Scientific Workshop - Adverse Outcome Pathways: From Research to Regulation Final Documents
September 3 - 5 , 2014
Group Discussion Summaries
- Breakout Group 1: The Process of Regulatory Acceptance
- Breakout Group 2: Using AOPs for Regulatory Decisions: Confidence and Criteria
- Breakout Group 3: Taking Qualitative AOPs to the Next (Quantitative) Level
Other Documents
Federal Register Notices September 3 - 5 , 2014
Scientific Workshop - Adverse Outcome Pathways: From Research to Regulation Meeting Materials
September 3 - 5 , 2014
Scientific Workshop - Adverse Outcome Pathways: From Research to Regulation Presentations
September 3 - 5 , 2014
Workshop Presentations
Opening Session
- Welcome
Warren Casey, NIEHS/NICEATM - Innovation in Toxicology at NCATS
Christopher Austin, U.S. National Center for Advancing Translational Sciences - From Mode of Action to Adverse Outcome Pathways: Moving Towards Regulatory Applicability
Bette Meek, University of Ottawa - What is an AOP (and What ISN’T It?)
Donna Mendrick, U.S. Food and Drug Administration (FDA)
Session 1: Building Upon Other Efforts
- AOP Activities at the OECD
Joop de Knecht, Organisation for Economic Co-operation and Development (OECD) - AOP Knowledge Base/Wiki Tool Set
Steven Edwards, U.S. Environmental Protection Agency (EPA) - Outcomes from the March Somma Lombardo Workshop
Edward Perkins, U.S. Army
Session 2: AOPs Under Development
- Embryonic Vascular Disruption and Adverse Prenatal Outcomes
Nicole Kleinstreuer, ILS/NICEATM - Using Adverse Outcome Pathway Analysis to Identify Gaps in High-Throughput Screening for Thyroid Disruption
Katie Paul, Bayer CropScience - Application of the Adverse Outcome Pathway (AOP) Concept to Neurotoxicology: A Challenging Approach
Ellen Fritsche, IUF Dusseldorf - AOP Development: After the Heights of the Mountains – the Hardship of the Plains; the Example of Liver Fibrosis
Brigitte Landesmann, European Commission Joint Research Center (JRC) - Fish Early Life Stage: Developing AOPs to Support Targeted Reduction and Replacement
Dan Villeneuve, EPA - Adverse Outcome Pathway for Effects of Anticoagulant Rodenticides on Predatory Birds
Barnett Rattner, U.S. Geological Survey, U.S. Department of the Interior - Adverse Outcome Pathway (AOP) for Sustained Aryl Hydrocarbon Receptor Activation Leading to Rodent Liver Tumor Promotion
Ted Simon, Ted Simon LLC - Developing AOPs from PPAR Activation Leading to Reproductive Toxicity
Malgorzata Nepelska, European Union Joint Research Centre - Framework for Computationally-Predicted AOPs
Shannon Bell, EPA
Session 3: Case Studies: Regulatory Uses for Well-Identified AOPs
- Testing of the Predictive Power and Robustness of an AOP Construct for Bile Salt Export Pump Inhibition to Cholestatic Injury
Mathieu Vinken, Vrije Universiteit Brussel - An Adverse Outcome Pathway (AOP) Framework for Screening for Potential Endocrine Disruption
David Dix, EPA - AOPs and Regulatory Decisions: Problem Formulation, Development and Acceptance
Rita Schoeny, EPA - Identifying Integrated In Vitro/In Silico Testing Strategies (IATA/ITS) by Mapping to the Skin Sensitization AOP
Joanna Matheson, U.S. Consumer Product Safety Commission
Session 4: The Risk Context
- Exposure and Dosimetry Considerations for AOPs
John Wambaugh, EPA - Ozone-Induced Lung Inflammation and Injury: From Mechanism to Adversity in Humans
Robert Devlin, EPA - Suspected Modes of Action Affected by Pesticides Exposure: Informing an Adverse Outcomes Pathway (AOP) for Cancer
Michael Alavanja, U.S. National Cancer Institute
Breakout Groups
Group 1: The Process of Regulatory Acceptance
- Breakout Group Summary Presentation
David Dix, EPA, and Craig Rowlands, The Dow Chemical Company - AOP Development Processes in OECD and Regulatory Agency Acceptance
Working Group of National Coordinators, OECD Test Guidelines Programme
Christine Olinger and Melissa Panger, EPA - How Do We Establish Scientific Confidence in AOPs?
Rick Becker, American Chemistry Council - Regulatory Acceptance: How to Strengthen Protection of Susceptible Populations in AOP Approaches
Ruthann Rudel, Silent Spring Institute
Group 2: Using AOPs for Regulatory Decisions: Confidence and Criteria
- Breakout Group Summary Presentation
Suzanne Fitzpatrick, FDA, and Annie Jarabek, EPA - Contaminants in the Food Supply: How the AOP Concept Can Help Regulators Make Decisions Using Arsenic as a Case Study
Christina Powers, EPA - Decision Analytic Approach to Advance Application of AOPs in Risk Assessment: Characterization Criteria to Establish Confidence
Annie Jarabek, EPA - Using Evidence-Based Toxicology to Evaluate AOPs
Thomas Hartung, Center for Alternatives to Animal Testing, Johns Hopkins University
Group 3: Taking Qualitative AOPs to the Next (Quantitative) Level
- Breakout Group Summary Presentation
Nicole Kleinstreuer, ILS/NICEATM, and Kristie Sullivan, Physicians Committee for Responsible Medicine - A Quantitative AOP for Skin Sensitization
Gavin Maxwell, Unilever - A Conceptual Model that Enables Quantitative Integration of Data Into an AOP
Catherine Willett, Humane Society of the United States - Applying Semantic and Network Methods in AOP Knowledge
David Wild, University of Indiana School of Informatics and Computing
Presentations by Junior Investigators with Outstanding Poster Abstracts
- Quantitative Weight of Evidence Model for Assessing Adverse Outcome Pathways
Dasha Agoulnik, University of Massachusetts Lowell/U.S. Army Engineer Research and Development Center - Developmental Neurotoxicity of Epigallocatechin Gallate by Interference With beta-1-Integrin Function: A Novel AOP Framework Supporting Neurodevelopmental Toxicity Research and Risk Assessment
Marta Barenys, Liebniz Research Institute of Environmental Medicine - Cross-Species Extrapolation of an Adverse Outcome Pathway for Ecdysteroid Receptor Activation
Carlie LaLone, EPA - Short-Term Atrazine Exposure Alters the Plasma Metabolome of Male C57BL/6 Mice and Disrupts Specific Metabolic Pathways
Zhoumeng Lin, University of Georgia
Hands-On Demonstration/Training
- Entering an AOP into the OECD Wiki
Stephen Edwards, EPA - Introduction to Effectopedia
Hristo Aladjov, OECD