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AOPs Workshop: Adverse Outcome Pathways: From Research to Regulation

September 3-5, 2014
Bethesda, MD

The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Physicians Committee for Responsible Medicine (PCRM) will cosponsor a scientific workshop on “Adverse Outcome Pathways: From Research to Regulation.” The workshop proposes to explore and discuss how interaction and collaboration among stakeholders can be initiated and maintained so that scientific progress in adverse outcome pathway (AOP) concepts may improve regulatory assessment of chemical toxicity. The Society of Toxicology endorses this workshop.

The meeting will take place from September 3–5, 2014 at the William H. Natcher Conference Center, National Institutes of Health, Bethesda, Maryland, USA. This workshop is free as is the concurrent plenary presentations webcast. Registration for the workshop or webcast along with other information and a preliminary agenda are available here.

Dr. Christopher Austin of the National Center for Advancing Translational Sciences will provide the opening plenary presentation. Days 1 and 2 of the workshop will include 21 symposium presentations in four sessions:

  1. Building Upon Other Efforts
  2. AOPs Under Development
  3. Case Studies: Regulatory Uses for Well-Identified AOPs
  4. The Risk Context.

Days 2 and 3 will include three different interactive and rotating breakout groups and each workshop attendee will participate in all three groups:

  • 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.

A poster session will be held at the Natcher Center on September 4 from 6:00 p.m. to 8:00 p.m. Abstracts can be submitted as per the instructions on the workshop website. Junior investigators will have the opportunity to receive travel support for the workshop by submitting a competitive write-up of their work. The workshop steering committee will determine the top abstracts and the winning investigators will present a short plenary talk about his/her poster at an evening poster session/reception. Federal employees are not eligible to receive travel support from the workshop sponsors.

The workshop will conclude on the afternoon of September 5 with moderated whole-group discussion and a hands-on demonstration/training of AOP Wiki/Effectopedia provided by Dr. Stephen Edwards of the U.S. Environmental Protection Agency.

Draft Program:

Wednesday, September 3, 2014

8:30–8:35
Welcome
Warren Casey, NICEATM

8:35–9:05
Innovation in Toxicology at NCATS
Christopher Austin, U.S. National Center for Advancing Translational Sciences

9:05–9:35
From Mode of Action to Adverse Outcome Pathways: Moving Towards Regulatory Applicability
Bette Meek, University of Ottawa

9:35–10:05
What is an AOP (and What ISN’T It?)
Donna Mendrick, U.S. Food and Drug Administration (FDA)

10:05–10:20
Break

10:20
Session 1: Building Upon Other Efforts

10:20–10:50
AOP Activities at the OECD
Joop de Knecht, Organisation for Economic Co-operation and Development (OECD)

10:50–11:20
AOP Knowledge Base/Wiki Tool Set
Steven Edwards, U.S. Environmental Protection Agency (EPA)

11:20–11:50
Outcomes from the March Somma Lombardo Workshop
Ed Perkins, U.S. Army

12:00–1:00
Lunch

1:00
Session 2: AOPs under Development

1:00–1:25
Embryonic Vascular Disruption and Adverse Prenatal Outcomes
Nicole Kleinstreuer, ILS/NICEATM

1:25–1:50
Using Adverse Outcome Pathway Analysis to Identify Gaps in High-Throughput Screening for Thyroid Disruption
Katie Paul, Bayer CropScience

1:50–2:15
Application of the Adverse Outcome Pathway (AOP) Concept to Neurotoxicology: A Challenging Approach
Ellen Fritsche, IUF Dusseldorf

2:15–2:40
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)

2:40–3:05
Fish Early Life Stage: Developing AOPs to Support Targeted Reduction and Replacement
Dan Villeneuve, EPA

3:05–3:30
Break

3:30–3:55
Adverse Outcome Pathway for Effects of Anticoagulant Rodenticides on Predatory Birds
Barnett Rattner, U.S. Geological Survey, U.S. Department of the Interior

3:55–4:20
An AOP for Activation of the Aryl Hydrocarbon Receptor
Richard Becker, American Chemistry Council

4:20–4:45
Developing AOPs from PPAR Activation Leading to Reproductive Toxicity
Malgorzata Nepelska, JRC

4:45–5:10
Framework for Computationally-predicted AOPs
Shannon Bell, ORISE Fellow, EPA

5:10–5:30
End of Day Wrap-Up

Thursday, September 4, 2014

8:30
Session 3: Case Studies: Regulatory Uses for Well-Identified AOPs

8:30–9:00
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

9:00–9:30
Using the Estrogen Receptor AOP to Prioritize and Screen Chemicals for EDSP
David Dix, EPA

9:30–10:00
Validating New Tools/Assays Against Carcinogenicity AOPs to Support Regulatory Decisions
Rita Schoeny, EPA

10:00–10:30
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

10:30–10:45
Break

10:45
Session 4: The Risk Context

10:45–11:15
Exposure and Dosimetry Considerations for AOPs
John Wambaugh, EPA

11:15–11:45
Ozone-Induced Lung Inflammation and Injury: From Mechanism to Adversity in Humans
Robert Devlin, EPA

11:45–12:15
Suspected Modes of Action Affected by Pesticides Exposure: Informing an Adverse Outcomes Pathway (AOP) for Cancer
Michael Alavanja, U.S. National Cancer Institute

12:15–1:15
Lunch

1:15–1:30
Introduction to Breakout Groups

1:30–3:00
Breakout Group Discussions (First Rotation)

1. The Process of Regulatory Acceptance 
    Moderators:
    David Dix, EPA
    Craig Rowlands, Dow Chemical Company

Case Study Presentations (8-10 min each):

  • What is the process for AOP development, peer review and application within OECD? How do you go from OECD acceptance to agency acceptance?
    Christine Olinger, EPA, U.S. National Coordinator, OECD Test Guidelines Programme
  • How do we establish scientific confidence in AOPs?
    Craig Rowlands, Dow Chemical Company
  • How are the critical relationships between chemical bioavailability, activity, and adversity established within an AOP in a way that protects the most sensitive subpopulations?
    Ruthann Rudel, Silent Spring Institute

2. Using AOPs for Regulatory Decisions: Confidence and Criteria
    Moderators:
    Suzanne Fitzpatrick, FDA
    Annie Jarabek, EPA

Case Study Presentations (8-10 min each):

  • Contaminants in the Food Supply: How the AOP Concept Can Help Regulators Make Decisions Using Arsenic as a Case Study
    Christina Powers, EPA
  • Considerations for Using AOPs in Human Health Risk Assessment of Environmental Contaminants
    Annie Jarabek, EPA
  • Using Evidence-Based Toxicology to Evaluate AOPs
    ​Thomas Hartung, CAAT

3. Taking Qualitative AOPs to the Next (Quantitative) Level
    Moderators:
    Nicole Kleinstreuer, ILS/NICEATM
    Kristie Sullivan, Physicians Committee for Responsible Medicine

Case Study Presentations (8-10 min each):

  • Case study Presentation: 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
  • Quantitative Literature Mining for AOP Development
    David Wild, University of Indiana

3:00–3:15
Break

3:15–4:45
Breakout Group Discussions (Participants rotate to a new group)

4:45–5:00
Break

5:00–6:00
Short Presentations by Junior Investigators With Outstanding Poster Abstracts
End of Day Wrap-Up

6:00–8:00
Poster Session and Independently Sponsored Reception

Friday, September 5, 2014

9:00–10:30
Breakout Group Discussions (Third and final rotation)

10:30–10:45
Break

10:45–12:00
Hands-on Demonstration/Training (AOP Wiki/Effectopedia)

12:00–1:30
Lunch

1:30–4:00
Breakout Group Reports and Facilitated Whole-Group Discussion

4:00
Adjourn

See NTP's website for more information.

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