Implementation of the U.S. National Research Council Report on Toxicity Testing in the 21st Century: Can We Make the Business Case for Alternatives?
November 5, 2009
University of Chicago Law School
Chicago, IL
It is our pleasure to invite you to attend a ground-breaking symposium, entitled “The Economic Implications of the U.S. National Research Council’s Report on Toxicity Testing in the 21st Century: Can We Make the Business Case for Alternatives?” This symposium will examine, from the perspective of business leaders in the U.S., the costs, benefits, challenges and opportunities generated by the vision contained in the NRC’s 2007 Toxicity Testing Report.
The symposium will feature speakers with considerable expertise in toxicology, costs of toxicity testing, products liability exposure and the potential for the development of cost effective in vitro models. We are excited to provide this opportunity for open dialogue and the exchange of diverse opinions and perspectives, with the goal of encouraging the implementation of the NRC’s vision.
The sponsors of this symposium are: The Johns Hopkins Bloomberg School of Public Health Center for Alternatives to Animal Testing (Baltimore, Maryland), Environmental Law Institute (Washington, DC), Center for Animal Law Studies at Lewis & Clark Law School (Portland, OR), the Animal Legal Defense Fund (CA) and Student Animal Legal Defense Fund at the University of Chicago Law School.
Agenda
The panel sessions will take place in the "Weymouth Kirkland Courtroom" and breakfast and lunch will take place in the "South Green Lounge."
8:00 – 8:45 a.m.
Breakfast
Served in the South Green Lounge.
8:45 – 9:00 a.m.
Introduction and Welcome
Pamela Frasch, Assistant Dean, Animal Law Program at Lewis & Clark Law School, Executive Director, Center for Animal Law Studies, David Zarfes, Associate Dean for Corporate and Legal Affairs and Schwartz Lecturer in Law, University of Chicago Law School
9:00 – 9:20 a.m.
Current State of the Science of Toxicology
Dr. Maria Trainer, Program Director, Council of Canadian Academies
9:20 – 10:00 a.m.
Summary of NAS 2007 Report
Dr. Martin Stephens, Vice President for Animal Research Issues, Humane Society of the U.S.
- The Development of the NAS Committee Vision
- How this Vision Incorporates the Best Science, Animal Welfare and Human Health Protection.
Dr. Thomas B. Knudsen, National Center for Computational Toxicology, Office of Research & Development, U.S. Environmental Protection Agency;
- EPA’s Future Testing Strategy; the State of the Science, Predictive Modeling and Virtual Tissues.
10:00 a.m. – 10:45 a.m.
Overview: Implementing the Recommendations of the 2007 Report
Dr. Thomas Hartung, Doerenkamp-Zbinden Professor and Chair for Evidence-Based Toxicology and Director, Center for Alternatives to Animal Testing Johns Hopkins Bloomberg School of Public Health
- Animal Testing Costs
- Globalization of Data
- Cost-Benefit Analysis
- Economics of Other Countries
- Indirect Costs – e.g., delay of shift impacts life expectancy
10:45 – 11:00 a.m.
Break
11:00 – 12: 15 p.m.
Analysis of Costs, Savings and Changing Perceptions
Dr. James McKim, CSO and Founder, CeeTox, Inc., James Zappia, 3M Medical Department, Toxicology Assessments and Compliance Assurance
- Short term costs/savings to make the change from in vivo to in vitro paradigm
- Long term economic impacts of switch to in vitro
Dr. Alan Goldberg, Professor of Toxicology and Chairman of the Board, Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University
- Changing Perceptions: How do we Market Internally (to industry) and then, Externally (to the public)?
12: 15 – 1:15 p.m.
Lunch
1:15 – 2:45 p.m.
Benefits of In Vitro
Dr. Frank Baker, Dr. Nancy Higley, Vice President of Scientific and Regulatory Affairs, PepsiCo, Inc., Dr. Pamela Lein, Associate Professor, University of California, Davis School of Veterinary Medicine, Dr. Ladd Smith, Research Institute for Fragrance Materials
- Direct Human Models will be more accurate
- Direct Human Models have potential to appeal to consumer base
- Already working for some industries, such as pharmaceutical
- Sustainability Issues: Good Corporate Citizen Model
2:45 – 3:00 p.m.
Break
3:00 – 4:30 p.m.
Challenges
E. Donald Elliott, Adjunct Professor of Law, Yale Law School, Dr. Steven Bradbury, Deputy Director of Programs, Office of Pesticide Programs, US Environmental Protection Agency, Annamaria Bottini, Managing Director, Johns Hopkins Medicine Int’l., John Ostergren, Office of General Counsel, 3M.
- What Challenges do US Regulators Face in Bringing the new Paradigm into Practice? What can be Done to Encourage U.S. Regulators to Accept In Vitro Data?
- What can be Done to Encourage Regulators from Other Countries to Accept In Vitro Data?
- Product Liability Lawsuits - how can Industry be Prepared to Respond Effectively?
4:30 – 5:00 p.m.
Summary: The Path Forward
Dr. Paul Locke, Associate Professor, Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing
Speaker Biographies
Frank Baker
Dr. Baker retired from Procter & Gamble in 2000 and has continued to
pursue his technical and managerial interests as a consultant in
technical management, toxicology, environmental safety and regulatory
affairs. more...
Annamaria Bottini
Annamaria Bottini is the Managing Director
at Johns Hopkins Medicine International, Baltimore, MD. She has been
working for twenty years for the European Commission in the legislative
field. more...
Steven Bradbury
Dr. Steven Bradbury was named Deputy Director for Programs, Office of Pesticide Programs (OPP) in January 2009. more...
E. Donald Elliott
E. Donald Elliott is a leading academic expert on improving the relationship between law and science, specializing in environmental law and chemical regulation. more...
Pamela Frasch
Dean Frasch is the Assistant Dean of the Animal Law Program at Lewis & Clark Law School and the Executive Director of the Center for Animal Law Studies. more...
Alan Goldberg
Dr. Goldberg is a Professor of Toxicology and Chairman of the Board at the Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University. more...
Thomas Hartung
Thomas Hartung, MD, PhD is the new Director of the Center for Alternatives to Animal Testing (CAAT) and the inaugural Doerenkamp-Zbinden Chair for Evidence-Based Toxicology in the Department of Environmental Health Sciences at the Johns Hopkins Bloomberg School of Public Health. more...
Nancy Higley
Nancy Higley, PhD is Vice President, Food Safety and Regulatory Affairs at PepsiCo, Inc. more...
Thomas Knudsen
Dr. Knudsen is a Developmental Systems Biologist at the U.S. Environmental Protection Agency’s National Center for Computational Toxicology. more...
Pamela Lein
Dr. Pamela J. Lein is an Associate Professor in the School of Veterinary Medicine at the University of California at Davis. more...
Paul Locke
Paul Locke, an environmental health scientist and attorney, is an Associate Professor at the Johns Hopkins University Bloomberg School of Public Health in the Department of Environmental Health Sciences, Division of Toxicology. more...
James McKim
Dr. James McKim is the CSO and Founder, CeeTox, Inc. He graduated with high honors from the doctoral program in biochemical and molecular toxicology at Oregon State University and trained as a postdoctoral fellow at the University of Kansas Medical School. more...
John Ostergren
Mr. Ostergren is Legal Counsel in the Office of General Counsel at the 3M Company in St. Paul, Minnesota. more...
Ladd Smith
Dr. Ladd Smith is trained as a scientist and since 1998 has been president of the Research Institute for Fragrance Materials, Inc., an international organization, which evaluates the safety of fragrance ingredients. more...
Martin Stephens
Martin Stephens received a Ph.D. in biology in 1984 from The University of Chicago, where he co-founded a campus-based animal protection organization. He is currently The HSUS's Vice President for Animal Research Issues and in that capacity, directs The HSUS's work on the use of animals in research, testing, and education. more...
Maria Trainer
Dr. Maria Trainer is a Program Director with the Council of Canadian Academies, where she is responsible for several assessments including the Expert Panel on the Integrated Testing of Pesticides. more...
James Zappia
James Zappia, MS, DABT, is the manager of 3M's Toxicology Assessment and Compliance Assurance group. He has served as a 3M toxicologist for 20 years working with a wide variety of 3M businesses and products. more...
David Zarfes
David Zarfes is the Associate Dean for Corporate and Legal Affairs and Schwartz Lecturer in Law, University of Chicago Law School. more...
Hotel Information
A block of rooms has been reserved at the Omni Hotel in downtown Chicago. To book a room, please ask for the "Toxicity Testing Symposium" group block to receive our special rate of $178.00/night, plus tax. Please note that reservations must be made by Wednesday, October 14, 2009 to receive this special rate.
Ground Transportation
We have booked shuttles to transport symposium panelists and guests from the Omni Hotel to the law school the morning of the event, then back to the hotel after the event concludes that afternoon. The shuttle schedule is as follows:
Thursday, November 5
Omni Hotel to University of Chicago Law School – departs hotel at 7:45 a.m.
University of Chicago Law School t0 Omni Hotel – departs law school at 4:45 p.m.
Directions
Maps and directions to the University of Chicago Law School.
Parking and safety information.
Registration
The deadline to register for this symposium is 5 p.m. on Monday, November 2, 2009. There is no fee for the symposium, but registration is required for attendance and participation. A complementary light breakfast and lunch will be provided. To register, please contact Liberty Mulkani at lmulkani@aldf.org.
Questions?
If you have any questions about the symposium, the accommodations, or ground transportation, please contact Liberty Mulkani at lmulkani@aldf.org.
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