Transcript Life Sciences Research Office LSRO, Inc.

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
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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
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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
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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
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
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
– No product endorsements
• Fit within our expertise
• Permit independent action
Facilitate the Process
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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
Activities
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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
Panel Expertise
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Toxicology
Neuro/behavioral tox
Pathology
Allergy
Immunology
Pediatrics
Developmental tox
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Reproductive tox
Psychology
Epidemiology
Public health
Environmental and
occupational health
• Toxicokinetics
• Risk assessment
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
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)
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.
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
Michael Falk, Ph.D.
Executive Director, LSRO
301-634-7030
301-634-7876 (fax)
[email protected]
www.LSRO.org