigo) in April 2006 and was Director of Pathology from February 2008 –June 2021. She was awarded the FRCPath in 2004, and has published and presented on procedural and background findings in a variety of species and study types at international meetings and conferences. In 2014 she co-authored an atlas of toxicological pathology with Dr C Gopinath.

Clinical Pathology - Jo Harding - and Peter Cotton, AstraZeneca

Jo Harding: Following completion of my BSc Hons degree in Biomedical Technology from Sheffield Hallam University, I worked in the multi-disciplinary Clinical Pathology laboratory at Sanofi for 9 years, ultimately as Laboratory Head. During this time I completed a MSc degree in Biomedical Sciences at the University of Northumbria, and became a member of the ACCP, eventually joining the committee as Secretary. In 2004, I left the lab and took a role as study director with responsibility for General Toxicology studies at Covance, whilst maintaining an interest and specialism in clinical pathology data interpretation, and choice of biomarkers on Toxicology studies. More recently, I have taken a new position as a Project Toxicologist at AstraZeneca. Throughout my career I have maintained my association with the ACCP and I am a strong supporter of the training, education, and information-sharing philosophy of the association.

Peter Cotton: Honours degree in Biology at Salford University graduating in 1979. Medical Laboratory Scientific Officer in Clinical Pathology at an NHS Hospital with a senior position from 1986 specialising in Haematology. In 1989 I joined Zeneca Toxicology Laboratory as Head of Haematology with responsibility for the running of the laboratory, data interpretation and reporting out of all preclinical toxicology studies on agrochemicals. In 1998 I became Deputy Clinical Pathologist and Haematology Specialist at AstraZeneca Pharmaceuticals initiating the Investigative Flow Cytometry laboratory. In 2001 became a Senior Scientist within Clinical Pathology with responsibility for the resource of the department to support Clinical and pre-Clinical studies and also responsible for the data interpretation in pre-clinical toxicology studies. In 2005 to date I obtained the position of Clinical Pathology Laboratory Manager at AstraZeneca with specialist knowledge of toxicological Clinical Pathology.

Organ Systems—Part 1 - John Foster, Senior Consultant Pathologist

John's first role as a pathologist was with the British Industrial Biological Research Association (BIBRA), at Carshalton in the UK, where he was head of the electron microscopy unit. He then joined the Pathology Department of ICI Central Toxicology Laboratory in Cheshire, United Kingdom in 1983. He became a member of the UK Royal College of Pathologists in 1988, was elected a Fellow in 1997, and ran the Specialty Advisory Committee for Toxicology from 2002-2005. He was Chair of the Panel of Examiners for the Toxicology Specialty of the RCPath from 2006-2012 and remains an examiner for the College. He was President of the British Society of Toxicological Pathologists from 2002-2004 and was appointed a Honorary Fellow of the British Society of Toxicology in 2008, was made an Emeritus Professor in the Faculty of Faculty of Health and Medical Sciences at University of Surrey in 2010 and was elected as an Honorary Fellow of the BSTP in the same year. He became a Fellow of the International Academy of Toxicologic Pathology in September of 2012. Dr Foster has published over 130 research papers, review articles and book chapters in toxicological pathology, and was the Editor in Chief of the journal, Toxicologic Pathology, from 2008-2013. He worked for AstraZeneca Pharmaceuticals from 2001 until retiring at the end of 2013 as a Senior Principal Pathologist and Deputy Director of Pathology. He was elected President of the International Academy of Toxicologic Pathology from 2018 until 2020. He worked as a consultant pathology associate with Regulatory Science Associates from 2014 until December 2020 but is now working as an independent pathology consultant for a company that he set up in 2013, ToxPath Sciences Ltd.

Organ Systems—Part 2 - Matt Jacobsen, AstraZeneca

Genetic Toxicology - George Johnson, Swansea University

George is an Associate Professor in Biomedical Sciences at Swansea University. George is a steering member of the Health and Environmental Sciences Institute (HESI) Genetic Toxicology Technical Committee (GTTC) and co-chair of the quantitative subgroup. HESI provides an international forum to advance the understanding of scientific issues related to human health, toxicology, risk assessment, and the environment. George has been lead academic on numerous international collaborations. These include FDA-NCTR, Health Canada, RIVM-Netherlands, AstraZeneca, Drugs for Neglected Disease Initiative (DNDi), Food Standards Agency, GlaxoSmithKline, Gentronix, Hoffman-La-Roche, Litron, Toxys and more. He also works with DNA damage group (in vitro Toxicology group) in the Institute of Life Science, as well as teaching on the Genetics and Medical Genetics BSc degree schemes, and having a role as Director of Employability and Entrepreneurship for the College of Medicine. George was awarded the prestigious UKEMS Young Scientist Award in 2012, and in 2013 he became a Fellow of the Higher Education Academy. He was also awarded the very prestigious European EEMGS Young scientist award, and is currently serving as President for this society.

Carcinogenicity - Nigel Roome, Toxicology and Toxicologic Pathology Consultant

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 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. As part of his Ph.D he also studies at the University of Marburg in Germany. He joined Synthelabo in 1984 as a routine Toxicological Pathologist with later specialization in Electron Microscopy and Histochemistry. 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 Agencies for toxicology and pathology safety issues in addition to a role for evaluation of drug safety aspects of external opportunities and collaborations with both Governmental and Academic Institutions. He is the author of more than 20 scientific publications and has regularly presented at teaching courses and conferences as an invited speaker.

Reproductive/Developmental Toxicology - Gary Chellman, Charles River Laboratories

Gary earned his PhD in toxicology from the University of Rochester in 1984, followed by postdoctoral training at the Chemical Industry Institute of Toxicology. Since 1986, 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, and in 2003 became the Program Director for Developmental and Reproductive Toxicology, specializing in the design, conduct and interpretation of nonhuman primate reproductive toxicology studies. Since July 2017, he has been a consultant to Charles River in reproductive and general toxicology. 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/coauthored numerous publications in reproductive toxicology, most recently related to optimizing these studies in nonhuman primates to support biopharmaceutical drug development.

Safety of Biotechnology Products, - Lolke de Hann, ADC Therapeutics

After academic training in biochemistry and immunology, a PhD in Medical Sciences from the University of Groningen (The Netherlands), and postdoctoral training at the University of Bristol (UK), Lolke started his career in industry at AstraZeneca as a discovery toxicologist in 2003, and joined Cambridge Antibody Technology (CAT) as a Toxicology Project Lead in 2007 when it was acquired by AstraZeneca. When CAT was incorporated into MedImmune in 2008, he became responsible for managing the Cambridge, UK toxicology team, assuming roles of increasing seniority. Upon incorporation of MedImmune into AstraZeneca in 2019, Lolke was appointed as Head of Biologics & Advanced Therapeutics Safety, and is responsible for managing a global team of toxicologists, spread over AstraZeneca sites in the US, UK and Sweden.

Cell and Gene Therapies - Jan Klapwijk, Cornelis Consulting

I originally trained as a veterinarian and practiced small animal and laboratory animal medicine for 10 years before moving into toxicological pathology. As a pathologist I have almost 30 years’ experience in regulatory toxicology / safety assessment and discovery support across a range of therapeutic areas (eg inhaled medicines, CNS, oncology) and modalities (small molecules and biopharmaceuticals) within large Pharma. In the last 10 years I have focused more on cell and gene therapies for rare diseases and oncology. I was the nonclinical project team member for Strimvelis (for treatment of ADA-SCID) which achieved a successful marketing application in 2016 - the first licensed ex vivo gene therapy anywhere in the world. Since March 2021 I am working as an independent pathology consultant. I am a Fellow of the Royal College of Pathologists.

Immunotoxicology - Marc Pallardy, Université Paris-Saclay

Marc Pallardy, Pharm D 1982, PhD in Toxicology 1987, Full professor and head of the Department of toxicology (School of Pharmacy, Université Paris-Saclay) since 1997. Pr Pallardy is currently Dean of the Faculty of Pharmacy, University Paris-Sud (since 2015) and head of the team 2 “Drug and Chemical Allergy, Immunotoxicology and Immunopathology”, INSERM UMR 996. Since 2004: Director, master program “Toxicology and pharmacovigilance”, Université Paris-Saclay (25 students/year). Marc has 132 publications in international peer-reviewed journals and more than 100 invited presentations in international or national meetings, seminars or conference chairman. His scientific activity is mainly in the field of Immunotoxicology. Marc is a current member of the Immunotoxicology Technical Committee of HESI and also on the HESI Board of Trustees since 2018. He is currently chairman of the “Immunotoxicology and Chemical Allergy Specialty Section” of EUROTOX and member of the “Scientific program committee” of EUROTOX and the coordinator of the education committee of the LABEX LERMIT a French research network dedicated to therapeutic innovation. 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 was co-coordinator of the IMI (Innovative Medecine Initiative) project ABIRISK (AntiBiopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the Risk, 39 partners from academia and industry). He has been 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).

Risk Assessment - Ernie Harpur, Newcastle University

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 Translational and Clinical Research Institute at Newcastle University UK and engaged in various scientific advisory roles. He has served as Scientific Meetings Secretary and President 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 Royal Society of Biology, 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 various scientific committees within the Washington DC based Health and Environmental Sciences Institute (HESI) and as Chair of its Board of Trustees and Executive Committee; as a member of the Advisory Committee of the Predictive Safety Testing Consortium of the Critical Path Institute; as Chair of the Scientific Advisory Board of the UK public private partnership, Stem Cells for Safer Medicines and as a member of the Registration Committee for Toxicologists in Austria. He has published more than 90 journal articles, reviews and book chapters and is a member of the editorial boards of several Toxicology journals.

Regulatory Toxicology - David Jones, MHRA

After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, David Jones currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London. His current role principally involves assessing nonclinical data for Clinical Trial Applications, both non-biological and biological. A further aspect of his job is to offer regulatory advice to companies on behalf of the MHRA or the EU’s Committee for Human Medicinal Products (CHMP). David is one of the UK’s accredited non-clinical experts to support the CHMP and is the UK representative on the EU’s Safety Working Party (SWP). He represented the EU in the ICH revision of the M3 Guideline and is now on the new ICH S11 Guidelines.