Life Sciences Research Office, Inc' LSRO

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Life Sciences Research Office, Inc.(LSRO)

• Michael Falk
• Executive Director

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Mission

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

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Brief History

• Formed by FASEB in 1962
• 60s 70s clients Army, Navy, NASA, FDA
• 72 82 GRAS Reviews
• 80s 90s clients USDA, FDA, Health Claims
• 1997 FASEB ASNS
• 2001 ASNS LSRO, Inc

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LSRO Inc

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

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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

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Board of Directors (2003)

• ChairWilliam 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.

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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

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Selected Recent Reports

• Nutrient Requirements for Preterm Infant Formula
• The Status and Future of Integrative and Organ
  System Sciences in the U.S.
• The Adequacy of Existing Scientific Information
  on Possible Adverse Reactions to Monosodium
  Glutamate (MSG)
• Alternative and Traditional Models for Safety
  Evaluation of Food Ingredients
• Military Dental Research Review

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What We Do

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

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Project Selection Criteria

• General public benefit
• No product endorsements
• Fit within our expertise
• Permit independent action

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Facilitate the Process

• Recruit the best experts
• Gather the available information
• Focus on the essential questions
• Reports address the contractual charge with
  transparent reasoning
• Focus on the science

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Activities

• Selected an Expert Panel
• Conducted a comprehensive literature search
• Call for public input (Federal Register)
• Additional public comment (this meeting)
• Web site
• Review, rank, and assess the literature
• Publicly available report

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Panel Expertise

• Toxicology
• Neuro/behavioral tox
• Pathology
• Allergy
• Immunology
• Pediatrics
• Developmental tox

• Reproductive tox
• Psychology
• Epidemiology
• Public health
• Environmental and occupational health
• Toxicokinetics
• Risk assessment

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Public Comment

• Federal Register 68 25047 (5/9/2003)
• Received 262 submissions
• 5,096 references
• Compiled website references
• Compiled public comments
• Gathered references
• Open Meeting
• 8 speakers

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Invited Speakers

• Sponsors Statement
• Dushanka V. Kleinman, D.D.S., M.S.D. (NIDCR, NIH)
• Mercury Toxicity
• Boyd E. Haley, Ph.D. (University of Kentucky)
• Material Properties, Use in Dentistry
• J. Rodway Mackert, D.M.D., Ph.D.(Med College of
  Georgia)
• Clinical Trial Design
• David C. Bellinger, M.S., Ph.D. (Harvard Med
  School)

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Perspectives on Amalgam Controversy

• Sean Delgado
• Merge Medicine
• Richard D. Fischer
• IAOMT
• Kathryn Chilcote
• Carol J. Ward
• DAMS

• Freya Koss
• Consumers for Dental Choice
• Anne Ferreira
• Charles Brown
• Consumers for Dental Choice
• Fred Eichmiller
• American Dental Assoc.

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Charge to Meeting Participants

• Keep on schedule
• Keep on subject (science not policy)
• Only LSRO Expert Panel may ask questions
• Submit all other comments in writing to LSRO

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Michael Falk, Ph.D. Executive Director,
LSRO 301-634-7030 301-634-7876 (fax) falkm_at_LSRO.or
g www.LSRO.org