Appendix C
Symposium Agenda

TOXICITY-PATHWAY-BASED RISK ASSESSMENT: PREPARING FOR PARADIGM CHANGE


Public Meeting: May 11-13, 2009

National Academy of Sciences

2101 Constitution Avenue, NW

Washington, DC 20418


MONDAY, MAY 11, 2009

A PARADIGM CHANGE ON THE HORIZON

8:30

Welcome and Introduction

 

Warren Muir

Executive Director, Division on Earth and Life Studies

National Academies

8:35

Background on Standing Committee on Risk Analysis Issues and Reviews

 

Bernard Goldstein

Chair, Standing Committee on Risk Analysis Issues and Reviews

Professor, Department of Environmental and Occupational Health

University of Pittsburgh

8:40

EPA Expectations on Symposium

 

Peter Preuss

Director, National Center for Environmental Assessment

U.S. Environmental Protection Agency



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Appendix C Symposium Agenda TOXICITY-PATHWAY-BASED RISK ASSESSMENT: PREPARING FOR PARADIGM CHANGE Public Meeting: May 11-13, 2009 National Academy of Sciences 2101 Constitution Avenue, NW Washington, DC 20418 MONDAY, MAY 11, 2009 A PARADIGM CHANGE ON THE HORIZON 8:30 Welcome and Introduction Warren Muir Executive Director, Division on Earth and Life Studies National Academies 8:35 Background on Standing Committee on Risk Analysis Issues and Reviews Bernard Goldstein Chair, Standing Committee on Risk Analysis Issues and Reviews Professor, Department of Environmental and Occupational Health University of Pittsburgh 8:40 EPA Expectations on Symposium Peter Preuss Director, National Center for Environmental Assessment U.S. Environmental Protection Agency 63

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64 Toxicity-Pathway-Based Risk Assessment: A Symposium Summary 8:45 Making Risk Assessment More Useful to Public and Private Decision- Makers in an Era of Paradigm Change E. Donald Elliott Member, Board on Environmental Studies and Toxicology National Academies Former EPA General Counsel 9:15 Emerging Science and Public Health Lynn Goldman Member, Symposium Planning Committee Member, Standing Committee on Risk Analysis Issues and Reviews Professor and Chair, Environmental Health Sciences Johns Hopkins Bloomberg School of Public Health Toxicity Testing in the 21st Century 9:45 Kim Boekelheide Professor of Medical Sciences Brown University 10:15 Symposium Roadmap Lorenz Rhomberg Chair, Symposium Planning Committee Member, Standing Committee on Risk Analysis Issues and Reviews Principal, Gradient Corporation 10:45 Break THE NEW SCIENCE Moderator: Lorenz Rhomberg, Chair, Symposium Planning Committee; Member, Standing Committee on Risk Analysis Issues and Reviews; Principal, Gradient Corporation 11:00 Overview of New Science John Groopman Anna M. Baetjer Professor of Environmental Health and Chair Department of Environmental Health Sciences Johns Hopkins Bloomberg School of Public Health

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65 Appendix C 11:30 Gene-Environment Interactions George Leikauf Member, Symposium Planning Committee Professor, University of Pittsburgh 12:00 Tools and Technologies for Pathway-Based Research Ivan Rusyn Associate Professor, Department of Environmental Science and Engineering University of North Carolina at Chapel Hill 12:30 Lunch PATHWAY-BASED APPROACHES FOR HAZARD ID Moderator: Michael Lawton, Member, Symposium Planning Committee; Associate Research Fellow, Head, Molecular Toxicology Group, Pfizer, Inc. 1:30 ToxCast: Redefining Hazard Identification Robert Kavlock Director, National Center for Computational Toxicology U.S. Environmental Protection Agency 2:00 Practical Applications: Pharmaceuticals William Pennie Executive Director, Compound Safety Prediction Worldwide Medicinal Chemistry Pfizer Global Research and Development 2:30 Practical Applications: Consumer Products George Daston Research Fellow Procter & Gamble Company 3:00 Break 3:15 Practical Applications: Mixtures John Groten Vice President, Drug Safety Europe Schering-Plough

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66 Toxicity-Pathway-Based Risk Assessment: A Symposium Summary 3:45 Pathway-Based Approaches: A European/REACH Perspective Thomas Hartung Director, Center for Alternatives to Animal Testing Johns Hopkins University 4:15 Panel Discussion Panelists: Speakers and invited panelists (Charles Auer, former Director, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency (retired); David Jacobson-Kram, Associate Director for Pharmacology and Toxicology, U.S. Food and Drug Administration) 5:00 Break 5:30 Poster Session 7:00 Adjourn TUESDAY, MAY 12, 2009 APPLICATION TO MODE-OF-ACTION ANALYSIS Moderator: Lauren Zeise, Member, Symposium Planning Committee; Chief, Reproductive and Cancer Hazard Assessment Section, California Environmental Protection Agency 8:30 What is Required for Acceptance John Bucher Associate Director, National Toxicology Program National Institute of Environmental Health Sciences 9:00 Environmental Disease: Evaluation at the Molecular Level Kenneth Ramos Distinguished Professor, Department of Biochemistry and Molecular Biology University of Louisville Health Science Center 9:30 Dioxin: Evaluation of Pathways at the Molecular Level Alvaro Puga Professor University of Cincinnati

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67 Appendix C 10:00 Systems Level Approaches for Understanding Principals of Nanomaterial Biocompatibility Brian Thrall Technical Group Leader, Cell Biology Group Pacific Northwest National Laboratory 10:30 Break 11:00 Panel Discussion Panelists: Speakers and invited panelists (William Kaufmann, Professor of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill; Jonathan Wiener, Perkins Professor of Law and Professor of Environmental Policy & Public Policy Studies, Duke University; Past President, Society for Risk Analysis) 12:00 Lunch CHALLENGES AND OPPORTUNITIES FOR RISK ASSESSMENT IN THE CHANGING PARADIGM Moderator: Joel Pounds, Member, Symposium Planning Committee; Senior Staff Scientist, Advisor to the Environmental Biomarkers Initiative, Pacific Northwest National Laboratory 1:00 Dose and Temporal Response Elaine Faustman Member, Symposium Planning Committee Professor, Environmental and Occupational Health University of Washington 1:30 Application of Genomic Dose-Response Data to Define Mode-of- Action and Low-Dose Behavior of Chemical Toxicants Rusty Thomas Director, Functional Genomics The Hamner Institutes for Health Sciences 2:00 Using PBPK Models to Interpret Dose-Response of –Omics Data Gregory L. Kedderis Independent Researcher and Consultant Chapel Hill, North Carolina

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68 Toxicity-Pathway-Based Risk Assessment: A Symposium Summary 2:30 Modular Network Modeling of Toxicity Pathways for Extrapolation Katrina Waters Senior Research Scientist, Computational Biology & Bioinformatics Pacific Northwest National Laboratory 3:00 Break 3:15 Integrating Global Gene Expression and Survival Across 60 Cell Lines: Applications for Risk Assessment Albert J. Fornace, Jr. Professor, Department of Biochemistry and Molecular and Cellular Biology, Biomedical Graduate Research Organization; Department of Oncology, Lombardi Comprehensive Cancer Center Georgetown University 3:45 The FDA Experience in Analyzing Genomic Data Federico Goodsaid Associate Director for Operations in Genomics U.S. Food and Drug Administration 4:15 Panel Discussion 5:30 Adjourn WEDNESDAY, MAY 13, 2009 WHAT THE FUTURE HOLDS Moderator: Lorenz Rhomberg, Chair, Symposium Planning Committee; Member, Standing Committee on Risk Analysis Issues and Reviews; Principal, Gradient Corporation 8:30 Are we “there” yet and Where is “there”? The Path Forward (1, 5, and 10 years in the future) A Perspective from EPA Peter Preuss Director, National Center for Environmental Assessment U.S. Environmental Protection Agency

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69 Appendix C A Perspective from NIEHS John Bucher Associate Director, National Toxicology Program National Institute of Environmental Health Sciences A Perspective from the Chemical Industry Tina Bahadori Managing Director Long Range Research Initiative American Chemistry Council A Perspective from the Pharmaceutical Industry Roger Ulrich Chief Development Officer Calistoga Pharmaceuticals, Inc. A Perspective from Academia Helmut Zarbl Professor of Environmental and Occupational Medicine University of Medicine and Dentistry of New Jersey A Perspective from an Environmental Advocacy Group Gina Solomon Senior Scientist Natural Resources Defense Council 10:30 Break 10:45 Panel Discussion 11:45 Symposium Close Lorenz Rhomberg Chair, Symposium Planning Committee Member, Standing Committee on Risk Analysis Issues and Reviews Principal, Gradient Corporation 12:00 Adjourn