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

Speaker: TBA

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, GlaxoSmithKline

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 Activity
Susan 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
Sean Hays, 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

Update Session: NIEHS-NTP

Linda Birnbaum, NIEHS-NTP

8:30 AM12:00 Noon SESSION: Alternatives to PFASs: Perspectives on the Science
8:30 AM–9:00 AM Analytical Methods Presentation
TBA - Academic
9:00 AM–9:30 AM

Exposure Data on Where We Are Seeing PFAS   
TBA - Academic/NGO

9:30 AM10:00 AM

Hazard Data and/or PBPK Modeling for Short Chain PFASs
TBA - Industry

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

Current Ongoing Research on Short Chain PFAS

11:00 AM11:30 AM

Regulatory Perspective on the EPA Phaseout of Long-Chain but Allowing Short-Chain
TBA - US EPA Risk Manager

11:30 AM12:00 Noon

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

12:00 Noon12:30 PM

Philippe Shubik Award Lecture

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
Oliver 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
Cian O’Mahony, Crème Global
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

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

8:30 AM8:55 AM

Nonclinical Case Study for an SDLT Therapeutic
Daniel LapadulaNovartis 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 + Alisa Vespa, Heath Canada; 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 Kerry Blanchard

10:30 AM–11:00 AM Automated 3D Stem Cell Profiling of Drug Candidates for Identification of Developmental Toxicity
Claudia McGinnis, Roche

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