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CIBR Comments on Bio Markers

CIBR Comments on Bio Markers

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Published by: vlathrop on Jun 17, 2010
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06/17/2010

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Steering CommitteeWilliam G. Bradley, Jr, MD, PhD
Chair, Dept. of RadiologyUniversity of California San Diego
Chairman 
Ronald Arenson, MD
Chair, Dept. of Radiology andBiomedical ImagingUniversity of California San Francisco
Jim Beckett
Vice President, Clinical ResearchPhilips Medical Systems, N.A.
N. Reed Dunnick, MD
Chair, Dept. of RadiologyUniversity of Michigan Medical Center
Steven Haberlein
Vice President, SalesFUJIFILM Medical Systems USA, Inc.
James Jorkasky
Executive DirectorNational Alliance forEye and Vision Research
Michael Kalutkiewicz
Director of Government AffairsInternational & American Associationsfor Dental Research
Bich Le
General Manager, Academic SegmentGE Healthcare
Richard Mather, PhD
Senior Manager, Clinical ProgramsToshiba Medical Research InstituteUSA
Christi M. Pedra
 Senior Vice President, Strategic NewBusiness Development & MarketingSiemens Healthcare
Lenny Reznik
Director, Enterprise Imaging andInformationAgfa HealthCare Corporation
Sheila Ross
Special CounselLung Cancer Alliance
PresidentRenée L. Cruea, MPA
Executive DirectorAcademy of Radiology Research
1029 Vermont Avenue NW, Suite 505 • Washington, DC 20005
 
Phone: 202.347.5872 • Fax: 202.347.5876 • www.imagingcoalition.org
 
May 26, 2010
DOCKET NO. FDA-2010-N-0233
Division of Dockets Management [HFA-305]Food and Drug Administration (FDA)5630 Fishers Lane, Room 1061, Rockville, Maryland 20852Re: NIH-FDA Joint Leadership CouncilComments for public meeting to be held on June 2, 2010Dear Ladies and Gentlemen,The Coalition for Imaging & Bioengineering Research (CIBR) is apermanent partnership of academic research departments, scientificsocieties, patient advocacy organizations, and imaging equipmentmanufacturers leading the education and advocacy efforts for imagingresearch. We welcome the opportunity to present comments to the NIH-FDA Joint Leadership Council as the council develops its strategy andpriorities to promote interdisciplinary biomedical research throughscientific exchange and new programs designed to advance innovationand the development of new therapies incorporating many of the latestbasic research discoveries.We will direct our comments at one specific area where we believe thatNIH and FDA can effectively promote promising new diagnostic andtherapeutic technological advances through coordinated research andregulatory efforts that bridge the gap between discoveries and newmedical products. Specifically CIBR recommends that the NIH-FDAJoint Leadership Council elevate the urgency of developing a regulatorypathway to accelerate the rapid and efficient clinical translation of diagnostic and therapeutic biomarkers.
Background.
The rapid advances in decoding biological processesthrough the efforts of research in genomics, proteomics, metabolomics,high-throughput screening, molecular imaging and other fields has raisedexpectations among physicians and the public that we are on the verge of (finally) enabling personalized medicine. These advances have alsoyielded new classes of biomarkers that hold promise for diseaseprevention, diagnosis and treatment. Recognizing this potential, in 2006the NIH, FDA and Pharmaceutical Research and Manufacturers of 
America created The Biomarkers Consortium “to identify and qualifynew, quantitative biological markers (“biomarkers”), for use by

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