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Human Relevance of Rodent Liver Tumors

Organizing Committee

Chairs: Susan Felter & Jennifer Foreman
Alan Boobis - Christopher Corton - Adriana Doi - David Eastmond - Lynn Flowers
Manuela Goettel - Jay Goodman - Abigail Jacobs - James Klaunig - Anna Lowit - Jonathan Moggs
Arun Pandiri - Reza Rasoulpour

Monday | Tuesday | Wednesday


Monday, October 24

7:30 AM - 8:30 AM Attendee Breakfast 
(Included with Registration)
8:30 AM - 12:30 PM SESSION I: A Background on Rodent Liver Tumors and Humans and Regulatory Perspectives 
8:30 AM - 8:35 AM Welcome to the Meeting
Robert Barter, President - The Toxicology Forum 
8:35 AM - 8:45 AM Introduction to the Session and Overview
Jennifer Foreman, ExxonMobil Biomedical Sciences
8:45 AM - 9:10 AM Comparative Pathology of Proliferative Liver Lesions
David Malarkey, NIEHS, Cellular and Molecular Pathology Branch
9:10 AM - 9:35 AM Comparison of Known MOA's of Rodent (Mouse, Rat) versus Human Hepatocellular Tumors
James Popp, Stratoxon, LLC
9:35 AM - 10:00 AM Rodent Liver Tumor Response in NTP Studies
Arun Pandiri, NIEHS-NTP
10:00 AM - 10:20 AM BREAK
10:20 AM - 12:00 PM Regulatory Perspectives
Moderated by Lynn Flowers, US EPA 
10:20 AM - 10:40 AM European Regulatory Perspective: 
Jan Willem Van der Laan, Medicines Evaluation Board
10:40 AM - 11:00 AM US Regulatory Perspective: Environmental Protection Agency
Vincent Cogliano, US EPA-IRIS
11:00 AM - 11:20 AM US Regulatory Perspective: Food and Drug Administration
Abigail Jacobs, US FDA-CDER
11:20 AM - 11:40 AM European Regulatory Perspective: European Chemicals Agency
Gesine Mueller, European Chemicals Agency
11:40 AM - 12:00 PM Canadian Regulatory Perspective: Health Canada
Ivy Moffat, Health Canada 
12:00 PM - 12:30 PM Moderated Discussions
12:30 PM - 1:30 PM Attendee Luncheon
(Included with Registration)
Moderated by Jay Goodman, Michigan State University; Adriana Doi, BASF; and Jonathan Moggs, Novartis
1:30 PM - 1:35 PM Introduction to the Session
Jay Goodman, Michigan State University 
1:35 PM - 1:55 PM Introduction to CAR Activation and Considering This As a Key Event in Rodent Liver Tumorigenesis
Curtis Omiecinski, Penn State University
1:55 PM - 2:20 PM The Molecular Epigenetic Basis for Species-Specific Hepatic Responses to Phenobarbital
Remi Terranova, Novartis Institute for Biomedical Research
2:20 PM - 2:45 PM Constitutive Androstane Receptor (CAR) Models Including the CAR KO Sprague-Dawley Rat Model
Brian Lake, CXR Biosciences
2:45 PM - 3:10 PM Rodent Liver Tumorigens That Act by a MOA Involving Activation of CAR As a Key Event Might Present a Risk for People
Michael Schwarz, University of Tubingen
3:10 PM - 3:30 PM BREAK
3:30 PM - 3:55 PM Role of Activation of CAR and Beta-Catenin in Liver Growth and Tumorigenesis
David Moore, Baylor College of Medicine 
3:55 PM - 4:20 PM Human Relevance of Rodent Liver Tumors by Compounds Whose MOA Includes Activation of CAR As a Key Event
Brian Lake, CXR Biosciences
4:20 PM - 5:00 PM Moderated Discussions
5:30 PM - 7:00 PM Attendee Welcome Reception


Tuesday, October 25

7:30 AM - 8:30 AM Attendee Breakfast 
(Included with Registration)
8:30 AM - 12:00 PM SESSION III: PPARalpha-dependent Mode of Action for Liver Tumor Induction
Moderated by James Klaunig, Indiana University; Christopher Corton, US EPA; and 
Jennifer Foreman, ExxonMobil Biomedical Sciences
8:30 AM - 8:40 AM Introduction to the Session
James Klaunig, Indiana University
8:40 AM - 9:00 AM Overview of PPAR in Normal Biology and Physiology
Jennifer Foreman, ExxonMobil Biomedical Sciences
9:00 AM - 9:35 AM Proposed Mode of Action for PPARa Induced Liver Tumors
Christopher Corton, US EPA
9:35 AM - 10:10 AM Human Relevance of PPARa Induced Liver Tumors
Jeff Peters, Penn State University
10:10 AM - 10:30 AM BREAK
10:30 AM - 11:05 AM Regulatory Perspective
Lynn Flowers, US EPA
11:10 AM - 11:55 AM Moderated Discussion
James Klaunig, Indiana University and Christopher Corton, US EPA 
11:55 AM - 12:00 PM Session Wrap-up and Closing Remarks
Jennifer Foreman, ExxonMobil Biomedical Sciences 
12:00 PM - 2:00 PM Attendee Luncheon & Poster Session
(Included with Registration) 
2:00 PM - 5:00 PM SESSION IV: Cytotox/Regen MOA and New Technologies
Moderated by Susan Felter,Procter & Gamble and Alan Boobis, Imperial College London
2:00 PM - 2:05 PM Introduction to the Session and Overview
Susan Felter, Procter & Gamble 
2:05 PM - 2:30 PM Role of Cytotoxicity and Regenerative Hyperplasia in Cancer
Samuel Cohen, University of Nebraska Medical Center
2:30 PM - 3:00 PM Evidence of Cytotoxicity As a MOA and Its Human Relevance
Paolo Boffetta, Mount Sinai School of Medicine
3:00 PM - 3:30 PM Use of AOPs/MOAs to Develop Strategies for Assessing Nongenotoxic Rodent Hepatocarcinogens
Bette Meek, University of Ottawa
3:30 PM - 3:50 PM BREAK
3:50 PM - 4:20 PM New Tools to Evaluate MOA (Toxicogenomics)
David Geter, Bayer Crop Science 
4:20 PM - 5:00 PM Moderated Discussions


Wednesday, October 26

7:30 AM - 8:30 AM Attendee Breakfast
(Included with Registration)
8:30 AM - 1:15 PM SESSION V: Definition of Nongenotoxic; Evaluating Alternative MOAs; Case Studies; Weight of Evidence
Moderated by Susan Felter, Procter & Gamble and Todd Bourcier, US FDA-CDER
8:30 AM - 8:35 AM Introduction to the Session and Overview
Susan Felter, Procter & Gamble 
8:35 AM - 9:00 AM Human Relevance Evaluation of Rodent Liver Neoplasms
Frank Sistare, Merck
9:00 AM - 9:30 AM How Do We Define "Non-Genotoxic"
David Eastmond, University of California - Riverside 
9:30 AM - 10:00 AM Evolving the MOA Framework: A Quantitative Evidence Integration Approach for Side-by-Side Comparison of Alternative Hypothesized MOAs
Richard Becker, American Chemistry Council
10:00 AM - 10:30 AM Decisions on Cancer Hazard Classifications – How Do We Obtain Global Harmonization?  
Reza Rasoulpour, Dow AgroSciences
10:30 AM - 11:00 AM ICHS1 Expert Working Group on Carcinogenic Waiver Considerations
Todd Bourcier, US FDA
11:00 AM - 11:30 AM BREAK
11:30 AM - 12:00 PM CAR Case Study: Epsilon-Momfluorothrin 
Gesine Mueller, European Chemicals Agency
12:00 PM - 12:30 PM Case Study on Pronamide – Dual CAR/PPARalpha Mode of Action
Matthew LeBaron, Dow AgroSciences
12:30 PM - 1:15 PM Moderated Discussions
1:15 PM - 1:20 PM Closing Remarks
Susan Felter, Procter & Gamble