FutureTox III: Bridges for Translation

Transforming 21st Century Science into Risk Assessment and Regulatory Decision-Making

November 19–20, 2015 | Arlington, Virginia

This is the third meeting in a series that began in 2012 to address the topic “Transforming 21st Century....” This event was held November 19–20, 2015, in Arlington, Virginia, and was developed by the Scientific Liaison Coalition.

Abstracts and Poster Presentations

The Abstracts and Poster Presentations were not included in the printed Program book. Please use the Abstract and Poster Presentation On-Demand option to download abstracts (select abstracts to include and sort criterium).

Attendee List

FutureTox III Attendee List

Program

FutureTox III Program

Program Agenda

Vision and Background

The 21st Century vision and strategy for assessing toxicity (TT21C science or Tox21 hereafter) was developed with the intent to increase throughput, decrease cost, and optimize chemical data collection for increased utility and relevance to inform chemical safety decision-making. Central to this strategy is the ability to predict human health risks from emerging ‘‘big data” and novel in vitro data collections using in silico models for exposure and hazard assessment. Automated high-throughput screening (HTS) and high-content screening (HCS) of large chemical inventories, together with newer complex culture models utilizing human cells, microtissue systems, and integrative models, are now providing vast amounts of data that can be used to inform regulatory toxicity testing. These methods, together with novel approaches to model exposure and kinetics, creates an opportunity for a paradigm shift toward diversified and high-throughput risk assessment (HTRA) approaches for regulatory decision-making. Overall, the approach results in more rapid, more relevant, and more nimble discovery-screening and prioritization efforts with less reliance on animal testing. The time is right to discuss and debate how TT21C science, approaches, and technologies will be applied in risk assessment and regulatory decision-making.

“FutureTox” was a Society of Toxicology Contemporary Concepts in Toxicology (SOT CCT) conference held in 2012 that focused on challenges and opportunities associated with implementing 21st Century toxicity testing technologies and tools into improved, science-informed hazard prediction and risk assessment. It was followed in 2014 by “FutureTox II,” a CCT that focused on the science to advance an outcome paradigm where improvements to predictivity and concordance are based solely on in vitro/in silico approaches. FutureTox III is a CCT focusing on building the high throughput risk assessment paradigm, taking the science of in vitro data and in silico models forward; thus, the conference will explore the central question: What progress is being made to address challenges in implementing the emerging ‘big-data’’ toolbox for regulatory decision-making? The TT21C testing paradigm provides a sustainable solution for tomorrow’s challenges in “creating a safer and healthier world by advancing the science and increasing the impact of toxicology” (SOT’s mission).

Conference Location

This SOT CCT, FutureToxIII, was held November 19–20, 2015, at the Hilton Hotel Crystal City at Washington Reagan National Airport, Arlington, Virginia, in close proximity to Washington, DC.

Speaker Presentations

Program: Thursday, November 19, 2015

To access any of the presentations, click on the title below.

8:30 AM–9:00 AM	Greeting and Conference Charge Daland R. Juberg, PhD, Chair, Dow AgroSciences, Indianapolis, Indiana, USA Peter L. Goering, SOT 2015−2016 President, US Food and Drug Administration, Silver Spring, Maryland, USA George P. Daston, PhD, SOT Council Contact, Procter & Gamble Company, Cincinnati, Ohio, USA Thomas B. Knudsen, PhD, Co-Chair, US Environmental Protection Agency, Research Triangle Park, North Carolina, USA
9:00 AM–10:00 AM	Keynote Lecture 1 Agency Perspective on 21st Century Approaches in Regulatory Decisions Jim Jones, Assistant Administrator, US Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, DC, USA
	Keynote Lecture 2 High Throughput Risk Assessment—What’s It Good For? Maurice Whelan, PhD, Head of System Toxicology Unit, European Commission, Joint Research Centre—Ispra, Italy
10:15 AM–12:15 PM	Plenary Session I—Hazard Characterization Using Tox21 Tools/Approaches Session will cover new hazard identification/characterization approaches that are underpinned and informed by more traditional approaches (e.g., animal testing) and pathway-based mechanisms: (1) approaches for mechanistic understanding of the ways in which chemicals and pharmaceutical agents perturb biological systems, leading to adverse outcomes; (2) integrative analytical tools and computational strategies for gaining mechanistic knowledge of biological networks; (3) identification and application of biomarkers for improved safety assessments; and (4) systems-based approaches for more quantitative evaluation of adverse outcome pathways (AOPs). Chairs: John “Jack” R. Fowle III, PhD, DABT, Science to Inform, LLC, Pittsboro, North Carolina, USA; and Raymond R. Tice, PhD, National Institute of Environmental Health Sciences/National Toxicology Program, Durham, North Carolina (Retired); and Discussant Leader: Suzanne Compton Fitzpatrick, PhD, DABT, US Food and Drug Administration, College Park, Maryland How Tox21 Risk Assessments Can Help Bridge Risk Management Uncertainties Facing 21st Century Regulatory Decisions Steven P Bradbury, PhD, Steven P. Bradbury and Associates, Washington DC, USA AOP Framework and OECD Knowledgebase Development Dan Villenueve, PhD, National Health and Environmental Effects Research Laboratory, US Environmental Protection Agency, Duluth Minnesota, USA Identification, Application, and Regulatory Qualification of New Translational Kidney Biomarkers for Improved Safety Assessment in Drug Development Frank D Sistare, PhD, Merck & Co. Inc, West Point, Pennsylvania, USA Systems-Based Approaches for More Quantitative Evaluation of AOPs Richard J Brennan, PhD, DABT Sanofi, Waltham, Massachusetts, USA
1:30 PM–4:30 PM	Plenary Session II—Exposure Characterization Using Tox21 Tools/Approaches Session covers: (1) a systems approach to exposure modeling (ExpoCast); (2) high-throughput PBPK models; (3) new approaches/concepts such as IVIVE, biomonitoring equivalents, toxicokinetic use in dose-setting, and informing on non-linearity in dose-response, and (4) lifestage-specific considerations in susceptibility. Chairs: David Watson, MBA, Lhasa Limited, Leeds, United Kingdom; and Ronald N. Hines, MS, PhD, US Environmental Protection Agency, Research Triangle Park, North Carolina, USA; and Discussant Leader: Barbara Anne Wetmore, PhD, The Hamner Institutes for Health Sciences, Research Triangle Park, North Carolina A Systems Approach to Exposure Modeling (ExpoCast) John Wambaugh, PhD, National Center for Computational Toxicology—US EPA, Research Triangle Park, North Carolina, USA High-Throughput PBPK Models Jos G.M. Bessems, PhD, ERT, Consultancy, Azzio, Italy (previously European Commission, DG Joint Research Center, Ispra, Italy)
	New Approaches/Concepts such as IVIVE, Biomonitoring Equivalents, Toxicokinetic Use in Dose-Setting, and Informing on Non-Linearity in Dose-Response Miyoung Yoon, PhD, Center for Human Health Assessment The Hamner Institutes for Health Sciences, Research Triangle Park, North Carolina, USA Lifestage-Specific Considerations in Susceptibility Melissa Runge-Morris, MD, Wayne State University, Institute of Environmental Health Sciences, Detroit, Michigan, USA
4:00 PM	First Day Rapporteur Tina Bahadori, DSc, US Environmental Protection Agency, Office of Research and Development, Washington, DC, USA
4:30 PM–6:00 PM	Poster Reception: Introduction and Awards Presentation: Nicole C. Kleinstreuer, PhD, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods Display and discussion of posters and recognition of award recipients Chairs: Elaine M. Faustman, PhD, DABT, University of Washington, Seattle, Washington USA; Thomas Knudsen, PhD, National Center for Computational Toxicology—US EPA, Research Triangle Park, North Carolina, USA; and Emmanuel Lemazurier, PhD, INERIS, Paris, France

Program: Friday, November 20, 2015

8:15 AM–8:30 AM	Welcome
8:30 AM–10:15 AM	Plenary Session III—21st Century Risk Assessment—Program-Specific Considerations on How New Approaches Can Impact Regulatory-Decision Making The regulatory laws and expectations are different for drugs, medical devices, and chemicals. The talks in this session will provide insight into these differences and begin the discussion of how Tox21-type approaches may help in regulatory-decision making. Speakers will cover regulatory programs at the FDA and EPA, provide the viewpoint from US FDA- and US EPA-regulated industries, and discuss perspectives from academia. Chair: Thomas Hartung, MD, PhD, Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing, Baltimore, Maryland, USA; and Douglas A. Keller, PhD, DABT, Sanofi, Bridgewater, New Jersey USA; and Discussant Leader: Patience Browne, PhD, US Environmental Protection Agency, Endocrine Disruptor Screening Program, Washington, DC US FDA David Strauss, MD, PhD, US Food and Drug Administration, Silver Spring, Maryland, USA US EPA David J. Dix, PhD, US Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Washington, DC, USA Pharmaceutical Industry Russell T. Naven, Takeda Pharmaceuticals International Co. Cambridge, Masschusetts, USA
10:15 AM–12:15 AM	Chemical/Consumer Products Industry George P. Daston, PhD, Procter & Gamble, Cincinnati, Ohio, USA Academia Elaine M. Faustman, PhD, University of Washington, Seattle, Washington, USA EU/REACH Emmanuel Lemazurier, PhD, INERIS, Paris, France Breakout Group Introduction and Discussant Leader : Nancy B. Beck, PhD, DABT, American Chemistry Council, Washington, DC
1:00 PM–2:45 PM	Breakout Groups Will address four key areas in regulatory toxicology and safety assessment within the context of scientific drivers where new methodologies can improve safety assessment in: Drug Development : David Watson, MBA, (Moderator) Identifying Endocrine Active Chemicals for Environmental Health Protection Using Pathways-Based Approaches for Screening and Testing : Warren Casey, PhD, DABT, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA (Moderator) TSCA Reform: Catherine Willett, PhD, The Humane Society of the United States, Washington, DC, USA (Moderator) Impact on Global Harmonization : Donna L. Mendrick, PhD, US Food and Drug Administration, Silver Spring, Maryland, USA (Moderator)
3:00 PM–3:45 PM	Breakout Group Reports
3:45 PM–4:00 PM	Wrap-up and Program Closing Kevin Michael Crofton, PhD, US Environmental Protection Agency, National Center for Computational Toxicology, Research Triangle Park, North Carolina, USA

Organizing Committee

Daland R. Juberg, Chair, Dow AgroSciences, Indianapolis, Indiana, USA
Thomas B. Knudsen,Co-Chair, US Environmental Protection Agency, Research Triangle Park, North Carolina, USA
Richard A. Becker, American Chemistry Council, Washington, DC, USA
Elaine M. Faustman, University of Washington, Seattle, Washington, USA
Suzanne Compton Fitzpatrick, US Food and Drug Administration, College Park, Maryland
John R. “Jack” Fowle III, Science to Inform, LLC, Pittsboro, North Carolina, USA
Alison Harrill, University of Arkansas for Medical Sciences, Little Rock, Arkansas, Contemporary Concepts in Toxicology Committee Liaison
Thomas Hartung, Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing, Baltimore, Maryland, USA
Ronald N. Hines, US Environmental Protection Agency, Research Triangle Park, North Carolina, USA
Douglas A. Keller, Sanofi, Bridgewater, New Jersey, USA
Emmanuel Lemazurier, INERIS-Chronic Risk Division, Vernueil-en-Halatte, France
John C. Lipscomb, US Environmental Protection Agency, Cincinnati, Ohio, USA
Donna L. Mendrick, US Food and Drug Administration, Silver Spring, Maryland, USA
Raymond R. Tice, National Institute of Environmental Health Sciences/National Toxicology Program, Durham, North Carolina, USA (Retired)
David Watson, Lhasa Limited, Leeds, United Kingdom
George P. Daston, SOT Council Contact, Procter & Gamble Company, Cincinnati, Ohio, United States