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 NAMs-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 experts to share candid perspectives on how they’ve overcome barriers to applying NAMs in their fields. Moderators then facilitate discussion about 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 recordings via the links below.

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

All DyNAMic Discussions recordings and materials for are available on the DyNAMic Discussions learning portal.

NAM-centered paradigms for regulatory decision-making: Leaving the animal tests behind

May 20, 2022

• Nicole Kleinstreuer, PhD, NIEHS/NICEATM: Acute Applications of Data-Driven Evaluations (View slides)
• Katie Paul-Friedman, PhD, US EPA: Integration of New Approach Methodologies for Prospective Selection of Chemicals for Additional Study (View slides)

You can read more about the session and speakers in the agenda, view the recording, or access other resources mentioned by the speakers.

DART: What can we do today?

July 8, 2022

• Ramya Rajagopal, PhD, DABT, Unilever: Mechanistic Evaluation and Application of New Approach Methodologies (NAMs) in an Integrated Approach to Testing Developmental and Reproductive Toxicity (DART) End Points for Next Generation Risk Assessment (NGRA) (View slides)
• Kelly Carstens, PhD, US EPA: Application of Developmental Neurotoxicity (DNT) New Approach Methods (NAMs) for Predicting Human Neurotoxicity (View slides)

You can read more about the session and speakers in the agenda, view the recording, or access other resources mentioned by the speakers.

NAMs as the new Gold Standard: Bringing validation into the 21st Century

August 12, 2022

• Amy Clippinger, PhD, PETA Science Consortium International e.V: Establishing Scientific Confidence in New Approach Methodologies (View slides)
• Patience Brown, OECD: The Future of Risk Assessment and International Collaboration (View slides)

You can read more about the session and speakers in the agenda, view the recording, or access other resources mentioned by the speakers.

Integrated Approaches for Testing and Assessment (IATA): NAM-based safety assessment frameworks

September 2, 2022

• Nick Ball, Dow Chemical Company: Can a framework using NAMS meet regulatory needs for Chemical management – EU-REACH as an example (View slides)
• Gladys Ouédraogo, PharmD, PhD, DABT, L’Oréal: IATAs for addressing systemic toxicity: a perspective on the safety assessment of cosmetics (View slides)

You can read more about the session and speakers in the agenda, view the recording, or access other resources mentioned by the speakers.

Moving beyond tick-box toxicology: Stakeholder partnerships to facilitate fit for purpose solutions

November 18, 2022

• Doug Wolf, Syngenta, & Monique Perron, US EPA: Process for non-animal inhalation case study development and acceptance, importance of regulatory-regulated communication (View slides)

You can read more about the session and speakers in the agenda or view the recording, or access other resources mentioned by the speakers.

P.E.P. x DyNAMic Discussions special joint webinar: Frameworks for establishing scientific confidence in new approach methodologies: Part 1

December 7, 2022

This webinar was held jointly with the P.E.P. Webinar Series on the Use of New Approach Methodologies (NAMs) in Risk Assessment, co-organized by PETA Science Consortium International, the US Environmental Protection Agency (EPA), and the Physicians Committee for Responsible Medicine (PCRM).

• Nicole Kleinstreuer, NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM): Flexible, Fit-For-Purpose NAMs Validation Across US Federal Agencies (View slides)
• Tala Henry, EPA Office of Pollution Prevention & Toxics: Applying a NAMs Confidence Framework at the EPA (View slides)

Additional Panelists:

• João Barroso, European Commission Joint Research Centre (JRC)
• Warren Casey, National Institute of Environmental Health Sciences (NIEHS)

You can read more about the session and speakers in the agenda, view the recording, or read A Framework for Establishing Scientific Confidence in NAMs.

P.E.P. x DyNAMic Discussions special joint webinar: Frameworks for establishing scientific confidence in new approach methodologies: Part 2

January 18, 2023

This webinar was held jointly with the P.E.P. Webinar Series on the Use of New Approach Methodologies (NAMs) in Risk Assessment, co-organized by PETA Science Consortium International, the US Environmental Protection Agency (EPA), and the Physicians Committee for Responsible Medicine (PCRM).

• Alistair Middleton, PhD, Unilever: Are Non-Animal Systemic Safety Assessments Protective? A Toolbox and Workflow (View slides)
• Amanda Ulrey, RQAP-GLP, Institute for In Vitro Sciences, Inc. (IIVS): How Following GIVIMP Aligns Your Work with the Framework (View slides)

Additional panelists:

• Helena Hogberg-Durdock, PhD, NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)
• Susanne Kolle, PhD, BASF SE Experimental Toxicology and Ecology
• Anna Lowit, PhD, US EPA Office of Pollution Prevention and Toxics (OPPT)

You can read more about the session and speakers in the agenda or view the recording.

Ecotox: What can we do today?

February 10, 2023

• Kristin Schirmer, PhD, Swiss Federal Institute of Aquatic Science and Technology (EAWAG): The RTgill-W1 fish cell line assay for predicting acute fish toxicity: development, acceptance and next steps (View slides)
• Mark Bonnell, Environment and Climate Change Canada: Confidence-Based Regulatory Prioritization in Canada Using Version 2.0 of the Ecological Risk Classification Approach for Organic Substances (View slides)

You can read more about the session and speakers in the agenda, view the recording or Q&A report, or access other resources mentioned by the speakers.

New Strategies for Safety Assessments of EDCs

April 14, 2023

• Richard Judson, PhD, US EPA Office of Research and Development: Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP) (View Slides)
• Tara Barton-Maclaren, PhD, Health Canada: Exploring the Use of New Approach Methods for Screening and Assessment of Endocrine Disrupting Chemicals under Canada’s Chemicals Management Plan (View Slides)

You can read more about the session and speakers in the agenda or view the recording.

Using NAMs to Solve Regulatory Challenges: Quantitative Investigations of PFAS chemicals

May 26, 2023

• George Loizou, PhD, HSE Science and Research Centre, & Arthur de Carvalho e Silva, PhD, University of Birmingham: A Human Health Based Guidance Value for Perfluorooctanoic acid – A NAM Based Approach (View Carvalho e Silva's slides & Loizou’s slides)
• Stella Fragki, PhD, esqLABS GmbH: Quantitative in vitro to in vivo extrapolation for the PFAS family: a comparison with dietary exposure (View slides)

You can read more about the session and speakers in the agenda, view the recording, or read the session’s Q&A Report.

Applications of ‘omics data to assess toxicology and ecological health

June 9, 2023

• Niladri Basu, PhD, McGill University: EcoToxChip Test System: A Toxicogenomic New Approach Method (NAM) for Chemical Prioritization and Environmental Management (View slides)
• Kamin Johnson, PhD, Corteva: A Transformative Vision for Using a Molecular
  Point of Departure in Agchem Regulatory Assessment (View slides)

You can read more about the session and speakers in the agenda or view the recording.

Gaining Confidence in NGRA approaches together

April 8, 2024

• 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.

Note: At the presenters’ requests, the slides were not made available for this session but other resources are available below.

Additional Panelists:

• Alistair Middleton, PhD, Unilever

You can read more about the session and speakers in the agenda or view the recording.

Next steps toward the implementation of Next Generation Risk Assessment

Date: November 14, 2024

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

You can read more about the session and speakers in the agenda or view the recording.

Using ‘Omics for in vitro toxicology and drug discovery

November 21, 2024

Speakers:

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

You can read more about the session and speakers in the agenda or view the recording.

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