Past Event

Strategies and Tools for Conducting Systematic Reviews of Mechanistic Data to Support Chemical Assessments

Workshop
December 10, 2018 - December 11, 2018

Location: National Academy of Sciences Building
2101 Constitution Ave NW Washington DC 20418



Download the posters shown during the event (46 MB download, PDF)

The National Academies of Sciences, Engineering, and Medicine will be holding a workshop on current state-of-the-art in performing systematic reviews of mechanistic data to support chemical assessments. Topic areas include:

-- Approaches and tools to search and screen the literature for mechanistic data,
-- Approaches to evaluating the validity of mechanistic studies,
-- Methods for assimilating and using mechanistic information to support evidence synthesis and integration, and
-- Practical experience with implementing systematic reviews of mechanistic evidence into human health assessments.

The objective of the workshop is to explore relevant strategies and tools that are being developed and used across the systematic review and risk assessment communities to assist the US Environmental Protection Agency with developing guidance on performing systematic reviews of mechanistic data to support the chemical assessments in its Integrated Risk Information System program. A poster session will accompany the workshop that will have examples demonstrating the application of systematic review approaches to mechanistic data.

Workshop Committee:
Ivan Rusyn, Texas A&M University (Chair)
Richard Corley, Greek Creek Toxicokinetics Consulting, LLC
Ana Navas-Acien, Columbia University
Andrew Rooney, National Toxicology Program
Holger Schunemann, McMaster University
Peter Thorne, University of Iowa
Katya Tsaioun, Johns Hopkins University
Joyce Tsuji, Exponent, Inc.


Click the presentation title to download a PDF of the presentation slides. Click the "video" link to watch video from the event.

 

Welcome and Overview of the Workshop | Video

Ivan Rusyn, Texas A&M University


Systematic Review:  Best Practices and Special Considerations for Mechanistic Data | Video

Holger Schünemann, McMaster University


The Systematic Review of Mechanistic Data in IRIS Assessments | Video

Catherine Gibbons, US Environmental Protection Agency

 


SESSION 1:  Problem Formulation for Evaluating Mechanistic Data


Principles of Problem Formulation and Approaches to Considering Mechanistic Data | Video

Julian Higgins, University of Bristol


Problem Formulation: Lessons and Tools from Practical Applications Involving Systematic Review of Mechanistic Data | Video

Daniele Wikoff, ToxStrategies


Panel Discussion | Video:

Moderator:  Holger Schünemann, McMaster University

Discussants: Session 1 Speakers; Andrew Rooney, National Toxicology Program; Maureen Gwinn, US Environmental Protection Agency

 


SESSION 2:  Approaches to Evaluating the Validity of Mechanistic Studies


Consideration of Internal and External Validity in Mechanistic Studies | Video

Andrew Rooney, Office of Health Assessment and Translation, National Toxicology Program


Quality Assessment of Big and Complex Data in Pharmaceutical Target and Chemical Safety Assessment | Video

Matthew Martin, Pfizer Drug Safety Research & Development


OECD Good In Vitro Method Practices (GIVIMP) Guidance and Its Implementation | Video

Sandra Coecke, European Commission Joint Research Centre


The SciRAP Tool for Evaluating the Quality of In Vitro Studies | Video

Anna Beronius, Karolinska Institutet


Panel Discussion | Video:  

Moderator:  Ivan Rusyn, Texas A&M University

Discussants:  Session 2 Speakers; David Dorman, North Carolina State University; Julian Higgins, University of Bristol; Tala Henry, US Environmental Protection Agency

 

Welcome, Day 2 | Video
Ivan Rusyn, Texas A&M University


SESSION 3:  Assimilating and Using Mechanistic Information to Support Evidence Synthesis and Integration


Experiences with the Mode-of-Action Framework as an Organizing Framework for Mechanistic Data | Video

James Klaunig, Indiana University


Development and Use of Quantitative Adverse Outcome Pathways: Lessons Learned from Application to Cardiotoxicity | Video

Weihsueh Chiu, Texas A&M University


The Key Characteristics Approach to Evaluating Mechanistic Data in Hazard Identification and Risk Assessment | Video

Martyn T. Smith, University of California, Berkeley


GRADE Evidence-to-Decision Frameworks for Considering Mechanistic Data with Animal and Human Data to Support Evidence Synthesis and Integration | Video

Holger Schünemann, McMaster University


Panel Discussion | Video

Moderator:  Joyce Tsuji, Exponent

Discussants:  Session 3 Speakers; David Dorman, North Carolina State University; Heather Lynch, Gradient Corporation; Elizabeth Méndez, US Environmental Protection Agency

 


SESSION 4:  Practical Experience with Implementing Systematic Reviews of Mechanistic Evidence into Human Health Assessments


Integrating Mechanistic Evidence into TCEQ Assessments | Video

Sabine Lange, Texas Commission on Environmental Quality


Approaches Used to Integrate Mechanistic Data into the Report on Carcinogens by the National Toxicology Program | Video

Amy Wang, Office of the Report on Carcinogens, National Toxicology Program


Implementing Systematic Review Methods and Approaches in TSCA Risk Evaluations | Video

Iris Camacho, US Environmental Protection Agency


Panel Discussion | Video:

Moderator: Katya Tsaioun, Johns Hopkins University

Discussants:  Session 4 Speakers; Daniele Wikoff, ToxStrategies; Heather Lynch, Gradient Corporation; Andrew Kraft, US Environmental Protection Agency

 


Closing Remarks | Video

Ivan Rusyn, Texas A&M University