Practical Application of Toxicology in Drug Development
October 7th – November 11th, 2024 - 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 - Neil Miller
Neil Miller is the Vice President, PBPK Product Development at Simulations Plus, driving the development and application of physiologically based pharmacokinetic (PBPK) modeling software tools for the pharmaceutical, biotechnology, chemicals, and consumer goods industries. Previously he was at GlaxoSmithKline for over 20 years gaining experience of working in the pharmaceutical industry. His last position was as a Scientific Director within the Systems Modeling and Translational Biology group, leading a team of advanced PBPK specialists that provided end-to-end mechanistic modelling for drug discovery and development. Key activities included predicting efficacious human doses at Candidate Selection (CS) and supporting drug product development with physiologically based biopharmaceutics modeling (PBBM).
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- Emily Wires, U.S. Food and Drug Administration (FDA)
Emily joined the FDA Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products in 2023 as a biological reviewer. Her duties include the review of pharmacology/toxicology data in regulatory submissions for cellular and gene therapy products. She also participates in the CBER Cell Therapy Working Group. Prior to joining the FDA, she was a post-doctoral fellow at the National Institutes of Health until 2021 and then a Research Fellow until 2023 where she investigated protein homeostasis and cellular stress. She received her PhD from University of Maryland, Baltimore in 2016 where she utilized adeno-associated and lentiviral vectors for in vitro and in vivo delivery of a novel intracellular calcium sensor. She has mentored undergraduate and graduate students, served on numerous institutional committees, presented at international conferences, and co-authored numerous publications.
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. Dr 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 - Chris Powell, BioPharmaceutical Consultant, University of Cambridge
Chris is a consultant on medicines safety and a visiting scientist at the University of Cambridge. He has broad experience of pharmaceutical research and development and advises established and start-up biopharmaceutical companies on the safety profile of medicines.
He was formerly Vice President of Translational Medicine and Safety at GlaxoSmithKline Pharmaceuticals, and he is a past President of the British Toxicology Society. Previously, Chris was Reader in Pharmaceutical and Chemical Safety at St Bartholomew’s Hospital Medical College at the University of London, where he led a research group working on mechanisms of hepatotoxicity. He is a Fellow of the Royal College of Pathologists, The Royal Society of Biology and the British Toxicology Society.
Chris has served on Scientific Advisory Committees for the UK/EU Government and for the World Health Organisation: including the UK Advisory Committee on Carcinogenicity, the Strategic Governing Group on Translational Safety, for the European Union’s Innovative Medicines Initiative, the grant Review Panel for the MRC Integrated Toxicology Training Programme and he was chair of the British Pharmaceutical Industries Association Expert Network on Preclinical Safety.
His research interests are: the human relevance of experimental safety studies, the application of mechanisms of toxicity to risk assessment and, epigenetic mechanisms of chemical carcinogenesis. Chris is a regular speaker at scientific meetings.
Regulatory Toxicology - David R Jones, BSc, MSc, CBiol, FRSB, ERT, FBTS
After spending 8 years in Contract Toxicology, 11 years as a Toxicologist in the Pharmaceutical Industry, David joined the Medicines and Healthcare products Regulatory Agency (MHRA) in London in 1996. He retired at the end of 2021 after 25 years at the agency, latterly as an Expert Pharmaco-Toxicologist and the most senior nonclinical assessor within the Agency. His role at the MHRA principally involved assessing nonclinical data for Clinical Trial Authorisation (CTA) Applications and Marketing Authorisation Applications (MAA), both for non-biological and biological products, including advanced therapy medicinal products (ATMPs) and Drug-Device combinations. David assessed every UK application regarding COVID 19 in 2020 and 2021. A further aspect of his job was to offer scientific and regulatory advice to companies on behalf of the MHRA. Dr Jones represented the EU in the ICH revision of the M3 Guideline, on the ICH S10 Guideline, on the Q&A document for ICH S3 (Toxicokinetics) guideline and on the ICH S11 (Nonclinical Studies to Support Paediatric Medicine) guideline while also adding input into most other ICH Safety Guidelines. David is now working as an Independent Pharmaco-Toxicology consultant while also being a guest lecturer at a number of universities and a frequent presenter at conferences around the world.
