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 20852

Steering Committee
Re: NIH-FDA Joint Leadership Council
Comments for public meeting to be held on June 2, 2010
William G. Bradley, Jr, MD, PhD
Chair, Dept. of Radiology
University of California San Diego Dear Ladies and Gentlemen,
Chairman
Ronald Arenson, MD The Coalition for Imaging & Bioengineering Research (CIBR) is a
Chair, Dept. of Radiology and
Biomedical Imaging permanent partnership of academic research departments, scientific
University of California San Francisco societies, patient advocacy organizations, and imaging equipment
Jim Beckett
Vice President, Clinical Research
manufacturers leading the education and advocacy efforts for imaging
Philips Medical Systems, N.A. research. We welcome the opportunity to present comments to the NIH-
N. Reed Dunnick, MD FDA Joint Leadership Council as the council develops its strategy and
Chair, Dept. of Radiology
University of Michigan Medical Center priorities to promote interdisciplinary biomedical research through
Steven Haberlein scientific exchange and new programs designed to advance innovation
Vice President, Sales and the development of new therapies incorporating many of the latest
FUJIFILM Medical Systems USA, Inc.
James Jorkasky
basic research discoveries.
Executive Director
National Alliance for
Eye and Vision Research
We will direct our comments at one specific area where we believe that
Michael Kalutkiewicz NIH and FDA can effectively promote promising new diagnostic and
Director of Government Affairs therapeutic technological advances through coordinated research and
International & American Associations
for Dental Research regulatory efforts that bridge the gap between discoveries and new
Bich Le medical products. Specifically CIBR recommends that the NIH-FDA
General Manager, Academic Segment Joint Leadership Council elevate the urgency of developing a regulatory
GE Healthcare
Richard Mather, PhD
pathway to accelerate the rapid and efficient clinical translation of
Senior Manager, Clinical Programs diagnostic and therapeutic biomarkers.
Toshiba Medical Research Institute
USA
Christi M. Pedra Background. The rapid advances in decoding biological processes
Senior Vice President, Strategic New through the efforts of research in genomics, proteomics, metabolomics,
Business Development & Marketing
Siemens Healthcare high-throughput screening, molecular imaging and other fields has raised
Lenny Reznik expectations among physicians and the public that we are on the verge of
Director, Enterprise Imaging and (finally) enabling personalized medicine. These advances have also
Information
Agfa HealthCare Corporation yielded new classes of biomarkers that hold promise for disease
Sheila Ross prevention, diagnosis and treatment. Recognizing this potential, in 2006
Special Counsel the NIH, FDA and Pharmaceutical Research and Manufacturers of
Lung Cancer Alliance
America created The Biomarkers Consortium to identify and qualify
President new, quantitative biological markers (biomarkers), for use by
Rene L. Cruea, MPA
Executive Director
Academy of Radiology Research
1029 Vermont Avenue NW, Suite 505 Washington, DC 20005
Phone: 202.347.5872 Fax: 202.347.5876 www.imagingcoalition.org
Comments of CIBR to NIH-FDA Joint Leadership Council
Page 2

biomedical researchers, regulators and health care providers. But at present, the lack of a clear
regulatory pathway for the approval, marketing and quality control of biomarkers has severely
limited the clinical relevance of these tools and inhibited progress toward realizing the promise of
personalized medicine.

Most biomarkers employed in current clinical practice are marketed as home-brew tests without
FDA approval.1 Radiopharmaceuticals (with few exceptions, such as 18F-FDG) are synthesized at
research hospitals under pathways such as investigator-initiated INDs for each agent. The FDAs
current regulatory pathways have proven ill-suited for clinical translation and many promising
biomarkers never leave the realm of research. As one of many examples, 18F-Estradiol has been
known (for decades) to label estrogen receptor positive breast cancer cells (with utility for staging
and monitoring), but has not progressed to FDA approval.

Recommendation. CIBR recommends that the NIH-FDA Joint Leadership Council, working
through the NIH, the Biomarkers Consortium, academic researchers or others, undertake a focused
and coordinated research effort to illuminate the process elements of a biomarker regulatory
pathway and create a framework that will allow (and encourage) biomarker development,
validation, approval and dissemination. In concert with this effort, FDA would develop
appropriate regulations that recognize the science, logistics and economics relevant to biomarkers.
The combined result would be the establishment of a scientific and regulatory pathway for the
development and commercialization of biomarkers, analogous to the pathway for generic drugs
and the pathway for biosimilars recently authorized in the amendments to the Public Health
Service Act signed by the President this Spring.

A clear, efficient pathway for the regulatory approval of biomarkers will accelerate the clinical
translation of promising biomarkers and will encourage the development of new biomarkers by
academic and industrial scientists. This effort will result in short-term and long-term public health
benefits that include increased access to useful biomarkers, improved safety and efficacy of
biomarkers, and rapid advances in the disease prevention, diagnosis and treatment through an
individualized approach to healthcare. For these reasons, CIBR urges the NIH-FDA Joint
Leadership Council to make this effort a priority for regulatory science research.

Sincerely,

William G. Bradley, M.D., Ph.D.

Chairman, Coalition for Imaging and Bioengineering Research

1
Wilson, C, Schulz, S and Waldman SA, Biomarker Development Commercialization, and Regulation:
Individualization of Medicine Lost in Translation, Clinical Pharmacology & Therapeutics 81, 153-155 (February 2007).