1. Life Sciences Research Office, Inc. (LSRO) Michael Falk Executive Director

2. Mission To benefit society by evaluating biological information and scientific opinion for the public and private sectors

3. Brief History Formed by FASEB in 1962 60’s – 70’s clients: Army, Navy, NASA, FDA 72 – 82 GRAS Reviews 80’s – 90’s clients: USDA, FDA, Health Claims 1997 FASEBASNS 2001 ASNSLSRO, Inc

4. LSRO Inc Non-profit 501(c)(3) Affiliated with scientific professional societies Independent, objective, respected National, international impact Biomedical, environmental, biological science issues

5. Member Societies American Society for Nutritional Sciences The American Physiological Society The Protein Society American Society for Pharmacology and Experimental Therapeutics American Society for Investigative Pathology The American Society for Bone and Mineral Research The American Society for Clinical Nutrition American College of Nutrition International Society of Regulatory Toxicology and Pharmacology

6. Board of Directors (2003) Chair:William Heird, M.D. Baylor College of Medicine Donald Beitz, Ph.D. Iowa State University Sam Enna, Ph.D. University of Kansas Medical Center (ASPET) Arnold Kahn, Ph.D. UC San Francisco (ASBMR) Gilbert Leveille, Ph.D. Cargill, Inc. (ASNS) Robert Newburgh, Ph.D. (The Protein Society) Terry Quill Duane, Morris LLP (ISRTP) Robert Russell, M.D. Tufts University (ASCN) Jacob J. Steinberg, M.D. Albert Einstein College of Medicine (ASIP) Taffy Williams Photogen Technologies, Inc.

7. Selected Current & Past Clients FDA USDA ONR Army Med R &D HHS FAA NASA NIH ASNS Monsanto California Walnut Commission National Dairy Council Calorie Control Council Philip Morris APS/ASPET Patton Boggs

8. What We Do Comprehensive Reviews –ad-hoc Expert Panels Authoritative Reports Conferences, Workshops, Symposia Programmatic and Proposal Peer Review Scientific Support Services

9. PolicyRegulation Science

10. Project Selection Criteria General public benefit Fit within our expertise Permit independent action

11. Value Added Bridge between science community and organizations who need advice Independent, un-biased organization affiliated only with science community Experts in the process Accepted by government agencies

12. Infomediate Infomediate the science –Between industry and government –Between scientists and government

13. Facilitate the Process Find the right experts –From the right disciplines –Un-biased and/or balanced Find the right information Focus on the right questions Report with the right language

14. Added Ingredient Review Sponsored by Philip Morris, USA Expert Panel review In process since 2001 Developing evaluation criteria Intend to conduct ingredient evaluations

15. Goals For This Meeting Input and comment on third-party evaluation of relative risk of added ingredients (to the LSRO and the Expert Panel) –Evaluation criteria –Evaluation framework Report on the process and current thinking (to the stakeholder communities)

16. Speakers Michael Falk (LSRO) Kara Lewis (LSRO) Paula Nixon (LSRO) Daniel Byrd (LSRO) Fawky Abdallah Peter Lee Richard Ford

17. Michael Falk, Ph.D. Executive Director, LSRO 301-634-7030 301-634-7876 (fax) falkm@LSRO.org www.LSRO.org