NAM Use for Regulatory Application

Regulatory Toxicology has reached a tipping point – animal tests are increasingly outmoded by New Approach Methodologies (NAMs) that offer the potential to improve human health and environmental protection.  So why is the transition out of animal testing and into a NAM-based approach to Chemical Safety Assessment predicted to take so long by so many commentators? And what can we collectively do to accelerate this transition?

This seminar series explores these questions by inviting speakers to share candid perspectives on how they’ve overcome barriers to apply NAMs in their fields and discuss how we can learn from these examples to increase NAM use together. Each presentation is approximately 30 minutes followed by an audience-led Q&A. You can watch the webinar recording by following the link below.  And be sure to stay tuned for updates on the next DyNAMic Discussions webinar!

This series is moderated by Eryn Slankster-Schmierer, PhD, Physicians Committee for Responsible Medicine, Kristie Sullivan, MPH, Institute for In Vitro Sciences, and Gavin Maxwell, PhD, Unilever.

Using ‘Omics for in vitro toxicology and drug discovery

Date: November 21, 2024

Time: 10:00 – 11:30 a.m. ET

Speakers:

• Dr. David Rouquie, Bayer. OASIS: a multi-stakeholder collaboration leveraging robust omics data to evaluate liver toxicity.
• Dr. Jessica Ewald, Broad Institute. Cell Painting as an emerging omics’ tool for toxicology and drug discovery.

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David Rouquie leads the Toxicology Data Science team at the Bayer Crop Science toxicology facility in Sophia Antipolis, France. His passion for science and research that addresses societal needs has kept him deeply engaged in innovative, collaborative, and multidisciplinary projects. With a background in biochemistry and molecular biology, he is continually evolving into a hybrid profile at the intersection of biological and computational sciences. Recently, he joined the scientific committee of ECETOC as Bayer’s representative and serve a vice Chairman. In the context of the Broad Institute/HESI collaboration, he co-chairs the OASIS initiative alongside Dr. Anne Carpenter. This initiative aims to build confidence in the use of Cell Painting, transcriptomics, and proteomics for chemical safety assessments, using hepatotoxicity as a case study.

Jessica Ewald is a Banting postdoctoral fellow in the Carpenter-Singh lab at the Broad Institute, where she is developing statistical methods for using multi-omics data from in vitro screens for chemical toxicity detection. She holds a Bachelor of Science in Engineering Sciences and Applied Math from Harvard University, and a PhD in Bioinformatics from McGill University. For her thesis, she developed a suite of web-based tools for analyzing toxicogenomics data. She is passionate about maximizing the translational applications of her research, leading her to participate in multi-sector working groups on transcriptomic dose-response analysis and cross-species extrapolation, and to teach courses on her software at numerous conferences, workshops, and webinar series.

All DyNAMic Discussions recordings and materials for Seasons 1-3 are available on the DyNAMic Discussions learning portal.

Gaining Confidence in NGRA approaches together

Date: April 8, 2024

Time: 10:00 – 11:30 a.m. ET

Speakers:

• Sophie Cable, MSc, Safety Scientist, Unilever’s Safety and Environmental Assurance Centre. Building confidence in the practical application of non-animal methods in safety decision making.
• Joshua Harrill, PhD, Cellular and Molecular Toxicologist Center for Computational Toxicology and Exposure (CCTE), US Environmental Protection Agency. Development and evaluation of new approach methods (NAMs) for use in next generation risk assessment: An EPA / Unilever collaboration.

Additional Panelists:

• Richard Judson, PhD, US EPA
• Alistair Middleton, PhD, Unilever

Watch Session 1

The US EPA Center for Computational and Exposure (CCTE) and Unilever’s Safety and Environmental Assurance Centre (SEAC) have established a cooperative research and development agreement (CRADA) aimed at development and evaluation of New Approach Methods (NAMs) for use in Next Generation Risk Assessment (NGRA). The CRADA has been exploring the utility of a battery of NAMs for evaluating the safety and potential hazard(s) of a set of ~40 case study chemicals. Research topics in this project include: 1) exploring the combinatorial use of safety pharmacology screening, cell stress assay panels and high-throughput transcriptomic and imaging-based phenotypic profiling assays conducted across a collection of biologically-diverse human cell lines for determining molecular points-of-departure (mPODs), 2) comparison of mPODs to hazardous and non-hazardous human exposure scenarios, 3) evaluating the impact of in vitro metabolism on bioactivity assay readouts and 4) methods for metabolite determination.

Sophie Cable, a safety scientist with Unilever's Safety and Environmental Assurance Centre, and Joshua Harrill, a cellular and molecular toxicologist at the US EPA's Center for Computational Toxicology and Exposure (CCTE), will highlight recent findings from this collaboration. The webinar will conclude with a Q&A and panel discussion including the speakers and additional experts Richard Judson, bioinformatician at US EPA, and Alistair Middleton, science leader in computational toxicology at Unilever, to allow for a Dynamic Discussion of how the approaches being investigated can be evaluated and implemented for safety assessment.

Next steps toward the implementation of Next Generation Risk Assessment

Date: November 14, 2024

Time: 10:00 – 11:30 a.m. ET

Speakers:

• Dr. Mirjam Luijten, Let's put next-generation risk assessment into practice – the ASPA framework.
• Dr. Matthias Herzler, Towards a unified NGRA framework.

Watch Session 2

Mirjam Luijten is a senior research toxicologist at the National Institute for Public Health and the Environment (RIVM). Her research is aimed at Next-Generation Risk Assessment, i.e., the development of a better and more human-relevant system for risk assessment of chemicals. Areas of expertise include genetic toxicity and carcinogenesis, Adverse Outcome Pathways (AOPs), New approach Methodologies (NAMs), human relevance and mixtures. She has been involved as work package leader in various international projects (e.g. PARC, RISK-HUNT3R, HBM4EU, EuroMix). In addition, she is member of various committees and expert groups, such as the OECD Expert Group on Integrated Approaches to Testing and Assessment of Non-Genotoxic Carcinogens and the Genetic Toxicology Technical Committee of HESI (Health and Environmental Sciences Institute).

Matthias Herzler is a scientific director and unit head at the German Federal Institute for Risk Assessment (BfR). He has more than 20 years of experience as a risk assessor under various European chemicals legislations (pesticides, biocides, REACH and CLP). Dr. Herzler’s scientific interests circle around the uptake of New Approach Methodologies (NAMs) into regulatory practice. Over the past 20 years, he has been member of numerous EU, OECD, WHO and UN expert groups in the field, in addition to providing regulatory advice to the EU Horizon 2020 projects EU-ToxRisk and RISK-HUNT3R. At present, Dr. Herzler and his unit are deeply engaged in transversal activities under the European PARC Partnership. They are also part of the consortium of the Horizon2020 project PANORAMIX.

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