41st Annual Summer Meeting of The Toxicology Forum
The Cheyenne Mountain Resort

Colorado Springs, Colorado

Sunday | Monday | Tuesday | Wednesday | Thursday


Sunday, July 12

1:00 PM - 5:00 PM The Toxicology Forum Board of Directors Meeting
5:30 PM - 7:30 PM Welcome Reception - With generous support from The Coca-Cola Company
Cheyenne Courtyard
(Included with Registration)

All Sessions will be held in the Centennial Ballroom
All breaks and attendee meals will be held in the Mountain View Restaurant unless otherwise noted 

Monday, July 13

7:30 AM - 8:15 AM Attendee Breakfast 
(Included with Registration)
8:15 AM - 8:30 AM Welcoming Remarks from the Toxicology Forum President
James Klaunig, Indiana University
8:30 AM - 9:15 AM IAN MUNRO KEYNOTE LECTURE: Thinking Inside the Box:  Is the Current Pharmaceutical Toxicology Testing Paradigm Useful for Predicting Clinical Outcomes?
Thomas Jones, Eli Lilly & Company
9:15 AM - 12:30 PM SESSION: How Clear is our Vision Regarding "Toxicity Testing" in the 21st Century?
Moderated by Rebecca Alyea
9:15 AM - 9:30 AM Welcome & Introduction

Craig Rowlands, Dow Chemical Company

9:30 AM - 10:00 AM Toxicity Testing in the 21st  Century: Making Progress by Maintaining a Focus on the Fundamentals

Jay Goodman, Michigan State University

10:00 AM - 10:30 AM Replacement of Apical Endpoints with Early Key Events – Implications for Dose Response and Risk Assessment

Paul Price, US EPA

10:30 AM - 11:00 AM BREAK
11:00 AM - 11:30 AM Computational Embryology and Predictive Models: Tools for Biological Understanding

Thomas Knudsen, US EPA

11:30 AM - 12:00 PM Practical Implications in Applying in vitro Data to Inform Risk Assessment

James Bus, Exponent

12:00 PM - 12:30 PM Moderated Panel Discussion
1:00 PM - 2:30 PM Attendee Luncheon
(Included with Registration)
2:00 PM - 2:30 PM The Toxicology Forum Annual Business Meeting
2:30 PM - 5:30 PM SESSION: Assessing Scientific Confidence in 21st Century Non-Animal Alternatives for Safety Assessments
Moderated by Katy Goyak 
2:30 PM - 3:00 PM Introduction and Setting the Stage: What is the Path for Establishing Regulatory Confidence in 21st Century Non-animal Alternatives for Safety Assessments?
Katy Goyak, ExxonMobil BioMedical Sciences
3:00 PM - 3:30 PM A Framework for Increasing Scientific Confidence in High-Throughput Assays, Prediction Models, and Adverse Outcome Pathways
Craig Rowlands, Dow Chemical Company
3:30 PM - 4:00 PM Moving Toward Data Interpretation, Transparency, and Scientific Confidence in EPA’s ToxCast Program 
Thomas Knudsen, US EPA
4:00 PM - 4:30 PM  BREAK
4:30 PM - 5:00 PM Applying OECD Guidance on Describing Non-Guideline in vitro Test Methods to ToxCast Assays
Catherine Willett, Humane Society of the United States
5:00 PM - 5:30 PM Moderated Panel Discussion


Tuesday, July 14

7:30 AM - 8:30 AM Attendee Breakfast 
(Included with Registration)
8:30 AM - 10:30 AM SESSION: Food Safety Considerations for Double Stranded RNAs: Plant Incorporated Protectants as a Case Study
Moderated by Kenneth Witwer
8:30 AM - 8:40 AM Session Introduction and RNAi Biology Overview
Kenneth Witwer, Johns Hopkins University & Jay Petrick, Monsanto
8:40 AM - 9:10 AM Safety of Ingested RNA: Applicability to Biotechnology-Derived Crops

Jay Petrick, Monsanto

9:10 AM - 9:40 AM Ingested RNA: A Strength of the Evidence Assessment
Kenneth Witwer, Johns Hopkins University
9:40 AM - 10:10 AM Regulatory Considerations for RNAi-based Pesticides
Chris Wozniak, US EPA
10:10 AM - 10:30 AM Moderated Panel Discussion
10:30 AM - 11:00 AM BREAK
11:00 AM - 11:30 AM UPDATE: Electrophile-Mediated Protein Modification via Bioactivation: Impact on Food and Chemical Safety
Serrine Lau, University of Arizona
11:30 AM - 12:00 PM UPDATE: FDA’s Perspective on the Current State and Future Direction of Juvenile Animal Testing to Support a Pediatric Development Program
Karen Davis-Bruno, US FDA CDER
12:00 PM - 12:30 PM GEORGE H. SCOTT MEMORIAL AWARD: Biological Reactive Intermediates and Their Contribution to Environmental Diseases
Serrine Lau, University of Arizona
12:30 PM - 1:30 PM Attendee Luncheon
(Included with Registration)
1:30 PM - 3:30 PM SESSION: Particulate Matter Health Effects - Causation vs. Association: Borrowing Analytical Methods from Other Disciplines
Moderated by Bruce Copley
1:30 PM - 1:40 PM Session Overview & Introduction
Bruce Copley, ExxonMobil BioMedical Sciences
1:40 PM - 2:10 PM Particulate Matter and Health: Fundamentals of Causal Reasoning
George Maldonado, University of Minnesota
2:10 PM - 2:40 PM Estimating and Validating Causal Concentration-Response Relations for PM2.5 from Data
Tony Cox, Cox Associates
2:40 PM - 3:10 PM Acute Deaths and Air Quality in California, 2000-2012
Stan Young, CGStat
3:10  PM - 3:30 PM Moderated Panel Discussion

Free Afternoon for Networking


Wednesday, July 15

7:30 AM - 8:30 AM Attendee Breakfast
(Included with Registration)
8:30 AM - 12:30 PM SESSION: Developmental Effects of Arsenic / Health Risk Assessment of Dietary Exposure to Inorganic Arsenic
Moderated by Daniel Doerge and Ji-Eun Lee
8:30 AM - 9:05 AM Overview on Sources of Arsenic Exposure, Issues in Arsenic Risk 
Sam Cohen, University of Nebraska Medical Center
9:05 AM - 9:40 AM The Long-Term Health Effects Associated with Early-Life Arsenic Exposure
Craig Steinmaus, University of California - Berkeley
9:40 AM - 10:15 AM Low-Dose Arsenic Risks Versus Benefits of Rice Consumption for the U.S. Diet 
Joyce Tsuji, Exponent
10:15 AM - 10:45 AM BREAK
10:45 AM - 11:20 AM Biological Correlation and Associations: Extrapolation of Pharmacokinetic and Mode of Action Data to Dose-Response Modeling of Human Health Endpoints for Arsenic 
Harvey Clewell, The Hamner Institutes for Health Sciences
 11:20 AM - 12:30 PM Moderated Panel Discussion
With Daniel Doerge, US FDA NCTR; Ila Cote, US EPA-NCEA; Ji-Eun Lee, Kellog
12:30 PM - 1:30 PM Attendee Luncheon
(Included with Registration)
1:30 PM - 4:45 PM SESSION: Assessing Natural Product – Drug Interactions: An End-to-End Safety Framework
Moderated by James Griffiths
1:30 PM - 1:45 PM Assessing Potential Natural Product-Drug Interactions:  Need for a Common Framework Approach
Amy Roe, Procter & Gamble
1:45 PM - 2:15 PM Predicting Natural Product-Drug Interactions: Pre-clinical Considerations
Mary Paine, Washington State University
2:15 PM - 2:45 PM Predicting Clinical Safety Outcomes:  in vitro Models That Integrate Hepatic Transport, Metabolism, and Regulatory Pathways
Kenneth Brouwer, Qualyst Transporter Solutions
2:45 PM - 3:15 PM BREAK
3:15 PM - 3:45 PM Dietary Supplement Dosage Form Performance: An Overlooked Parameter in Assessing Clinical Efficacy and Safety of Natural Products
Bill Gurley, University of Arkansas for Medical Sciences
3:45 PM - 4:15 PM Regulatory Considerations of Herb-Drug Interactions
Scott Jordan, Health Canada
 4:15 PM - 4:45 PM Moderated Panel Discussion
6:00 PM Attendee Dinner - Cheyenne Courtyard
(Included with Registration) 


Thursday, July 16

7:30 AM - 8:30 AM Attendee Breakfast 
(Included with Registration)
8:30 AM - 9:00 AM UPDATE: Does GRAS Concept Still Work?
John Hallagan, FEMA
9:00 AM - 9:30 AM UPDATE: Pharmacokinetic Analysis and Comparison of Caffeine Administered Rapidly or Slowly in Coffee Chilled or Hot vs. Chilled Energy Drink in Healthy Young Adults
John White, Washington State University
9:30 AM - 10:00 AM UPDATE: Use of Epidemiologic Data in Regulatory Decision Making
Janet Collins, CropLife America
10:00 AM - 10:30 AM BREAK
10:30 AM - 12:30 PM SESSION: Drivers for Revision of ICH S5(R2) Reproductive Toxicity Guidelines: Labeling, Science, Inadequate Approaches, and Alternative Testing Approaches
Moderated by Jose Lebron and Joseph DeGeorge
 10:30 AM - 11:00 AM Reasons for Revising ICHS5(R2)
Mary Ellen McNerney, Bristol-Myers Squibb
11:00 AM - 11:30 AM Potential Use of in vitro Alternatives for Embryo/Fetal Development of Assessment of Pharmaceuticals
Jose Lebron, Merck
11:30 AM - 12:00 PM FDA's New Reproductive and Developmental Labeling Law and Implications for Labeling
Abigail Jacobs, US FDA CDER
12:00 PM - 12:30 PM Moderated Panel Discussion
12:30 PM Closing Remarks
James Klaunig, Indiana University