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 Associate Professor of Immunotoxicology and Unit Leader of Toxicology in the School of Medical Sciences. He is also Program Co-ordinator of the world's first fully-online Toxicology postgraduate program. He has completed extensive research in immunotoxicology and nanotoxicology.
Associate Professor Paul Wright is a specialist lecturer in toxicology, toxicity testing, nanotoxicology/nanosafety, and drug design, development and regulation for a wide range of courses in the following RMIT undergraduate and postgraduate programs: Bachelor of Applied Science degrees in Pharmaceutical Sciences, Biomedical Science, Laboratory Medicine, and Nanotechnology; Graduate Diploma in Laboratory Medicine; and Master of Applied Science in Biotechnology and Business. Paul also lectures on toxicology and preclinical drug testing to the Graduate Diploma of Drug Evaluation and Pharmaceutical Sciences at Melbourne University.
Ms Sharleen Menezes PhD
Senior Toxicologist
Novotech
Toxicology challenges of emerging pharmaceutical modalities
Biography
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 based in our Melbourne office, with over 15 years’ experience in conducting screening and detailed human health and ecological risk assessments for a variety of industries and government. This includes industrial and vehicle 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. She also has considerable experience in sourcing, collating and interpreting toxicological hazard information. Tarah creates chemical toxicology profiles in which hazards and toxicity reference values are carefully described thereby ensuring the information is fit for the purpose of the risk assessment. She is also adept in building exposure scenarios for human and environmental risk assessment.
Tarah has been involved with numerous projects requiring health impact assessment of criteria pollutants from vehicular and industrial emission exposures to the general public including for large new urban developments.
Tarah has considerable expertise in classifying mineral ores and concentrates as to their health and environmental hazard for transport purposes. This includes sourcing toxicity and ecotoxicity information for numerous metals and metalloids, evaluating data quality and collating the information into databases, deriving toxicity reference value to be used for dangerous goods classification, and interpreting test reports.
She has been involved in several complicated risk assessments dealing with lead contamination and is adept at using and applying the results of the US EPA Integrated Exposure Uptake and Biokinetic (IEUBK) Model for lead. She has also applied this knowledge in helping derive recommendations for ambient air license limits for industries handling concentrates of lead ores (as well as other metal ores), as well providing advice for recommended changes to the occupational exposure limit for lead. She has also provided advice regarding the interpretation of biological monitoring results for arsenic exposure by mine process workers, as well as providing the associated communication to workers.
Tarah has also been involved with various publications reviewing the toxicity of engineered nanomaterials in relation to work and public health and safety, the latter particularly concerning their use as food additives and migration from food packaging into foods. She has also been involved in several complex human health risk assessment for occupational and public exposure to per and poly fluorinated alkylated substances (PFAS). This work has included reviewing and interpreting toxicology information for consideration of appropriate toxicity reference values, delineating potential exposure pathways, as well as estimating and interpreting internal exposure metrics with respect to human health. This work also has involved desktop assessments of livestock health and productivity.
She has also been one of the lead researchers on long running projects investigating the clearance and tissue distribution of PFAS in cattle and sheep. The results of this research have been presented at numerous conferences, written up as reports for government, and written up for publication in the scientific community. The research provides integral data for PFAS risk assessment and has facilitated derivation of suggested stock water guideline for PFAS protective of stock and human health, the latter due to produce consumption.
Tarah has a good understanding and experience in ecotoxicity testing which has been used to derive trigger values for contaminants in water using probabilistic species sensitivity distribution methodology.
She has acted as an independent expert in the fields of toxicology and human health risk assessment in several court cases.
She regularly teaches University master’s students in the fields of toxicology and epidemiology.
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. My experience and training base comes from the 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 main 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
