37th Annual Winter Meeting of The Toxicology Forum - Agenda

Agenda

Monday, January 30, 2012
Tuesday, January 31, 2012
Wednesday, February 1, 2012
Thursday, February 2, 2012

Monday, January 30, 2012

8:00 AM	Breakfast
9:00 AM	Opening Remarks David Longfellow, President The Toxicology Forum
	SESSION I: Advancing Risk Assessment Approaches in the 21st Century Co-Chairs: Edward Ohanian, U.S. EPA, DC - Michael Dourson, TERA, OH
9:10 AM	Introduction Co-Chairs
9:20 AM	EPA Framework for Human Health Risk Assessment to Inform Decision Making Julie Fitzpatrick, U.S. EPA, DC
9:40 AM	Discussion
9:50 AM	Problem Formulation to Dose-Response: Advances via the ARA: Beyond Science and Decisions Workshops Bette Meek, University of Ottawa, Canada
10:10 AM	Discussion
10:20 AM	Break
10:50 AM	Development of an Integrated Evaluation Strategy for the 21st Century: Advances via the HESI Risk21 Project John Doe, Parker Doe Partnership LLP, U.K.
11:10 AM	Discussion
11:20 AM	Translating the Molecular Basis of Hazard to 21st Century Risk Assessment Approaches: Advances via Tox21 Project TBA, NIEHS, NC
11:40 AM	Discussion
11:50 AM	Improving Risk Assessment Policies and Practices to Meet the Challenges Posed by 21st Century Science Richard Becker, American Chemistry Council, DC
12:10 PM	Panel Discussion All Speakers
12:40 PM	Lunch
1:40 PM	Presentation of the Philippe Shubik Distinguished Scientist Award
	SESSION II: Recent Successes and Future Challenges in Accelerating Implementation of the NRC Tox 21 Report Chair: Ed Carney, The Dow Chemical Company, MI
2:00 PM	Introduction Chair
2:10 PM	Technical Challenges in Using Case Study Approaches to Accelerate Toxicity Testing in the 21st Century Mel Andersen, The Hamner Institutes, NC
2:30 PM	Discussion
2:40 PM	Regulatory Successes and Challenges to Accelerate Toxicity Testing in the 21st Century Vicki Dellarco, EPA, VA
3:00 PM	Discussion
3:10 PM	Break
3:40 PM	Current Applications of 21st Century Toxicology: Tiered Approaches to Predicting Toxicity George Daston, Proctor & Gamble, OH
4:00 PM	Discussion
4:10 PM	Global Challenges to Accelerate Toxicity Testing in the 21st Century Marty Stephens, Johns Hopkins University, MD
4:30 PM	Discussion
4:40 PM	Panel Discussion All Speakers George Gray, The George Washington University, DC
5:10 PM	UPDATE: NTP Workshop: Role of Environmental Chemicals in the Development of Diabetes and Obesity Linda Birnbaum, NIEHS, NC
5:25 PM	Discussion
5:30 PM	Opening Reception All Welcome

Tuesday, January 31, 2012

8:00 AM	Breakfast
9:00 AM	Keynote Address Janet Woodcock, FDA, MD
9:50 AM	Keynote Address Peter Kim, Merck Research Laboratories, PA
10:45 AM	Break
11:15 AM	UPDATE: FDA’s Guidance for Industry on Reproductive and Developmental Toxicities Abigail Jacobs, U.S. FDA, DC
11:30 AM	Discussion
11:35 AM	UPDATE: The ELSIE Database: Extractable, Leachable and Knowledge Sharing Amongst Pharmaceutical Companies and Regulators Lewis Kinter, Astra-Zeneca, NJ
11:50 AM	Discussion
12:00 PM	Lunch
	SESSION III: Patient Risk Assessment Based on Carcinogenicity Evaluation of Pharmaceuticals Chair: Lutz Mueller, F. Hoffmann-La Roche Ltd., CH
1:00 PM	Introduction Chair
1:10 PM	Recent Activities in the ICH Arena Regarding ICH-S1 Guidances for Carcinogenicity Testing of Pharmaceuticals Joe DeGeorge, Merck, PA
1:30 PM	Discussion
1:40 PM	Consideration of How to Appropriately Test Immune Suppressors and Immune Modulators for Tumorigenicity Robert Johnson, Novartis, NJ
2:00 PM	Discussion
2:10 PM	Use of a Xenograft Model as a Test Case to Demonstrate Absence of Growth Enhancement Lorrene Buckley, Eli Lilly, NJ
2:30 PM	Discussion
2:40 PM	Break
3:00 PM	Considerations on a Human Cancer Risk Assessment Model for Pharmaceuticals Without the Use of Lifetime Rodent Bioassays Lutz Mueller, F. Hoffmann-La Roche Ltd., CH
3:20 PM	Discussion
3:30 PM	Panel Discussion All Speakers David Jacobson-Kram, FDA, MD Todd Bourcier, FDA, MD
4:00 PM	UPDATE: FDA’s Dietary Supplements Office: New Director/New Directions Daniel Fabricant, FDA, MD
4:15 PM	Discussion
	SESSION IV: Irradiation in the Production, Processing and Handling of Food: The U.S. Framework Chair: Antonia Mattia, FDA, MD
4:20 PM	Introduction Chair
4:30 PM	FDA’s Perspective on the Regulatory Framework of Food Irradiation Lane Highbarger, CFSAN, FDA, MD
4:40 PM	Discussion
4:45 PM	Leafy Greens: Current Research on Microbial Control, a Case Study Chris Sommers, ARS, USDA, PA
4:55 PM	Discussion
5:00 PM	Industry Perspective: Consumer Acceptance and Benefits Shannon Cole, Grocery Manufacturers Association, DC
5:10 PM	Discussion
5:15 PM	Panel Discussion All Speakers
5:30 PM	Meeting Adjourned

Wednesday, February 1, 2012

8:00 AM	Breakfast
	SESSION V: Threshold of Toxicological Concern: Designs, Domains, and Databases Chair: Susan Felter, Procter & Gamble, OH
9:00 AM	Introduction Chair
9:10 AM	Workshop Introduction/Background Susan Barlow, Independent Consultant, UK
9:30 AM	Discussion
9:40 AM	Noncancer Endpoints Tim Adams, FEMA, DC
10:00 AM	Discussion
10:10 AM	Break
10:40 AM	Cancer Endpoints Mitchell Cheeseman, FDA, MD
11:00 AM	Discussion
11:10 AM	Route-to-Route Extrapolation Bob Safford, Unilever, UK
11:30 AM	Discussion
11:40 AM	Workshop Recommendations Ian Dewhurst, Chemical Regulation Directorate, UK
12:00 PM	Discussion
12:10 PM	Panel Discussion All Speakers Vicki Dellarco, EPA, VA
12:40 PM	Lunch
	SESSION VI: Improving our Understanding of the Cancer Risk Posed by Hexavalent Chromium in Drinking Water Chair: Laurie Haws, ToxStrategies Inc. TX
1:40 PM	The Use of Mode of Action Information in Risk Assessment Bette Meek, University of Ottawa, Canada
1:55 PM	Discussion
2:00 PM	Overview of the Hexavalent Chromium Mode of Action Research Project Laurie Haws, ToxStrategies, Inc., TX
2:15 PM	Discussion
2:20 PM	Using Toxicogenomics to Identify Key Events in the MOA for Oral Carcinogenicity of Cr(VI) Tim Zacharewski, Michigan State University
2:35 PM	Discussion
2:40 PM	Using Pharmacokinetics to Improve Extrapolation of High Dose Findings in Rodents Exposed to Hexavalent Chromium in Drinking Water to Low Dose Exposures in Humans Sean Hays, Summit Toxicology Inc., CO
2:55 PM	Discussion
3:00 PM	Break
3:20 PM	Using MOA Information and Pharmacokinetics to Improve Quantitative Estimates of Human Cancer Risk Associated with Oral Exposures to Hexavalent Chromium Deborah Proctor, ToxStrategies Inc., CA
3:40 PM	Discussion
3:45 PM	Implications of Developing an Oral Cancer Slope Factor for Hexavalent Chromium: Levels in U.S. Drinking Water David Kimbrough, Pasadena Water District, CA
4:05 PM	Discussion
4:10 PM	Panel Discussion All Speakers Julie Fitzpatrick, U.S. EPA, DC Resha Putzrath, U.S. Navy & Marine Corps Public Health Center, DC Steve Via, American Water Works Association, DC
4:40 PM	Meeting Adjourned

Thursday, February 2, 2012

8:00 AM	Breakfast
	SESSION VII: When Epidemiology and Toxicology Collide: Navigating the Path Forward for Formaldehyde Chair: William Farland, Colorado State University
9:00 AM	Introduction Chair
9:10 AM	Overview of the NRC Framework David Dorman, North Carolina State University
9:30 AM	Discussion
9:40 AM	Selecting Studies Timothy Pastoor, Syngenta, NC
10:00 AM	Discussion
10:10 AM	Break
10:40 AM	Formaldehyde Epidemiology: A Contemporary Review Framework Phillip Cole, Emeritas University of Alabama, Birmingham
11:00 AM	Discussion
11:10 AM	Weighing the Evidence for Causality Lorenz Rhomberg, Gradient Corporation, MA
11:30 AM	Discussion
11:40 AM	Mode of Action for Endogenous Chemicals James Swenberg, University of North Carolina
12:00 PM	Discussion
12:10 PM	EPA’s Response to NRC Framework Vincent Cogliano, NCEA, EPA, DC
12:30 PM	Discussion
12:40 PM	Panel Discussion All Speakers David Bussard, EPA, DC Bernard Goldstein, University of Pittsburgh, PA John Bucher, NIEHS, NC
1:10 PM	Lunch
2:10 PM	UPDATE: FDA’s Medical Countermeasures (MCM) Initiative: Responding Faster and More Effectively to Bioterrorism and Infectious Diseases Luciana Borio, FDA, DC
2:25 PM	Discussion
2:30 PM	UPDATE: A Therapeutic Intervention that Mitigates Intestinal Acute Radiation Poisoning Martin Hauer-Jensen, University of Arkansas for Medical Sciences
2:45 PM	Discussion
	SESSION VIII: Use of New Data on the Former Fuel Additive, MTBE, in Hazard Identification and Risk Assessment Chair: TBA
2:50 PM	Introduction Chair
3:00 PM	Using a Rat MTBE PBPK Model as a Tool to Evaluate: Mode of Action and Route to Route Extrapolation Susan Borghoff, Integrated Laboratory Systems, NC
3:20 PM	Discussion
3:30 PM	Results of Subchronic and Chronic Studies of MTBE Administered in the Drinking Water of Wistar Rats John Moore, Hollyhouse Inc, VA
3:50 PM	Discussion
4:00 PM	Panel Discussion All Speakers
4:30 PM	Update: Protecting the U.S. Food Supply in the Event of a Nuclear Reactor Accident From a Nuclear Reactor Accident Speaker: Patricia Hansen, CFSAN, FDA, MD
4:45 PM	Discussion
4:50 PM	Meeting Adjourns

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