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2018 Winter Meeting Agenda



Organizing Committee Members


Cynthia Rider, NIEHS-NTP (Chair)
Bethany Hannas, Dow Chemical Company (Co-Chair)
Virunya Bhat, NSF International
Christine Crincoli, Cargill
Rhiannon Hardwick, Theravance
Syed Imam, US FDA-NCTR
John Lipscomb, US EPA-NHSRC
Ed Ohanian, US EPA-OW
Julia Rager, ToxStrategies, Inc.
Leslie Steen, US FDA-CFSAN


Detailed Program Schedule By Day



Monday, January 29


8:00 AM–9:00 AM

An Open Discussion of Science Communication
Speaker: Julia Belluz, VOX Media

9:00 AM–12:00 Noon

SESSION: After 50+ Years, Is There a More Effective and Efficient Alternative to the Chronic Rodent Cancer Bioassay?

Moderated by Vicki Dellarco and Suzanne Fitzpatrick

9:00 AM–9:25 AM History of the Rodent Cancer Bioassay and Regulatory Use 
A. Wallace Hayes, Harvard University
9:25 AM–9:50 AM Rodent Cancer Bioassays Are Not Necessary for Protection of Public Health
Douglas Wolf, Syngenta Crop Protection, Inc.
9:50 AM–10:20 AM BREAK
10:20 AM–10:45 AM Moving towards an Integrated Alternative Testing Paradigm to Identify Carcinogenic Hazards
Russell Thomas, US EPA-NCCT

10:45 AM–11:10 AM Exploring Integrative and Alternative Strategies for Carcinogenicity Testing in Chemical and Pharmaceutical Risk Assessment
Brian Berridge, NIEHS/NTP

11:10 AM–12:00 Noon Moderated Panel Discussion
(Included with Registration) 
1:00 PM–3:30 PM

SESSION: Key Characteristics of Carcinogens: Refining Approaches to Systematic Evaluations of Mechanistic Data

Moderated by Brian Hughes and Susan Borghoff

1:00 PM–1:30 PM Identification of Mechanistic Data According to Key Characteristics of Carcinogens (KCC) and Review of Studies for Reliability, Relevance, and ActivitySusan Borghoff, ToxStrategies, Inc.

1:30 PM–2:00 PM Using Computational Data and High-Throughput Testing (ToxCast Data) in Support of the KCC
Weihsueh Chiu, Texas A&M University

2:00 PM–2:30 PM Case Studies for Integrating Data Collected to Build MOA/AOP and Identify Data Gaps
Nikolai Chepelev, Health Canada
2:30 PM–3:00 PM Consensus Building through Crowd-Sourced Expert Review
Chris Kirman, SciPinion
3:00 PM–3:30 PM Moderated Panel Discussion
3:30 PM4:00 PM BREAK
4:00 PM–6:00 PM

SESSION: Sufficient Similarity of Complex Substances and Mixtures: From Case Studies to Application

Moderated by Cynthia Rider

4:00 PM4:30 PM Evaluating the Similarity of Complex Drinking-Water Disinfection By-Product Mixtures: Overview of the Issues
Glenn Rice, US EPA

4:30 PM5:00 PM How Similar Is Similar Enough? Sufficient Similarity Case Studies with Botanical Dietary Supplements
Cynthia Rider, NIEHS-NTP

5:00 PM5:30 PM Grouping of UVCBs Using Chemical-Biological Read-Across: Case Study of Petroleum Substances
Ivan Rusyn, Texas A&M University

5:30 PM6:00 PM Moderated Panel Discussion
(Included with Registration) 


Tuesday, January 30


8:00 AM–8:30 AM

NIEHS and NTP: Advancing Environmental Health Science

Linda Birnbaum, NIEHS-NTP

8:30 AM12:00 Noon SESSION: Alternatives to PFASs: Perspectives on the Science

Moderated by Mark Miller

8:30 AM–9:00 AM Per- and Poly-Fluorinated Products, Structure, Classification, Properties and Analytical Challenges
Steve Korzeniowski, FluoroCouncil
9:00 AM–9:30 AM

Research Challenges Associated with PFASs: Ubiquitous Multisystem Toxicants  
Jamie Dewitt, East Carolina University

9:30 AM10:00 AM

The Persistence of Fluorinated Chemicals in Food Wrappers and Consumer Products
David Andrews, Environmental Working Group

10:00 AM–10:30 AM BREAK
10:30 AM–11:00 AM

Class Comparison of PFAS Sulfonates (PFBS, PFHxS, PFOS) and Carboxylates (PFHxA, PFOA, PFNA, PFDA) after a 28-Day Exposure in Hsd:Sprague Dawley Rats
Chad Blystone, NIEHS/NTP

11:00 AM–11:30 AM

Current and Future Remediation Options for Reducing Exposure and Protecting Human Health from PFAS Contamination
Andrea Leeson, US Strategic Environmental Research and Development Program

11:30 AM12:00 Noon

Moderated Panel Discussion 
Panel with perspectives on whether short-chain PFASs are a safer alternative or an unfortunate substitution?

12:00 Noon12:30 PM

Philippe Shubik Award Lecture: The Importance of Aggregate Exposure and TTC in Fragrance Material Safety Assessments
Anne Marie Api, Research Institute for Fragrance Materials

12:30 PM–1:30 PM Attendee Luncheon
(Included with registration)
1:30 PM2:00 PM UPDATE: Cross-Sector Partnerships As a Driver for Liver Toxicity Modeling Platform DILIsym
Paul Watkins, University of North Carolina - Chapel Hill
2:00 PM–5:30 PM

SESSION: Putting Models to Work: When Can We Actually Use High-Throughput Exposure Estimates?

Moderated by Caroline Ring and John Wambaugh

2:00 PM–2:30 PM High-Throughput Exposure Estimates and High-Throughput In Vitro Screening: How to Combine Them for High-Throughput Risk-Based Chemical Prioritization
Caroline Ring, ToxStrategies, Inc.

2:30 PM–3:00 PM High-Throughput Modeling of Near- and Far-Field Exposure to Chemicals in Consumer Products
Olivier Jolliet, University of Michigan

3:00 PM–3:30 PM BREAK
3:30 PM–4:00 PM Use of High-Throughput Exposure Tools for TSCA Implementation
Cathy Fehrenbacher, US EPA-OPPT
4:00 PM–4:30 PM High-Tier Multi-Route Aggregate Exposure Assessment for Fragrance Materials
Anne Marie Api, RIFM
4:30 PM–5:00 PM Predicting Exposure Pathways Allows Risk-Based Prioritization
John Wambaugh, US EPA-NCCT
5:00 PM–5:30 PM Moderated Panel Discussion
(Included with Registration) 


Wednesday, January 31


8:00 AM–10:00 AM

SESSION: Evaluation of Therapeutics for the Treatment of Severely-Debilitating or Life-Threatening Diseases

Moderated by Judith Prescott

8:00 AM8:05 AM

Proposal for International Regulatory Guidance for the Development of SDLT Disease Therapeutics
Judith Prescott, Merck & Co., Inc.

8:05 AM8:30 AM

Proposal for Development of Pharmaceuticals for Severely Debilitating and Life Threatening Indications
Daniel LapadulaNovartis Institutes for Biomedical Research

8:30 AM8:55 AM

Rare, Fatal, and In Babies: The SDLT ‘Perfect Storm’ of Spinal Muscular Atrophy and LMI070 Therapy
Ronenn Roubenoff, Novartis Institutes for Biomedical Research

8:55 AM9:30 AM

FDA-OHOP Regulatory Perspective on Development of SDLT Disease Therapeutics
Haleh Saber, US FDA-CDER

9:30 AM10:00 AM

Moderated Panel Discussion
All Speakers + Karen Davis-Bruno, US FDA-CDER; Joseph DeGeorge, Merck & Co., Inc.; Timothy Hart, GlaxoSmithKline; and Jennifer Goldman, Rush University

10:00 AM–10:30 AM BREAK
10:30 AM–2:00 PM

SESSION: Use of Alternative Embryo-Fetal Development Assays for Potential Regulatory Acceptance 

Moderated by Jose Lebron

10:30 AM–11:00 AM Application of a Human Pluripotent Stem Cell-Based Assay for Developmental Toxicity Screening
Jessica Palmer, Stemina Biomarker Discovery, Inc.

11:00 AM–11:30 AM Zebrafish Assay for the Assessment of Potential Developmental Toxicity
Karen Augustine, Bristol-Myers Squibb
11:30 AM–12:00 Noon Assay Development Challenges and Considerations When Developing Exposure-Based Alternative Developmental Toxicity Assays to Assess the Teratogenic Potential of Drugs
Maia Green, Merck & Co., Inc.
12:00 Noon–12:30 PM BREAK  

12:30 PM–1:00 PM Computational Embryology As a Translational Tool for Modeling In Vitro Data
Thomas Knudsen, US EPA-NCCT
1:00 PM1:30 PM Regulatory Expectations on the Qualification of Alternative Assays for Regulatory Decision Making 
Paul Brown, US FDA-CDER

1:30 PM–2:00 PM Moderated Panel Discussion - "How to Address ICH S5 (R3) Step 2 Regarding Alternative Assays"
All Speakers + Thomas Hartung, Center for Alternatives to Animal Testing; Mary Ellen McNerney, Bristol-Myers Squibb