43rd Annual Summer Meeting Agenda



Organizing Committee Members


Laurie Haws, ToxStrategies, Inc. (Chair)
Cynthia Rider, NIEHS-NTP (Co-Chair)
Rebecca Fry, University of North Carolina, Chapel Hill
Bethany Hannas, Dow Chemical Company
Alison Harrill, NIEHS
Jeffrey Moffit, Bioverativ
George Pugh, The Coca-Cola Company
Szabina Stice, US FDA-CFSAN
John Wambaugh, US EPA-NCCT


Detailed Program Schedule By Day



Monday, July 10


9:00 AM–10:00 AM

Advancing Regulatory Toxicology at the US FDA

Presentation will cover current efforts at the US FDA including the incorporation of read-across data and the use of Tox21 methods.

Panel Discussion will feature scientists from various divisions within FDA for a unique and informative dialogue on the state and future of regulatory toxicology at the US FDA.

led by: Suzanne Fitzpatrick, US FDA-CFSAN
Panelists Include: Paul Brown, US FDA-CDER, Ron Brown, US FDA-CDRH, Tracy Chen US FDA-OC, Andrew O'Carroll, US FDA-CBER

10:00 AM–1:30 PM

SESSION: How Much Mode of Action Data Is Enough for Risk Assessment: A Case Study With Hexavalent Chromium

Moderated by Chad Thompson

10:00 AM–10:25 AM Mode of Action: Judging the Sufficiency of Evidence 
Vicki Dellarco, US EPA (Retired)
10:25 AM–10:50 AM Mechanistic Insights from Repeated Dose Studies on Cr(VI) and Other Small Intestine Carcinogens 
Samuel Cohen, University of Nebraska Medical Center
10:50 AM–11:20 AM BREAK
11:20 AM–11:55 AM Mode of Action Analysis for Cr(VI)-Induced Intestinal Tumors: Evidence for a Threshold
Chad Thompson, ToxStrategies, Inc.
11:55 AM–12:20 PM Setting Regulatory Standards for Oral Exposure to Cr(VI) – Regulatory Perspective 
Joseph Haney, Texas Commission on Environmental Quality
12:20 PM–12:40 PM Water Systems Response to Drinking Water Standards: Cr(VI) As a Case Story
Steve Via, American Waterworks Association
12:40 PM–1:30 PM Moderated Discussion
(Included with Registration) 
2:30 PM3:00 PM

Annual Business Meeting

3:00 PM6:00PM

SESSION: Use of Humanized Immune System Mice for Drug Development

Moderated by James Monroe

3:00 PM–3:30 PM Use of Humanized Mice to Analyze Human Biologics
Kevan Herold, Yale University
3:30 PM–4:00 PM Humanized Mouse Models: Progress and Perils
Kristina Howard, US FDA-CDER
4:00 PM–4:30 PM Characterizing Humanized Immune System Mice for Use As Preclinical Safety Models
Michael Oropallo, Merck
4:30 PM–5:00 PM BREAK
5:00 PM–5:30 PM Scaling Production of Humanized Immune System Mice:  Insights on the Consistency, Reproducibility, Strengths and Limitations of the huNOG and huNOG-EXL Humanized Mouse Models
Michael Seiler, Taconic Biosciences
5:30 PM–6:00 PM Moderated Discussion
(Included with Registration) 
With generous support from The Coca-Cola Company


Tuesday, July 11


9:00 AM–11:00 AM

SESSION: Systematic Review – (When) Is it Worth it? A Survey of the Systematic Review Landscape in Toxicology and a Discussion to Inform When and How Systematic Review Can Most Meaningfully Be Used As an Approach to Evaluate Toxicological and Risk Assessment Questions

Moderated by Daniele Wikoff

9:00 AM–9:35 AM Systematic Review in Toxicology – A Survey of the Landscape, Current Applications, and Lessons Learned
Daniele Wikoff, ToxStrategies, Inc.   
9:35 AM–10:00 AM

Lessons From the Conduct of Systematic Reviews in Risk Assessment: The Utility of Multidisciplinary Teams, Thorough Problem Formulation, and Software Tools   
Katya Tsaioun, Johns Hopkins School of Public Health

10:00 AM–10:25 AM Systematic Review at EFSA 
Elisa Aiassa, European Food Safety Authority
10:25 AM–11:00 AM

Moderated Panel Discussion
Panelists: Kris Thayer, Suzanne Fitzpatrick, Nancy Beck, and Speakers

11:00 AM11:30 AM


11:30 AM–12:00 Noon

Update Session - Predicting Likelihood of Potential Human In Vivo Interactions Using the Tox21/ToxCast Datasets
Nisha Sipes, NIEHS-NTP

12:00 Noon–12:30 PM George Scott Award Lecture: Role of the Aryl Hydrocarbon Receptor in Human Stem Cell to B Cell Lineage Commitment
Awardee: Norbert Kaminski, Michigan State University
12:30 PM–1:30 PM Attendee Luncheon
(Included with registration)
1:30 PM-2:00 PM Update Session - Nitrates in Food
Richard Lane, PepsiCo
2:00 PM–2:30 PM Update Session - ACC's Campaign for Accuracy in Public Health Research
David Fischer, American Chemistry Council
2:30 PM–3:00 PM Update Session - New Draft Guidance for Food Contact Materials Intended to Contact Infant Formula or Human Milk: Regulatory Research to Support Toxicology Recommendations
April Neal-Kluever, US FDA-CFSAN
3:00 PM–6:00 PM

SESSION: Evaluating Potential Sources of Bias That May Lead to False Associations in Epidemiological Studies

Moderated by Robert Barter

3:00 PM–3:30 PM Is Clearance a Common Explanation Across the Epidemiological Associations Reported at “Low” PFOA and PFOS Concentrations? 
Geary Olsen, 3M
3:30 PM–4:00 PM Quantitative Bias Analysis  of Epidemiological Data with Pharmacokinetic Simulations – A Primer with Examples
Matthew Longnecker, Ramboll-Environ
4:00 PM4:30 PM BREAK
4:30 PM–5:00 PM Evaluation of Pharmacokinetic Bias in Reported Epidemiological Associations for Phthalates
Miyoung Yoon, ScitoVation, LLC  
5:00 PM–5:30 PM Use of Bias Analysis in the Regulatory Setting
Tim Lash, Emory University  
5:30 PM–6:00 PM Moderated Discussion
Panel Participants: Jeff Lewis, Harvey Clewell, and Speakers
(Included with Registration) 


Wednesday, July 12


9:00 AM–9:50 AM

Implementation of the Lautenberg Chemical Safety Act:  Implications for Risk Assessment
Panel #1: Assessing the Risks of New Chemicals
Moderated by Michael Walls

Maria Doa, US EPA-OPP: Process and Requirements of TSCA Section 5, Including Deadlines

Athena Keene, Afton Chemical CorporationIndustry Perspective and Experience on the New Chemicals Program

Richard Denison, Environmental Defense FundStakeholder Perspectives on the New Chemicals Program

9:50 AM–10:40 AM

Implementation of the Lautenberg Chemical Safety Act:  Implications for Risk Assessment
Panel #2: Existing Chemicals:  Prioritizing Existing Substances for Review and Conducting Risk Evaluations
Moderated by Michael Walls

Tala Henry, US EPA: Describing the Requirements for the Prioritization and Risk Evaluation Process, Including Scoping and Deadlines

Suzanne Hartigan, International Fragrance Association North America: Stakeholder Perspectives on Existing Chemical Reviews

Karyn Schmidt, American Chemistry CouncilIndustry Perspectives on Existing Chemical Risk Evaluations

10:40 AM - 11:00 AM

Dialogue and Questions with All Panelists
Opportunity for audience questions and sustained dialogue

11:00 AM–11:30 AM BREAK
11:30 AM–2:15 PM

SESSION: When Will Microphysiological Systems (Organ-On-Chip Technologies) Be Ready to Replace Animals in Nonclinical Safety Assessments to Support Phase 1 Clinical Pharmacology Studies? 

Moderated by David Watson

11:30 AM–12:00 Noon Organs-on-Chips – Innovative Tools for Drug Development 
Lucie Low, NIH/NCATS
12:00 Noon–12:30 PM Scientific and Technical Strengths and Limitations of MPS For Drug Toxicity Testing
John Wikswo, Vanderbilt University
12:30 PM–1:00 PM Microphysiological Systems in Pharma: Defining a Paradigm
Brian Berridge, GlaxoSmithKline
1:00 PM–1:15 PM BREAK  

1:15 PM–1:45 PM Regulatory Perspective on the Use of MPS in Human Pharmaceutical Development
Paul Brown, US FDA-CDER
1:45 PM–2:15 PM Moderated Discussion