Winter Meeting Detailed Program



Organizing Committee Members


Amy Roe, Procter & Gamble (Chair)
Laurie Haws, ToxStrategies, Inc. (Co-Chair)
A. Wallace Hayes, Harvard University & Michigan State University
Tetyana Kobets, New York Medical College
Todd Page, Eli Lilly & Co
Cynthia Rider, NIEHS-NTP


Detailed Program Schedule By Day


All Sessions and Breaks will be held in the Athens Ballroom. All Attendee Meals & Events will be held in the Paris Ballroom


Monday, February 6


8:15 AM–9:00 AM KEYNOTE LECTURE: Future of Precision Medicine
Luciana Borio, Acting Chief Scientist - US Food and Drug Administration
9:00 AM–12:30 PM SESSION: A Search for Biomarkers of Neurotoxicity: A Practical Approach
Moderated by Syed Imam & William Slikker
9:00 AM–9:30 AM Overview of the Biomarker Initiative to Identify Biological Fluid-Based Indicators of Neurotoxicity
Merle Paule, US FDA-NCTR
9:30 AM–10:00 AM Glial Fibrillary Acidic Protein (GFAP) and Related Astroglial Proteins as Biomarkers of Neurotoxicity
James O’Callaghan, CDC-NIOSH
10:00 AM–10:30 AM Lipidomics Approach to Understand TMT-Induced Neurotoxicity 
Andrea Armirotti, Istituto Italiano di Tecnologia
10:30 AM–11:00 AM BREAK
11:10 AM–11:30 AM Alterations in the Metabolome in CSF and Plasma May Provide Fluidic Biomarkers of CNS Toxicity 
11:30 AM–12:00 PM Oxidative Stress and Neuroinflammatory Biomarkers of Neurotoxicity: Correlation with Neuropathological Damage
Syed Imam, US FDA-NCTR
12:00 PM–12:30 PM Moderated Discussion
(Included with Registration) 
1:30 PM–5:15 PM SESSION: Observational Low-Dose Effects and Non-Monotonic Responses: Relevance for Research, Risk Assessment and Regulatory Decision-Making
Moderated by Daland Juberg & Suzanne Fitzpatrick
1:30 PM–2:00 PM A Grounding Amongst Stakeholders on the Need for Common Understanding of Definition and Problem Formulation
Kun Don Yi, Syngenta Crop Protection  
2:00 PM–2:30 PM Biological Mechanisms Underlying Low-Dose and Nonmonotonic Effects
Mark Miller, NIEHS
2:30 PM–3:00 PM Some Experiences with LDNM Responses in Guideline Toxicity Studies
Sue Marty, Dow Chemical Company
3:00 PM–3:30 PM BREAK
3:30 PM–4:00 PM How the US EPA Uses LDNM in Risk Assessment
Stanley Barone, US EPA-OSCPP
4:00 PM–4:30 PM Points to Consider When Assessing Dose Response Data for Use in Safety Assessment
Janet Zang, US FDA-CFSAN
4:30 PM–5:15 PM Moderated Discussion
(Included with Registration) 


Tuesday, February 7


8:30 AM–12:00 PM SESSION: Evolution of the Mode of Action Framework: Building Confidence and Consistency
Moderated by Vicki Dellarco & A. Wallace Hayes
8:30 AM–9:00 AM Evolution of the Bradford Hill Considerations and Comparative Analysis of Weight of Evidence 
Alan Boobis, Imperial College London  
9:00 AM–9:30 AM

Importance of Integrating Mode of Action into a Regulatory Risk Assessment  
Jennifer Seed, US EPA (Retired) and Suzanne Fitzpatrick, US FDA-CFSAN

9:30 AM–10:00 AM Recent Experience and Challenges in Using MOA in Regulatory Application 
Bette Meek, University of Ottawa
10:00 AM–10:30 AM BREAK
10:30 AM–11:00 AM

A Method for Quantitative Scoring of Causality for Side-by Side Comparison of Confidence for Alternative MOAs (Including Case Examples)
Richard Becker, American Chemistry Council & Mary Ko Manibusan, Exponent

11:00 AM–11:30 AM Multisector Perspectives on the Application of the MOA Framework and the Remaining Scientific and Regulatory Challenges Ahead
Anna Lowit, US EPA  & Vincent Cogliano, US EPA & Reza Rasoulpour, Dow AgroSciences
11:30 AM–12:00 PM Moderated Discussion
12:00 PM–12:30 PM Philippe Shubik Award Lecture: Ah Receptor Ligands: Bad, Good or Both?
Stephen Safe, Texas A&M University 
(Included with Registration) 
1:30 PM–5:00 PM SESSION: From Assay to Assessment: Incorporating High Throughput Strategies into Health and Safety Evaluations
Moderated by Julia Rager & Reza Rasoulpour & Cynthia Rider
1:30 PM–1:55 PM Integration of High Content and High Throughput Screening Predictions to Inform Ongoing Metals Risk Assessment
Julia Rager, ToxStrategies
1:55 PM–2:20 PM Integrating Multiple Sources of High-Dimensional Data to Quantify Effects of Genetic Variability in Chemical Risk Assessment
David Reif, North Carolina State University
2:20 PM–2:45 PM Combining High Content Chemical and Biological Data to Determine Sufficient Similarity of Complex Botanical Mixtures 
Cynthia Rider, NIEHS-NTP  
2:45 PM–3:15 PM BREAK
3:15 PM–3:40 PM Building Scientific Confidence in Read-Across: Progress in Using HT/HC Data to Inform Read-Across Performance
Grace Patlewicz, US EPA-NCCT  
3:40 PM–4:05 PM Where the Rubber Meets the Road—Applications of High Throughput Screening for Product Safety Assessment
Reza Rasoulpour, Dow AgroSciences
4:05 PM–4:30 PM Application of In Vitro and High Throughput Screening in EPA Pesticide Risk Assessment: Recent Examples and Looking Forward
Anna Lowit, US EPA-OPP
4:30 PM–5:00 PM Moderated Discussion
(Included with Registration) 


Wednesday, February 8


A series of short topical presentations intended to start and build scientific dialogue  
8:30 AM–9:00 AM EPA Plan for TSCA-Reform Implementation
Jeff Morris, US EPA
9:00 AM–9:30 AM Need for Clear Regulation of Pesticide Residue Limits for Articles of Botanical Origin
Josef Brinckmann, Traditional Medicinals
9:30 AM–10:00 AM A Lite Approach to Tumor Mode of Action: Ready for Prime Time? 
Richard Peffer, Syngenta Crop Protection LLC
10:00 AM–1:30 PM SESSION: Emerging Insecticidal Proteins in Biotechnology: Evolution of the Safety Evaluation Framework
Moderated by Jay Petrick
10:00 AM–10:30 AM What Does a Toxicologist Need to Know About Proteins Introduced into GM Crops? 
Joseph Jez, Washington University in St. Louis
10:30 AM–11:00 AM Proteins for Insect Control: Pore-Forming Proteins 
Juan Luis Jurat-Fuentes, University of Tennessee
11:00 AM–11:30 AM BREAK
11:30 AM–12:00 PM Role of Protein Domains and Other Key Aspects of Protein Biology in Evaluating the Toxicity of New Proteins 
Scott McClain, Syngenta Crop Protection
12:00 PM–12:30 PM Regulatory Perspective on Evaluating Safety of Proteins for Insect Control  
John Kough, US EPA–Microbial Pesticides Branch
12:30 PM–1:00 PM Toxicological Assessment of β-Pore Forming Proteins for Insect Control
Jay Petrick, Monsanto
1:00 PM–1:30 PM Moderated Discussion