Life Sciences Research Office, Inc.

(LSRO)

Michael Falk Executive Director

Mission

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

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 FASEB • 2001 ASNS ASNS LSRO, Inc

LSRO Inc

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

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

Board of Directors (2003)

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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.

Selected Current & Past Clients

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FDA USDA ONR Army Med R &D HHS FAA NASA NIH

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ASNS Monsanto California Walnut Commission National Dairy Council Calorie Control Council Philip Morris APS/ASPET Patton Boggs

What We Do

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Comprehensive Reviews

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ad-hoc Expert Panels Authoritative Reports Conferences, Workshops, Symposia Programmatic and Proposal Peer Review Scientific Support Services

Policy Regulation Science

Project Selection Criteria

• General public benefit • Fit within our expertise • Permit independent action

Value Added

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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

Infomediate

• Infomediate the science – Between industry and government – Between scientists and government

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

Added Ingredient Review

• Sponsored by Philip Morris, USA • Expert Panel review • In process since 2001 • Developing evaluation criteria • Intend to conduct ingredient evaluations

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)

Speakers

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

Michael Falk, Ph.D.

Executive Director, LSRO 301-634-7030 301-634-7876 (fax) [email protected]

www.LSRO.org