Symposium 1: Toxicology Today and Tomorrow: Global Trends in Focus, Techniques and Regulation
Tracks
Track 1
Wednesday, December 10, 2025 |
11:00 AM - 1:00 PM |
Details
The research and regulatory landscape for drug development and toxicological testing is undergoing rapid transformation. These shifts also carry marked implications for environmental impact and the way findings are communicated to stakeholders. Emerging modalities—such as mRNA, siRNA, lipid nanoparticles (LNPs), gene therapies, and CAR-T cells—are introducing new complexities in toxicological assessment. These challenges are further compounded by evolving scientific research and regulatory frameworks, including recent announcements that the FDA is considering broader acceptance of non-animal models for drug approval.
We have a panel of experts from academia, industry and regulatory fields with presentations to guide participants through current areas of research and regulatory interest in this rapidly shifting landscape.
Speaker
Assoc Prof Paul Wright
Toxicologist
RMIT University
Climatoxicology: ACTRA warns that climate change is impacting the toxicology and risk assessment of chemical exposures
Biography
Paul Wright is the Toxicologist in the School of Health and Biomedical Sciences at RMIT University and an Adjunct of the School of Chemistry at Monash University, Melbourne, Australia. He is the previous president of the Australasian College of Toxicology and Risk Assessment (ACTRA, 2019-23), and a Fellow of both ACTRA and the International Union of Pure and Applied Chemistry (IUPAC), and a former elected Director of the International Union of Toxicology (IUTOX). Paul is a researcher in toxicology, nanotoxicology/nanosafety, natural product development and the safety of Australian native foods, supported by external government and industry grants, and is an appointed toxicology expert on various government and university panels. Paul teaches toxicology at several universities and institutions while based at RMIT University for over 3 decades, including for the Masters of Green Chemistry and Sustainable Technologies since it commenced in 2022 at Monash University. He received an ACTRA Award of Merit in 2023 in Recognition of Excellence in Toxicology Education and contributed to Edith Cowan University’s new short course in Applied Toxicology.
Dr Sharleen Menezes PhD
Senior Toxicologist
Novotech
Toxicology challenges of emerging pharmaceutical modalities
Biography
Sharleen is a Senior Regulatory Toxicologist at a global clinical research organisation (CRO), Novotech and works in drug development. She is involved in providing technical toxicology advice and product development strategy for clinical trial entry and testing of therapeutics in humans. As a toxicologist, she is involved in interpreting toxicity data conducted by clients and assisting in nonclinical study design, as well as writing and reviewing regulatory submission documents and packages for new medicinal drug products across ANZ, Asia, the US, and Europe. Sharleen received her PhD from the University of Sydney and previously worked at the university as a Post-Doc in molecular biology and oncology.
Tarah Hagen MSc DABT FACTRA
Technical Director Toxicology & Risk Assessment
SLR Consulting Australia Pty Ltd
Thought for food: assessing agricultural risks from PFAS in the current regulatory environment
Biography
Tarah is a certified toxicologist and fellow of the Australasian College of Toxicology and Risk Assessment (ACTRA) who has over 15 years’ experience in conducting screening and detailed human health and ecological risk assessments for a variety of industries and government. Included are industrial emissions, contaminated land and water, consumer goods and food. She has written and co-written numerous major reports, which have been influential in shaping Australian health risk assessment methodology and policy decisions in relation to environmental issues. Included are guidance documents for undertaking risk assessments, complicated risk assessments dealing with a variety of emissions to the environment, deriving the scientific basis for workplace exposure standards, interpretation of biological monitoring results for chemical exposures, toxicological reviews on various chemicals in relation to work and public health and safety, as well as research into clearance and distribution of per- and poly-fluorinated alkylated substances (PFAS) in livestock. She has also acted as an expert witness in a number of legal cases involving chemical emissions. She is currently President of ACTRA and has been actively involved with ACTRA for over 12 years. She is a ministerial appointed member of the Industrial Chemical Environmental Management Standard (IChEMS) advisory committee and regularly teaches University Masters students in the fields of toxicology and epidemiology. She has also acted as an independent expert in the fields of toxicology and human health risk assessment in several court cases.
Dr Slade Matthews
Senior Lecturer in Toxicology
University of Sydney
Non-animal models: Current status for toxicology and specific challenges including virtual control groups, in silico modelling, AI predictive tools, organ on a chip/organoids
Biography
Slade Matthews is a researcher and educator whose career has been marked by his dedication to the intersection of biomedical science and machine learning. He is committed to fostering mathematical literacy among students and has made contributions to both research and education in the field. He holds two teaching awards for university teaching. Recognizing the importance of effective pedagogy, Slade completed a Graduate Certificate in Higher Education in 2011. He has a Bachelor of Medical Science, Honours (1995) which included an investigation into the venom of the Australian copperhead snake using classical pharmacological bioassays, chromatography, and electrophysiology. His doctoral research (PhD 2007) focussed on the integration of machine learning techniques for cell classification tasks and modelling relationships in clinical data. Slade's primary research focus centres on the fusion of experimental design, statistical analysis, and machine learning to investigate biomedical problems, especially in toxicology. He has published 43 publications in peer-reviewed journals and has been cited 1275 times.
Ms Lynne Clapham
Principal Toxicologist
Agilex Biolabs
Co-presenter
Biography
I’m a regulatory toxicologist with +35 years’ experience in the preclinical arena; currently Principal Toxicologist at Agilex Biolabs. For over 20+ years I worked for a UK-based global toxicology CRO. My final position being Toxicology Consultant. I have worked with a wide range of animal species, administration routes and study designs; attended numerous toxicology training courses and meetings; sat on National and International Working groups. My focus areas are regulatory preclinical study requirements, study design, animal ethics, toxicology data interpretation and knowledge sharing. To complement my preclinical research skills, from 2008-2018, I held risk assessment/management positions within Australian and New Zealand food, chemical and pharmaceutical regulators. I’ve facilitated many toxicology training sessions and presented posters at various toxicology meetings, including the US Society of Toxicology (SOT). I support ethical testing on animals, but I also have a keen interest in alternatives. In 2023, based on my preclinical experience I was appointed as a HREC member.
Chair
Tayler Catherine Kent
Associate Lecturer in Human Pharmacology
Murdoch University
Ian Musgrave
Senior Lecturer
University of Adelaide
