Practical Application of Toxicology in Drug Development

20-24 October 2025 - Topics & Speakers

Topics

• Welcome and Introduction

• Overview of Drug Discovery and Development

• Pharmacology

• Safety Pharmacology

• DMPK and ADME, Concepts and Technologies

• Organ Systems

• Genetic Toxicology

• Carcinogenicity

• Clinical Pathology

• Pathology

• Immunotoxicology

• Safety of Biotechnology Products

• Reproduction/Developmental Toxicology

• Cell and Gene Therapy

• Risk Assessment

• Regulatory Toxicology

• Regulatory Case Studies Review

• Workshop of A Drug Programme with Regulatory Assessors

Speakers

Chris Powell, BioPharmaceutical Consultant

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. 

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.

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).

Matt Jacobsen, AstraZeneca

George Johnson, Swansea University

George is an Associate Professor in Genetics at Swansea University. George is a co-chair 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. He has also been chair of multiple International Workshops on Genotoxicity Testing (IWGT), expert at European Medicines Agency meetings, member of the Committee on Mutagenicity  along with other expert roles. 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, Merck, Toxys, Teva 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. George is ex-President of the EEMGS, a British and European Registered Toxicology (BRT/ERT) and Fellow of the Higher Education Academy. 

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.

Jo Harding, Recursion

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 responsible for the data interpretation in pre-clinical toxicology studies. From 2005 I obtained the position of Clinical Pathology Laboratory Manager at AstraZeneca with specialist knowledge of toxicological Clinical Pathology before retiring in 2021.  From 2021 to date, I currently run Peter Cotton Consultancy Limited providing clinical pathology expertise to several clients within the preclinical toxicology field.

Vasanthi Mowat, Labcorp

Vasanthi Mowat is a Senior Pathologist at Labcorp, Huntingdon. She graduated as a vet and completed a master’s degree in veterinary pathology in India. She has worked in toxicological pathology for 35 years and was awarded the FRCPath in 2004. She joined Labcorp (formerly Envigo) in April 2006 and was Director of Pathology there until 2020. She was a member of the INHAND Cardiovascular working Group of the STP and has a special interest in cardiovascular pathology.  She has published and presented on induced and background findings in a variety of species and study types at international meetings.

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)

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.

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.