NCI Advisory Board

Attachment 1. Consultations NCI Advisory Boards
NCI Advisory Boards
NCI staff members have made 17 presentations concerning the CTRP Database to three NCI
federal advisory committees, each of which is authorized pursuant to 42 U.S.C. 285a-2(b)(7),
section 413(b)(7) of the Public Health Service Act, as amended, and governed by the provisions
of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
1. Clinical and Translational Research Advisory Committee (CTAC)
NCI staff members have made 7 presentations to the NCI Clinical and Translational Research
Advisory Committee (CTAC) concerning the CTRP Database as follows: January 2007, July 2007,
November 2007, February 2008, June 2008, December 2008, March 2009, December 2010,
November 2013, July 2015, July 2016, and November 2017. Minutes for CTAC meetings can be
found at http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm.
The CTAC is the NCI advisory committee that reviews and delivers feedback on the plans,
progress and timelines for the CTRP Database. The CTAC is charged with overseeing the
implementation of all 22 recommendations of the 2005 report of the Clinical Trials Working
Group to the National Cancer Advisory Board.
The CTAC consists of 25 members, including the Director, NCI, who chairs the Committee. At
least five members must hold concurrent membership on either the National Cancer Advisory
Board, Board of Scientific Advisors, Board of Scientific Counselors (Basic Sciences and Clinical
Sciences and Epidemiology), or Director’s Consumer Liaison Group. CTAC members are required
to be authorities knowledgeable in the fields of community oncology, surgical oncology, medical
oncology, radiation oncology, patient advocacy, extramural clinical investigation, regulatory
agencies, pharmaceutical industry, public health, clinical trials design, management and
evaluation, drug development and developmental therapeutics, cancer education, cancer
information services, community outreach, vaccine development, cellular oncology, molecular
oncology, pediatric oncology, clinical, basic and translational research, cancer center
administration, cancer biology and diagnosis, cancer epidemiology, chemotherapy, community
outreach, oncology health care providers, pharmacology, pathology, biostatistics, quality of life,
pain management, cancer treatment and restorative care, and education of health professionals.
Ex officio members include NCI Deputy Directors, the Director for the Division of Extramural
Activities, NCI, the Director for the Division of Cancer Treatment and Diagnosis, an NCI
intramural scientist engaged in clinical research, and representatives from the Food and Drug
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Administration, Centers for Medicare and Medicaid Services, the Department of Defense and
Department of Veterans Affairs.
The CTAC makes recommendations on the NCI-supported national clinical trials enterprise to
build a strong scientific infrastructure by bringing together a broadly developed and engaged
coalition of stakeholders involved in the clinical trials process. This encompasses oversight of all
trials both extramural and intramural. The CTAC provides broad scientific and programmatic
advice on the investment of tax payer dollars in clinical trials and supportive science, resulting in
enormous potential for more specific cancer treatment, coupled with the complexity of
evaluating new, highly specific agents integrating knowledge, insights, and skills of multiple fields
into a new kind of cross-disciplinary, scientifically-driven, cooperative research endeavor. In
addition, the CTAC makes recommendations regarding the effectiveness of NCI’s translational
research management and administration program, including needs and opportunities across
disease sites, patient populations, translational developmental pathways, and the range of
molecular mechanisms responsible for cancer development. The CTAC advises on the
appropriate magnitude for dedicated translational research priorities and recommend allocation
of translational research operations across organizational units, programs, disease sites,
populations, developmental pathways, and molecular mechanisms. The CTAC also ensures that
appropriate emphasis is placed on rare cancers, medically underserved populations, and
historically lower-resourced pathways to clinical goals.
The goal is to foster an open, collaborative system involving all the critical stakeholders in the
prioritization process bringing diverse institutions and individuals together into an integrated
and efficient, but innovative and responsive effort, thus moving discoveries to benefit cancer
patients.
Meetings of the full Committee are held approximately 3 times within a fiscal year. Meetings are
open to the public except as determined otherwise by the Secretary of Health and Human
Services (Secretary) in accordance with subsection (c) of section 552b of Title 5 U.S.C.
MEMBERS:
Patrick, J. Loehrer, Sr., M.D., Director, Melvin and Bren Simon Cancer Center, Associate Dean for
Cancer Research, Indiana University School of Medicine (Chairperson)
Debra L. Barton, Ph.D., F.A.A.N., Mary Lou Willard French Professor of Oncology Nursing,
University of Michigan School of Nursing
Walter J. Curran, M.D., Ph.D., F.A.C.R., Executive Director, Winship Cancer Institute of Emory
University
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Janet Ellen Dancey, M.D., F.R.C.P.C., Professor, Department of Oncology, Queen’s University,
Director, Canadian Cancer Trials Group
Nancy E. Davidson, M.D., Senior Vice President, Director and Full Member Clinical Research
Division, Fred Hutchinson Cancer Research Center, President & Executive Director, Seattle
Cancer Care Alliance Head, Division of Medical Oncology Department of Medicine, University of
Washington
Timothy J. Eberlein, M.D. Director, Alvin J. Siteman Cancer Center, Spencer T. and Ann W. Olin
Distinguished Professor, Bixby Professor and Chairman, Department of Surgery, Washington
University School of Medicine in St. Louis
Howard J. Fingert, M.D., F.A.C.P., Senior Medical Director, Oncology Clinical Research,
Millenium, The Takeda Oncology Research Company, Takeda Pharmaceuticals International, Inc.
David M. Gershenson, M.D., Professor of Gynecology, Department of Gynecologic Oncology and
Reproductive Medicine, Division of Surgery, The University of Texas, MD Anderson Cancer
Center
Anne-Marie R. Langevin, M.D. Greehey Distinguished Chair in Pediatric Oncology, Department
of Pediatrics Hematology/Oncology, The University of Texas Health Science Center at San
Antonio
Michael LeBlanc, Ph.D., Member, Fred Hutchinson Cancer Research Center, University of
Washington
David A. Mankoff, M.D., Ph.D., Gerd Muehllehner Professor of Radiology, Vice-Chair for
Research, Department of Radiology, Perelman School of Medicine, University of Pennsylvania
Lynn M. Matrisian, Ph.D. Chief Science Officer, Pancreatic Cancer Action Network
Neal J. Meropol, M.D. Vice President of Research Oncology, Flatiron Health
Augusto C. Ochoa, M.D.*, Director, Stanley S. Scott Cancer Center, Professor, Department of
Pediatrics, Louisiana State University Health Sciences Center
Roman Perez-Soler, M.D., Chairman, Department of Oncology, Montefiore Medical Center,
Deputy Director, Albert Einstein Cancer Center, Director, Division of Medical Oncology, Albert
Einstein College of Medicine
Gloria M. Petersen, Ph.D., Deputy Director, Mayo Clinic Cancer Center, Professor of
Epidemiology, Department of Health Sciences Research, Mayo Clinic College of Medicine
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Sheila A. Prindiville, M.D., M.P.H., Director, Coordinating Center for Clinical Trials, National
Cancer Institute (Executive Secretary)
Steven T. Rosen, M.D., F.A.C.P., Provost & Chief Scientific Officer Director Comprehensive
Cancer Center and Beckman Research Institute Irell & Maella Cancer Center Director’s
Distinguished Chair Comprehensive Cancer Center City of Hope
Dan Theodorescu, M.D., Ph.D., Director Samuel Oschin Comprehensive Cancer Institute CedarsSinai Medical Center
EX OFFICIO MEMBERS:
William L. Dahut, M.D. Scientific Director for Clinical Research Center for Cancer Research
National Cancer Institute National Institutes of Health
James H. Doroshow, M.D., Deputy Director, Clinical and Translational Research, National Cancer
Institute, National Institutes of Health
Paulette Gray, Ph.D., Director, Division of Extramural Activities, National Cancer Institute,
National Institutes of Health
Michael J. Kelley, M.D., F.A.C.P., National Program Director for Oncology Veterans Health
Administration, Department of Veterans Affairs
Anthony Kerlavage, Ph.D. Acting Director, Center for Biomedical Informatics and Information
Technology Office of the Director National Cancer Institute National Institutes of Health
Richard Pazdur, M.D., F.A.C.P., Director Oncology Center of Excellence, U.S. Food and Drug
Administration
Katherine Szarama, Ph.D. Epidemiologist, Centers for Medicare & Medical Services

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2. NCI Board of Scientific Advisors (BSA)
NCI staff members have made 3 presentations to the NCI’s Board of Scientific Advisors (BSA)
concerning the CTRP Database as follows: March 2007, June 2007, and March 2008. Minutes for
BSA meetings can be found at http://deainfo.nci.nih.gov/advisory/bsa/bsa.htm
The BSA consists of 35 members, including the Chair appointed by the Director, NCI, from
authorities knowledgeable in the fields of laboratory, clinical and biometric research, clinical
cancer treatment, cancer etiology, and cancer prevention and control, with emphasis on training
and experience in the various disciplines and fields related to scientific areas relevant to
carcinogenesis, cancer biology and diagnosis, cancer center administration, medicine,
radiological and surgical oncology, cancer chemotherapy, cancer epidemiology, cancer
prevention and control, cancer education, cancer information services, community outreach,
biological, chemical and physical carcinogenesis, DNA repair and effects, tumor biology and
immunology, humoral and cellular immunity, hematopoiesis, cell differentiation and
transformation, oncogenes and growth factors, molecular and structural biology and genetic
regulation, viral oncology, vaccine development, transplantation, chemotherapy, clinical trial
design, management and evaluation, pharmacology, drug development and developmental
therapeutics, genetic and immunotherapies, pathology, diagnostic research and cytogenetics,
biological response modifiers, imaging, nutrition, survey research, epidemiology, biostatistics,
rehabilitation, psychology and behavioral medicine, public health and community oncology,
quality of life, pain management, cancer detection and diagnosis, cancer treatment and
restorative care, dentistry, nursing, public health, nutrition, education of health professionals,
medical oncology, surgery, radiotherapy, gynecologic oncology, pediatric oncology, pathology,
and biostatistics.
The BSA advises the Director and Deputy Director for Extramural Science, NCI, and the Director
of each NCI Division on a wide variety of matters concerning scientific program policy, and
progress and future direction of extramural research programs of each of the Divisions. This
includes the evaluation of NCI awarded grants, cooperative agreements and contracts and
concept review of those activities which it considers meritorious and consistent with the
Institute's programs. The advisory role of the Board is scientific and does not include
deliberation on matters of public policy.
Meetings of the full Board are held approximately three times a year. Meetings are open to the
public except as determined otherwise by the Secretary of Health and Human Services in
accordance with subsection (c) of section 552b of Title 5, U.S.C.

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MEMBERS:
Robert C. Young, M.D., Chancellor, Fox Chase Cancer Center, Philadelphia, Pennsylvania
(Chairperson)
Paul M. Allen, Ph.D., Robert L. Kroc Endowed Professor of Pathology Department of Pathology
and Immunology, Washington University School of Medicine, St. Louis, Missouri
Christine B. Ambrosone, Ph.D., Professor of Oncology, Chair, Departments of Epidemiology and
Cancer Prevention and Control Roswell Park Cancer Institute, Buffalo, New York
Kirby I. Bland, M.D., Fay Fletcher Kerner Professor and Chairman, Department of Surgery, Deputy
Director, Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham,
Alabama
Andrea Califano, Ph.D., Director, Center for the Multiscale Analysis of Genetic Networks,
Professor of Biomedical Informatics, Dept. of Biomedical Informatics, Institute of Cancer
Genetics, Columbia University Medical Center, New York, New York
Michael A. Caligiuri, M.D., CEO and Director, The Comprehensive Cancer Center Ohio State
University (OSUCCC), Columbus, Ohio
Curt I. Civin, M.D., Herman & Walter Samuelson Professor of Oncology, Professor of Pediatrics,
The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer
Center, Baltimore, Maryland
Susan J. Curry, Ph.D., Professor and Dean, College of Public Health, The University of Iowa, Iowa
City, Iowa
William S. Dalton, M.D., Ph.D., Chief Executive Officer and Center Director, H. Lee Moffitt Cancer
Center and Research Institute, University of South Florida, Tampa, Florida
Robert B. Diasio, M.D., Director, Mayo Clinic Cancer Center, William J. and Charles H. Mayo
Professor
Professor of Pharmacology, Department of Molecular Pharmacology and Experimental
Therapeutics, Mayo Clinic, Rochester, Minnesota
Kathleen M. Foley, M.D., Director, Pain and Palliative Care Service, Department of Neurology,
Memorial Sloan Kettering Cancer Center, New York, New York
Sanjiv S. Gambhir, M.D., Ph.D., Professor, Department of Radiology and Bio-X Program Director,
Molecular Imaging Program, Stanford University, Stanford, California

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Todd R. Golub, M.D., Associate Professor, Cancer Program, The Broad Institute of Massachusetts
Institute of Technology and Harvard University, Cambridge, Massachusetts
Joe W. Gray, Ph.D., Director, Division of Life Sciences Associate Director, Biosciences, Lawrence
Berkeley National Laboratory, Berkeley, California
Leland H. Hartwell, Ph.D., President and Director, Fred Hutchinson Cancer Research Center,
Department of Genetics, University of Washington, Seattle, Washington
James R. Heath, Ph.D., Elizabeth W. Gilloon Professor and Professor of Chemistry Division of
Chemistry and Chemical Engineering, California Institute of Technology, Pasadena, California
Mary J. Hendrix, Ph.D., President and Scientific Director, Children’s Memorial Research Center,
Professor of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
Leroy E. Hood, M.D., Ph.D., President and Founder, Institute for Systems Biology, Seattle,
Washington
Marc A. Kastner, Ph.D., Dean, School of Science, Donner Professor of Science, Massachusetts
Institute of Technology, Cambridge, Massachusetts
Timothy J. Kinsella, M.D., Vincent K. Smith Chair in Radiation Oncology, Professor, Department of
Radiation Oncology, Case Western Reserve University School of Medicine, Cleveland, Ohio
Christopher J. Logothetis, M.D., Chairman and Professor, Department of Genitourinary Medical
Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas
Kathleen H. Mooney, Ph.D., F.A.A.N., R.N., Louis S. Peery, M.D., and Janet B. Peery Presidential
Endowed Chair in Nursing Research, Professor, University of Utah College of Nursing, Salt Lake
City, Utah
James L. Omel, M.D., Education and Advocacy Volunteer, International Myeloma Foundation
Volunteer, Multiple Myeloma Research Volunteer, Leukemia, Lymphoma, Myeloma Society,
Grand Island, Nebraska
Edith A. Perez, M.D., Professor of Medicine, Division of Hematology/Oncology, Mayo Medical
School,
Director, Breast Cancer Program, Mayo Clinic, Jacksonville, Florida
Richard L. Schilsky, M.D., Professor of Medicine, Section of Hematology/Oncology, Biological
Sciences Division, University of Chicago, Pritzker School of Medicine, Chicago, Illinois

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Robert D. Schreiber, Ph.D., Alumni Endowed Professor of Pathology and Immunology,
Department of Pathology and Immunology, Washington University School of Medicine, St. Louis,
Missouri
Stuart L. Schreiber, Ph.D., Morris Loeb Professor and Chair, Director, Chemical Biology, Broad
Institute of Harvard and MIT Harvard University, Cambridge, Massachusetts
Ellen V. Sigal, Ph.D., Chairperson, Friends of Cancer Research, Arlington, Virginia
Bruce W. Stillman, Ph.D., President and Chief Executive Officer, Cold Spring Harbor Laboratory,
Cold Spring Harbor, New York
Victor J. Strecher, Ph.D., MPH, Professor, Department of Health Behavior and Health Education,
Cancer Prevention and Control, School of Public Health, University of Michigan, Ann Arbor,
Michigan
Louise C. Strong, M.D., Sue and Radcliff Killam Chair, Professor of Cancer Genetics, Department of
Cancer Genetics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (pending)
Jean Y. Wang, Ph.D., Professor, Department of Medicine, Moores School of Medicine, University
of California, San Diego, La Jolla, California
Jane C. Weeks, M.D., Professor of Medicine, Chief, Division of Population Sciences,
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston,
Massachusetts
Irving L. Weissman, M.D., Director, Stanford University Comprehensive Cancer Center, Stanford
University, Stanford, California
James K. Willson, M.D., Director, Simmons Comprehensive Cancer Center University of Texas
Southwestern Medical Center, Dallas, Texas
3. National Cancer Advisory Board (NCAB)
NCI staff members have made 2 presentations to the National Cancer Advisory Board (NCAB)
concerning the CTRP Database as follows: February 2008 and February 2009. Minutes for NCAB
meetings can be found at http://deainfo.nci.nih.gov/advisory/ncab/ncabmeetings.htm
The NCAB consists of: 18 members appointed by the President and 12 nonvoting ex officio
members who include the Secretary; the Director of the Office of Science and Technology Policy;
the Director of the National Institutes of Health, (NIH); the Chief Medical Director of the
Department of Veterans Affairs; the Director of the National Institute for Occupational Safety
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and Health; the Director of the National Institute of Environmental Health Sciences; the
Secretary of Labor; the Commissioner of the Food and Drug Administration; the Administrator of
the Environmental Protection Agency; the Chairman of the Consumer Product Safety
Commission; the Assistant Secretary of Defense for Health Affairs; and the Director of the Office
of Energy Research of the Department of Energy (or their designees).
Not more than 12 of the appointed members are selected from among the leading
representatives of the health and scientific disciplines (including not less than two individuals
who are leaders in the fields of public health and the behavioral or social sciences) that are
relevant to the activities of the Institute. Not more than six of the appointed members are
representatives from the general public, including leaders in fields of public policy, law, health
policy, economics and management. Not less than five of the appointed members are individuals
knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational
and dietary factors).
The NCAB duties are to advise, assist, consult with, and make recommendations to the Secretary
and the Director, National Cancer Institute, with respect to the activities carried out by and
through the Institute and policies respecting these activities; the NCAB may recommend for
support grants and cooperative agreements, following technical and scientific peer review; and
relating to the functions pertaining to the NCI described under sections 405, 406, 413, and 414
of the PHS Act, as amended.
The NCAB may implement procedures for expediting en bloc concurrence of Scientific Review
Group recommendations. A member or members may be selected by the Executive Secretary or
Chair to provide en bloc concurrence on behalf of the Board. Only those applications that do not
require individual consideration shall be included in this expedited process. A report of the en
bloc recommendations will be presented at each Board meeting.
Meetings shall be open to the public except as determined otherwise by the Secretary. Notice of
all meetings shall be given to the public.
The current membership of the NCAB includes:
MEMBERS
Carolyn D. Runowicz, M.D., Director, The Carole and Ray Neag Comprehensive Cancer Center,
and Northeast Utilities Chair in Experimental Oncology, University of Connecticut Health Center
(Chairperson)

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Anthony Atala, M.D., Director, Wake Forest Institute for Regenerative Medicine
Professor and Chairman, Department of Urology, Wake Forest University School of Medicine,
Winston-Salem, NC
Bruce Allan Chabner, M.D., Clinical Director, Massachusetts General Hospital Cancer Center,
Chief of Hematology/Oncology Massachusetts General Hospital Boston, MA
Victoria L. Champion, D.N.S., Associate Dean for Research, Mary Margaret Walther
Distinguished Professor of Nursing, Center for Research & Scholarship Indiana University School
of Nursing Indianapolis, IN
Donald S. Coffey, Ph.D., The Catherine Iola and J. Smith Michael, Distinguished Professor of
Urology, Professor of Urology/Oncology/Pathology/ Pharmacology and Molecular Science, Johns
Hopkins University School of Medicine, Baltimore, MD
Lloyd K. Everson, M.D., Vice Chairman and Member of the Board of Directors, US Oncology
Incorporated, Houston, TX
Kathryn Giusti, M.B.A., CEO and Founder, Multiple Myeloma Research Foundation, Inc. Multiple
Myeloma Research Consortium Norwalk, CT
William H. Goodwin, Jr., M.B.A., Chairman and President CCA Industries, Inc. Richmond, VA
Waun Ki Hong, M.D., Professor, Head, Division of Cancer Medicine Department of
Thoracic/Head & Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center
Houston, TX
Robert A. Ingram, Vice Chairman, Pharmaceuticals, GlaxoSmithKline, Research Triangle Park, NC
Judith S. Kaur, M.D., Medical Director, Native American Programs, Mayo Comprehensive Cancer
Center, Professor of Oncology Department of Medical Oncology Mayo Clinic, Rochester, MN
David H. Koch, M.S., Executive Vice President, Koch Industries, New York, NY
Mary Vaughan Lester, Board of Directors University of California, San Francisco Foundation, Los
Angeles, CA
Diana M. Lopez, Ph.D., Professor, Department of Microbiology and Immunology, University of
Miami Miller School of Medicine, Miami, FL
Daniel D. Von Hoff, M.D., F.A.C.P., Physician in Chief, Senior Investigator, Translational
Genomics Research Institute (TGen), Clinical Professor of Medicine, University of Arizona,
Arizona Cancer Center, Arizona Health Sciences Center, Phoenix, AZ
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H. Kim Lyerly, M.D., Director, Duke Comprehensive Cancer Center, George Barth Geller
Professor of Cancer Research, Duke University Medical Center, Durham, NC
Karen M. Meneses, Ph.D., Professor and Associate Dean for Research University of Alabama at
Birmingham School of Nursing, Birmingham, AL
Jennifer A. Pietenpol, Ph.D., Director, Vanderbilt-Ingram Cancer Center B.F. Byrd, Jr. Professor of
Oncology Professor of Biochemistry, Vanderbilt University Medical Center, Nashville, TN
EX OFFICIO MEMBERS
Linda S. Birnbaum, Ph.D., D.A.B.T., A.T.S., Director, National Institute of Environmental
Health Sciences and The National Technology Program, National Institutes of Health,
Research Triangle Park, NC
Christine Branche, Ph.D., Acting Director, National Institute for Occupational Safety and Health
(NIOSH), Washington, DC
Ms. Ellen P. Embrey, Performing the duties of the Assistant Secretary of Defense for Health
Affairs, The Pentagon, Washington, DC
Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration, Silver Spring, MD
John P. Holdren, Ph.D., Science Advisor to the President, Director, Office of Science and
Technology Policy, Executive Office of the President, Washington, DC
Lisa Jackson, M.S., Administrator, Environmental Protection Agency, Washington, DC
Raynard S. Kington, M.D., Ph.D., Acting Director, National Institutes of Health, Bethesda, MD
The Honorable Dr. Michael J. Kussman, Under Secretary for Health, Veterans Health
Administration Department of Veterans Affairs Washington, DC
Mr. Thomas H. Moore, Acting Chairman and Commissioner Consumer Product Safety
Commission, Bethesda, MD
Anna Palmisano, Ph.D., Associate Director, Office of Biological and Environmental Research,
Department of Energy Washington, DC
The Honorable Kathleen Sebelius, M.P.A., Secretary, Department of Health and Human Services,
Washington, DC
The Honorable Hilda L. Solis, Secretary, Department of Labor, Washington, DC
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