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.

Matt Jacobsen, AstraZeneca

Following a veterinary degree at Cambridge, Matt undertook an anatomic pathology residency at Cornell University, 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 agrochemicals and pharma. He took a particular interest in neurotoxicity and developmental neurotoxicity studies. Matt then joined the Safety Assessment Department of AstraZeneca at Alderley Parkin the UK as a senior pathologist, supporting oncology, infection and respiratory and Inflammation 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 a Senior Director in the Pathology department, and therapy area Pathology lead for vaccines and immune therapy. He also has accountability for drafting responses to regulatory authorities, and has remained an active project pathologist involved in the assessment of early safety and efficacy studies, as well as peer review of outsourced toxicology studies to include rodent carcinogenicity.

Carrie Larner, AstraZeneca

Carrie Larner serves as Director of Secondary Pharmacology Strategy within Safety Sciences at AstraZeneca. With more than twenty years of experience across the biotech and pharmaceutical sectors, Carrie’s career encompasses both in vitro and in vivo research, bringing a broad perspective to drug discovery and safety evaluation. Her career includes significant roles at Cambridge Biotechnology, Biovitrum, Proximagen, and Heptares Therapeutics, where she established primary pharmacology discovery programs and led pioneering scientific teams. Carrie is an active member of the DruSafe Secondary Pharmacology Working Group, contributing to best practices in pharmacological safety, and serves on the BPS Education and Training Committee, supporting professional development across the sector. She holds an undergraduate degree from the University of Sheffield and earned her PhD in Molecular Pharmacology from the University of Cambridge. Carrie’s strategic vision and dedication to scientific excellence continue to influence and enhance safety science initiatives, ensuring the advancement of innovative medicines.

Norman N. Kim, MS, DABT, ERT, Vice President, Preclinical Development & Clinical Pharmacology

Norman is a board-certified toxicologist with a wide-ranging experience in nonclinical safety within the biopharmaceutical industry for over 30 years.  He is currently a Vice President of Preclinical Development and Clinical Pharmacology at BlueRock Therapeutics, a cell therapy company based in Cambridge, MA, USA.  Previously, he was employed at Magenta Therapeutics, Relay Therapeutics, Roivant Sciences and its subsidiary Immunovant, Biogen, Inotek Pharmaceuticals, Sepracor and Alkermes.  His experience in nonclinical safety spans discovery, development, and post-marketing phases with exposure to various modalities and diverse programs that include CNS and ophthalmology of cellular therapy.  He has worked on numerous global regulatory submissions including INDs and CTAs, and has been involved in filings of marketing applications that led to approvals of multiple drug products.  Norman has participated in various regulatory and safety-related external committees including expert working groups within the European Federation of Pharmaceutical Industry and Association (Efpia), Pharmaceutical Research and Manufacturers of America (PhRMA), and Health Effects Safety Institute (HESI).  He has served as a board of director with the American Board of Toxicology, as an executive committee member with the American College of Toxicology (ACT), and as a councilor with the Society of Toxicology (SOT) Regulatory and Safety Evaluation Specialty Section (RSESS); has been an active member and contributor to professional societies (ACT and SOT); and has organized multiple toxicology training courses including Practical Application of Drug Development and Toxicology for Pharmaceutical and Regulatory Scientists.  In 2014, Norman received the ACT Service Award for a recognition of his long-term contributions to the College. 

Neil Miller

Neil Miller is the Vice President, PBPK Product Development at Simulations Plus, driving the development and application of physiologically based pharmacokinetic (PBPK) modelling 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 Modelling 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 modelling (PBBM).

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 Association of Comparative Clinical Pathology (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. In 2015, I took a new position a Project Toxicologist at AstraZeneca. In 2023 I moved into Biotech and I am currently Head of Toxicology at Recursion. 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.

Paul Barrow

Paul Barrow is currently a freelance consultant specialized in developmental, reproductive and paediatric toxicology, based in Basel. Until 2022, he was Global Head of Reproductive Toxicology at Roche. Paul served as president of the European Teratology Society in 2014-15. He was a member of the ICH S5 Expert Working Group, responsible for the current harmonized guideline on Reproductive Toxicology. He has published about 60 peer-review papers, books and book chapters. Over his career, Paul has worked for various pharmaceutical companies and CROs in 4 European countries.

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).

Michaela Sharp, Moare Solutions

Michaela Sharpe is Founder and a Senior Director of Moare Solutions Ltd. A specialist adviser and consultant on the non-clinical safety assessment of advanced therapy medicinal products(ATMPs) and vaccines with over 20 years’ experience in the biotech and pharma sector. Michaela has developed bespoke non-clinical strategies for over 50complex therapies to facilitate progression into clinical trial; including pluripotent stem cell therapies, somatic cell therapies, immune therapies, genetically modified cell therapies, tissue engineered products and prophylactic and therapeutic vaccines. Supported by an in depth understanding of regulatory agency(MHRA, EMA and FDA) non-clinical safety requirements for ATMPs and vaccines including GLP regulations. Michaela received her PhD in Genetics from the University of Cambridge and did her post-doctoral research at the Sir William Dunn School of Pathology, University of Oxford.

Lolke de Haan, 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. When AstraZeneca acquired Cambridge Antibody Technology (CAT), he joined CAT as a Toxicology Project Lead in 2007. He was appointed as Director of Toxicology when CAT was incorporated into MedImmune in 2008, and became responsible for managing the Cambridge (UK) toxicology team, in addition to continuing to support biologic drug molecules -including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), fusion proteins, Fabs, therapeutic proteins, peptides and oligonucleotides- into clinical development, and, in case of PD-L1 mAb durvalumab (Imfinzi – now a blockbuster oncology drug), to approval by the US FDA, EMA, PMDA and other worldwide authorities. Other key programs he was involved in include those in support of tremelimumab (CTLA4 mAb – now FDA/EMA approved in combination with durvalumab as Imjudo), monalizumab (NKG2A mAb), tavolizumab (OX40 mAb), oleclumab (CD73 mAb), volrustomig (PD-1/CTLA4 bispecific), efizonerimod alfa (OX40L Fc fusion protein), efgivanermin alfa (GITRL Fc fusion protein) and MEDI1191 (IL-12 mRNA).  He was appointed as Senior Director, Immuno-Oncology Safety Lead in 2016, and, upon incorporation of MedImmune into AstraZeneca in 2019, he briefly held the position of Head of Biologics & Advanced Therapeutics Safety, before joining ADC Therapeutics (ADCT) in London as Head of Toxicology. At ADCT, Lolke supported FDA and EMA approval of loncastuximab tesirine (now known as Zynlonta) for the treatment of diffuse B cell lymphoma, supported clinical development of camidanlumab tesirine (CD25-targeted ADC) and ADCT-601(mipasetamab uzoptirine), and IND filing in support of ADCT-701 (DLK1-targeted ADC) and ADCT-901 (KAAG1-targeted ADC). In 2023, he was appointed as VP, Toxicology at ADCT, and in his current role oversees non-clinical toxicology, pharmacokinetics and ADME, and is also a member of of the R&D leadership team.

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. 

Ken Hastings

Hastings received his Doctor of Public Health degree from the University of North Carolina at Chapel Hill in 1987. He completed his doctoral research at the Chemical Industry Institute of Toxicology under the direction of Dr. Jack Dean. Dr. Hastings then served as a US Peace Corps Volunteer in Fiji under the Permanent Secretary for Health. From 1988 – 1991 Dr. Hastings completed a post-doctoral fellowship and was then appointed Research Associate in the Pharmacology/Toxicology Research Laboratory, Department of Anesthesiology, College of Medicine, University of Arizona, under the direction of Dr. A. Jay Gandolfi. From 1991 – 2007 Dr. Hastings worked in the Center for Drug Evaluation and Research, US Food and Drug Administration, in various positions: pharmacology/toxicology reviewer in the Division of Anti-viral Drug Products (1991 – 1997), pharmacology/toxicology supervisor in the Division of Special Pathogen and Immunologic Drug Products (1997 – 2003), and as an Associate Director in the Office of New Drugs (2003 – 2007). Dr. Hastings served on numerous committees and working groups while at FDA, including lead representative for CDER/FDA on the ICCVAM validation of the murine local lymph node assay and as lead negotiator on ICH S8 (Immunotoxicology Evaluation of New Drugs). From 2007 – 2014 Dr. Hastings was Associate Vice President for Regulatory Policy, Sanofi US, serving as corporate representative on numerous industry working groups dealing with regulatory science and policy. Dr. Hastings has served in many professional societies (President, Society of Toxicology Immunotoxicology Specialty Section; President, American College of Toxicology; President, SOT Regulatory and Safety Evaluation SS). Dr. Hastings served as President of the American Board of Toxicology and has numerous publications, included editor of books on use of mini-pigs in biomedical research and international standards for nonclinical safety evaluation of medical products. Dr. Hastings is currently an independent consultant specializing in toxicology studies in drug development.

Julianna Berrie

Julianna Berrie is a Non-clinical Assessor in the Medicines & Healthcare products Regulatory Agency (MHRA). Julianna has 9 years’ experience in regulatory toxicology, across a range of sectors including pesticides and biocides, cosmetics and toys, and now specialises in the risk-based assessment of medicines for use in clinical trials. The clear potential to protect human health, at both an individual and societal level, inspires Julianna daily. Julianna has made the most of her opportunities to expand her expertise and gain a better understanding of toxicology in non-clinical drug development. Julianna is keen to contribute to her profession and is actively involved in the British Toxicological Society (BTS). Her contributions led to her being made a Fellow of the BTS in 2022 and she was awarded the President’s Award in 2023. 

Will Redfern

Will leads the QSTS team to apply computational approaches to assess the safety of pharmaceuticals and other chemicals.  He is an experienced safety pharmacologist, having worked at Syntex, Quintiles and AstraZeneca.  He is a former President of the Safety Pharmacology Society.