Life Sciences Research Office, Inc.(LSRO)

Michael FalkExecutive 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 ASNS• 2001 ASNS LSRO, Inc

LSRO Inc

• 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)• 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• 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

What We Do

• Comprehensive Reviews – 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• 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)

falkm@LSRO.org

www.LSRO.org