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RECOMBINANT DNA ADVISORY COMMITTEE Minutes of Meeting December 3 - 4, 2003 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service
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Document Date: 2013-12-16 11:07:03


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City

Washington / D.C. / Bethesda / Baltimore / San Diego / /

Company

Gene Transfer Clinical Trial Design Working Group / San Francisco RAC / RAC Gene Transfer Clinical Trial Design Working Group / Consent Working Group / AEs / Tourette’s Syndrome Association Inc. / Molecular Diagnostics Inc. / Oncocidex Inc. / /

Country

United States / /

Event

FDA Phase / Person Communication and Meetings / Judicial Event / Natural Disaster / /

Facility

Dana-Farber Cancer Institute / Chapel Hill Sue L. Levi-Pearl / Marina O’Reilly / Chapel Hill Philip R. Johnson / University of North Carolina / University of Wisconsin Medical School Theodore Friedmann / University of California / University of Virginia Neal A. DeLuca / National Human Genome Research Institute / National Institute of Allergy / Bethesda Marriott Hotel / University of Pittsburgh David L. DeMets / Mayo Clinic / Baylor College of Medicine / The Burnham Institute / Hospital Terry Kwan / University David Sidransky / Sinai Hospital / /

IndustryTerm

magnetic resonance imaging / study product / transfer protocol / Web-Based Resource / /

MedicalCondition

neoplasms / Summary Glioblastoma multiforme / syngeneic mouse tumor / human tumor / diabetic neuropathy / bladder cancer / degenerative joint disease / melanoma / X-linked severe combined immunodeficiency disease / Squamous Cell Cancer / prostate cancer / breast cancer / undiagnosed cardiac disease / tumor / small-vessel necrosis / cancer / Tumors / neoplasm / chills / IV metastatic melanoma / fever / neovascular age-related macular degeneration / progressive glioblastoma multiforme / Cytolytic Immune Response Against Melanoma Tumors / diseases / AIDS / lung and cardiac disease / disorders / leptomeningeal necrosis / subsequently developed seizures / primary brain tumor / lung disease / stable angina / tachycardia / neither tumor / hypotension / disease / cardiovascular disease / severe hemophilia B / rigors / infectious diseases / SCID / thrombosis / /

MedicalTreatment

Vaccination / bone marrow transplant / /

Organization

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES / National Human Genome Research Institute / Northwestern University Medical School / Sinai Hospital / Henry Ford Cancer Center / University of Virginia / University of Pittsburgh / National Institute of Allergy and Infectious Diseases / Baylor College of Medicine / Tourette’s Syndrome Association / office of Biotechnology Activities / Georgetown University / Burnham Institute / Applied Research Ethics National Association / University of California / San Francisco / University of California / San Diego / Fred Hutchinson Cancer Research Center / National Institute of Health / Johns Hopkins University School of Medicine Robert D. Simari / University of Michigan Medical School / Columbus Children’s Hospital / University of North Carolina / American Biological Safety Association / Association of Clinical Research Professionals / Dana-Farber Cancer Institute / Federal Government / U.S. Food and Drug Administration / University of Wisconsin Medical School / University of North Carolina / Chapel Hill / Howard Hughes Medical Institute / Inc. Cheryl L. McDonald / /

Person

Terry Kwan / D. Simari / Dave Harrington / Cheryl L. McDonald / Laurie Lewallen / Henry Ford / Bernard Lo / David Sidransky / Harry L. Malech / Nancy M.P. King / Larry G. Johnson / Martha C. Bohn / Allan Shipp / David L. DeMets / Richard W. Slauter / Jim Wheaton / Gisele White / Albert B. Deisseroth / Stephen M. Rose / Tom Mikklesen / Shawn M. Burgess / Diane W. Wara / Maureen Montgomery / Robert Jambou / P. Johnson / Theodore Friedmann / Donald L. Budenz / Maxine L. Linial / Melanoma Tumors / W. Emmett Barkley / Alexander Rakowsky / James F. Childress / Sussan Eftekhari / Evan Y. Snyder / Gene Rosenthal / Sidney Kimmel / Alan K. Smith / L. Johnson / Thomas Shih / Jennifer M. Puck / Thomas D. Gelehrter / Baruch A. Brody / /

Position

King / pathologist / Executive Secretary / Pilot / senior statistician / Investigator / statistician / Director of Outreach / principal investigator / chair of the institutional review board / Pilot Trial Principal Investigator / Director / Chair / RAC Executive Secretary / /

Product

acetaminophen / Intratumoral Injections / Demerol / Single Injection / hydrocortisone / Ad5 / Glaucoma Subjects Receiving / E7 / into / single / III-1 / /

ProvinceOrState

Michigan / California / Wisconsin / Maryland / North Carolina / /

PublishedMedium

Public Law / the RAC review / /

Technology

two protocols / Human Genome / three protocols / magnetic resonance imaging / RECOMBINANT DNA / tomography / antibodies / Biotechnology / Burnham Institute A. Protocol / MRI / pharmacokinetics / six protocols / 13 A. Protocol / few protocols / selecting a few protocols / /

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