Orientation for the Frederick National Laboratory Advisory Committee
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health FNLAC Bethesda, Maryland
Orientation for the Frederick National Laboratory Advisory Committee
National Institutes of Health Bethesda, Maryland
FOREWORD
Congratulations on your recent appointment to the Frederick National Laboratory Advisory Committee (FNLAC). As you join this distinguished committee, we could not be more honored to have you working with the National Cancer Institute (NCI).
The primary task of the FNLAC is to advise the Director of the NCI and the Associate Director, Frederick National Laboratory of Cancer Research (FNLCR), on the state of research (extramural and intramural) being conducted at the FNLCR and to make recommendations for the best use of the FNLCR capabilities and infra- structure. Specifically, you will review new projects proposed to be performed at the FNLCR with respect to the intrinsic merit of the projects and whether they should be conducted at the FNLCR. In addition, you will periodically review the existing portfolio of projects at the FNLCR, evaluate their productivity and scientific impact, help determine which of these projects should be transitioned to more conventional mechanisms of support (i.e., grants, contracts, cooperative agreements), and which should be considered for termination. As a FNLAC member, you will help to ensure that the operations at the FNLCR are open, transparent, and in the best interests of the entire cancer research community.
This briefing document has been prepared to provide new members of the FNLAC with an overview of the mission, history, and activities of the FNLCR and the NCI.
The first section of the book presents the NCI in the context of the total U.S. Department of Health and Human Services (HHS) and National Institutes of Health (NIH) organization. It includes budgetary information, cites current legislative statutes, and describes organizational structure, program disciplines, and mechanisms of funding used by the NCI.
The second section provides a description of the FNLCR, including a timeline that chronicles the establishment and evolution of the FNLCR and the establishment of the FNLAC. It also delineates the roles of external committees that advise the NCI in the conduct of its activities.
We are pleased to provide you with this FNLAC Orientation Book and hope you will refer to it in fulfilling your responsibilities as a member of the FNLAC.
Paulette S. Gray, Ph.D. Director Division of Extramural Activities National Cancer Institute
NCI FNLAC Orientation Book iii iv NCI FNLAC Orientation Book TABLE OF CONTENTS
Page Page FOREWORD...... iii Office of Advocacy Relations (OAR)...... 18 Office of Communications and Public U.S. DEPARTMENT OF HEALTH AND Liaison (OCPL)...... 18 HUMAN SERVICES (HHS)...... 1 Office of Government and Congressional Mission and Organization...... 1 Relations (OGCR)...... 18 Office of HIV and AIDS Malignancy THE NATIONAL INSTITUTES OF HEALTH...... 1 (OHAM)...... 18 Mission, Organization, and History...... 1 Office of Acquisitions (OA)...... 18 Overview of NIH History...... 1 Office of Budget and Finance (OBF)...... 18 Office of Grants Administration (OGA)...... 18 THE NATIONAL CANCER INSTITUTE...... 10 Office of Management Policy and NCI Mission...... 10 Compliance (OMPC)...... 18 NCI and the National Cancer Program...... 10 NCI Programs and Activities...... 18 NCI Legislative Authority...... 11 NCI Cancer Programs...... 19 Bypass Budget...... 11 Cancer Causation...... 19 NCI Organizational Structure...... 12 Detection and Diagnosis...... 19 NCI Extramural Divisions...... 12 Treatment...... 19 Division of Cancer Biology (DCB)...... 12 Cancer Biology...... 19 Division of Cancer Control and Cancer Prevention and Control...... 19 Population Sciences (DCCPS)...... 12 NCI Resources...... 20 Division of Cancer Treatment and Cancer Centers...... 20 Diagnosis (DCTD)...... 12 Specialized Programs of Research Division of Cancer Prevention (DCP)...... 12 Excellence (SPORE)...... 20 Division of Extramural Activities (DEA).... 15 Comprehensive Minority Institution/ NCI Intramural Divisions and Centers...... 15 Cancer Center Partnership...... 20 Division of Cancer Epidemiology and Research Manpower Development...... 20 Genetics (DCEG)...... 15 NCI Funding Mechanisms...... 20 Center for Cancer Research (CCR)...... 15 NCI Offices and Centers Within the FREDERICK NATIONAL LABORATORY FOR Office of the Director...... 15 CANCER RESEARCH (FNLCR)—FEDERALLY NCI Center for Biomedical Informatics FUNDED RESEARCH AND DEVELOPMENT and Information Technology (CBIIT)...... 15 CENTER (FFRDC)...... 23 Center for Research Strategy (CRS)...... 15 Overview...... 23 Center to Reduce Cancer Health Frederick National Laboratory for Cancer Disparities (CRCHD)...... 16 Research (FNLCR)...... 23 Center for Strategic Scientific Chronological History of the FNLCR and Initiatives (CSSI)...... 16 FNLAC...... 24 Small Business Innovation Research FNLCR Facilities...... 28 (SBIR) Development Center...... 16. FNLCR Budget...... 30 Center for Cancer Training (CCT)...... 16 FNLCR Scientific Support...... 31 Coordinating Center for Clinical FNLCR Support of NCI Divisions, Offices, Trials (CCCT)...... 16 and Centers...... 32 Center for Cancer Genomics (CCG)...... 16 Additional FNLCR–Supported Programs Center for Global Health (CGH)...... 17 and Laboratories...... 33 Technology Transfer Center (TTC)...... 17 FNLCR National Programs and Initiatives...... 35 NCI-Frederick Office of Scientific RAS Initiative...... 35 Operations...... 17 Human Papillomavirus (HPV) Serology Office of Cancer Nanotechnology Laboratory...... 35 Research (OCNR)...... 17 Cryo-Electron Microscopy (EM) Facility.... 35 Office of Cancer Clinical Proteomics Beau Biden Cancer Moonshot...... 36 Research (OCCPR)...... 17 Accelerating Therapeutics for Office of Cancer Centers (OCC)...... 17 Opportunities in Medicine (ATOM)...... 36
NCI FNLAC Orientation Book v Page Page APPENDICES NCI ADVISORY BOARDS, COMMITTEES, APPENDIX A: President’s Cancer Panel...... 43 AND REVIEW GROUPS...... 37. APPENDIX B: National Cancer Advisory Presidentially Appointed Panel and Board...... 37 Board...... 44. Program Advisory Boards and Committees..... 37 APPENDIX C: Board of Scientific NCI Review Groups and Panels...... 38 Advisors...... 47 NCI Leadership...... 38 APPENDIX D: Board of Scientific Counselors—Basic Sciences...... 50. FREDERICK NATIONAL LABORATORY APPENDIX E: Board of Scientific ADVISORY COMMITTEE (FNLAC)...... 39 Counselors—Clinical Sciences and Background...... 39 Epidemiology...... 53 FNLAC Charter...... 39 APPENDIX F: Clinical Trials and FNLAC Legislative Authority...... 39 Translational Research Advisory Membership and Designation...... 39 Committee (CTAC)...... 56. FNLAC Meetings...... 40 APPENDIX G: Frederick National Conflict of Interest and Ethics Rules for Laboratory Advisory Committee...... 59 FNLAC Members...... 40 APPENDIX H: NCI Council of Research FNLAC Subcommittees and Working Advocates...... 62 Groups...... 40 APPENDIX I: NCI Scientific Program RAS Oversight Subcommittee...... 40 Leadership Committee...... 63. National Cryo-Electron Microscopy (EM) APPENDIX J: Summary of Ethics Rules Facility Oversight Subcommittee...... 41 for Special Government Employees Ad Hoc RAS Working Group ...... 41 Serving on Advisory Committees...... 65. Ad Hoc National Cryo-EM Facility APPENDIX K: Related Documents...... 68 Oversight Working Group...... 41 APPENDIX L: Websites of Interest...... 69. Ad Hoc NCI/DOE Collaborations Working DEA Websites...... 69 Group...... 41 NCI Websites...... 70 NCI Cancer Information Websites...... 70 NIH Websites...... 71 General Government-Related Websites...... 71 APPENDIX M: List of Abbreviations...... 72
vi NCI FNLAC Orientation Book U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Mission and Organization The ACF supports a variety of initiatives that promote the economic and social well-being of The mission of the U.S. Department of Health families, children, individuals, and communities. and Human Services (HHS) is to enhance the The ACL works to maximize the independence, health and well-being of Americans by providing well-being, and health of older adults, people for effective health and human services and by with disabilities across the lifespan, and their fostering strong, sustained advances in the scienc- families and caregivers. The CMS manages health es underlying medicine, public health, and social insurance programs. NIH, AHRQ, ATSDR, CDC, services. The HHS consists of the Office of the FDA, HRSA, IHS, and SAMHSA are all devoted to Secretary, which provides leadership; the Program public health and compose PHS. (See Exhibit I for Support Center, which provides centralized HHS Organization). administrative support; and 11 operating divi- sions, including eight agencies in the U.S. Public Health Service (PHS), and three human services. THE NATIONAL INSTITUTES The Office of the Secretary (OS), the chief policy OF HEALTH officer and general manager of HHS, administers and oversees the organization, its programs, and Mission, Organization, and History its activities. The deputy secretary and several assistant secretaries and offices support the OS. NIH’s mission is to uncover new knowledge that The operating Divisions of HHS include: will lead to better health for everyone. The NIH works toward that mission by conducting research ● Administration for Children and Families in its own laboratories; supporting the research (ACF) of non-Federal scientists in universities, medical schools, hospitals, and research institutions ● Administration of Community Living (ACL) throughout the country and abroad; helping to train research investigators; and fostering ● Agency for Healthcare Research and Quality communication of medical information. The NIH (AHRQ) is composed of the OD, 20 Institutes, six Centers (four of which have funding authority), and the ● Agency for Toxic Substances and Disease National Library of Medicine with 75 buildings in Registry (ATSDR) a campus-like environment located on more than 300 acres in Bethesda, Maryland. An organizational ● Centers for Disease Control and Prevention chart for the NIH is presented in Exhibit II. The (CDC) NIH budget has grown from $300 in 1887, when the NIH was a one-room Laboratory of Hygiene, ● Centers for Medicare and Medicaid Services to $37.3 billion in 2018 (Exhibit III). A guide to the (CMS) Bethesda campus is provided in Exhibit IV.
● Food and Drug Administration (FDA) Overview of NIH History
● Health Resources and Services The NIH is a component of the Public Health Administration (HRSA) Service (PHS) of HHS. The PHS traces its origin to “An Act for the Relief of Sick and Disabled ● Indian Health Service (IHS) Seamen” of 1798 (Stat. L. 604), which authorized the establishment of marine hospitals for the care ● National Institutes of Health (NIH) of American merchant seamen. In 1912, the Public Health and Marine Hospital Service became the ● Program Support Center (PSC) Public Health Service. The actual forerunner of the NIH was established ● Substance Abuse and Mental Health in 1887 as the Laboratory of Hygiene, located at Services Administration (SAMHSA) the Marine Hospital of Staten Island, New York. In 1930, this laboratory was renamed the National
NCI FNLAC Orientation Book 1 , CL ) (A Administration Assistant Secretary for Community Living Exhibit I. U.S. Department of Health and Human Services
2 NCI FNLAC Orientation Book Institute of Health. The first of the present 1912 The Public Health and Marine Hospital Institutes, the National Cancer Institute (NCI), Service was renamed Public Health was established in 1937 by an act of Congress. Service (PHS). In 1938, the National Advisory Cancer Council approved the first awards for research training 1922 The Library of the Office of the Surgeon fellowships in cancer research. In 1948, the General was renamed Army Medical National Heart Institute was established, and the Library. National Institute of Health became the National Institutes of Health (NIH). During the years 1930 The Hygienic Laboratory was renamed 1949–2001, the NIH expanded to include 27 the National Institute of Health (NIH). Institutes and Centers. Congress authorized construction of two buildings for the NIH and a system of The following timeline chronicles the establish- fellowships. ment and evolution of the current NIH Institutes 1937 Congress authorized the establishment of and Centers: the National Cancer Institute (NCI) and the awarding of research grants. Rocky 1798 President John Adams signed “an act for Mountain Laboratory became part of the relief of sick and disabled Seamen,” the NIH. The National Advisory Cancer which led to the establishment of the Council held its first meeting. Marine Hospital Service. 1938 The NIH was moved to land donated by 1803 The first permanent Marine Hospital Mr. and Mrs. Luke I. Wilson, located in was authorized to be built in Boston, Bethesda, Maryland. Cornerstone for the Massachusetts. Shannon Building was laid.
1836 The Library of the Office of the Surgeon 1939 The Public Health Service (PHS) became General of the Army was established. part of a newly created Federal Security Agency; until that time, it was part of the 1870 President Grant signed a law establishing Treasury Department. a “Bureau of the U.S. Marine Hospital Service” within the Treasury Department. 1946 The Division of Research Grants (DRG) This Bureau, headed by a Supervising was established to process NIH grants and Surgeon (later Surgeon General), was fellowships to non-Federal institutions given central control over the hospitals. and scientists. (Originally established as the Research Grants Office, it was 1887 The Laboratory of Hygiene at the Marine renamed the Research Grants Division Hospital in Staten Island, New York, was and, finally, the Division of Research established for research on cholera and Grants.) other infectious diseases. 1948 The National Heart Institute (NHI) 1891 The Laboratory of Hygiene was was authorized. Several laboratories re-designated the Hygienic Laboratory (including Rocky Mountain Laboratory) and moved from Staten Island to the were regrouped to form the National Marine Hospital Service headquarters in Microbiological Institute. The Washington, DC. Experimental Biology and Medicine Institute and the National Institute of 1902 The Advisory Board for the Hygienic Dental Research were established. The Laboratory was established; later became National Institute of Health became the the National Advisory Health Council. National Institutes of Health. Act of Congress changed the name of the Marine Hospital Service to the Public 1949 The Mental Hygiene Program of the PHS Health and Marine Hospital Service. was transferred to the NIH and expanded Hygienic Laboratory was authorized by to become the National Institute of Mental Congress to regulate laboratories that Health. produced “biologicals.” The Hygienic Laboratory was expanded to four divisions: Bacteriology and Pathology, Chemistry, Pharmacology, and Zoology.
NCI FNLAC Orientation Book 3 1950 The “Omnibus Medical Research Act” 1968 The John E. Fogarty International Center authorized the establishment of the (FIC) for Advanced Study in the Health National Institute of Neurological Sciences was created. The Bureau of Diseases and Blindness (NINDB), as well Health Manpower and the NLM became as the National Institute of Arthritis and part of the NIH. The National Eye Metabolic Diseases (NIAMD). The latter Institute (NEI) was created. The National absorbed the Experimental Biology and Institute of Neurological Diseases and Medicine Institute. Blindness was renamed the National Institute of Neurological Diseases and 1953 The PHS became part of the newly created Stroke. Department of Health, Education, and Welfare. The Clinical Center opened. 1969 The Division of Environmental Health Sciences was renamed the National 1955 The National Microbiological Institute Institute of Environmental Health Sciences was renamed National Institute of (NIEHS). The National Heart Institute was Allergy and Infectious Diseases (NIAID). renamed the National Heart and Lung The Laboratory of Biologics Control Institute. was renamed the Division of Biologics Standards. The Division of Research 1972 The National Institute of Arthritis and Services (DRS) was created. Metabolic Diseases was renamed the National Institute of Arthritis, Metabolism, 1956 The Armed Forces Medical Library was and Digestive Diseases (NIAMDD). renamed the National Library of Medicine (NLM) and placed in the PHS. 1974 The National Institute on Aging (NIA) was created. 1957 The Center for Aging Research was established. 1975 The National Institute of Neurological Diseases and Stroke was renamed the 1958 The Division of General Medical Sciences National Institute of Neurological and was created. The Center for Aging Communicative Disorders and Stroke Research was transferred from the (NINDS). National Heart Institute to the Division of General Medical Sciences. 1976 The National Heart and Lung Institute was renamed the National Heart, Lung, 1961 The Center for Research in Child Health and Blood Institute (NHLBI). was established within the Division of General Medical Sciences. 1981 The National Institute of Arthritis, Metabolism, and Digestive Diseases 1962 The NLM was moved to the NIH campus. was renamed the National Institute of Arthritis, Diabetes, and Digestive and 1963 The Division of General Medical Sciences Kidney Diseases (NIADDK). was renamed the National Institute of General Medical Sciences (NIGMS). The 1986 The National Institute of Arthritis, National Institute of Child Health and Diabetes, and Digestive and Kidney Human Development (NICHD) was Diseases was renamed the National created. Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The National 1966 The Division of Environmental Health Institute of Arthritis and Musculoskeletal Sciences was created. and Skin Diseases (NIAMS) was created. The Center for Nursing Research was 1967 The National Institute of Mental Health transferred from the Health Resources was separated from the NIH and became a and Services Administration (HRSA) and separate bureau of the PHS. renamed the National Center for Nursing Research.
4 NCI FNLAC Orientation Book 1989 The National Institute on Deafness and 1998 The Division of Research Grants was Other Communication Disorders (NIDCD) renamed the Center for Scientific Review. was established. The National Institute The National Center for Complementary of Neurological and Communicative and Alternative Medicine (NCCAM) Disorders and Stroke was renamed was established. The National Institute the National Institute of Neurological of Dental Research was renamed Disorders and Stroke (NINDS). The the National Institute of Dental and National Center for Human Genome Craniofacial Research (NIDCR). Research was established. The National Center for Biotechnology Information was 2001 The National Center on Minority Health established within the NLM. and Health Disparities was established. The National Institute of Biomedical 1990 The National Center for Research Imaging and Bioengineering (NIBIB) was Resources (NCRR) was created by consol- established. idating the Division of Research Services and the Division of Research Resources. 2010 The National Center on Minority Health and Health Disparities was redesignated 1992 The National Institute on Alcohol Abuse as the National Institute on Minority and Alcoholism (NIAAA), National Health and Health Disparities (NIMHD) Institute on Drug Abuse (NIDA), and National Institute of Mental Health 2011 The National Center for Advancing (NIMH) were transferred to the NIH from Translational Sciences (NCATS) was the Alcohol, Drug Abuse, and Mental established. Health Administration. 2012 NCI-Frederick Cancer Research and 1993 The National Center for Nursing Research Development Center was renamed the was renamed the National Institute of Frederick National Laboratory for Cancer Nursing Research (NINR). Research (FNLCR).
1995 The NIH was established as an HHS 2014 The National Center for Complementary Operating Division, thereby elevating it to and Alternative Medicine became the report directly to the Secretary of HHS. National Center for Complementary and Integrative Health. 1997 The National Center for Human Genome Research was renamed the National Human Genome Research Institute (NHGRI).
NCI FNLAC Orientation Book 5 the Director Immediate Office of Exhibit II. National Institutes of Health lanning, and Strategic er Eunice Kennedy Shriv es Initiativ Division of Program Coordination, P
6 NCI FNLAC Orientation Book Exhibit III. NIH FY2016–2019 Funding*
FUNDING (Dollars in Thousands) INSTITUTE/CENTER 2016 2017 2018 2019
NCI 5,214,701 5,689,329 5,964,800 6,143,892
NHLBI 3,115,538 3,206,589 3,383,201 3,488,335
NIDCR 415,582 425,751 447,735 461,781
NIDDK 1,968,357 2,010,245 2,120,797 2,179,823
NINDS 1,696,139 1,783,654 2,188,149 2,274,413
NIAID 4,629,928 4,906,638 5,260,210 5,523,324
NIGMS 2,512,073 2,650,838 2,785,400 2,872,780
NICHD 1,339,802 1,380,295 1,452,006 1,506,459
NEI 715,903 732,618 772,317 796,536
NIEHS 771,051 791,610 828,492 852,056
NIA 1,600,191 2,048,610 2,574,091 3,083,410
NIAMS 542,141 557,851 586,661 605,065
NIDCD 423,031 436,875 459,974 474,404
NIMH 1,548,390 1,601,931 1,754,775 1,870,296
NIDA 1,077,488 1,090,853 1,383,603 1,419,844
NIAAA 467,700 483,363 509,573 525,591
NINR 146,485 150,273 158,033 162,992
NHGRI 518,956 528,566 556,881 575,570
NIBIB 346,795 357,080 377,871 389,464
NIMHD 279,718 289,069 303,200 314,679
NCCIH 130,789 134,689 142,184 146,473
NCATS 685,417 705,903 742,354 806,373
FIC 67,786 72,213 75,733 78,109
NLM 394,664 407,510 428,553 441,997
OD 1,571,200 1,729,783 1,925,893 2,117,675
B&F 128,863 128,863 128,863 200,000
TOTAL 32,311,349 34,300,999 37,311,349 39,311,349
*Source: NIH Office of Budget,2019.
NCI FNLAC Orientation Book 7 Exhibit IV. NIH Facilities Map
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46 Dr y 18 Gatewa NIH Employee Parking ••Employee Pedestrian Entry
Building Key
Building 1 James Shannon Building (NIH Administration) Building 38 National Library of Medicine Building 10 Warren Grant Magnuson Clinical Center; Building 38A Lister Hill Mark Hatfield Clinical Research Center Building 40 Vaccine Research Center Building 11 Central Utility Plant Building 45 Natcher Building and Conference Center Building 13 Engineering Services Building 49 Sylvio Conte Building Building 14 Office of Research Facilities Building 50 Stokes Laboratories Building 16 Stone House Building 60 Mary Woodard Lasker Center Building 31 Claude D. Pepper Building (General Office Building) Building 62 The Children’s Inn at NIH Building 36 Lowell P. Weicker Building
8 NCI FNLAC Orientation Book NIH Institutes National Cancer Institute (NCI) (see https://www.cancer.gov/) National Eye Institute (NEI) (see https://nei.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (see https://www.nhlbi.nih.gov/) National Human Genome Research Institute (NHGRI) (see https://www.genome.gov/) National Institute on Aging (NIA) (see https://www.nia.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (see https://www.niaaa.nih.gov/) National Institute of Allergy and Infectious Diseases (NIAID) (see https://www.niaid.nih.gov/) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (see https://www.niams. nih.gov/) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (see https://www.nibib.nih.gov/) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (see https://nichd.nih.gov/) National Institute on Deafness and Other Communication Disorders (NIDCD) (see https://www.nidcd. nih.gov/) National Institute of Dental and Craniofacial Research (NIDCR) (see https://www.nidcr.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (see https://www.niddk.nih.gov/) National Institute on Drug Abuse (NIDA) (see https://www.drugabuse.gov/) National Institute of Environmental Health Sciences (NIEHS) (see https://www.niehs.nih.gov/) National Institute of General Medical Sciences (NIGMS) (see https://www.nigms.nih.gov/) National Institute of Mental Health (NIMH) (see https://www.nimh.nih.gov/) National Institute on Minority Health and Health Disparities (NIMHD) (see https://www.nimhd.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (see https://www.ninds.nih.gov/) National Institute of Nursing Research (NINR) (see https://www.ninr.nih.gov/) National Library of Medicine (NLM) (see https://www.nlm.nih.gov/)
NIH Centers Center for Information Technology (CIT) (see https://www.cit.nih.gov/) Center for Scientific Review (CSR) (see https://public.csr.nih.gov/) Fogarty International Center (FIC) (see https://www.fic.nih.gov/) National Center for Advancing Translational Sciences (NCATS) (see https://ncats.nih.gov/) National Center for Complementary and Integrative Health (NCCIH) (see https://nccih.nih.gov/) NIH Clinical Center (see https://clinicalcenter.nih.gov/)
NCI FNLAC Orientation Book 9 THE NATIONAL CANCER INSTITUTE
NCI Mission of its programs are collaborations and partner- ships that further NCI’s progress in serving cancer The National Cancer Institute (NCI) is a patients and those who care for them. The NCI component of the National Institutes of Health supports a broad range of research to expand (NIH), one of 11 operating divisions that com- scientific discovery at the molecular and cellular pose the Public Health Service (PHS) in the U.S. level, within a cell’s microenvironment, and in Department of Health and Human Services (HHS). relation to human and environmental factors that The NCI, established under the National Cancer influence cancer development and progression. Act of 1937, is the Federal Government’s principal Each year, more than 5,000 principal investigators agency for cancer research and training. The lead research projects that result in better ways to National Cancer Act of 1971 broadened the scope combat cancer. Intramural research serves as a hub and responsibilities of the NCI and created the for new development through cutting-edge basic, National Cancer Program (NCP). Over the years, clinical, and epidemiological research. Extramural legislative amendments have maintained the NCI program experts provide guidance and oversight authorities and responsibilities and added new for research conducted at universities, teaching information dissemination mandates as well as a hospitals, and other organizations. Proposals are requirement to assess the incorporation of state-of- selected for funding by peer review, a rigorous the-art cancer treatments into clinical practice. process by which scientific experts evaluate new proposals and recommend the most scientifically The NCI is committed to dramatically lessening meritorious for funding. In addition to direct the impact of cancer. The NCI is the primary research funding, the NCI offers the Nation’s means of support for America’s cancer research cancer scientists a variety of useful research tools enterprise, whether in its own laboratories or in and services: tissue samples, statistics on cancer our Nation’s research universities. The NCI is incidence and mortality, bioinformatic tools for dedicated to the understanding, diagnosis, treat- analyzing data, databases of genetic information, ment, and prevention of cancer for all people. The and resources through NCI-supported Cancer NCI works toward this goal by providing vision Centers, Centers of Research Excellence, and the to the Nation and leadership for both domestic Mouse Models of Human Cancer Consortium. and international NCI-funded researchers. The NCI also works to ensure that research results are The NCI also uses collaborative platforms and applied in clinical practice and public health-relat- an interdisciplinary environment to promote ed programs to reduce the burden of cancer for all translational research and intervention develop- populations. ment. Discovery of a new tool that first helps to understand the underlying mechanism of cancer Within this framework, NCI researchers work to may eventually be used to help diagnose it, and more fully integrate discovery activities through then may be further developed to help treat it. For interdisciplinary collaborations; accelerate example, recent advances in bioinformatics and development of interventions and new technology the related explosion of technology for genomics through translational research; and ensure the and proteomics research are dramatically accel- delivery of these interventions for application in erating the rate for processing large amounts of the clinic and public health programs as state-of- information for cancer screening and diagnosis. the-art care for all those in need. The largest collaborative research activity is the Clinical Trials Program for testing interventions NCI and the National Cancer Program for preventing cancer, diagnostic tools, and cancer treatments as well as providing access as early as As the leader of the National Cancer Program possible to all who can benefit. The NCI supports (NCP), the NCI provides vision and leadership to more than 1,300 clinical trials a year, assisting the global cancer community. The NCI conducts more than 200,000 patients. and supports research, training, health informa- tion dissemination, and other programs with NCI’s research impacts the delivery of improved respect to the cause, diagnosis, prevention, and cancer interventions to cancer patients and those treatment of cancer, rehabilitation from cancer, who care for them. Timely communication of and the continuing care of cancer patients and NCI scientific findings helps people make better families of cancer patients. Critical to the success health choices and advises physicians about
10 NCI FNLAC Orientation Book treatment options that are more targeted and less greater cancer research community, professional invasive, resulting in fewer adverse side effects. organizations, advisory groups, advocacy organi- NCI researchers also are seeking the causes zations, and public and private policymakers. As of disparities among underserved groups and a result, the Bypass Budget and its development gaps in quality cancer care, helping to translate serve as a planning process for the entire NCP, research results into better health for groups at outlining clearly the areas of highest priority. high risk for cancer, including cancer survivors and the aging population. In addition, the NCI In addition to informing the President, the Bypass is fostering partnerships with other agencies and Budget document also serves as the Institute’s organizations to accelerate the pace for moving strategic plan and has become a powerful targeted drugs through the pipeline of discovery, communication and priority setting tool used by development, and delivery. Information about constituents across the NCP. Updated each year, NCI’s research and activities is available through the plan provides a guide for building on research its public website, http://www.cancer.gov/. successes, supporting the cancer research work- force with the technologies and resources it needs, NCI Legislative Authority and ensuring that research discoveries are applied to improve human health. This strategic plan is The NCI, established under the National Cancer based on the authority and the responsibilities Act of 1937, is the Federal Government’s principal entrusted to the Presidentially appointed NCI agency for cancer research and training. The Director to coordinate the research activities of the National Cancer Act of 1971 broadened the scope NCI with the other parts/members of the NCP. and responsibilities of the NCI and created the NCP. Under the National Cancer Act of 1971, In so doing, the Director is aided by the National the Director of the NCI is authorized to submit, Cancer Advisory Board (NCAB), a group directly to the President, a professional judgment composed of scientists, medical personnel, and budget reflecting the full funding needs of the consumers from all sectors, public and private, of NCP. This budget is referred to as the “Bypass the cancer enterprise who have the needed exper- Budget.” tise and experience to help formulate a national agenda in cancer research. The NCAB meets with Bypass Budget the President’s Cancer Panel (PCP) members to facilitate transfer of PCP observations on the barri- The mandate to produce a Bypass Budget is a ers to progress in the NCP and the development of unique authority established by the National possible solutions. Their deliberations are directly Cancer Act of 1971 and given to the NCI Director. coordinated with other Government agencies The Bypass Budget builds on research successes through the participation of ex officio Federal and ensures that research discoveries are applied members representing key agencies involved to improve human health, and allows the NCI in executing the NCP. For example, discussions Director to express to the President the plans and at the NCAB meetings with ex officio members priorities of the NCI and the NCP, along with an representing the U.S. Department of Defense and indication of the associated costs. Veterans Affairs health care systems directly led to the availability of NCI clinical trials through their Each year, the NCI produces this document to health care systems. Close coordination across reflect the Professional Judgment of the Nation’s agencies is critical in the formulation of a strategic top cancer experts about the realities of cancer plan that takes advantage of the capabilities of research and control, and how much money each agency and the constituencies it serves. could be spent wisely in the conduct of the entire program. The ability of the NCI and its partners to address the initiatives in the Bypass Budget is a measure The authority to produce the Bypass Budget has of the success of the NCP. In this way, the Bypass many benefits. The extensive strategic planning Budget enables efficient strategic coordination of process that is used to develop the Bypass Budget the NCP. As part of the evaluation process, the builds on research successes, supporting the can- Presidentially appointed PCP is charged to review cer research workforce with the technologies and the implementation of such plans and identify resources it needs. In addition to being submitted directly for the President and the Nation the extent to the President, this comprehensive research plan of their success. also is provided to Congress, and is used by the
NCI FNLAC Orientation Book 11 NCI Organizational Structure form the intellectual and scientific foundation on which strategies for the prevention, diagnosis, and The current NCI organizational structure is treatment of cancer are developed. (http://dcb.nci. shown in Exhibits V and VI. The Office of the nih.gov/) Director (OD) serves as the focal point for the National Cancer Program (NCP) with advice from Division of Cancer Control and Population several external advisory groups that include the Sciences (DCCPS) President’s Cancer Panel (PCP) (Appendix A), The DCCPS aims to reduce the risk, incidence, the National Cancer Advisory Board (NCAB) and number of deaths from cancer, as well as to (Appendix B), the Board of Scientific Advisors enhance the quality of life for cancer survivors. (BSA) (Appendix C), the Boards of Scientific This division conducts and supports an integrated Counselors (BSC) for Basic Sciences (Appendix D) program of the highest quality genetic, epidemio- and Clinical Sciences and Epidemiology (Appendix E), logic, behavioral, social, applied, and surveillance the Clinical Trials and Translational Research cancer research. DCCPS-funded research aims Advisory Committee (CTAC) Appendix( F), the to: (1) understand the causes and distribution of Frederick National Laboratory Advisory cancer in various populations, (2) support the Committee (FNLAC) Appendix( G), and the development and implementation of effective Council of Research Advocates (CRA) (Appendix H). interventions, and (3) monitor and explain cancer trends in all segments of the population. Central The NCI Director also is assisted by a Scientific to these activities is a process of synthesis and Program Leadership (SPL) Committee Appendix( I) decision making, which aids in evaluating what that meets on a regular basis to discuss various has been learned, identifying new priorities and matters of NCI policy, including the review and strategies, and effectively applying research approval of Requests for Applications (RFAs) discoveries to reduce the cancer burden at the and research and development (R&D) contract population level. (http://dccps.nci.nih.gov) concepts prior to review by the BSA; review of program announcements; development of funding Division of Cancer Treatment and Diagnosis plans; grant payment by exceptions, and so on. (DCTD) The DCTD attempts to identify and exploit the The research and research-related activities and most promising areas of science and technology functions of the Institute are monitored and and to initiate, enable, and conduct research that administered by various NCI Divisions, Offices, will yield important new knowledge that is likely and Centers (DOCs). to lead to better diagnostic or therapeutic interven- tions in the various childhood and adult cancers. NCI Extramural Divisions The division administers grants, contracts, and cooperative agreements, and offers strategically NCI extramural research and research-related planned workshops and conferences with scien- activities are conducted by five divisions under tists, clinicians, and public and private partners. the supervision of the OD. The functions of the It also sponsors a vigorous program of in-house divisions and the major areas of research and applied research linked to investigators and goals research support activities for which each is in the extramural community. (http://dctd.cancer. responsible are described below. gov/)
Division of Cancer Biology (DCB) Division of Cancer Prevention (DCP) The mission of the DCB is to ensure continuity and The DCP plans and conducts programs in basic stability in basic cancer research, while encourag- and applied research and development, tech- ing and facilitating the emergence of new ideas, nology transfer, demonstration, education, and concepts, technologies, and possibilities. The information dissemination. DCP’s programs are DCB strives to achieve this goal by promoting a designed to: expedite the use of new information balance between the continued support of existing relevant to the prevention, detection, and diagno- research areas and selective support of emerging sis of cancer; expedite the use of new information research areas. The DCB provides guidance, about pretreatment evaluation, treatment, advice, funding information, and financial support rehabilitation, and continuing care; plan, direct, to grantees and applicants. The DCB encourages and coordinate the support of research on cancer the expansion of new research areas through a prevention at Cancer Centers and community range of initiatives and funding mechanisms. hospitals, and through organ systems programs; The scientific discoveries from this research base support cancer research training, clinical are critical to the goal of the NCI, because they education, continuing education, and career
12 NCI FNLAC Orientation Book Exhibit V. The National Cancer Institute Exhibit V.
NCI FNLAC Orientation Book 13 ce ndravi eingarten al d A. Springfield ter Garre Chie f a Director Director Director Disparities . Pe Mr and Public Liaison . Mehrdad To . Sany ter Greenw . Michael S. W ce of Communication s Dr Institute Review Of Dr Of SBIR Development Center Mr . Pe . Maureen Johnso n Ms. Donna Siegle Center to Reduce Cancer Health Dr Dr Special Assistant to the Director Associate Director for Prevention Deputy Director for Management illiam s archoan my W Director Director Director Malignanc y . Satish Gopa l . Robert Y Acting Director Dr . L. Michelle Benne ce of HIV and AIDS Ms. A Dr Dr ce of Advocacy Relations Of Center for Global Health Center for Research Strategy Of Director . Norman Sharples s Dr ce of the Director Of rials Director Director Director . Sara Hook . Henry Ciolin o Clinical T Dr NCI-Frederick Acting Director . Sheila Prindiville . Douglas R. Lowy Dr ce of Cancer Center s Center for Strategic Scienti c Initiatives Dr Dr Coordinating Center for Of ce of Scienti c Operations Of Exhibit VI. The National Cancer Institute (Continued) w aining ag e Informatics echnolog y er Bogler . Dinah S. Singe r . James Dorosho . Douglas R. Low y ny Kerlav Director Director Director anslational Research Dr Dr Dr . Louis Staudt . Oliv Tr Biomedical . To Principal Deputy Director Strategy and Development Dr ce of Management Dr Ms. Donna Siegl e for Deputy Director for Scienti c Dr Deputy Director for Clinical and Of Acting Deputy Director Center for Cancer Tr Center for Cancer Genomic s and Information T Center
14 NCI FNLAC Orientation Book development in cancer prevention; coordinate Bethesda campus. The mission of the CCR is to program activities with other divisions, Institutes, reduce the burden of cancer through exploration, and Federal and state agencies; and establish discovery, and translation. It provides a new liaison with professional and voluntary health forum for cancer research without scientific, agencies, Cancer Centers, labor organizations, institutional, or administrative barriers. The cancer organizations, and trade associations. Center is achieving this by conducting outstand- (http://prevention.cancer.gov/) ing, cutting-edge, basic and clinical research on cancer and translating these discoveries into Division of Extramural Activities (DEA) treatment and prevention. The overall goal is to The mission and responsibilities of the DEA in form a highly interactive, interdisciplinary group some way affect all extramural scientists receiving of researchers who have access to technology and research or training support from the NCI. The are able to participate in clinical investigations. DEA coordinates the review of special initiatives, The CCR also maintains a foundation of investiga- large grants, and contracts. It is involved in all tor-initiated, independent research. CCR scientists aspects of grant development and tracking, from conduct innovative basic and clinical research the original conception of extramural research aimed at discovering the causes and mechanisms and training programs to follow-up after funds of cancer to improve the diagnosis, treatment, and are dispersed. In brief, the DEA was established prevention of cancer and other diseases. (https:// to: provide advice and guidance to potential ccr.cancer.gov/) applicants; receive and refer incoming grant applications to appropriate programs within NCI Offices and Centers Within the NCI; provide the highest quality and most the Office of the Director effective scientific peer review and oversight of extramural research; coordinate and administer NCI Center for Biomedical Informatics and Federal Advisory Committee activities related to Information Technology (CBIIT) the various aspects of the NCI mission, such as The CBIIT helps speed scientific discovery and the NCAB and BSA; establish and disseminate facilitates translational research by building extramural policies and procedures, such as many types of tools and resources that enable requirements for inclusion of certain populations information to be shared along the continuum in research, actions for ensuring research integrity, from the scientific bench to the clinical bedside or budgetary limitations for grant applications; and back. The CBIIT (1) coordinates and deploys and track the NCI research portfolio (more informatics in support of NCI research initiatives; than 7,500 research and training awards) using (2) provides all manner of informatics support, consistent, budget-linked scientific information including platforms, services, tools, and data to to: (1) provide a basis for budget projections and NCI-supported research initiatives; (3) participates (2) serve as a resource for the dissemination of in the evaluation and prioritization of NCI’s information about cancer. (https://deainfo.nci.nih. bioinformatics research portfolio; (4) conducts gov/) or facilitates research that is required to fulfill NCI’s bioinformatics requirements; (5) serves NCI Intramural Divisions and Centers as the focus for strategic planning to address NCI’s expanding research initiative’s informatics Division of Cancer Epidemiology and Genetics needs; (6) establishes bioinformatics technology (DCEG) standards (both within and outside of the NCI); The DCEG is an intramural research program in (7) communicates, coordinates, and establishes which scientists conduct an international program bioinformatics exchange standards; (8) provides of population-based studies to identify environ- direct support to four NCI research programs: mental and genetic determinants of cancer. In the Cancer Genome Anatomy Project (CGAP), carrying out its mission, the DCEG is at the cutting the Mouse Models of Human Cancer Consortium edge of approaches to untangle complex gene- (MMHCC), the Director’s Challenge: Toward a environment and gene-gene interactions in cancer Molecular Classification of Cancer, and Clinical etiology. To conduct these studies, investigators Trials and develops core infrastructure to support at all levels of their careers work collaboratively the integration of these efforts. to bring together a variety of scientific disciplines. (http://dceg.cancer.gov/) Center for Research Strategy (CRS) The CRS is a science-based office that collabora- Center for Cancer Research (CCR) tively develops recommendations for addressing As the intramural component of the NCI, the scientific opportunities, monitors the direction and CCR conducts basic clinical investigations at the application of the NCI’s scientific knowledge and
NCI FNLAC Orientation Book 15 resources, and identifies research funding gaps. Small Business Innovation Research (SBIR) The CRS responsibilities are to: synthesize input Development Center from NCI leadership and external stakeholders The SBIR Development Center serves as the to inform priority initiatives; identify scientific NCI focal point for the management of all opportunities within priority initiatives; coordi- SBIR and Small Business Technology Transfer nate development of programs across the NCI to (STTR) Program activities, and implementation address opportunities; conduct portfolio analysis of pertinent legislation, rules, and regulations to support priority setting and scientific strategic and associated matters related to the SBIR/STTR planning; collect and analyze data to identify Program consisting of grant and contractor awards research accomplishments; and recommend and providing expertise, advice, and services to strategies for allocating resources effectively. applicants and NCI programs.
Center to Reduce Cancer Health Disparities Center for Cancer Training (CCT) (CRCHD) The CCT is responsible for: (1) coordinating and The CRCHD is the keystone of NCI’s efforts to providing research training and career develop- reduce the unequal burden of cancer in our soci- ment activities for fellows and trainees in NCI’s ety. As the organizational focus for these efforts, laboratories, clinics, and other research groups; the Center directs and supports initiatives that (2) developing, coordinating, and implementing advance the understanding of what causes health opportunities in support of cancer research disparities. It also supports programs that develop training, career development, and education and integrate effective interventions to reduce or at institutions nationwide; and (3) identifying eliminate these disparities. The CRCHD, through workforce needs in cancer research and adapting its Diversity Training Branch (DTB), leads NCI’s NCI’s training and career development programs efforts in the training of students and investigators and funding opportunities to address these needs. from diverse populations who will be part of the next generation of competitive researchers in Coordinating Center for Clinical Trials (CCCT) cancer and cancer health disparities research. The CCCT is central to NCI’s efforts to accelerate the delivery of new tools into the clinic through its Center for Strategic Scientific Initiatives (CSSI) translational science and clinical trial enterprises. The CSSI directs the planning, development, and The CCCT facilitates collaborations that expedite implementation of a number of strategic scientific translational and clinical cancer research by: and technology initiatives and partnerships that supporting the implementation of the Clinical emphasize innovation, transdisciplinary teams, Trials Working Group and Translational Research and convergence of scientific disciplines to Working Group recommendations; facilitating enable progress against cancer. These programs also stress the development and application of prioritization of NCI’s most important clinical advanced technologies, the synergy of large- trials by Scientific Steering Committees working scale and individual initiated research, novel with NCI clinical programs; and partnering with partnerships, and translation of discoveries into NCI’s Center for Biomedical Informatics and new interventions to detect, prevent, and treat Information Technology (CBIIT) to establish cancer more effectively. Several offices in CSSI the Clinical Trials Reporting Program (CTRP), a are committed to accelerating the progress of comprehensive database with up-to-date informa- cancer research through its technology-driven tion on all NCI-funded clinical trials. initiatives, collaboration with other government programs, and engagement with the private Center for Cancer Genomics (CCG) sector in the areas of nanotechnology, proteomics, The CCG is focused on understanding the molec- cancer genomics, and biospecimen resources. By ular mechanisms of cancer with the ultimate goal placing a heavy emphasis on advanced technology of improving the prevention, early detection, development, the NCI is accelerating the creation diagnosis, and treatment of cancer. To meet this and use of tools that are already facilitating goal, the CCG provides information, technology, the translation of basic knowledge into clinical methods, informatics tools, and reagents to serve advances to benefit patients with a new generation the needs of the cancer research community; and of molecularly based diagnostics and therapeutics. manages the following research programs: NCI Programs include: Alliance for Nanotechnology Genomic Data Commons (GDC); Cancer Driver in Cancer, Clinical Proteomic Technologies Discovery Program (CDDP); Cancer Genome Initiative for Cancer, Innovative Molecular Characterization Initiative (CGCI); Cancer Analysis Technologies (IMAT), and Provocative Target Discovery and Development Network Questions Initiative. (CTD2); Cancer Genome Atlas (TCGA); and
16 NCI FNLAC Orientation Book Therapeutically Applicable Research to Generate for high school and undergraduate students; Effective Treatments (TARGET). (10) coordinates the expansion of student/fellow- ship mentoring programs at the FNLCR; and Center for Global Health (CGH) (11) coordinates FNLCR facility “activities” such The CGH coordinates NCI’s worldwide activities as the Spring Research Festival, Take Your Child in a number of arenas, including: liaison with to Work Day, the Summer Student Seminar foreign and international agencies; and other Series, Summer Student Poster Day, the Housing U.S. Government agencies involved in global Resources List, speaker requests, and visits for health; coordination of cancer research activities students, teachers, and other interested groups. under agreements between the United States and other countries; planning and implementation Office of Cancer Nanotechnology Research of international scientist exchange programs; (OCNR) sponsorship of international workshops; and The OCNR accelerates the development of dissemination of cancer information. promising molecular discoveries to benefit cancer patients through the development of Technology Transfer Center (TTC) nanotechnology-based tools for cancer detection, The TTC builds partnerships and fosters col- treatment, and monitoring. laboration agreements between NIH scientists, universities, nonprofits, and industry to commer- Office of Cancer Clinical Proteomics Research cialize NIH inventions, and supports research and (OCCPR) development that benefits public health. The mission of NCI’s OCCPR is to improve prevention, early detection, diagnosis, and NCI-Frederick Office of Scientific Operations treatment of cancer by enhancing the under- The NCI-Frederick Office of Scientific Operations standing of the molecular mechanisms of (1) oversees and manages scientific operations at cancer, advance proteome and proteogenome FNLCR and serves as the Project Office for the science and technology development through three main operation and support contracts at community resources (data and reagent), the FNLCR; (2) directs and develops advanced and accelerate the translation of molecular technologies that are made available to customers findings into the clinic. This is achieved of the FNLCR; (3) implements programmatic through OCCPR-supported programs such decisions approved by the NCI Director and the as the Clinical Proteomic Tumor Analysis Associate Director for the FNLCR to transition Consortium (CPTAC), partnerships with new efforts to the FNLCR by developing con- Federal agencies, and collaborations with tractual requirements and budgets, arranging for international organizations/institutions. The needed space, and providing technical and project OCCPR analyzes protein content in tumor management advice to the Contracting Officer; cells through the application of state-of-the- (4) works closely with customers (including other art proteomic technologies and workflows, NCI and NIH components, the FDA, the DoD, the open-data policies, and community reagents Department of Agriculture, and the Department to advance our understanding of proteins of Homeland Security), as well as contractors to derived from cancer genomes in clinical ensure that contractors understand customers’ research and medicine. The OCCPR also needs and that the customers receive planned characterizes the discovery and deployment of outcomes; (5) assists the NCI Associate Director evidence-based biomarkers for clinical use. for Frederick with the administrative and business operations of the FNLCR; (6) assists the NCI Office of Cancer Centers (OCC) Associate Director for Frederick with planning Currently, the OCC supports 70 NCI-designated and prioritizing of space and the maintenance of Cancer Centers nationwide that are actively all buildings and grounds; (7) monitors contractor engaged in transdisciplinary research to reduce performance, obtains customer satisfaction cancer incidence, morbidity, and mortality. The feedback, and provides this information to the NCI-designated Cancer Centers are designated Management Operations and Support Branch for as either Comprehensive Cancer Centers (49), the Award Fee processes; (8) tracks and reports Clinical Cancer Centers (14), or Basic Laboratory funds received and costs associated with all work Cancer Centers (7), and are a major source of performed at NCI-Frederick; (9) develops and discovery on the nature of cancer and of the manages educational, employee outreach, and development of more effective approaches to public outreach programs, including programs cancer prevention, diagnosis, and therapy. for students K-12 and internship opportunities Comprehensive Cancer Centers also deliver
NCI FNLAC Orientation Book 17 medical advances to patients and their families, the Divisions and other Offices to manage the educate health care professionals and the public, portfolio of HIV/AIDS and AIDS malignancy and reach out to underserved populations. Cancer research within the NCI; (2) advises the NCI Centers are characterized by strong organiza- Director and other NCI managers on issues related tional capabilities, institutional commitment, and to research in HIV/AIDS and AIDS malignancies; transdisciplinary, cancer-focused science; experi- (3) coordinates, helps prioritize, and facilitates enced scientific and administrative leadership; and the NCI research effort in HIV/AIDS and AIDS state-of-the-art cancer research and patient care malignancies and works with NCI management facilities. to redirect the HIV/AIDS and AIDS malignancy research effort, as appropriate, into the highest Office of Advocacy Relations (OAR) priority areas; (4) interfaces with the NIH Office of The OAR engages the advocacy and NCI AIDS Research (OAR) and other ICs with regard communities in dialogue about cancer research to research in HIV/AIDS and AIDS malignancies opportunities and priorities to advance progress in the NCI; and (5) directly manages certain AIDS and improve outcomes. The OAR (1) serves as the and AIDS malignancy research programs, such Institute’s expert and central resource for advo- as the AIDS and Cancer Specimen Resource, the cacy matters; (2) facilitates dynamic relationships AIDS-Associated Malignancies Clinical Trial and collaborations to promote mutual goals; and Consortium (AMC), the NCI Component of the (3) disseminates information and fosters under- Centers for AIDS Research (CFARS), and the NCI standing of key cancer issues and priorities. component of the Women’s Interagency HIV Study (WIHS). Office of Communications and Public Liaison (OCPL) Office of Acquisitions (OA) The OCPL advances the mission of the NCI by The OA plans, negotiates, awards, and adminis- disseminating evidence-based cancer information ters NCI contracts and simplified acquisitions to to the public to improve the lives of those affected support a coordinated cancer research program. by cancer. Working closely with scientists and partners, the OCPL uses effective methods to Office of Budget and Finance (OBF) reach diverse audiences and meet their needs The OBF advises the OD and other senior staff on for the latest, evidence-based cancer information financial and personnel resource management to about NCI-funded research, cancer research ensure fiscally responsible and efficient operation findings, cancer clinical trials, funding, and of the NCI. partnership opportunities to patients, caregivers, health professionals, researchers, advocates, the Office of Grants Administration (OGA) new media, and other stakeholders across the The OGA manages all NCI business-related cancer community. activities associated with the negotiation, award, and administration of NCI grants and cooperative Office of Government and Congressional agreements to help financially support cancer Relations (OGCR) research activities throughout the United States The OGCR advises the NCI Director, staff, and and around the world. advisory boards on legislative and Congressional activities as they relate to the NCI mission. The Office of Management Policy and Compliance OGCR coordinates, monitors, and analyzes (OMPC) Congressional activities; reviews, processes, and The OMPC advises the Office of Management responds to all requests for information from the and other senior staff on the implementation of NCI that fall under the jurisdiction of the Freedom Institute-wide administrative policies and pro- of Information (FOIA) and Privacy Act; and cedures, management controls, and evaluations serves as NCI’s liaison for the U.S. Government while ensuring compliance with Federal require- Accountability Office (GAO) and HHS Office of ments. the Inspector General. The OGCR aims to ensure that the NCI community is kept abreast of the NCI Programs and Activities Congressional issues and interests that affect the Institute and, in turn, the NIH. The OGCR The Institute conducts and leads intensive work also works closely with other offices at both the to advance knowledge of cancer’s biology and pro- Institute and agency level. cesses; to discover and develop new interventions; and to employ a bench-to-bedside approach that Office of HIV and AIDS Malignancy (OHAM) strives to rapidly make new treatments—the latest The OHAM (1) coordinates and works with science—available to patients in the communities
18 NCI FNLAC Orientation Book where they live. Across these complex endeavors, clinical trials. These agents include both syn- the NCI works to foster the collaborations of thetic compounds and natural products. Clinical government, the private sector, and academia. research involves demonstrating the effectiveness In addition to the broad range of both basic and of new anticancer treatments through systematic applied laboratory and clinical programs that testing in clinical trials. Phase I trials establish the it supports, the NCI provides various research maximum tolerated dose of a new agent; Phase support services, including the development and II trials examine its efficacy against a variety of distribution of critical materials such as viruses, cancers; and Phase III trials compare the new animals, equipment, tissues, and standardized treatment with the best standard therapy, in terms reference bibliographies. These activities are of improved survival and decreased toxicity. In conducted within the DOCs of the NCI, under the FY2017, cancer treatment research expenditures supervision of the OD. totaled about $1.29 billion, accounting for 22.9 percent of the total NCI budget. NCI Cancer Programs Cancer Biology Cancer Causation Cancer biology supports a broad spectrum of basic Cancer causation research concentrates on the research on cancer and the body’s response to events involved in the initiation and promotion cancer. Studies include investigations of cellular of cancer. It encompasses chemical and physical and molecular characteristics of tumor cells, carcinogenesis, biological carcinogenesis, epidemi- interactions among cells within a tumor, and the ology, chemoprevention, and nutrition research. components of the host immune defense mech- Studies in this area focus on external agents such anisms. Cancer is the result of genetic damage as chemicals, radiation, fibers, and other particles, that accumulates in stages. It is the goal of cancer as well as viruses, parasitic infections, and host biology to identify and explain the stepwise factors such as hormone levels, nutritional and progression between the initiating event in the immunologic status, and the genetic endowment cell and final tumor development. In FY2017, of the individual. In FY2017, cancer causation cancer biology expenditures totaled approximate- research expenditures totaled about $1.33 billion, ly $838 million, accounting for 14.9 percent of the accounting for 23.6 percent of the total NCI total NCI budget. budget. Cancer Prevention and Control Detection and Diagnosis The NCI conducts cancer prevention and control Detection and diagnosis research includes studies basic and applied research through both intramu- designed to improve diagnostic accuracy; provide ral and extramural mechanisms in all phases of better prognostic information to guide therapeutic cancer prevention and control, as well as cancer decisions; monitor the response to therapy more surveillance. A key priority of this program is to effectively; detect cancer at its earliest presenta- develop strategies for the effective translation of tion; and identify populations and individuals at knowledge gained from prevention and control increased risk for the development of cancer. research into health promotion and disease pre- vention activities for the benefit of the public. An Areas of emphasis include: improvements in the integrated system of basic research, clinical trials, detection and diagnosis of breast, cervical, uterine, and applications research is in place and seeks to and prostate cancer; the transfer of molecular tech- promote cancer prevention and control activities nologies from the laboratory to clinical practice; across the country. the identification of better prognostic markers; increased availability of human tumor samples The Cancer Prevention and Control Program with associated clinical information; and research includes four components and several subpro- to identify genetic alterations involved in tumor grams, many of which relate to other program pathogenesis and behavior. In FY2017, cancer activities of the NCI, including information detection and diagnosis research expenditures dissemination, epidemiology, and cancer totaled about $533 million, accounting for treatment. The four components are Cancer 9.5 percent of the total NCI budget. Prevention Research, Cancer Control Science, Early Detection and Community Oncology, Treatment and Cancer Surveillance. In FY2017, the Cancer Treatment research is composed of preclinical Prevention and Control Program expenditures and clinical research. Preclinical research focuses totaled approximately $312 million, accounting for on the discovery of new antitumor agents and 5.5 percent of the total NCI budget. their development in preparation for testing in
NCI FNLAC Orientation Book 19 NCI Resources research and one or more target areas in cancer research, training and career development, edu- Cancer Centers cation, or outreach activities designed to benefit The Cancer Centers Program consists of a group of racial and/or ethnic minority populations in the nationally recognized, geographically dispersed, region the Cancer Center serves. The partnership individual institutions with outstanding scientific also creates a stable, long-term, collaborative reputations. Each institution reflects particular relationship between the MSI and NCI-designated research talents and special technological capabil- Cancer Centers and raises awareness about prob- ities. lems and issues relevant to the disproportionate rates of cancer incidence and mortality in minority Cancer Centers have developed in several differ- populations. ent organizational settings. Some are independent institutional entities entirely dedicated to cancer Research Manpower Development research (free-standing centers); some have been The Cancer Training Branch (CTB) in the Center formed as clearly identifiable entities within for Cancer Training manages the Institute’s extra- academic institutions and promote interactive mural research training, career development, and cancer research programs across departmental education programs, and provides guidance to the and/or college structures (matrix centers); and extramural biomedical research community and others involve multiple institutions (consortium administration of awards. This assures continued centers). development of well-trained investigators in the basic, clinical, population, and behavioral sciences, The NCI uses the P30 Cancer Center Support who are prepared to address problems in cancer Grant (CCSG) mechanism to provide support to biology, causation, prevention and control, detec- the peer-reviewed research base of the Cancer tion and diagnosis, treatment, and rehabilitation. Center within the larger institution. The CCSG Operationally, the CTB has three functions. The supports the operational framework (infrastruc- first is the management of NCI-funded grants in ture) of the center and partially pays for shared research training, career development, and cancer laboratory resources and facilities. Research education. The second function is the administra- projects themselves are supported through the tion of the Ruth L. Kirschstein National Research individual grants and contracts from the NIH and Service Award (NRSA) components (F32 and T32) from a variety of other grant funding agencies of the CTB grant portfolio. The NRSA Program is and organizations. In FY2017, there were 69 NCI the major mechanism for providing long-term, sta- designated Cancer Centers (49 Comprehensive, ble support to a wide range of promising scientists 13 Clinical, and 7 Basic), which received a total of and clinicians. Individual awards are made direct- $313 million in support, accounting for 5.6 percent ly to postdoctoral fellows (F32), and institutional of the total NCI budget. awards (T32) are made to scientists who, together with a group of faculty-preceptors, administer Specialized Programs of Research Excellence a comprehensive training program for pre- and (SPORE) postdoctoral trainees. CTB administers a research The SPORE Program is designed to stimulate career development program that supports the translational research from the laboratory to clin- training of both scientists and research physicians ical practice and are funded under the P50 grant during the first 3 to 5 years between receipt of mechanism. These are awarded to institutions a Ph.D., M.D., or other professional degree and that demonstrate the ability to perform significant receipt of an individual, investigator-initiated translational research in the prevention, detection, award. Among the career mechanisms are three diagnosis, and treatment for a single cancer site. In additional non-NRSA institutional mechanisms FY2017, the SPORE Program totaled approximate- (K12, R25T, and R25E) and six individual career ly $111 million, accounting for 2.0 percent of the development awards (K-series). The third function total NCI budget. is the oversight and coordination of the NIH Loan Repayment Program. Comprehensive Minority Institution/Cancer Center Partnership NCI Funding Mechanisms NCI’s Comprehensive Minority Institution/Cancer Center Partnership awards are U54 Cooperative The NCI supports cancer research, cancer control, Agreements designed to establish comprehensive and cancer support activities through an extramu- partnerships between the Minority Serving ral program of grants, cooperative agreements, Institution (MSI) and the NCI-designated Cancer and contracts, and through an intramural program Centers. The partnership focuses on cancer of in-house research. In accordance with NIH
20 NCI FNLAC Orientation Book tradition, NCI’s extramural programs emphasize research scientists. The cooperative agreement grant-supported, investigator-initiated research mechanism, which is a cross between a grant and a projects that are conducted at both nonprofit and contract, became available in 1979 as an additional for-profit institutions in the United States and procurement mechanism. Annual appropriations abroad. Research contracts are awarded to both from Congress provide the funds for all research nonprofit and for-profit institutions. Intramural supported by the NCI. Exhibits VII–IX present the funds support continuing investigations by NCI NCI’s funding allocations for the last several years.
Exhibit VII. NCI Funding History*†
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Grants $3,145,011 $3,182,832 $3,289,368 $3,255,003 $3,236,946 $3,987,438 3,055,661 $3,082,008 $3,163,531 $3,399,282
Contracts 586,883 618,062 621,682 594,955 597,635 623,950 660,283 596,951 748,344 910,377
In-house 1,095,658 1,166,033 1,187,097 1,208,147 1,232,760 1,177,626 1,216,424 1,273,633 1,294,293 1,326,732
Total 4,827,552 4,966,927 5,098,147 5,058,105 5,067,341 4,789,014 4,932,368 4,952,592 5,206,168 5,636,391
$6,000,000
$5,500,000 Dollars in Thousands
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Fiscal Year *Source: NCI Fact Book, FY2017. †Includes Cancer Moonshot Funding.
Exhibit VIII. Research Project Grants and Dollars Awarded FY2008–2017
$500
$400
$300
$200
$100
$0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
No. Awarded 5,472 5,380 5,179 5,019 5,021 4,816 4,814 4,767 4,666 4,663
$ in Millions $2,053 $2,021 $2,063 $2,088 $2,075 $1,925 $1,940 $2,093 $2,146 $2,195 Avg Cost in Thousands $375.2 $375.7 $398.3 $416.1 $413.3 $399.7 $403.0 $438.9 $459.9 $471.0
NCI FNLAC Orientation Book 21 Exhibit IX. Research Funding for Various Research Areas (Dollars in Millions)*
2013 2014 2015 2016 2017 Disease Area Actual Actual Actual Actual Actual†
Total NCI Budget 4,789.0 4,932.4 4,952.6 5,214.7 5,636.4
AIDS 261.6 269.9 269.6 266.4 249.0
Brain & CNS 176.8 180.4 204.8 196.3 219.8
Breast Cancer 559.2 528.5 543.6 522.6 544.9
Cervical Cancer 63.5 71.1 57.1 71.5 68.8
Clinical Trials 676.5 749.8 769.2 801.0 806.6
Colorectal Cancer 239.0 223.0 209.3 212.1 208.4
Head and Neck Cancers 40.6 57.1 60.2 58.9 46.4
Hodgkin Disease 14.7 15.4 13.6 12.8 13.0
Leukemia 235.3 236.7 246.9 241.0 250.5
Liver Cancer 64.5 60.0 70.3 75.7 72.7
Lung Cancer 287.6 254.1 255.8 283.9 320.6
Melanoma 122.7 126.2 132.8 142.9 153.2
Multiple Myeloma 45.5 46.6 48.9 52.1 60.7
Non-Hodgkin Lymphoma 113.9 118.0 122.4 116.7 119.5
Ovarian Cancer 101.0 91.5 92.8 95.6 110.1
Pancreatic Cancer 102.0 122.4 125.3 152.5 178.3
Prostate Cancer 256.3 217.8 228.9 241.0 233.0
Stomach Cancer 11.2 11.3 13.5 13.3 13.4
Uterine Cancer 17.9 15.5 13.0 16.8 17.5
*Source: Office of Budget and Finance, NCI, FY2017 † FY 2017 data are estimates.
22 NCI FNLAC Orientation Book FREDERICK NATIONAL LABORATORY FOR CANCER RESEARCH (FNLCR)—FEDERALLY FUNDED RESEARCH AND DEVELOPMENT CENTER (FFRDC) Overview access and quality at a sustainable cost. In FY2015, the Federal Government allocated $11.1 billion or The Federal Government supports a wide range 8.6% of its total $130 billion R&D expenditures to of research and development (R&D), studies and FFRDCs (https://fas.org/sgp/crs/misc/R44629.pdf). analyses, and engineering endeavors conducted by various entities, including Federal laboratories, A master list and description of activities of public and private colleges and universities, current FFRDCs can be accessed at https://www. private companies, and other research institutions. nsf.gov/statistics/ffrdclist/ A special class of R&D institutions, referred to as federally funded research and development Frederick National Laboratory for centers, or FFRDCs, where most or all of the Cancer Research (FNLCR) facilities are either owed or financially supported The FNLCR, which is overseen by the NCI, had by the U.S. Government, but operated by private its origin in 1971 with the signing of the National contractors, provide Federal agencies with R&D Cancer Act by President Nixon. In 1972, the capabilities that cannot be met by the Federal NCI-Frederick Cancer Research Center (FCRC) Government or the private sector alone. FFRDCs was established by a Presidential directive to differ from other performers of Federal R&D— convert the former Department of Defense (DoD) such as Federal laboratories, public or private Biological Defense Research Laboratories at colleges and universities, nonprofit organizations, Frederick, Maryland, into a contractor-operated or private firms—in that they are designed to meet “leading center for cancer research.” The directive a “special long-term research or development stipulated that “operation of the NCI-Frederick need that cannot be met as effectively by existing should be by a private contractor, to allow the in-house or contractor resources” and that they necessary flexibility, which would be difficult have “access, beyond that which is common to the under direct Government operations.” Litton normal contractual relationship, to Government Bionetics, Inc. was the first NCI contractor for the and supplier data, including sensitive and pro- FCRC. In 1975, the FCRC was formerly designated prietary data, and to employees and installations as a FFRDC. In 2012, two years after Dr. Harold equipment and real property.” FFRDCs are Varmus became the NCI director, the Center was Government-owned, contract-operated (commonly designated as a National Laboratory, and renamed referred to as “GOCO”) research facilities that are the FNLCR, elevating its broader national mission. owned or leased by the U.S. Government, and At the same time, Dr. Varmus and the NCI, upon managed by third-party contractors who operate recommendation by the NCAB, empaneled the GOCO facilities and function in accordance the Frederick National Laboratory Advisory with strict statutory and regulatory rules in Committee (NFAC), a committee consisting of accordance with U.S. Code of Federal Acquisition up to 16 members, including the Chair, and Regulations, Section 35.017. Although GOCO appointed by the Director of NCI, to meet three contractors operate within a Government-owned times a year, to review the state of research at the facility, they do not represent the U.S. Government. FNLCR facility, align the mission and goals of NCI investigators and contract investigators, and There are currently 42 FFRDCs sponsored by 12 make recommendations to the NCI Director for different Federal agencies. These FFRDCs provide the best use of the FNLCR capabilities and infra- a wide variety of R&D capabilities to Federal agen- structure. Members were authorities in drug and cy missions in a broad range of areas from energy vaccine development, clinical trials support, AIDS (DOE), defense (DoD), health and human services research, bioinformatics, genomics, nanotechnol- (HHS), space agency modernization (NASA) to ogy, biological repositories, and basic research homeland security (DHS). The Frederick National in cancer, immunology, and infectious diseases. Laboratory for Cancer Research (FNLCR), one of The NFAC was subsequently renamed to the two HHS-sponsored FFRDCs, is the only FFRDC current Frederick National Laboratory Advisory dedicated exclusively to biomedical R&D to Committee (FNLAC) in the fall of 2014. discover, innovate, and improve human health. As a national resource, the FNLCR provides The other HHS-sponsored FFRDC, the Centers cancer researchers a bridge between basic, for Medicare & Medicaid Services (CMS) Alliance translational, preclinical, and clinical practice to Modernize Healthcare (CAMH), established bringing together public and private partners, in 2012, seeks to advance the Nation’s progress including intramural investigators from the NCI toward an integrated health system with improved and other NIH intramural laboratories, extramural
NCI FNLAC Orientation Book 23 NCI-supported laboratories, biotechnical and Development Center (FFRDC), a pharmaceutical companies, and contract research Government-owned, contractor-operated groups. Because of its status as a FFRDC, FNLCR (GOCO) facility designed to provide a affords the NCI and other NIH Institutes with unique national resource for the devel- a unique national resource and capabilities opment of new technologies and the (flexibility, rapid response, and increased efficiency) translation of basic science discoveries to accelerate the development and delivery of into novel agents for the prevention, effective preventive, diagnostic, and therapeutic diagnosis, and treatment of cancer. The agents for rare and recalcitrant cancers, HIV/AIDS, FCRC at that time was one of 37 FFRDCs and rapid response to emerging infectious disease that were operated on behalf of nine (e.g., HIV/AIDS, Ebola, Zika, Chikungunya, sponsoring agencies by universities, Influenza, MERS, etc.) challenges. nonprofit organizations, or industrial The breadth of FNLCR activities are extensive and firms under long-term contracts or spon- designed specifically to support the research goals soring agreements. It was, at that time, the and mission of the NIH, including investigator-ini- only FFRDC in the HHS and NIH and was, tiated, hypothesis-driven research; drug discovery and currently still is, the only FFRDC in and development; biomarker identification and the Nation dedicated solely to biomedical validation; translational genomics; next generation research. preclinical assay development; oncology-focused computational science; production of clinical- 1976 All buildings and acreage utilized by the grade biopharmaceuticals for first-in-human FCRC were formally transferred from the studies; acceleration of nanotechnology applica- Department of Defense (DoD) and the tions for treatments and diagnostics; preclinical Department of the Army to HHS and model development, validation, and testing; Center the NIH. for Cancer Research (CCR) clinical operations in support of the NCI, the National Institute of Allergy 1978 National Institute of Allergy and and Infectious Diseases (NIAID), and other NIH Infectious Diseases (NIAID) started Institute-sponsored clinical trials; and management utilizing the FCRC to do recombinant and operations of biopharmaceutical development DNA experiments. and manufacturing programs under two current Good Manufacturing Practice (GMP) facilities. 1980 FCRC was instrumental in developing a Chronological History of the FNLCR blood test to protect the Nation’s blood and FNLAC supply from HIV infection. 1981 FCRC was renamed the Frederick Cancer 1971 President Richard Nixon signed the Research Facility (FCRF) in December. National Cancer Act and converted Fort Detrick, Frederick, Maryland, from a bio- 1982 The NCI divided the existing single logical warfare facility to a national cancer FFRDC contract into five contracts: Basic research center. The act expanded Federal funding for cancer research and created Research, Operations and Technical the National Cancer Institute (NCI) in Support, Animal Production, Computer Frederick, part of the National Institutes of Services, and Scientific Library Services. Health (NIH) under the U.S. Department Required work included extensive of Health and Human Services (HHS). laboratory renovations, developmental and applied cancer research, providing 1972 The Frederick Cancer Research Center research resources, scientific support ser- (FCRC) was established on June 26. vices, a strong safety program, computer Approximately 70 acres and 67 buildings and scientific library services, laboratory of the U.S. Army were transferred to HHS, animal production, and complete facility which includes the NIH. maintenance in September.
Litton Bionetics, Inc. was the first NCI 1984 FCRF helped develop and manufacture an contractor at the FCRC. HIV/AIDS test on a large-scale for national use. 1975 The National Science Foundation (NSF) notified HHS that NCI-Frederick met 1985 The FCRF Advisory Committee was the criteria for and was designated established on November 20, and as a Federally Funded Research and consisted of 12 members who collectively
24 NCI FNLAC Orientation Book had authorities knowledgeable in the disci- evaluation, and optimization of its own drug plines pertinent to reviewing the activities candidates. The NCI-Frederick facility and its of the Basic Research Program contract portfolio of support functions via a contract at the FCRF. The primary purpose of this mechanism are competitively reviewed every Committee was to review contractor research 5 years. and the overall multiple-contractor operation of the NCI FCRDC to ensure that required The Human Papillomavirus (HPV) resources were provided. Immunology Laboratory was established at Frederick to support the development of 1990 FCRF was renamed the NCI-Frederick a cervical cancer vaccine that was tested in Cancer Research and Development Center Phase III clinical trials. (FCRDC). 2007 The NIH Director approved the renewal of 1993 NCI-Frederick Biopharmaceutical the NCI-Frederick FFRDC and to extend the Development Program (BDP) was estab- SAIC contract to manage and operate the lished. BDP supports the development FFRDC for a potential period of performance of monoclonal antibodies, recombinant not to exceed 10 years. proteins, therapeutic peptides and DNA vaccines, oligonucleotides, virus therapeutics 2009 The Advanced Technology Partnerships and vaccines, gene therapy products, and (ATP) Initiative was established to accelerate other biological agents. the delivery of new products to cancer patients through the strategic application of 1995 SAIC-Frederick (Science Applications advanced technologies and by facilitating International Corporation) competed and translational research partnerships. was selected as the operations and technical A new research facility was built at Frederick support contractor at the NCI-FCRDC. by the Matan Corporation and leased by the NCI to house additional drug development 1998 The FCRDC Advisory Committee was laboratories. terminated on September 22. 2010 An ad hoc NCAB Working Group was 2001 The name NCI-Frederick Cancer Research formed to create a Strategic Scientific Vision and Development Center was changed for the National Cancer Program and to to National Cancer Institute at Frederick review progress at the NCI. The Working (NCI-Frederick). Group recommended the establishment of a chartered committee to advise and evaluate 2003 The Nanotechnology Characterization ongoing activities at the Frederick facility. Laboratory (NCL) was established for The report findings and recommendations accelerating nanotechnology research at were presented at the NCAB meeting held Frederick. The NCI established the NCL as on December 7. The Board unanimously a collaboration with NIST and the FDA. The approved the establishment of a Federal NCL conducts preclinical characterization Advisory Committee at Frederick. and toxicity testing on nanomaterials that have been developed in academic, gov- 2011 The establishment of the NCI-Frederick ernment, and commercial laboratories to Advisory Committee (NFAC) was diagnose and treat cancer. announced on March 9. The NFAC consists of 16 members, including the Chair, appoint- 2005 NCI-Frederick was providing scientific ed by the Director of NCI, to meet twice support for 25 of the 27 NIH Institutes and a year, review the state of research at the Centers. Extramural scientists also have facility, and make recommendations for the access to its services, reagents, and facilities. best use of its capabilities and infrastructure. Additionally, NCI-Frederick supports a Members were authorities in drug and significant percentage of NCI’s drug discov- vaccine development, clinical trials support, ery and development activities through its AIDS research, bioinformatics, genomics, collaborative activities with the Division of nanotechnology, biological repositories, and Cancer Treatment and Diagnosis (DCTD). basic research in immunology and infectious These activities include drug discovery diseases. screening, candidate selection, preclinical
NCI FNLAC Orientation Book 25 An orientation was given to the NFAC discussed were: (1) a change of leadership members on August 31 in Bethesda, within SAIC-Frederick; (2) creation of a Maryland. At this orientation, the NCI c-CRADA policy; and (3) steps to improve Director led a discussion on the naming how FNLCR’s capabilities and resources of the NCI-Frederick enterprise. Members are communicated to the extramural discussed inclusion of different concepts in community. The draft strategic plan for the name, including national, technology the FNLCR also was discussed. development, and translational research, as well as distinctions between intramural December – The new c-CRADA program and extramural programs, and cancer to enhance partnering opportunities and AIDS. Also, there were presentations highlighting the contractor’s unique capa- on Contractor Cooperative Research and bilities at FNLCR was established. Under Development Agreement (c-CRADA) and the c-CRADA, SAIC-Frederick initiates the use of “Contractor-CRADAs” at other and manages CRADA projects that do FFRDCs. Members strongly supported the not involve direct participation from NCI establishment of a c-CRADA. staff in research. These unique capabilities and the construction of the ATRF, whose 2012 January – The first regular NFAC meeting primary function was to foster partner- was held on January 25 in Frederick, ships, were the driving forces behind the Maryland. Consensus was reached to c-CRADA program. change the name from NCI-Frederick to Frederick National Laboratory for 2013 The fourth NFAC meeting was held on Cancer Research (FNLCR). A motion to February 4 in Berkeley, California. The express the NFAC’s strong endorsement meeting was dedicated to the continued of the importance and usefulness of the discussion of the draft FNLCR strategic c-CRADA was approved unanimously. plan. NFAC members also toured the Advanced Technology Research Facility (ATRF), The fifth NFAC meeting was held on which was still under construction. September 24 in Frederick, Maryland. The RAS initiative was discussed and mem- March – NCI-Frederick was renamed as bers expressed enthusiasm for the RAS the Frederick National Laboratory for Program and its direction and encouraged Cancer Research (FNLCR) designating the the NCI and FNLCR leadership to facility as a Federal National Laboratory promote the RAS study as a model for (FNL) and elevating its national mission. other investigations. NFAC members also toured the ATRF. May – The second NFAC meeting was held on May 30 in Bethesda, Maryland. SAIC-Frederick contractor changed its Members expressed approval for the name to Leidos Biomedical Research, Inc. revised external website that presents on September 27. the FNLCR as a national resource. The website displays products, services, and The NCI established the RAS Initiative to collaboration opportunities available explore innovative approaches for attack- to extramural investigators. The draft ing the proteins encoded by mutant forms strategic plan for the FNLCR also was of RAS genes and to ultimately create discussed. effective new therapies for RAS-related cancers. RAS initiative collaborations June – The Advanced Technology with both organizations and individual Research Facility (ATRF) opened with scientists have expanded research capa- research capabilities in Genetics and bilities and maximized the impact of RAS Genomics, Proteins and Proteomics, initiative discoveries. Imaging and Nanotechnology, Advanced Biomedical Computing and Cell Biology. The NFAC approved the establishment of the: (1) ad hoc RAS Subcommittee; September – The third NFAC meeting (2) Immuno-Multiple Reaction Monitoring was held on September 12 in Bethesda, (MRM) Working Group; and (3) ad hoc Maryland. Several FNLCR updates RAS Working Group. The ad hoc RAS Subcommittee was established to provide
26 NCI FNLAC Orientation Book the highest quality oversight to the to launch a National Cryo-EM Facility, the technical aspects of the RAS Program. The FNLAC voted via mail ballot to establish ad hoc RAS Working Group will provide the ad hoc National Cryo-EM Facility findings and recommendations to the Oversight Subcommittee. NFAC and the ad hoc RAS Subcommittee. The ad hoc RAS Working Group evaluated The first FNLAC virtual meeting was held the scientific goals, direction, priorities, on October 21 in Rockville, Maryland. and progress of the hub projects at the The RAS ad hoc Working Group report FNLCR, as well as how the hub interfaces and recommendations were presented. A with industry and the extramural motion to accept the report was approved community. unanimously. The NFAC was instrumental in approving The 11th FNLAC meeting was held the concept of the RAS Initiative and November 16–17 in Frederick, Maryland. suggested receiving periodic updates from A site visit review of the FNLCR included: the ad hoc RAS Working Group. (1) discussion of the overall operations; (2) evaluation of the research programs; 2014 The sixth NFAC meeting was held and (3) discussion of unpublished RAS February 4–5 in Bethesda, Maryland. research findings and data. Also, a final Members received an overview of the report of the findings was written by FNLCR and its interactions with the FNLAC. NCI intramural research program and an update on the RAS Project. Potential projects for the FNLCR were presented December – Final report and recommen- and discussed. dation for the RAS Initiative Renewal Request from the FNLAC Review Team The seventh NFAC meeting was held on was accepted by a mail ballot and sent to September 30 in Bethesda, Maryland. the NCI Director. Members discussed the discrepancy between the NFAC name and the FNLCR. 2017 The establishment of the FNLAC The Committee members voted unani- NCI/U.S. Department of Energy (DOE) mously to rename NFAC as the Frederick Collaborations Working Group was National Laboratory Advisory Committee approved by the National Cancer (FNLAC). Advisory Board on February 15, 2017. The FNLAC Working Group will provide 2015 The eighth FNLAC meeting was held scientific evaluation of programs, projects, on February 3 in Bethesda, Maryland. and collaborations formed in support of or At this meeting, it was announced that a relevant to NCI/DOE collaborations. The community website, commonly referred Working Group is charged with exploring to as RAS Central or the RAS Initiative the domains and activities in which at Cancer.gov (https://www.cancer.gov/ collaborations between the NCI and DOE research/key-initiatives/ras), was devel- would be mutually beneficial and advance oped as a space for the RAS community the missions of these entities. to gather and exchange ideas, and have discussions. The 12th FNLAC meeting was held on May 8 in Bethesda, Maryland. Updates The ninth FNLAC meeting held on on several NCI initiatives that included September 30 in Bethesda, Maryland, the NCEF, two collaborations with DOE resulted in a motion to support the launch and the FNLCR, and the implementation of a National Cryo-EM User Facility at of the Beau Biden Cancer MoonshotSM the FNLCR. The recommendation to Blue Ribbon Panel recommendations were establish a Steering Committee of experts presented and discussed. and an evaluation in the second year was approved unanimously. The NCEF at the NCI provides cancer researchers access to the latest Cryo-EM 2016 The 10th FNLAC meeting was held technology for high resolution imaging. on May 11 in Rockville, Maryland. In The NCEF is a service facility under the follow-up to the September 2015 decision
NCI FNLAC Orientation Book 27 umbrella of the FNLCR that opened for to expand both institutions’ research user access on May 15. and training missions in the biomedical sciences. June – The FNLCR and the Weizmann Institute of Science, located in Rehovot, May – The 14th FNLAC meeting was held Israel, signed a contractor Cooperative on May 2 at the Shady Grove Campus, Research and Development Agreement Rockville, Maryland. Members received (cCRADA) with the purpose of identifying an overview of the current operations and small molecules that bind to or influence future plans for the FNLCR and updates the activity of KRAS4b—a protein that is on several NCI Initiatives, including the frequently mutated in pancreatic, colon, National Cryo-EM and the Accelerating and lung cancers. Therapeutic for Opportunities in Medicine (ATOM). NCI staff provided overviews The second FNLAC virtual meeting was of the NCI Experimental Therapeutics held on July 18 in Rockville, Maryland. An (NExT) program, the Role of Molecular overview of the FNLCR research portfolio Pharmacodynamics in Drug Discovery was provided and newly initiated research and Development, and NCI’s Early projects at FNLCR were presented and Therapeutic Trials Network. discussed. FNLCR Facilities August – A new solicitations page The FNLCR campus is located 50 miles north- was launched on the FNLCR website west of Washington, DC, and 50 miles west of on August 31. It is designed to bring Baltimore, Maryland, in Frederick, Maryland. increased visibility to business opportuni- Satellite locations include leased and Government ties through a new, user-friendly platform owned facilities extending south along the I-270 that facilitates searching for open solicita- Technology Corridor to Bethesda, Maryland, home tions. of the NIH, NCI’s parent organization. Many of the original FNLCR offices and laborato- October – Ethan Dmitrovsky, M.D., was ries were housed in 67 buildings co-located on a appointed as the President of Leidos 68-acre “NCI island campus” within the perimeter Biomedical Research, Inc. and the of the Fort Detrick U.S. Army Base in Frederick, Laboratory Director of the FNLCR. Maryland, along with NCI-Frederick intramural Dr. Dmitrovsky succeeded David laboratories and scientists from the NCI Center for Heimbrook, Ph.D., who retired after Cancer Research (CCR) along with NCI staff and 6 years. contractors from other NCI divisions, including the Division of Cancer Treatment (DCTD) and the The 13th FNLAC meeting was held Division of Cancer Epidemiology and Genetics on October 30 in Bethesda, Maryland. (DCEG) (Exhibit X). Updates on several NCI initiatives, including the FNLCR operations, National In addition to the FNLCR offices and laboratories Cryo-EM Facility, RAS Initiative, and located on the main Fort Detrick NCI-Frederick campus, the FNLCR in 2012 opened the Advanced the Chemical Biology Consortium were Technology Research Facility (ATRF) (Exhibit XI), presented and discussed. a multi-building complex which consolidated many of the original FNLCR laboratories and November – FNLCR entered into a new operations that had been scattered among partnership with the Fred Hutchinson more than 30 buildings on the Fort Detrick Cancer Research Center that, if successful, NCI-Frederick campus. The ATRF is an off-site could improve current methods of donor 330,000-square foot state-of-the-art R&D and pro- selection and thereby make lifesaving duction complex located at the Riverside Research transplant procedures more readily avail- Park, approximately 5 miles from the main Fort able for patients with leukemia, multiple Detrick NCI-Frederick campus. The ATRF houses myeloma, and other disorders. advanced technology laboratories, biopharma- ceutical development, advanced biomedical 2018 February – FNLCR and Georgetown computing, cell biology, and cGMP production University launched a Research and facilities. The ATRF is designed to foster co-located Education Collaboration, which aims public-private partnership projects, with dedicated laboratory and “think tank” space for collabora-
28 NCI FNLAC Orientation Book Exhibit X. NCI-Frederick Campus Map
National Cancer Institute at Frederick Fort Detrick, Frederick, Maryland
Old Farm Gate
Family Housing OLD FARM GATE Fort Detrick Federal/NIH PIV card-holders ONLY: 6:00 a.m. - 9:00 p.m., Weekdays 9:00 a.m. - 9:00 p.m., Weekends/Holidays National Ditto Ave. Cancer Institute Research at Frederick Plaza Doughten Dr.
Palacky Dr. Nallin Gate Schneider Veterans Dr. Campus Dr. Porter St. St. Construction Porter St. Contracts STARK ST. Receiving NCI at Frederick visitors must
Veterans Freedman Dr. Gate report to building 426
1063
1041 1042 NALLIN GATE Library and Conference Center Oppossumtown 1043 Pike Entrance (Open 24/7) 1019 Visitors, deliveries, Federal/NIH PIV 540 card-holders
561
537 575
566
PALACKY572 DR. 527 377 436
425 VETERANS GATE th 313A 7 Street Entrance 311 NCI at Frederick Administration 310 Federal/NIH PIV card-holders ONLY: Facilities Maintenance 474 5:30 a.m. - 5:30 p.m. and Engineering CCR 471 Administration 5:30 p.m. - 8:30 p.m. (exit only) 380 Weekdays Closed on weekends and holidays
318 319 359
Parking lots and roads Data Management Services NCI at Frederick buildings Army buildings TO RT. 15 Fort Detrick boundary NCI at Frederick boundary
206851 October 2015
NCI FNLAC Orientation Book 29 Exhibit XI. Frederick Advanced Technology Research Facility (ATRF) – Frederick, MD
tive work with partners across a continuum of provides operational management expertise and translational R&D technologies and platforms, scientific capability to accomplish the research including genomics, proteomics, nanotechnology, objectives assigned by the NCI to the FNLCR. molecular diagnostics, bioinformatics, and bio- Specific support activities include strategic pharmaceutical development. Government-Contractor planning, program coordination, cooperation, and collaboration. These The FNLCR also manages and operates additional functions are executed through several different facilities located in Frederick, Gaithersburg, mechanisms, including Statement of Work (SOW) Bethesda, and Rockville, Maryland, including agreements and Work Order Requests formulated the NCI Advanced Technology Center (ATC), the by, and with oversight provided by, the NCI home for the National Cryo-Electron Microscopy Director and the Director, Office of Scientific Facility (Frederick); the Core Genotyping Facility Operations (NCI-Frederick). (Gaithersburg); the Laboratory Animal Sciences Program (LASP) (Bethesda); the Vaccine Pilot In FY2016, the FNLCR operations and technical Plant for the production of clinical-stage vaccine support budget, including indefinite delivery/ candidates for major infectious diseases (HIV/ indefinite quantity (IDIQ) contracts (e.g., Work AIDS, malaria, tuberculosis, Zika, etc.) for the Order Requests) was $669 million involving more National Institute of Allergy and Infectious than 3,000 biomedical investigators, laboratory Diseases (NIAID) (Frederick); and the Clinical technicians, and support staff that included Monitoring Research Program (CMRP), which contractor (Leidos Biomedical) employees, and provides clinical research support for human other contractual personnel on the NCI campus clinical trials for diseases and viruses such as in Frederick and additional Leidos employees in cancer and AIDS, influenza, malaria, Zika, Ebola, Bethesda, Rockville, and other sites in Maryland. chikungunya, parasitic diseases, and a wide Approximately $489 million (73%) of the total range of other infectious diseases for the NCI and $669 million FNLCR costs were allocated for NIAID (Frederick and Rockville). NCI programs with $180 million (27%) related to non-NCI support, including those associated with FNLCR Budget the NIAID/Vaccine Research Center programs and other NIH Institutes or Agencies. Exhibit XII Leidos Biomedical Research, Inc. (formerly known summarizes the total support provided to the as SAIC-Frederick, Inc.) currently provides FNLCR and to the individual NCI DOCs excluding Operations and Technical Support (OTS) for NCI intramural and extramural Government the FNLCR under contract and on behalf of the full-time equivalent (FTE) personnel salary and National Cancer Institute (NCI). Leidos Biomedical benefit-associated costs.
30 NCI FNLAC Orientation Book Exhibit XII. FY2016 FNLCR Budget C Total u ort 669 CI u ort 489 †
ther Inst tutes ther CI s ons 13 - 2 6 - 1 2 I - CI I I 61 - 12 5 167 - 25 CT 121 - 24 8
C G 24 - 4 9
- re er c 162 - 33 1
CC 85 - 17 4 CI C IIT 489 - 73 30 - 6 1
CI CT son o Cancer Treat ent an a nos s
I I - C I I s ons C G son o Cancer e olo an Genet cs
ther Inst tutes enc es CC Center or Cancer esearch
C ro ress an ro ra s u ate a 8 2017 C eet n C IIT Center or o e cal In or at on an Technolo
- re er c erat ons an c ent c u ort
I - CI Center or trate c c ent c In t at es Center or Cancer Geno cs Center or Glo al ealth Coor nat n Center or Cl n cal Tr als I e ate ce o the CI rector
ther CI s ons s on o Cancer olo C s on o Cancer re ent on C s on o Cancer Control an o ulat on c ences CC
† CI su ort totals o not Inclu e Go ern ent CI ersonnel an su l assoc ate costs
FNLCR Scientific Support technical laboratory staff to deliver tactical “hands-on” clinical or laboratory support During the early days of the NCI at Frederick, and for NCI Principal Investigator-directed even after the formal establishment of the Frederick intramural projects. Contractor personnel Cancer Research Center (FCRC) as an FFRDC, the perform studies under overall guidance by major role of the contracting agency was to provide operational and technical support to the NCI and Government employees. For example, Leidos other NIH Institutes’ research missions, needs, and technical staff are imbedded in NCI Center for priorities and administrative services to maintain Cancer Research (CCR) and Division of Cancer the FFRDC infrastructure. To fully capitalize on the Epidemiology and Genetics (DCEG) Principal unique capabilities and authorities allowed under Investigator laboratories supporting their governmental FFRDC regulations, the FNLCR, intramural research projects. while still providing essential operational support to the NCI at Frederick and to the NCI DOCs, has ● Government-Initiated Research Projects, developed national research programs and projects Contractor-Provided Research Resources: with direct benefit to the external research commu- Leidos provides research resources for NCI- nity. The different types of projects and support are directed intramural and extramural research briefly described below: activities. Research support is generally furnished by the availability of essential core ● Government-Initiated Research Projects, facilities, laboratory services, and specialized Contractor-Provided Research Support: laboratories to facilitate the research activities Contractor (currently Leidos Biomed) provides of NCI and other NIH IC programs. For
NCI FNLAC Orientation Book 31 example, Leidos personnel provide essential population and multidisciplinary research to Laboratory Animal Services and radiophar- discover the genetic and environmental causes macy assistance for animal husbandry, model of cancer and ways to prevent it. development, imaging, immunology, and ● Division of Cancer Biology (DCB) treatment evaluation. (Extramural) — encourages and facilitates ● Government-Initiated Research Projects, continued support of basic research in all Contractor/Subcontractor-Executed Projects: areas of cancer biology to provide the research Extramural NCI-directed research projects are foundation that enables improved under- standing of the disease and may lead to new executed through outside subcontracts (exter- approaches for prevention, diagnosis, and nal companies and universities). For example, treatment. investigators from member institutions of the Chemical Biology Consortium in the NCI ● Division of Cancer Prevention (DCP) Experimental Therapeutics (NExT) Program (Extramural) — conducts and supports participate in NCI extramural projects through research to find ways to prevent and detect task order agreements administered by Leidos cancer, and to prevent or relieve symptoms Biomed as part of the NCI Division of Cancer from cancer and its treatments. Treatment and Diagnosis (DCTD) program. ● Division of Cancer Treatment and Diagnosis ● Contractor-Initiated, Contractor-Executed (DCTD) (Extramural) — supports the Research Projects: Leidos personnel conduct translation of promising research into clinical research both strategically as well as scien- applications to improve the diagnosis and tifically in NCI mission associated projects treatment of cancer in areas of unmet need that are often too risky or difficult for industry such as the RAS Initiative, AIDS and Cancer or academia to develop alone. Virus Program, and the Nanotechnology Characterization Laboratory (NCL). The ● Division of Cancer Control and Population NCI has broadly defined the objectives and Sciences (DCCPS) (Extramural) — supports an missions of these initiatives while Leidos integrated program of genetic, epidemiologic, personnel conduct the day-to-day studies behavioral, social, applied, and surveillance under the direction of the FNLCR Laboratory cancer research to reduce risk, incidence, and Director with oversight provided by the NCI death from cancer, as well as to enhance the Director and senior leadership. quality of life for cancer survivors. FNLCR Support of NCI Divisions, ● Center for Strategic Scientific Initiatives Offices, and Centers (CSSI) (Office of the NCI Director) — creates and implements exploratory programs The FNLCR provides direct program support to focused on emerging scientific discoveries numerous intramural and extramural divisions, and innovative technologies to accelerate the offices, and centers (DOCs) within both the NCI pace of cancer research and the translation of and other NIH Institutes. The NCI DOCs include: research results into new therapies, diagnos- tics, and preventive agents. ● Center for Cancer Research (CCR) (Intramural) — NCI intramural basic ● Center for Cancer Genomics (CCG) (Office researchers, clinicians, and translational of the NCI Director) — unifies NCI’s activities scientists who integrate basic and clinical in cancer genomics by aiming to synthesize research discovery to develop novel therapeu- research in different fields of cancer genomics tic interventions that better treat adults and — structural, functional, and computational — children living with cancer or HIV/AIDS. to improve patient outcomes. ● Center for Biomedical Informatics and ● Center for Global Health (CGH) (Office Information Technology (CBIIT) (Office of the NCI Director) — provides assistance of the NCI Director) — collaborates across and guidance to nations as they develop and the NCI to plan, provide, and coordinate implement cancer control plans; trains inter- technology, standards, and scientific comput- national investigators; and strengthens U.S. ing in support of the NCI mission to speed national, regional, multilateral, and bilateral discovery, facilitate open science, and progress collaboration in health research, cancer towards precision treatment in cancer care and research, and cancer control to advance global a learning health care system. cancer research, build expertise, and reduce ● Division of Cancer Epidemiology and cancer deaths worldwide. Genetics (DCEG) (Intramural) — conducts
32 NCI FNLAC Orientation Book ● Coordinating Center for Clinical Trials for new drug development and breakthroughs (CCCT) (Office of the NCI Director) — facil- into new cancer therapies. For example, through itates efforts across the NCI to enhance the the NExT program, promising molecules such as effectiveness of NCI’s clinical trials enterprise the angiogenesis inhibitor cediranib and olaparib, through collaboration and harmonization which inhibits the repair of DNA damage, are among NCI programs and extramural stake- being tested as a combination treatment for ovari- holder communities. an cancer and mesothelioma. The NExT Program also is supporting the application of selumetinib In addition to providing support for NCI efforts, the FNLCR also provides significant assistance to treat childhood brain tumors (see https://next. to NIAID. Support is provided to the following cancer.gov/). NIAID divisions and centers: The AIDS and Cancer Virus Program (ACVP) ● Division of Intramural Research — conducts seeks to improve the diagnosis, prevention, basic and clinical research in a wide range of and treatment of HIV infection, AIDS, and disciplines related to immunology, allergies, AIDS-related tumors, including cancer causing and infectious diseases. viruses such as KSHV, through basic and applied research. The current program directly stems from ● Division of Clinical Research — provides efforts of scientists who, in 1984, helped contribute multidisciplinary trans-NIAID services for to the first generation of AIDS blood screening facilitating clinical research and managing special projects as directed by NIAID leader- tests that helped prevent further spreading of ship. the newly identified AIDS virus throughout the U.S. blood supply. The ACVP consists of highly ● Division of Acquired Immunodeficiency collaborative investigator-led research sections Syndrome — supports a global research port- conducting investigator-initiated research and folio on HIV/AIDS and its related co-infections research core support laboratories. Program and co-morbidities. scientists conduct and support AIDS studies ● Vaccine Research Center — conducts research through research, including fundamental molec- that facilitates the development of effective ular virology, in vitro studies, nonhuman primate vaccines for human disease. models, and performing and supporting clinical and epidemiological studies in the United States Support also is provided to approximately and internationally. As an explicit feature of its 15 other Institutes within the NIH and other mission and as a part of the FNLCR, the ACVP Federal agencies, including the National Heart, also develops and proactively shares unique Lung, and Blood Institute (NHLBI); National and cutting-edge technologies with the broader Institute of Arthritis, Musculoskeletal, and Skin research community to facilitate overall research Diseases (NIAMS); National Institute of Mental progress (see https://frederick.cancer.gov/science/ Health (NIMH); National Center for Advancing basic-research/aids-and-cancer-virus-program). Translational Sciences (NCATS); and the U.S. Army Center for Environmental Health Research. Clinical Monitoring Research Program Additional FNLCR-Supported Programs (CMRP) and Vaccine Clinical Materials Program and Laboratories (VCMP) — The CMRP provides expertise in regulatory affairs, clinical trials management, The NCI Experimental Therapeutics (NExT) pharmacovigilance, protocol development and Program is led by the Division of Cancer navigation, and project/program management Therapeutics and Diagnosis (DCTD) and consoli- services to more than 400 domestic and inter- dates NCI’s Developmental Therapeutics Program national clinical trials, including human clinical (DTP) to create coordinated cancer therapeutics trials, for diseases and viruses such as cancer and discovery and development resources in support AIDS, influenza, malaria, Zika, Ebola, chikungun- of a balanced therapeutics pipeline, from the ya, parasitic diseases, and a wide range of other validation of new targets to evaluation in phase emerging and re-emerging infectious diseases. III clinical trials. The NCI partners with appli- Most recently, the CMRP supported the NIAID cants from the external scientific community to Vaccine Research Center’s (VRC) rapid response facilitate the milestone-driven progression of new to the global health threat posed by infectious anticancer drugs (small molecules, biologics) and diseases such as the Zika virus and chikungunya, imaging agents towards clinical evaluation and thus accelerating a range of clinical research efforts registration. The goal is to shorten the timeline to understand infection, replication, pathogenesis,
NCI FNLAC Orientation Book 33 and transmission, and to develop and test vaccine The Cancer Research Technology Program candidates for protection against these infections. (CRTP) leads scientific initiatives and provides In 2016, the program developed an accelerated technical solutions to meet the challenges of schedule to produce, test, and release a Zika and performance of mission-driven biomedical vaccine candidate in just 90 days. The VCMP com- research. A major research area for the program pleted several batches of Zika vaccine vialed drug is NCI’s RAS Initiative to explore innovative product (DP) and physical drug substance (DS) approaches for attacking proteins encoded by totaling roughly 10,000 vaccine doses. The CMRP mutant forms of the RAS family of genes. In also provides support for programs and initiatives addition to RAS studies, the CRTP also is involved such as the Brain Tumor Trials Collaborative, NCI- in quantification of the impact of the HIV-1 glycan MATCH and other precision medicine initiatives, shield on antibody elicitation; genetic alterations NCI Center for Global Health, and NIAID Vaccine associated with prostate cancer may be identified Research Center and Division of Clinical Research by sequencing metastatic tumor genomes to (for CMRP see https://frederick.cancer.gov/science/ identify molecular markers at this lethal stage of clinical/clinical-monitoring-research-program and disease; and the development of nanomedicine for VCMP see https://frederick.cancer.gov/science/ strategies to overcome the pathophysiological vaccine-clinical-materials-program). barriers of pancreatic cancer (see https://frederick. cancer.gov/science/cancer-research-technology- The Laboratory Animal Sciences Program (LASP) program). provides an integrated portfolio of research animal programs, including the development of The Biopharmaceutical Development Program genetically engineered mouse models, cryopreser- (BDP), established in 1993, is funded by NCI’s vation and assisted reproduction, pathology and Division of Cancer Treatment and Diagnosis histotechnology, a small animal imaging core, a (DCTD) and produces novel antibodies and genome modification core, gnotobiotics facility, proteins as therapeutics when industry is not molecular diagnostics, and animal husbandry. The prepared to develop them. When the Children’s LASP also provides oversight of animal research Oncology Group could not find a manufacturer facilities by guarding against the accidental intro- to produce ch14.18, a monoclonal antibody being duction of pathogens in experiments, administers evaluated as a treatment for neuroblastoma accurate clinical diagnosis and preoperative care, tumors in children, BDP manufactured the anti- and offers quality animal holding facilities and body for the clinical trial. The trial demonstrated related services. These include the quarantine of that ch14.18 reduced the risk of recurrence when imported animals, rederivation of pathogen-carry- given to children whose cancer responded to che- ing strains, and the comprehensive monitoring of motherapy. The monoclonal antibody has become the health status of animal research colonies. LASP the standard of care for children with certain types management in FY2016 included 27 rodent and of neuroblastoma, and the pharmaceutical com- nonhuman primate facilities (22 in Frederick and pany, United Therapeutics, is now manufacturing 5 in Bethesda) encompassing 133,000 animals, 315 the antibody (see https://ncifrederick.cancer.gov/ LASP personnel (234 in Frederick, 81 in Bethesda), research/brb/biopharmaceutical.aspx). and support to 206 research investigators involved in 550 active animal study protocols (see https:// The Nanotechnology Characterization frederick.cancer.gov/science/technology/ Laboratory (NCL), established in 2004, seeks to laboratory-animal-sciences-program). accelerate the development of nanotechnology for basic and applied cancer research. Working The Center for Advanced Preclinical Research in collaboration with the FDA and the National (CAPR) is funded by the NCI-CCR and provides Institute of Standards and Technology (NIST), the a comprehensive preclinical trial framework for NCL standardizes the preclinical characterization evaluating the anti-tumor efficacy and selectivity, of nanomaterials that academic, government, and biodistribution, and metabolism of early-stage industry researchers are developing as cancer candidate drugs using genetically engineered therapeutics and diagnostics (see https://ncl. mouse models. The CAPR serves as a national cancer.gov/). resource for the comprehensive preclinical test- ing of early-stage candidate drugs. Candidate The Basic Science Program (BSP) pursues inde- compounds are assessed for anti-tumor efficacy pendent, multidisciplinary research programs in and selectivity in genetically engineered animal basic and applied molecular biology, immunology, models (see https://ccr.cancer.gov/capr). retrovirology, cancer biology, and human genet-
34 NCI FNLAC Orientation Book ics. Research efforts and support are an integral contract researchers working in collaboration with part of the intramural NCI Center for Cancer multiple external partners. By using an integrat- Research (CCR) at the FNLCR. The goal of the BSP ed, team-based approach centered at the FNLCR, is to gain new knowledge and understanding of and in collaboration with an extensive network biological processes relevant to cancer and other of academic laboratories, the NCI, and industrial diseases, and to develop cutting-edge tools to partners, the RAS Initiative seeks to develop drug accelerate progress. Areas of focus include cancer, candidates that target RAS proteins directly, or retrovirology, basic biology, structural biology, block RAS activity in cancer cells. It is expected informatics, cellular mechanisms, and the genetic that these candidates will advance quickly to- factors that influence disease susceptibility and wards pre-clinical testing and that therapies for progression (see https://frederick.cancer.gov/ this deadly group of RAS-driven cancers will be science/basic-research/basic-science-program). a reality (see https://www.cancer.gov/research/ key-initiatives/ras). A more extensive description of the activities and Human Papillomavirus (HPV) Serology facilities provided at the FNLCR can be found at Laboratory https://frederick.cancer.gov/. Human Papillomavirus (HPV) is one of the major FNLCR National Programs and infectious agents that causes cervical and other Initiatives cancers (anal, oropharyngeal, vaginal) and is responsible for approximately 5 percent of all The FNLCR, as an FFRDC, is currently under- cancers worldwide. Although an effective vaccine taking multiple scientific challenges of national is available, efforts at the FNLCR are underway importance to accelerate the development and to increase the number of people receiving vacci- delivery of effective preventive, diagnostic, and nations. FNLCR’s HPV Serology Laboratory was therapeutic products to people living with cancer launched in early 2017 with the goal of establish- and HIV/AIDS. These programs and initiatives are ing standardization to promote harmonization described below. and proficiency of HPV serology testing in vaccine trials. The aim is to accelerate the development RAS Initiative and implementation of HPV vaccines worldwide, The RAS Initiative seeks to develop therapies especially in resource-limited countries where against tumors that contain mutations in mem- cervical cancer is a public health burden. The bers of the RAS family of oncogenes. In contrast laboratory provides expertise and leadership on to outstanding progress in other areas of cancer the development, validation, and standardization therapeutics, researchers have not been able to of HPV serology assays, which measure antibody successfully develop effective treatments against responses following exposure to HPV or HPV proteins produced by RAS oncogenes. RAS genes vaccines to be used in vaccine trials (see https:// are mutated in more than 30 percent of all human frederick.cancer.gov/news/new-hpv-serology- cancers, including 95 percent of pancreatic adeno- laboratory-aims-standardize-assays-and- carcinomas, 45 percent of colorectal cancers, and 5 contribute-vaccine-implementation-and percent of lung adenocarcinomas. To address this critical challenge, Drs. Harold Varmus, the previ- Cryo-Electron Microscopy (EM) Facility ous Director, NCI, and Doug Lowy, the previous The National Cryo-Electron Microscopy (EM) Acting Director, NCI, with input from the FNLAC, Facility (NCEF) was launched in 2015 and pro- launched the national NCI RAS Initiative in 2013 vides cancer researchers access to the latest state- to explore innovative approaches of targeting mu- of-the-art cryo-EM and detector technologies for tant forms of RAS directly and treating RAS-driv- obtaining the highest resolution images of biolog- en cancers. A “Hub and Spoke” model was pro- ical structures. NCEF is a user-access facility that posed, in which the RAS Initiative would be based meets the needs of cancer researchers who are at the FNLCR, which acts as the hub, and would engaged in structural biology cryo-EM research connect with an international network of RAS and who do not have access to these instruments investigators, including academic, contract, and at their own institutions. The NCEF houses a Titan biopharmaceutical partners. RAS Initiative Hub KriosTM microscope, which is fitted with a Falcon areas include Structural Biology and Biochemistry, II direct detector and a K2 Summit direct detector RAS Assays, Biology of Mutant KRAS Cell Lines, at the end of a Gatan imaging filter. Specialists in Pathway Analysis, Cell Surface Analysis, and RAS cryo-EM data collection and microscope operation Reference Reagents. Currently, the RAS Initiative staff the FNLCR NCEF facility and provide exter- is fully implemented with more than 70 FNLCR nal users with data for their research. The aim of
NCI FNLAC Orientation Book 35 the NCEF is to produce high resolution cryo-EM ● Genomic Data Commons: The FNLCR sup- images for scientists who have high quality speci- ports Cancer Moonshot through the Genomic mens ready for high resolution imaging. A FNLAC Data Commons, a data sharing platform NCEF Oversight Committee and NCEF Working designed to give researchers the capability to Group provide advice to the NCI on operational share genomic and clinical data from cancer aspects of the facility. Access to the facilities was research programs to promote precision made available in 2017 to prospective users whose medicine in oncology (see https://gdc.cancer. work is relevant to cancer research. Information on gov/about-gdc). how to submit projects to the NCEF and get access to the latest technology for high resolution imag- ● Making Cancer Research More ing can be obtained at https://www.cancer.gov/ Accessible: The FNLCR helps make it easier for patients and oncologists to access infor- research/resources/cryoem). mation from clinical research trials through Beau Biden Cancer Moonshot a partnership between the NCI and White Announced in 2016 by then Vice President Joe House Presidential Innovation Fellows (see Biden, the Beau Biden Cancer MoonshotSM to https://presidentialinnovationfellows.gov/) accelerate cancer research aims to make more Accelerating Therapeutics for Opportunities in therapies available to more patients, while also Medicine (ATOM) improving the ability to prevent and detect cancer at an early stage. Congress passed the 21st Centu- The FNLCR is a founding member of the Acceler- ry Cures Act in December 2016 authorizing $1.8 ating Therapeutics for Opportunities in Medi- billion in funding for the Cancer Moonshot over cine (ATOM) Consortium, a public- 7 years. An additional $300 million was appropri- private cCRADA partnership with the mission ated in FY2017 to fund Moonshot initiatives. of transforming drug discovery by accelerating the development of more effective therapies for The FNLCR supports four Cancer Moonshot patients. The ATOM Consortium was officially projects: established in October 2017. Founding members are GlaxoSmithKline (GSK), Lawrence Livermore ● High-performance Computing/DOE National Laboratory (LLNL), FNLCR, and the Partnership: The FNLCR plays a significant University of California, San Francisco (UCSF). role in a national partnership to expand the Scientists aim to create a new pre-competitive plat- use of high-performance computing in cancer form for drug discovery that integrates high-per- research. Through work with the NCI and formance computing, diverse biological data sets, the Department of Energy (DOE), the FNLCR and emerging biotechnologies. This new platform is developing a promising strategy for using will ultimately be offered as a shared national re- exascale computing capabilities together with source to accelerate drug discovery, transforming urgent scientific applications. the process from a slow, sequential, and high-fail- ● Precision Medicine Clinical Trial: The ure undertaking into a rapid, integrated, and pa- FNLCR supports key components of an tient-centric model. The goal is to move validated ambitious nationwide precision medicine oncolytic targets to patient-ready therapeutics in clinical trial (NCI-MATCH) that matches less than 1 year, a process that currently takes an cancer patients to potential therapies based average of 6 years (see https://frederick.cancer.gov/ on the genetic makeup of their tumors, rather science/ATOM). than tumor location in the body (see https:// www.cancer.gov/about-cancer/treatment/ clinical-trials/nci-supported/nci-match).
36 NCI FNLAC Orientation Book NCI ADVISORY BOARDS, COMMITTEES, AND REVIEW GROUPS
The NCI relies on advisory boards, committees, NCI-supported extramural science. The BSA, and review groups to provide objective and expert composed of distinguished scientists from outside advice on the coordination of the National Cancer the NCI and representatives from the advocacy Program (NCP), NCI scientific priorities, devel- community, advises the NCI leadership on the opment of major extramural program initiatives, progress and future direction of the Institute’s future directions of NCI intramural, extramural, Extramural Research Program. The BSA evaluates and clinical trials programs, and the FNLCR. NCI extramural programs and policies, and it These advisory committees are established under reviews concepts for new research opportunities the Federal Advisory Committee Act (FACA) of and solicitations to ensure that those concepts are 1972. meritorious and consistent with the Institute’s mission (See Appendix C). The NIH Office of Federal Advisory Committee Policy (OFACP) develops policies and provides Boards of Scientific Counselors (BSCs) for guidance and resources to the public advisory Basic Sciences, and Clinical Sciences and committee members, Congress, the President, and Epidemiology. The two BSCs, managed through those managing Federal advisory groups at the the OD, NCI, advise the NCI leadership on the NIH, HHS, and other Federal agencies. The NCI progress and future direction of NCI’s Intramural DEA works closely with the OFACP in establish- Research Program (IRP) residing in the Center for ing advisory boards and committees and in the Cancer Research (CCR) and the Division of Cancer appointment of members. The membership and Epidemiology and Genetics (DCEG). The two activities of these advisory bodies are coordinated BSCs, composed of scientific experts from outside by the NCI Division of Extramural Activities. the NCI, evaluate the performance and productiv- ity of NCI Intramural Principal Investigators (PIs) Presidentially Appointed Panel and and Staff Scientists through periodic site visits to Board the intramural laboratories and provide evaluation and advice on the course of research for each President’s Cancer Panel (PCP). The PCP consists Laboratory and Branch (See Appendices D and E). of three members appointed by the President, who by virtue of their training, experience, Clinical Trials and Translational Research and background, are exceptionally qualified to Advisory Committee (CTAC). The CTAC advises appraise the NCP. At least two members of the and makes recommendations to the NCI Director, Panel are distinguished scientists or physicians, NCI Deputy Directors, and the NCI DOC Directors and the third member is a nationally recognized on the NCI-supported national clinical trials cancer research advocate. The Panel monitors the enterprise to build a strong scientific infrastructure development and execution of the activities of the by bringing together a broadly developed and NCP and reports directly to the President. Any engaged coalition of stakeholders involved in the delays or hindrances in the rapid execution of the clinical trials process. In addition, CTAC makes Program are immediately brought to the attention recommendations regarding the effectiveness of of the President (See Appendix A). NCI’s translational research management and administration program, including needs and National Cancer Advisory Board (NCAB). NCI’s opportunities across disease sites, patient popula- principal advisory body is the presidentially tions, translational developmental pathways, and appointed NCAB. The NCAB advises the HHS the range of molecular mechanisms responsible for Secretary and the NCI Director on issues related cancer development. CTAC also will advise on the to the entire NCP and provides a second level of appropriate magnitude for dedicated translational review for grant applications referred to the NCI research priorities and recommend allocation of and for the FDA (See Appendix B). translational research operations across organiza- tional units, programs, disease sites, populations, Program Advisory Boards and developmental pathways, and molecular mecha- Committees nisms. This responsibility encompasses oversight of all clinical trials, both extramural and intramu- Board of Scientific Advisors (BSA). The BSA ral. The Committee provides broad scientific and represents the scientific community’s voice in programmatic advice on the investment of taxpay-
NCI FNLAC Orientation Book 37 er dollars in clinical trials and related science (See in the areas of cancer causation, diagnosis, Appendix F). treatment, and prevention. There are currently four NCI IRGs: Cancer Centers (Subcommittee Frederick National Laboratory Advisory A); Institutional Training and Education Committee (FNLAC). The FNLAC provides (Subcommittee F); Transition to Independence advice and makes recommendations to the (Subcommittee I); and Career Development Director, NCI, and the Associate Director, (Subcommittee J) Frederick National Laboratory for Cancer Research (FNLCR), on the optimal use of the NCI Special Emphasis Panels (SEPs). The SEPs Laboratory to rapidly meet the most urgent provide concept review of proposed contract needs of the Institute. The NCI facility in or grant solicitations and review grant and Frederick, Maryland, was established in 1972 as a cooperative agreement applications and contract Government-owned Contractor-operated facility. proposals for research projects and for research In 1975, the facility was designated as a Federally and training activities in the broad areas of Funded Research and Development Center basic and clinical cancer sciences, clinical trials (FFRDC) to provide a unique national resource prioritization evaluation, and applied research for the development of new technologies and the and development programs of special relevance translation of basic science discoveries into novel to the NCI. The preclinical and clinical discovery agents for the prevention, diagnosis, and treat- and development program Panels, managed by ment of cancer and AIDS. The FFRDC has been the Division of Cancer Treatment and Diagnosis renamed as the FNLCR. The FNLAC reviews new (DCTD), also evaluate proposals for support to projects proposed to be performed at the FNLCR make available to the research community, on and advises the Director, NCI, and the Associate a competitive basis, contract resources for the Director, FNLCR, about the intrinsic merit of the preclinical development of drugs, biologics, projects and about whether they should be done at clinical assays, and other developmental programs the Frederick facility (See Appendix G). that would ultimately benefit the advancement of clinical studies. Furthermore, the Panel will pro- NCI Council of Research Advocates (NCRA). vide input to the NCI on scientific prioritization The NCRA, previously known as the Director’s of NCI Clinical Trials Network (NCTN) concepts Consumer Liaison Group (DCLG), advises the across diseases guided by a set of criteria when NCI Director with respect to promoting research there are insufficient resources to support trials for outcomes that are in the best interest of cancer all NCTN Scientific Steering Committee approved patients. To this end, the NCRA conducts these concepts. activities with the intent to identify new approach- es, promote innovation, recognize unforeseen risks NCI Leadership or barriers, and identify unintended consequences that could result from NCI decisions or actions. NCI Scientific Program Leadership (SPL). The Additionally, the NCRA will provide insight SPL, which includes the NCI Director, Deputy into enhancing input, optimizing outreach, and Directors, Division Directors, and other senior promoting strong collaborations, all with respect scientific staff, meets on a regular basis to discuss to non-scientist stakeholders (See Appendix H). various matters of NCI policy, including but not limited to review and approval of Request for NCI Review Groups and Panels Application (RFA) and research and development contract concepts before review by the BSA; NCI Initial Review Groups (IRGs). The IRGs review of program announcements; develop- advise and make recommendations on the ment of funding plans; and grant payment by scientific and technical merit of applications exceptions. NCI’s cancer research activities are for grants-in-aid for research, research train- monitored and administrated through several ing, research-related grants and cooperative extramural and intramural divisions, centers, and agreements, and contract proposals for projects offices (SeeAppendix I).
38 NCI FNLAC Orientation Book FREDERICK NATIONAL LABORATORY ADVISORY COMMITTEE (FNLAC)
Background Membership and Designation
In 1971, President Richard Nixon signed the The FNLAC will consist of up to 16 members, National Cancer Act converting Fort Detrick, including the Chair (see Appendix G), appointed Frederick, Maryland from a biological warfare by the Director, NCI. Members will be authorities facility to a national cancer research center. knowledgeable in cancer research, drug and The act expanded Federal funding for cancer vaccine development, clinical trials support, AIDS research and created the National Cancer Institute research, bioinformatics, genomics, nanotechnol- (NCI) in Frederick (NCI-Frederick), part of the ogy, biological repositories, and basic research in National Institutes of Health (NIH) within the immunology and infectious diseases. Additionally, U.S. Department of Health and Human Services a nonvoting representative from the NCAB, the (HHS). In 1972, the Frederick Cancer Research NCI Board of Scientific Advisors, and the NCI Center (FCRC) was established and administra- Board of Scientific Counselors (Basic Sciences and tively reorganized and renamed the Frederick Clinical Sciences and Epidemiology) will serve on Cancer Research Facility (FCRF) in 1981, which the committee and are limited to the duration of was subsequently renamed the NCI-Frederick their terms on their respective Boards. Ex officio Cancer Research and Development Center members will include NCI Deputy Directors; (FCRDC) in 1990. In 2010, an ad hoc National select NCI Division Directors; and the Associate Cancer Advisory Board (NCAB) Working Group Director, FNLCR. All non-Federal members serve was convened to create a Strategic Scientific Vision as Special Government Employees. Members and for the National Cancer Program (NCP) and to the Chair will be invited to serve overlapping review progress of the NCI. The Working Group 4-year terms. A quorum for the conduct of findings were presented at the December 7, 2010 business by the full Committee will consist of NCAB meeting and the Board unanimously a majority of currently appointed members. A approved the establishment of the chartered member may serve after the expiration of that NCI-Frederick Advisory Committee (NFAC) to member’s term until a successor has taken office. advise and evaluate ongoing activities at the NCI- Frederick facility. The first NFAC meeting was Description of Duties held on January 25, 2012, in Frederick, Maryland, at which time consensus was reached to change FNLAC members will review the state of research the name from NCI-FCRDC to Frederick National (extramural and intramural) at FNLCR and make Laboratory for Cancer Research (FNLCR). At the recommendations for the best use of the FNLCR September 30, 2014 NFAC meeting, committee capabilities and infrastructure. Specifically, members discussed the name discrepancy between the Committee will review major new projects the NFAC and the FNLCR and voted unanimously proposed to be performed at FNLCR and advise to rename NFAC as the Frederick National the Director, NCI, and Associate Director, NCI- Laboratory Advisory Committee (FNLAC). Frederick, with respect to the intrinsic merit of the projects and whether they should be done at the FNLCR. In addition, the Committee will period- FNLAC CHARTER ically review the existing portfolio of projects at FNLCR, evaluate their productivity, help deter- FNLAC Legislative Authority mine which of these projects should be conducted at FNLCR or transitioned to more conventional Authorized by 42 U.S.C. 285a-2(b)(7), section mechanisms of support (i.e., grants, contracts, 413(b)(7) of the Public Health Service Act, as cooperative agreements), and which should be amended. The FNLAC (Committee) to the NCI considered for termination. The Committee will is governed by the provisions of the Federal help to ensure that the operations at FNLCR are Advisory Committee Act (FACA), as amended open, transparent, and in the best interests of the (5 U.S.C. app.), which sets forth standards for the entire cancer research community. formation and use of advisory committees. Contractor-initiated research at the FNLCR will be monitored and evaluated periodically within the span of a contract period. The Committee will con-
NCI FNLAC Orientation Book 39 sider proposed research and provide advice as to follow defined Standards of Ethical Conduct for whether the FNLCR is the best venue for conduct- Employees of the Executive Branch. ing these projects, which it deems to be of merit and to be consistent with the mission of the NCI The Office of Government Ethics (OGE) has issued and FNLCR. The Committee will submit a written the following conflict of interest guidelines for description of the research and its recommen- multi-campus institutions and private institutions dations to the Director, NCI; Deputy Directors, and affiliates: NCI; and the Associate Director, FNLCR. The advisory role of the Committee is scientific and ● Policy for State Multi-Campus Institutions: does not include deliberation of matters of public The OGE has provided a regulatory waiver policy. No individual who is affiliated with the under 5 CFR 2640.203(c) for SGE Federal Contractor organization involved in management advisory committee members employed in of the FNLCR will serve on this Committee. one university of a state multi-university system to review applications from a separate As needed, and with the approval of the FNLAC university of the same system, provided the Executive Secretary, the Committee may call upon member has no conflicting multi-institutional special consultants, assemble ad hoc working duties and responsibilities that affect the entire groups, appoint subcommittees, and convene educational system. workshops and conferences to assist in the func- tioning of the FNLAC. ● Policy for Private Institutions and Affiliates: In addition, an SGE member of an advisory FNLAC Meetings committee who is employed by a private institution may participate in the review of Meetings of the full FNLAC will be held approx- a grant application submitted by an affiliate imately three (3) times within each fiscal year. of the private institution if the SGE: does not Meetings will be open to the public except as hold a joint appointment with that affiliate, determined otherwise by the Secretary of Health does not have affiliate-wide responsibilities, and Human Services (Secretary) in accordance and has a waiver to do so. with subsection (c) of section 552b of Title 5 U.S.C. Notice of all meetings will be given to the public. At each FNLAC meeting, FNLAC members sign a In the event that a portion of a meeting is closed statement certifying that they did not participate to the public, as determined by the Secretary, in in the discussion of or vote on any application accordance with the Government in the Sunshine from their own institution or an institution in Act (5 U.S.C. 552b(c)) and within FACA regula- which they have a financial interest. tions, a report will be prepared that will contain, as a minimum, a list of members and their Detailed ethics rules that govern the conduct of business addresses, the Committee’s functions, SGEs are provided in Appendix J. dates and places of meetings, and a summary of the Committee’s activities and recommendations Additional information related to past and future made during the fiscal year. A copy of the report FNLAC meetings, including meeting dates, will be filed annually and will be provided to agendas, minutes, and presentations, can be found the Department Committee Management Officer at https://deainfo.nci.nih.gov/advisory/fac/fac.htm. (CMO). FNLAC Subcommittees and Working Conflict of Interest and Ethics Rules for Groups FNLAC Members To expedite the FNLAC’s work, ad hoc subcom- Regular members of the FNLAC are Special mittees and working groups, composed of FNLAC Government Employees (SGE). By definition, an and non-FNLAC members, can be established to SGE is an officer or employee in the Executive provide additional advice and oversight on specif- Branch of the Federal Government who is ic topics or initiatives. Subcommittee meetings are appointed to perform temporary duties, with or open to the public and announced in the Federal without compensation, for a period not to exceed Register. The current subcommittees are: 130 days during any period of 365 consecutive RAS Oversight Subcommittee days. During the term of their appointments, SGEs must be aware of relevant statutes regarding The RAS Oversight subcommittee provides criminal conflicts of interest, and you must oversight to FNLAC, the Associate Director,
40 NCI FNLAC Orientation Book FNLCR, and the Director, NCI, on the research The evaluations will include the scientific goals, and development of the RAS Initiative. direction, priorities, and timelines of the RAS research projects at the FNLCR hub. A major There is a high incidence of RAS mutations goal of the program is to mobilize the cancer in cancer, but currently there are no drugs or research community to collaboratively undertake therapies available that target mutant RAS the mission of developing therapeutic strategies directly or indirectly. Despite past failures, the towards the KRAS oncogene. The evaluation will NCI believes that new developments in structural biology, chemistry, signaling, systems biology, therefore, also include the means in which the RAS gene-based screening methods, immunology, and Program engages the extramural community and nanotechnology support the idea of a reactivated industry such as through collaboration, input on effort to make progress, especially in view of the funding opportunities, and sharing ideas, data, and substantial number of cancers that might be better reagents. The findings of this Working Group will controlled if the effects of mutant RAS could be be invaluable for assessing the progress on this countered. The RAS Oversight Subcommittee, “national mission” as well as provide insight for the which is composed of current FNLAC members development of new national missions. and participants from academia and industry with appropriate expertise, will provide oversight of Ad Hoc National Cryo-EM Facility Oversight the RAS Initiative. Working Group The purpose of the Ad Hoc National Cryo-EM National Cryo-Electron Microscopy (EM) Facility Oversight Subcommittee Facility Oversight Working Group is to provide the highest quality oversight to the technical aspects The National Cryo-EM Facility (NCEF) Oversight of the NCEF and to provide findings and recom- subcommittee provides oversight to the FNLAC, mendations to the FNLAC and the ad hoc Cryo-EM Associate Director, FNLCR, and the Director, NCI, Oversight Subcommittee. on the operation of the NCEF, which is hosted by the FNLCR.The NCEF subcommittee will The NCEF is designed to support high-resolution evaluate the goals, scientific priorities and scope, structural analysis by utilizing the latest in Cryo-EM technical and operational aspects, and equipment technologies. A major initial goal of the NCEF is to and staffing needs of the NCEF in support of the provide users who can demonstrate that they have cryo-EM community. The FNLCR facility houses specimens ready for high-quality data collection the latest in cryo-EM technologies, and is designed with rapid access to Cryo-EM infrastructure. The to support high-resolution structural analysis by Working Group will evaluate the goals, scientific cryo-EM. A major initial goal of the NCEF is to priorities and scope, technical and operational provide users who can demonstrate that they have aspects, and equipment and staffing needs of the specimens ready for high-quality data collection NCEF in support of the Cryo-EM community. The with rapid access to cryo-EM technology. The Working Group also will assess the progress of the subcommittee will evaluate the progress of the NCEF and oversee potential expansions based on NCEF and oversee potential expansions of staff demand. The findings of this Working Group will and equipment based on demand. The findings of be invaluable for assessing the effectiveness of the this subcommittee will be invaluable for assessing operations at the NCEF, and in gauging the future the effectiveness of the NCEF, and in gauging the need for cryo-EM facilities in the extramural need for Cryo-EM and related technologies and community. services that support the extramural community.
Three ad hoc Working Groups, a RAS, an NCEF, Ad Hoc NCI/DOE Collaborations Working Group and an NCI/DOE Collaborations Working Group, The purpose of the Ad Hoc NCI/DOE also exist to provide in-depth analysis and recom- Collaborations Working Group is to provide mendations to their respective subcommittees, the scientific evaluation of programs, projects, and full FNLAC, and the Director, NCI. collaborations formed in support of or relevant to NCI/Department of Energy (DOE) collaborations. Ad Hoc RAS Working Group The Working Group is charged with exploring The purpose of the Ad Hoc RAS Working Group is the domains and activities in which collaborations to provide the highest quality oversight to the tech- between the NCI and DOE would be mutually ben- nical aspects of the RAS Program and to provide eficial and advance the missions of these entities. findings and recommendations to the FNLAC and Activities will include technical evaluation of the the ad hoc RAS Subcommittee. Joint Design of Advanced Computing Solutions
NCI FNLAC Orientation Book 41 for Cancer (JDACS4C) pilot projects, guidance biology and data science, and (3) the acceleration of on relevant partnerships with other entities, and predictive modeling for cancer. expanding the benefits of the partnership to the broader scientific community. The Working Group The Working Group will advise the FNLAC and will serve to optimize the functionality and output the Director, NCI. In accordance with the NCI/DOE of the partnership and maximize impact on (1) the memorandum of understanding (MOU), the broader research community, (2) the benefits of Secretary, DOE, and DOE FACA committees may High Performance Computing (HPC) to systems use the public products and public findings in furthering the DOE mission.
42 NCI FNLAC Orientation Book APPENDIX A PRESIDENT’S CANCER PANEL
Chair
John P. Williams, M.D., F.A.C.S. (2021)* Breast Cancer Surgeon Medical Director Breast Cancer School for Patients Clinical Professor Institute for Biohealth Innovation George Mason University Gainesville, VA
Members
Robert A. Ingram (2022)* General Partner Hatteras Venture Partners Durham, NC
Edith P. Mitchell, M.D., F.A.C.P., F.C.P.P. (2020)* Clinical Professor of Medicine and Medical Oncology Department of Medical Oncology Director, Center to Eliminate Cancer Disparities Associate Director, Diversity Affairs Sidney Kimmel Cancer Center Thomas Jefferson University Philadelphia, PA
Executive Secretary
Maureen R. Johnson, Ph.D. Special Assistant to the Director Office of the Director National Cancer Institute National Institutes of Health Bethesda, MD
______* Pending.
NCI FNLAC Orientation Book 43 APPENDIX B NATIONAL CANCER ADVISORY BOARD
Chair
Elizabeth M. Jaffee, M.D. 2018 Deputy Director The Sidney Kimmel Comprehensive Cancer Center The Dana and Albert “Cubby” Broccoli Professor of Oncology Co-Director, Skip Viragh Center for Pancreas Cancer Johns Hopkins University Baltimore, MD
Members David C. Christiani, M.D., M.P.H. 2018 Elkan Blout Professor of Environmental Peter C. Adamson, M.D. 2020 Genetics Chair, Children’s Oncology Group Departments of Environmental Health Alan R. Cohen Endowed Chair in Pediatrics and Environmental and Occupational The Children’s Hospital of Philadelphia Medicine and Epidemiology Philadelphia, PA Harvard School of Public Health Professor of Medicine Francis Ali-Osman, D.Sc. 2022 Harvard Medical School Margaret Harris and David Silverman Boston, MA Distinguished Professor of Neuro-Oncology Professor of Surgery Howard J. Fingert, M.D., F.A.C.P.* 2024 Professor of Pathology Consultant Duke University Medical Center Chestnut Hill, MA Durham, NC Judy E. Garber, M.D., M.P.H. 2018 Anna D. Barker, Ph.D.* 2024 Director Chief Strategy Officer Center for Cancer Genetics and Prevention Lawrence J. Ellison Institute Dana-Farber Cancer Institute for Transformative Medicine Professor of Medicine University of Southern California Harvard Medical School Beverly Hills, CA Boston, MA
Deborah Watkins Bruner, R.N., Ph.D., Lawrence O. Gostin, J.D. 2022 F.A.A.N. 2020 University Professor Robert W. Woodruff Chair of Nursing Faculty Director, Founding Linda D. Nell Hodgson Woodruff School of Nursing and Timothy J. O’Neill Professor Associate Director for Outcomes Research in Global Health Law Winship Cancer Institute O’Neill Institute for National and Global Health Emory University Georgetown University Atlanta, GA Washington, DC
Yuan Chang, M.D. 2020 Andrea A. Hayes-Jordan, M.D., F.A.C.S, 2024 American Cancer Society Research Professor F.A.A.P.* Distinguished Professor of Pathology Byah Thompson Doxey Distinguished UPCI Chair of Cancer Virology Professor of Surgery University of Pittsburgh Cancer Institute Division Chief, Pediatric Surgery Pittsburgh, PA Surgeon-in-Chief University of North Carolina Children’s Hospital ______Chapel Hill, NC * Pending.
44 NCI FNLAC Orientation Book Scott W. Hiebert, Ph.D. 2022 Charles L. Sawyers, M.D. 2018 Hortense B. Ingram Chair in Caner Research Chairman Professor of Biochemistry Human Oncology and Pathogenesis Program Department of Biochemistry Memorial Sloan-Kettering Cancer Center Vanderbilt University School of Medicine Investigator Nashville, TN Howard Hughes Medical Institute Professor of Medicine Beth Y. Karlan, M.D. 2018 Weill-Cornell Medical College Director, Women’s Cancer Program New York, NY Samuel Oschin Comprehensive Cancer Institute Director of Obstetrics and Gynecology Margaret R. Spitz, M.D. 2022 Department of Obstetrics and Gynecology Professor Cedar-Sinai Medical Center Dan L. Duncan Cancer Center Professor, Obstetrics and Gynecology Baylor College of Medicine David Geffen School of Medicine Houston, TX University of California, Los Angeles Los Angeles, CA Susan Thomas Vadaparampil, Ph.D., 2024 M.P.H.* Timothy J. Ley, M.D. 2020 Vice Chair, Health Outcomes and Behavior Professor of Medicine and Genetics Associate Center Director Division of Oncology Community Outreach, Engagement, and Equity Washington University School of Medicine Moffitt Cancer Center St. Louis, MO Tampa, FL
Electra D. Paskett, Ph.D. 2022 Max S. Wicha, M.D. 2020 Marion N. Rowley Professor of Cancer Research Deputy Director of the Taubman Institute Director, Division of Cancer Prevention Distiguished Professor of Oncology and Control Professor, Internal Medicine Department of Internal Medicine Division of Hematology and Oncology College of Medicine University of Michigan The Ohio State University Ann Arbor, MI Columbus, OH Ex Officio Members Nancy J. Raab-Traub, Ph.D. 2022 Professor Robert S. Adler, J.D. Department of Microbiology and Immunology Acting Chairman School of Medicine U.S. Consumer Product Safety Commission Lineberger Comprehensive Cancer Center Bethesda, MD The University of North Carolina at Chapel Hill Chapel Hill, NC The Honorable Alex Azar, J.D. Secretary Mack Roach III, M.D., F.A.C.R., FASTRO 2018 U.S. Department of Health and Human Services Professor of Radiation Oncology Washington, DC and Urology Chair, Department of Radiation Oncology Francis S. Collins, M.D., Ph.D. University of California, San Francisco Director Helen Diller Family Comprehensive National Institutes of Health Cancer Center Bethesda, MD San Franscisco, CA The Honorable Mark T. Esper, Ph.D. Secretary of Defense The Pentagon Washington, DC
______* Pending.
NCI FNLAC Orientation Book 45 Stephen Hahn, M.D. Michael A. Babich, Ph.D. Commissioner Directorate for Epidemiology and Health U.S. Food and Drug Administration Sciences Silver Spring, MD U.S. Consumer Product Safety Commission Bethesda, MD John Howard, M.D., M.P.H., J.D., LL.M. (Ms. Ann Marie Buerkle, J.D.–CPSC) Director National Institute for Occupational Safety and Vincent J. Cogliano, Ph.D. Health Acting Director Washington, DC Integrated Risk Information System Program National Center for Environmental Assessment The Honorable Rick Perry Office of Research and Development Secretary U.S. Environmental Protection Agency Department of Energy Washington, DC Washington, DC (Scott Pruitt, J.D.–EPA)
The Honorable Eugene Scalia, J.D. Michael Kelley, M.D., FACP Secretary National Program Director for Oncology U.S. Department of Labor Veterans’ Health Administration Washington, DC U.S. Department of Veterans Affairs Washington, DC Robert A. Stone, M.D. (Robert A. Stone, M.D.–VA) Executive in Charge Veterans Health Administration Aubrey Miller, M.D., M.P.H. U.S. Department of Veterans Affairs Senior Medical Officer Washington, DC National Institute of Environmental Health Sciences Andrew Wheeler, J.D. National Institutes of Health Acting Administrator Bethesda, MD U.S. Environmental Protection Agency (Richard Woychik, Ph.D.–NIEHS) Washington, DC Richard Pazdur, M.D., F.A.C.P. Richard Woychik, Ph.D. Director Acting Director Oncology Center of Excellence National Institute of Environmental Health U.S. Food and Drug Administration Sciences Silver Spring, MD National Toxicology Program (Stephen Hahn, M.D.–FDA) National Institutes of Health Research Triangle Park, NC Craig D. Shriver, M.D., F.A.C.S., COL., M.C. Director, John P. Murtha Cancer Center TBN Chief, General Surgery Science Advisor to the President Program Director, National Capital Consortium Director General Surgery Office of Science and Technology Policy Principal Investigator, Clinical Breast Care Project Executive Office of the President Professor of Surgery, Uniformed Services Washington, DC University Bethesda, MD Alternates to Ex Officio Members (The Honorable Mark T. Esper, Ph.D.–DOD)
Robert T. Anderson, Ph.D. Kerry Souza, Sc.D., M.P.H. Director, Biological Systems Science Division Epidemiologist Office of Biological and Environmental National Institute for Occupational Safety Research and Health Department of Energy Washington, DC Washington, DC (John Howard, M.D., M.P.H., J.D., LL.M. (The Honorable Rick Perry–DOE) NIOSH)
46 NCI FNLAC Orientation Book Lawrence A. Tabak, D.D.S., Ph.D. Executive Secretary Principal Deputy Director National Institutes of Health Paulette S. Gray, Ph.D. Bethesda, MD Director (Francis S. Collins, M.D., Ph.D.–NIH) Division of Extramural Activities National Cancer Institute, NIH Richard J. Thomas, M.D., M.P.H. Bethesda, MD Deputy Director Office of Occupational Medicine Committee Management Officer OSHA/Department of Labor Washington, DC Ms. Joy Wiszneauckas (The Honorable R. Alexander Acosta, J.D.–DOL) Division of Extramural Activities National Cancer Institute, NIH TBN Bethesda, MD Office of Science and Technology Policy Executive Office of the President Washington, DC (TBN–OSTP)
NCI FNLAC Orientation Book 47 APPENDIX C BOARD OF SCIENTIFIC ADVISORS
Chair
Dafna Bar-Sagi, Ph.D. 2021 Saul J. Farber Professor Department of Biochemistry and Molecular Pharmacology and Medicine Senior Vice President and Vice Dean for Science Chief Scientific Officer NYU Langone Medical Center New York University School of Medicine New York, NY
Members Otis W. Brawley, M.D., M.A.C.P., F.A.S.C.O., 2023 F.A.C.E. Kenneth C. Anderson, M.D., Ph.D. 2018 Bloomberg Distinguished Professor of Oncology Kraft Family Professor of Medicine and Epidemiology Harvard Medical School The Sidney Kimmel Comprehensive Cancer Center Director, Lebow Institute for Johns Hopkins University Myeloma Therapeutics Baltimore, MD Dana-Farber Cancer Institute Boston, MA Arul M. Chinnaiyan, M.D., Ph.D. 2018 S.P. Hicks Endowed Professor Ethan M. Basch, M.D., M.Sc. 2018 Professor of Pathology and Urology Professor of Medicine, Division of Oncology, Director, Pathology Microarray Center School of Medicine Director, Pathology Research Informatics Professor of Public Health Director, Cancer Bioinformatics Department of Health Policy and Management Director, Michigan Center for Gillings Global School of Public Health Translational Pathology Director, Cancer Outcomes Research Program University of Michigan Co-Leader, Cancer Prevention and Controls Ann Arbor, MI Program Lineberger Comprehensive Cancer Center Graham A. Colditz, M.D., Dr.P.H. 2019 University of North Carolina at Chapel Hill Niess-Gain Professor of Surgery Chapel Hill, NC Professor of Medicine and Associate Director, Prevention and Control Michael John Becich, M.D., Ph.D. 2021 Alvin J. Siteman Cancer Center Professor, Pathology Information Deputy Director, Institute for Public Health Sciences/Telecommunications, Barnes Jewish Hospital Clinical/Translational Chief, Division of Public Health Sciences Department of Biomedical Informatics Department of Surgery University of Pittsburgh School Medicine Washington University School of Medicine Pittsburgh, PA St. Louis, MO Melissa L. Bondy, Ph.D. 2021 Christopher M. Counter, Ph.D. 2021 Professor and Associate Director Professor and Associate Professor Department of Pediatrics Department of Pharmacology and Cancer Biology Dan L. Duncan Cancer Center Duke University School of Medicine Baylor College of Medicine Durham, NC Houston, TX
48 NCI FNLAC Orientation Book Carol E. Ferrans, Ph.D., R.N., FAAN 2020 Leslie L. Robison, Ph.D. 2022 Professor and Associate Dean for Research Chairman Director, UIC Center of Excellence in Department of Epidemiology and Cancer Control Eliminating Health Disparities St. Jude Children’s Research Hospital Department of Biobehavioral Health Sciences Associate Director College of Nursing St. Jude Comprehensive Cancer Center University of Illinois at Chicago Memphis, TN Chicago, IL Martine F. Roussel (Sherr), Ph.D. 2020 Keith T. Flaherty, M.D. 2023 St. Jude Children’s Research’s Endowed Director, Clinical Research Chair in Molecular Oncogenesis Massachusetts General Hospital Cancer Center Full Professor, Department of Molecular Boston, MA Sciences The University of Tennessee Karen E. Knudsen, Ph.D. 2023 Full Member Executive Vice President Department of Tumor Cell Biology Oncology Services, Jefferson Health Enterprise St. Jude Children’s Research Hospital Director, NCI-Designated Sidney Kimmel Memphis, TN Cancer Center at Jefferson Chair & Hilary Koprowski Endowed Professor Robert D. Schreiber, Ph.D. 2021 Department of Cancer Biology Alumni Endowed Professor of Pathology Thomas Jefferson University and Immunology Philadelphia, PA Professor of Molecular Microbiology Director, Washington University Center for James V. Lacey, Jr., Ph.D., M.P.H. 2020 Human Immunology and Immunotherapy Director and Associate Professor Programs Division of Cancer Etiology Program Co-Leader, Tumor Immunology Department of Population Sciences Siteman Comprehensive Cancer Center Beckman Research Institute Washington University School of Medicine City of Hope St. Louis, MO Duarte, CA Victoria L. Seewaldt, M.D. 2020 Michelle M. Le Beau, Ph.D. 2023 Ruth Ziegler Professor Arthur and Marian Edelstein Professor Chair, Department of Population Sciences of Medicine Beckman Research Institute Director, University of Chicago Comprehensive City of Hope Cancer Center Duarte, CA The University of Chicago Chicago, IL Kevin M. Shannon, M.D. 2020 Roma and Marvin Auerback Distinguished Sylvia Katina Plevritis, Ph.D. 2021 Professor in Molecular Oncology Professor American Cancer Society Research Professor Department of Radiology Department of Pediatrics Department of Biomedical Data Science University of California, San Francisco Stanford University School of Medicine San Francisco, CA Stanford, CA David Sidransky, M.D. 2022 W. Kimryn Rathmell, M.D., Ph.D. 2023 Director Cornelius A. Craig Professor Head and Neck Cancer Research Department of Medicine Professor of Otolaryngology–Head Director, Division of Hematology and Oncology and Neck Surgery Vanderbilt University Medical Center Department of Otolaryngology–Head Nashville, TN and Neck Surgery Johns Hopkins University School of Medicine Baltimore, MD
NCI FNLAC Orientation Book 49 Mary L. Smith, J.D., M.B.A. 2018 Eileen P. White, Ph.D. 2019 Co-Founder Distinguished Professor Research Advocacy Network Department of Molecular Biology Naperville, IL and Biochemistry Associate Director for Basic Science Ian M. Thompson, Jr., M.D. 2021 Rutgers Cancer Institute of New Jersey President New Brunswick, NJ CHRISTUS Santa Rosa Medical Center Hospital Cheryl L. Willman, M.D. 2021 Texas Urology Group The Maurice and Marguerite Liberman San Antonio, TX Distinguished Chair in Cancer Research Director and CEO, University of New Mexico David A. Tuveson, Ph.D., M.D. 2021 Comprehensive Cancer Center Professor and Deputy Director University of New Mexico Cancer Center Albuquerque, NM Cold Spring Harbor Laboratory Cold Spring Harbor, NY Executive Secretary
Robert H. Vonderheide, M.D. 2022 Paulette S. Gray, Ph.D. John H. Glick MD Abramson Cancer Center’s Director Professor Division of Extramural Activities Professor of Medicine National Cancer Institute Perelman School of Medicine National Institutes of Health Director, Abramson Cancer Center Bethesda, MD University of Pennsylvania Philadelphia, PA
Cheryl L. Walker, Ph.D., A.T.S., FAAAS 2018 Professor and Director Institute of Biosciences and Technology Center for Translational Cancer Research Welch Chair in Chemistry Texas A&M Health Science Center Houston, TX
50 NCI FNLAC Orientation Book APPENDIX D BOARD OF SCIENTIFIC COUNSELORS Basic Sciences Chair
Martin McMahon, Ph.D. 2021 Cumming-Presidential Professor of Cancer Biology Department of Dermatology Senior Director for Preclinical Translation Huntsman Cancer Institute University of Utah Salt Lake City, UT
Members M. Luisa Iruela-Arispe, Ph.D. 2021 Professor and Vice-Chair Hashim M. Al-Hashimi, Ph.D. 2020 Department of Molecular, Cell, and James B. Duke Professor of Biochemistry Developmental Biology Director, Duke Center for RNA Biology Director, Molecular Biology Institute Professor, Department of Biochemistry and University of California, Los Angeles Chemistry Los Angeles, CA Duke University Medical Center Stephen C. Jameson, Ph.D. 2021 Durham, NC Professor Department of Laboratory Medicine Peter Cresswell, Ph.D., FRS 2020 and Pathology Investigator, Howard Hughes Medical Institute Eugene Higgins Professor Center for Immunology Department of Immunobiology University of Minnesota Medical Yale University School of Medicine School New Haven, CT Minneapolis, MN Sue Jinks-Robertson, Ph.D. 2020 Denise A. Galloway, Ph.D. 2020 Professor Associate Director Department of Molecular Genetics and Human Biology Division Microbiology Fred Hutchinson Cancer Research Center Duke University Medical Center Research Professor Durham, NC Department of Microbiology University of Washington Tracy L. Johnson., Ph.D. 2022 Seattle, WA Maria Rowera Ross Chair of Cell Biology Angela M. Gronenborn, Ph.D. 2020 and Biochemistry UPMC Rosalind Franklin Professor and Chair Professor Department of Structural Biology Department of Molecular, Cell, and Professor, Department of Bioengineering Developmental Biology Swanson School of Engineering Associate Dean for Inclusive Excellence Director, Pittsburgh Center for HIV Protein Division of Life Sciences Interactions University of California, Los Angeles University of Pittsburgh Los Angeles, CA Pittsburgh, PA
NCI FNLAC Orientation Book 51 Jonathan Karn, Ph.D. 2019 Mary Ann Osley, Ph.D. 2023 Reinberger Professor of Molecular Biology The Victor and Ruby Hanson Surface and Microbiology Professor in Cancer Epigenetics Director, CWRU/UH Center for AIDS Department of Molecular Genetics Research School of Medicine and Microbiology Case Western University The University of New Mexico Cleveland, OH Co-Director, Cancer Genetics, Epigenetics, and Genomics Program Mitchell Kronenberg, Ph.D. 2023 The University of New Mexico Cancer Center President and Chief Scientific Officer Albuquerque, NM La Jolla Institute for Allergy and Immunology San Diego, CA M. Celeste Simon, Ph.D. 2021 Professor, Department of Cell and Kit S. Lam, M.D., Ph.D. 2021 Developmental Biology Professor and Chair Scientific Director Department of Biochemistry and Molecular The Abramson Family Cancer Research Medicine Institute Perelman School of Medicine Professor, Division of Hematology and Oncology University of Pennsylvania UC Davis Comprehensive Cancer Center Philadelphia, PA University of California, Davis Sacramento, CA Erik J. Sontheimer, Ph.D. 2023 Professor Paul F. Lambert, Ph.D. 2022 RNA Therapeutics Institute Howard M. Temin Professor University of Massachusetts Medical School Chair Worcester, MA Department of Oncology Director Paul W. Spearman, M.D. 2020 McArdle Laboratory for Cancer Research Professor, Division Director and Vice Chair University of Wisconsin School of Medicine for Research and Public Health Department of Pediatrics Madison, WI Division of Infectious Diseases Emory University School of Medicine Anna K. Mapp, Ph.D. 2022 Atlanta, GA Edwin Vedejs Collegiate Professor of Chemistry Research Professor David W. Threadagill, Ph.D. 2021 Director, Cancer Biology Program University Distinguished Professor Life Sciences Institute University of Veterinary Pathobiology University of Michigan Department of Molecular and Cellular Ann Arbor, MI Medicine Texas A&M University Health Science Denise J. Montell, Ph.D. 2023 Center College Station, TX Robert and Patricia Duggan Professor Department of Molecular, Cellular, and JoAnn Trejo, Ph.D. 2023 Developmental Biology Professor and Vice Chair of Pharmacology University of California, Santa Barbara Associate Dean for Health Sciences Santa Barbara, CA Faculty Affairs Department of Pharmacology Alexandra C. Newton, Ph.D. 2021 School of Medicine Professor of Pharmacology University of California, San Diego Co-Director, Molecular Pharmacology Track La Jolla, CA University of California, San Diego La Jolla, CA
52 NCI FNLAC Orientation Book David L. Wiest, Ph.D. 2021 Executive Secretary Professor Immune Cell Development and Host Mehrdad Tondravi, Ph.D. Defense Program Chief Blood Cell Development and Cancer Institute Review Office Keystone Office of the Director Fox Chase Cancer Center National Cancer Institute, NIH Philadelphia, PA Bethesda, MD
NCI FNLAC Orientation Book 53 APPENDIX E BOARD OF SCIENTIFIC COUNSELORS Clinical Sciences and Epidemiology
Chair
Raymond N. Dubois, Jr., M.D., Ph.D. 2021 Dean, College of Medicine Professor, Departments of Biochemistry and Medicine Medical University of South Carolina Charleston, SC
Members Nancy E. Davidson, M.D. 2023 Senior Vice President and Full Member Lynne V. Abruzzo, M.D., Ph.D. 2023 Clinical Research Division Professor Fred Hutchinson Cancer Research Center Department of Pathology President and Executive Director Division of Cytogenetics Seattle Cancer Care Alliance The Ohio State University Wexner Medical Center Head, Division of Medical Oncology Columbus, OH Department of Medicine University of Washington Rebecca A. Betensky, Ph.D. 2021 Seattle, WA Director, Biostatistics Program Professor, Department of Biostatistics Faith G. Davis, Ph.D. 2022 Harvard T. H. Chan School of Public Health Professor and Vice Dean Boston, MA School of Public Health University of Alberta Julie E. Buring, Sc.D. 2019 Edmonton, Alberta, Canada Professor of Medicine Harvard Medical School Mary L. Disis, M.D. 2022 Division of Preventive Medicine Director, Institute for Translational Health Brigham and Women’s Hospital Sciences Boston, MA Director, University of Washington Vaccine Institute John D. Carpten, Ph.D. 2021 Professor, Division of Oncology Professor and Chair Department of Medicine Department of Translational Genomics University of Washington Director, Institute of Translational Genomics Member, Clinical Research Division Keck School of Medicine Fred Hutchinson Cancer Research Center University of Southern California Seattle, WA Los Angeles, CA Gary D. Hammer, M.D., Ph.D. 2020 Arnab Chakravarti, M.D. 2022 Millie Schembechler Professor of Adrenal Professor and Chair, Department of Radiation Cancer Oncology Director, Endocrine Oncology Program Max Morehouse Chair of Cancer Research Director, Center for Organogenesis Director, Brain Tumor Program The University of Michigan The Ohio State University Comprehensive Ann Arbor, MI Cancer Center Richard L. Solove Research Institute Arthur G. James Cancer Hospital Columbus, OH
54 NCI FNLAC Orientation Book Eric A. Klein, M.D. 2023 Virgil H. Simons 2023 Andrew C. Novick Distinguished Professor Founder and President and Chair The Prostate Net, Inc. Glickman Urological and Kidney Institute Sanford, NC Cleveland Clinic Foundation Professor of Surgery Vernon K. Sondak, M.D. 2021 Cleveland Clinic Lerner College of Medicine Chair Cleveland, OH Department of Cutaneous Oncology Director of Surgical Education Steven K. Libutti, M.D. 2023 H. Lee Moffitt Cancer Center & Research Director, Rutgers Cancer Institute of New Jersey Institute Vice Chancellor for Cancer Programs Tampa, FL Rutgers Biomedical and Health Sciences Rutgers, The State University of New Jersey Ren Sun, Ph.D. 2020 New Brunswick, NJ Professor Department of Molecular and Medical Patricia M. Lorusso, D.O. 2020 Pharmacology Associate Director David Geffen School of Medicine Innovative Medicine at Yale Cancer Center Professor, Department of Bioengineering Professor, Department of Medicine University of California, Los Angeles Smilow Cancer Hospital at Yale-New Haven Los Angeles, CA Yale University New Haven, CT Mary Beth Terry, Ph.D. 2023 Professor Duane A. Mitchell, M.D., Ph.D. 2022 Department of Epidemiology Director, University of Florida Brain Tumor Mailman School of Public Health Immunotherapy Program Columbia University Associate Chair of Research New York, NY Phyllis Kottler Friedman Professor Department of Neurosurgery Gail E. Tomlinson, M.D., Ph.D. 2021 University of Florida Professor of Pediatrics Gainesville, FL Greehey Distinguished Chair in Genetics and Cancer Roman Perez-Soler, M.D. 2020 Division Chief, Pediatric Hematology- Professor and Chairman Oncology Department of Oncology University of Texas Health Science Center Montefiore Medical Center at San Antonio Deputy Director, Albert Einstein Cancer Center San Antonio, TX Director, Division of Medical Oncology Albert Einstein College of Medicine Sally W. Vernon, Ph.D. 2020 Bronx, NY Chair Department of Health Promotion and Joan H. Schiller, M.D. 2020 Behavioral Sciences Deputy Director for Clinical Investigation Center for Health Promotion and Prevention Invo Schar Cancer Institute Research Falls Church, VA Blair Justice, Ph.D. Professorship in Mind-Body Medicine and Public Health Stephen M. Schwartz, Ph.D., M.P.H. 2020 The University of Texas School of Member, Program in Epidemiology Public Health Division of Public Health Sciences Houston, TX Fred Hutchinson Cancer Research Center Professor, Department of Epidemiology Executive Secretary University of Washington Seattle, WA Brian Wojcik, Ph.D. Scientific Review Officer Institute Review Office Office of the Director National Cancer Institute Bethesda, MD
NCI FNLAC Orientation Book 55 APPENDIX F CLINICAL TRIALS AND TRANSLATIONAL RESEARCH ADVISORY COMMITTEE (CTAC)
Chairperson
Patrick J. Loehrer, Sr., M.D. 2020 Director Melvin and Bren Simon Cancer Center Associate Dean for Cancer Research Indiana University School of Medicine Indianapolis, IN
Members Anne-Marie R. Langevin, M.D. 2021 Greehey Distinguished Chair in Pediatric Debra L. Barton, Ph.D., R.N., F.A.A.N. 2021 Oncology Mary Lou Willard French Professor Department of Pediatrics Hematology/ of Oncology Nursing Oncology University of Michigan School of Nursing The University of Texas Health Science Center Ann Arbor, MI at San Antonio San Antonio, TX Janet Ellen Dancey, M.D., F.R.C.P.C. 2021 Professor Lynn M. Matrisian, Ph.D., M.B.A. 2021 Department of Oncology Chief Research Officer Queen’s University Pancreatic Cancer Action Network Director, Canadian Cancer Trials Group Washington, DC Kingston, Ontario, Canada Neal J. Meropol, M.D. 2021 Nancy E. Davidson, M.D. (BSC) 2022 Vice President of Research Oncology Senior Vice President, Director, Flatiron Health and Full Member New York, NY Clinical Research Division Fred Hutchinson Cancer Research Center Augusto C. Ochoa, M.D. 2019 President and Executive Director Director Seattle Cancer Care Alliance Head Stanley S. Scott Cancer Center Division of Medical Oncology Professor Department of Medicine Department of Pediatrics University of Washington Louisiana State University Health Sciences Seattle, WA Center New Orleans, LA Timothy J. Eberlein, M.D. 2020 Bixby Professor and Chairman Roman Perez-Soler, M.D. (BSC) 2020 Department of Surgery Chairman Washington University School of Medicine Department of Oncology in St. Louis Montefiore Medical Center St. Louis, MO Deputy Director Albert Einstein Cancer Center David M. Gershenson, M.D. 2020 Director Professor of Gynecology Division of Medical Oncology Department of Gynecologic Oncology and Albert Einstein College of Medicine Reproductive Medicine Bronx, NY Division of Surgery The University of Texas M.D. Anderson Cancer Center Houston, TX
56 NCI FNLAC Orientation Book Gloria M. Petersen, Ph.D. 2020 Michael J. Kelley, M.D., FACP Professor of Epidemiology National Program Director for Oncology Department of Education Administration Veterans Health Administration Mayo Clinic College of Medicine U.S. Department of Veterans Affairs Rochester, MN Washington, DC
Steven T. Rosen, M.D., F.A.C.P. 2021 Anthony Kerlavage, Ph.D. Provost & Chief Scientific Officer Director Director Center for Biomedical Informatics and Comprehensive Cancer Center Information Technology and Beckman Research Institute Office of the Director Irell & Manella Cancer Center Director’s National Cancer Institute Distinguished Chair National Institutes of Health City of Hope Comprehensive Cancer Center Bethesda, MD Duarte, CA Richard Pazdur, M.D., FACP Dan Theodorescu, M.D., Ph.D. 2020 Director Professor and Director Oncology Center of Excellence Department of Pharmacology and Urology U.S. Food and Drug Administration University of Colorado Comprehensive Rockville, MD Cancer Center Aurora, CO Xiufen Sui, M.D., M.S. Biostatistician Ex Officio Members Center for Clinical Standards and Quality Center for Medicare and Medicaid Innovation William Dahut, M.D. Baltimore, MD Scientific Director of Clinical Research and Clinical Director, Center for Cancer Research Executive Secretary National Cancer Institute National Institutes of Health Sheila A. Prindiville, M.D., M.P.H. Bethesda, MD Director Coordinating Center for Clinical Trials James H. Doroshow, M.D. Office of the Director Deputy Director for Clinical and Translational National Cancer Institute Research National Institutes of Health Director, Division of Cancer Treatment and Bethesda, MD Diagnosis National Cancer Institute National Institutes of Health Bethesda, MD
Paulette S. Gray, Ph.D. Director Division of Extramural Activities National Cancer Institute National Institutes of Health Bethesda, MD
NCI FNLAC Orientation Book 57 APPENDIX G FREDERICK NATIONAL LABORATORY ADVISORY COMMITTEE
Chair
Lawrence J. Marnett, Ph.D. 2021 Dean of Basic Sciences University Professor Mary Geddes Stahlman Professor of Cancer Research Professor of Biochemistry, Chemistry and Pharmacology Vanderbilt University School of Medicine Nashville, TN
Members Raymond N. DuBois, M.D., Ph.D. (BSC4) 2021 Dean, College of Medicine Catherine M. Bollard, M.D. 2022 Professor, Departments of Biochemistry Director, Center for Cancer and Immunology and Medicine Director, Program for Cell Enhancement and Medical University of South Carolina Technologies for Immunotherapy Charleston, SC Children’s Research Institute Children’s National Health System Angela M. Gronenborn, Ph.D. (BSC3) 2020 Washington, DC UPMC Rosalind Franklin Professor and Chair Department of Structural Biology Andrea Califano, Ph.D. 2022 Professor, Department of Bioengineering Swanson Clyde and Helen Wu Professor of School of Engineering Chemical and Systems Biology Director, Pittsburgh Center for HIV Protein Director, JP Sulzberger Columbia Genome Center Interactions Associate Director for Bioinformatics University of Pittsburgh Herbert Irving Comprehensive Cancer Center Pittsburgh, PA Columbia University New York, NY Robert L. Grossman, Ph.D. 2021 Director, Center for Data Intensive Science Timothy A. Chan, M.D., Ph.D.* 2023 Professor, Department of Medicine Professor, Weill Cornell School of Medicine University of Chicago Director, Division of Translational Oncology Chicago, IL Vice Chair, Department of Radiation Memorial Sloan Kettering Cancer Center Klaus M. Hahn, Ph.D. 2020 New York, NY Thurman Professor of Pharmacology Director, UNC-Olympus Imaging Center Lisa M. Coussens, Ph.D. 2020 Department of Pharmacology Hildegard Lamfrom Chair in Basic Science University of North Carolina at Chapel Hill Professor and Chair, Cell, Developmental and Chapel Hill, NC Cancer Biology Associate Director for Basic Research David I. Hirsh, Ph.D. 2019 Knight Cancer Institute Professor Oregon Health & Science University Department of Biochemistry and Molecular Portland, OR Biophysics College of Physicians & Surgeons Kevin J. Cullen, M.D. 2020 Columbia University Director New York, NY Marlene and Stewart Greenebaum Cancer Center Professor of Medicine University of Maryland School of Medicine Baltimore, MD ______* Pending.
58 NCI FNLAC Orientation Book Elizabeth M. Jaffee, M.D. (NCAB2) 2018 Nilsa C. Ramirez Milan, M.D., FCAP 2020 Deputy Director, The Sidney Kimmel Medical Director, Biopathology Center Comprehensive Cancer Center Director, Autopsy Pathology The Dana and Albert Cubby Broccoli Department of Pathology and Laboratory Professor of Oncology Medicine Co-Director, Skip Viragh Center for Nationwide Children’s Hospital Pancreas Cancer Professor of Clinical Pathology Johns Hopkins University The Ohio State University College of Medicine Baltimore, MD Columbus, OH
Candace S. Johnson, Ph.D.* 2023* Lincoln D. Stein, M.D., Ph.D. 2022 President and CEO Director, Informatics and Biological Computing Director, Wallace Family Chair in Platform Ontario Institute for Cancer Research Translational Research Professor, Department of Molecular Genetics Chair, Department of Pharmacology and University of Toronto Therapeutics Toronto, ON, Canada Roswell Park Cancer Institute Buffalo, NY Cheryl L. Willman, M.D. (BSA1) 2021 Maurice and Marguerite Liberman Sanford D. Markowitz, M.D., Ph.D. 2020 Distinguished Chair in Cancer Research Markowitz - Ingalls Professor of Cancer Genetics Director and CEO, University of New Mexico Department of Medicine Comprehensive Cancer Center Case Western Reserve University University of New Mexico School of Medicine Albuquerque, NM Head, Cancer Genetics Program Case Comprehensive Cancer Center Jedd D. Wolchok, M.D., Ph.D. 2019 Cleveland, OH Associate Director, Ludwig Center for Cancer Immunotherapy Patrick Nana-Sinkam, Ph.D. 2022 Associate Member, Ludwig Cancer Research Professor of Medicine Associate Professor of Medicine Chair, Division of Pulmonary Disease Weill Medical College of Cornell University and Critical Care Medicine Memorial Sloan-Kettering Cancer Center Virginia Commonwealth University New York, NY Richmond, VA Executive Secretary Piermaria J. Oddone, Ph.D. 2019 Director Emeritus Caron A. Lyman, Ph.D. Fermi National Accelerator Laboratory Chief, Research Programs Review Branch Healdsburg, CA Division of Extramural Activities National Cancer Institute Kenneth J. Pienta, M.D. 2022 National Institutes of Health The Donald S. Coffey Professor of Urology Bethesda, MD Professor of Oncology Professor of Pharmacology and Representatives: Molecular Sciences Johns Hopkins Hospital 1BSA Board of Scientific Advisors The James Buchanan Brady 2NCAB National Cancer Advisory Board Urological Institute 3BSC Board of Scientific Counselors— Baltimore, MD Basic Sciences 4BSC Board of Scientific Counselors— Clinical Sciences and Epidemiology
______* Pending.
NCI FNLAC Orientation Book 59 Ex Officio Members Anthony Kerlavage, Ph.D. Acting Director, Center for Biomedical Stephen J. Chanock, M.D. Informatics and Information Technology Director National Cancer Institute Division of Cancer Epidemiology and Genetics National Institutes of Health National Cancer Institute Bethesda, MD National Institutes of Health Bethesda, MD Tom Misteli, Ph.D. Director James H. Doroshow, M.D. Center for Cancer Research Deputy Director for Clinical and Translational National Cancer Institute Research National Institutes of Health Director, Division of Cancer Treatment and Bethesda, MD Diagnosis National Cancer Institute Donna Siegle National Institutes of Health Acting Deputy Director of Management and Bethesda, MD Executive Officer National Cancer Institute Paulette S. Gray, Ph.D. National Institutes of Health Director Bethesda, MD Division of Extramural Activities National Cancer Institute Dinah S. Singer, Ph.D. National Institutes of Health Deputy Director Bethesda, MD Scientific Strategy and Development National Cancer Institute Sara Hook, Ph.D. National Institutes of Health Director, Office of Scientific Operations Bethesda, MD NCI at Frederick National Cancer Institute National Institutes of Health Frederick, MD
60 NCI FNLAC Orientation Book APPENDIX H NCI COUNCIL OF RESEARCH ADVOCATES
Chair
Gregory H. Aune, M.D., Ph.D. 2019 Assistant Professor of Pediatrics The University of Texas Health Science Center San Antonio, TX
Members Danielle Leach, M.P.A. 2020 Director of Advocacy and Government Rick Bangs, M.B.A., PMP 2020 Relations Chair, SWOG Patient Advocate Committee St. Baldrick’s Foundation Rochester Hills, MI Huntington, MD
Mary Ann Battles, M.S. 2019 Jennifer W. Pegher 2021 Head, Clinical Quality and Compliance Executive Director Genentech/Roche Association of American Cancer Institutes South San Francisco, CA Pittsburgh, PA
Angelica Q. Davis 2021 Roberto A. Vargas, M.P.H. 2019 President Navigator Fight Colon Cancer Community Engagement and Health Policy Springfield, MO Program Clinical and Translational Sciences Institute Julie Fleshman, J.D., M.B.A. 2020 University of California San Francisco President and Executive Officer San Francisco, CA Pancreatic Cancer Action Network Manhattan Beach, CA Executive Secretary
Sue J. Friedman, D.V.M. 2019 Amy Williams Acting Director Executive Director Office of Advocacy Relations Facing Our Risk of Cancer Empowered National Cancer Institute, NIH Coral Springs, FL Bethesda, MD
NCI FNLAC Orientation Book 61 APPENDIX I NCI SCIENTIFIC PROGRAM LEADERSHIP COMMITTEE
Members Dr. Paulette Gray Director Dr. Norman Sharpless Division of Extramural Activities Director Dr. Toby Hecht Dr. Douglas Lowy Deputy Director, Division of Cancer Treatment Principal Deputy Director and Diagnosis
Dr. James Doroshow Dr. Sara Hook Deputy Director for Clinical and Translational Director Research Office of Scientific Operations Director, Division of Cancer Treatment NCI Campus at Frederick and Diagnosis Dr. Tony Kerlavage Dr. Dinah Singer Director, Center for Biomedical Informatics Deputy Director for Scientific Strategy and and Information Technology Development Mr. Patrick McCarey Dr. L. Michelle Bennett Associate Director Director Finance and Legislation Center for Research Strategy Dr. Glenn Merlino Dr. Oliver Bogler Scientific Director for Basic Research, Director Center for Cancer Research Center for Cancer Training Dr. Tom Misteli Dr. Stephen Chanock Director Director Center for Cancer Research Division of Cancer Epidemiology and Genetics Dr. Meg Mooney Dr. Henry Ciolino Deputy Director for Clinical Research and Director Associate Director, Cancer Therapy Evaluation Office of Cancer Centers Program Division of Cancer Treatment and Diagnosis Dr. Robert Croyle Director Dr. Sheila Prindiville Division of Cancer Control and Population Director Sciences Coordinating Center for Clinical Trials
Dr. William Dahut Dr. Henry Rodriguez Scientific Director of Clinical Research and Acting Deputy Director Clinical Director, Center for Cancer Research Center for Strategic Scientific Initiatives
Dr. Daniel Gallahan Mr. Jeffrey Shilling Acting Director Acting Chief Information Officer Division of Cancer Biology National Cancer Institute
Mr. Peter Garrett Ms. Donna Siegle Director Executive Officer and Office of Communications and Public Liaison Deputy Director for Office of Management
62 NCI FNLAC Orientation Book Dr. Sanya Springfield Dr. Deborah Winn Director Acting Director Center to Reduce Cancer Health Disparities Division of Cancer Prevention
Dr. Thomas M. Stackhouse Dr. Robert Yarchoan Director Director Technology Transfer Center Office of HIV and AIDS Malignancy
Dr. Louis M. Staudt Dr. Maureen Johnson Director Executive Secretary Center for Cancer Genomics
Mr. Michael Weingarten Director SBIR Development Center
NCI FNLAC Orientation Book 63 APPENDIX J SUMMARY OF ETHICS RULES FOR SPECIAL GOVERNMENT EMPLOYEES SERVING ON ADVISORY COMMITTEES
Introduction tion in matters that affect all institutions, or types of institutions, similarly. As a Special Government Employee (SGE), you are a Federal Government employee. As such, you Concurrent Representation: While you are are covered by the Executive Branch ethics rules, serving, there are representational restrictions on although in a somewhat less restrictive manner contacting the Government on behalf of another— than regular Government employees. for example, as an agent or attorney—with intent to influence on a specific party matter that you are The Criminal Conflict of Interest Stat- working on as an SGE. utes 18 U.S.C. §§ 203, 205, 207, 208 Post-Employment Representation: You cannot Financial Conflicts: You are prohibited from “switch sides” in the private sector and represent participating personally and substantially in any back to the Government concerning the same particular matter that directly and predictably specific party matter—the same contract or grant, affects your own financial interests or the financial for example, that you worked on as an SGE. interests of certain other persons or organizations: (Remember also the restrictions resulting from your spouse, minor child, general partner, and employment negotiations that are covered by the outside organizations with which you serve financial conflict statute.) as an officer, director, trustee, or employee, or with which you are negotiating for or have an Standards of Ethical Conduct arrangement for future employment. If your 5 CFR Part 2635 duties would require you to participate in any particular matter that affects your financial You are prohibited from receiving compensation interests, you have a conflict of interest which you for teaching, speaking, or writing about your will have to resolve. Of most concern are reviews Government duties or about any topic if the of grant proposals or contract applications, or invitation to teach, speak, or write comes from a similar funding decisions; recommendations or person substantially affected by the matters on approvals of scientific studies, projects, clinical which you work as an SGE. However, you may trials, and new drug applications; and other teach courses about general topics requiring actions that involve deliberation, decision, or multiple presentations. action affecting the legal rights of identified parties. You also might be prohibited from You may not accept gifts offered as a result of involvement in Particular Matters of General your advisory committee membership. In many Applicability. For example, recommendations of circumstances, you may not participate as an regulations, policies, or standards that affect an expert witness on any matter or proceeding that industry, group of manufacturers, or health care you work on as an SGE. providers. Impartiality: You are prohibited from participat- Divestiture: Sell or otherwise dispose of the ing in a specific party matter where a reasonable financial interest that is creating the conflict. person would question your impartiality—for example, conducting a review of a grant applica- Waiver: Get written approval from a senior official tion submitted by your mentor or someone with to continue with your work for the whom you have a close relationship—unless committee despite the conflict. Waivers can be authorized by an agency designee to participate. granted where there is a pressing need for a partic- ular individual’s services on the committee and Misuse of Position—Use of Public Office for this outweighs the potential for conflict of interest. Private Gain: This includes the misuse of nonpub- Specific criteria must be met. This is considered a lic information, government property, and official “general waiver” in that it only allows participa- time. You may not use your position to imply that
64 NCI FNLAC Orientation Book the Committee endorses your private activities or • Monitor changes in your circumstances that refer to your Government position for your own might create new conflicts. private gain. • Be sure to contact your Designated Federal Official (DFO) or ethics officials with any Employment by, or Gifts From, Foreign questions. Governments: Committee members may be employed by a foreign government, which Excerpted from: Overview of the Ethics Rules includes positions with foreign universities that for Special Government Employees Serving on an are government operated. There are also statutory Advisory Committee,U.S. Office of Government provisions restricting acceptance of gifts, includ- Ethics, NIH. ing awards, educational scholarships, and travel expenses occurring outside the Unites States, but Financial Conflicts of Interest Office of not on travel or honoraria for a speaking engage- Government Ethics – OGE 450 Form ment or employment for consulting. Office of Government Ethics (OGE) 450 Form: Lobbying: In their official capacities or as a group, http://ethics.od.nih.gov/topics/450-info.htm committee members are prohibited from engaging in any activity which directly or indirectly encour- Financial Interests to be reported on the OGE 450 ages or directs any person or organization to Form include: lobby one or more members of Congress. You may appear for the purpose of informing or educating • Stocks, stock options, bonds the public about a particular policy and you may • Sector funds (Waiver available for biotech/ communicate with members of Congress at their health care sector funds up to aggregate value request. of $50,000) • Earned income, including salaries, fees, and/or Political Activities (Hatch Act): While on honoraria Government duty (unlike the other rules which • Limited partnerships and venture capital always apply during your time of appointment), corporations you may not engage in partisan political activities, • Non-Federal research/training support run for political office in a partisan election, or • Invention rights and royalties solicit contributions from the public. For more • Real estate, trades and businesses, and part- information on political activity restrictions, please nership interests see the Office of Special Counsel website at https:// • Speaking engagements and consultant work osc.gov. SGEs report assets with a fair market value greater Ethics for SGEs: Your Responsibilities as than $1,000 at the close of the reporting period, a Government Employee which produced income over $200.
• Complete the OGE-450 Financial Disclosure Conflict of Interest and Ethics Websites Report and submit it for review. You should not attend meetings or participate in commit- U.S. Office of Government Ethics tee business until this form is submitted and • Online training on Completing reviewed. the OGE Form 450: https://www. • Complete the HHS-697 Foreign Activities oge.gov/Web/oge.nsf/Resources/ Questionnaire and submit it for review. How+to+file+an+OGE+Confidential+ • If conflicts of interest are identified, work with Financial+Disclosure+Form+ committee managers and ethics officials to (OGE+form+450) resolve them. • Complete a financial disclosure form 30 days A Guide on the Ethics Rules That Apply to prior to each Board meeting. Advisory Committee Members Serving as Special • Complete initial ethics orientation and Government Employees: https://ethics.od.nih.gov/ yearly ethics training—you should have a topics/SGE-Training-Oct-04.pdf basic knowledge of the Standards of Ethical Conduct and the Conflict of Interest (COI) Statutes.
NCI FNLAC Orientation Book 65 Overview of the Ethics Rules for Special Conflict of Interest and the Special Government Government Employees Serving on Advisory Employee: http://ethics.od.nih.gov/topics/OGE- Committees:http://ofacp.od.nih.gov/ethics/index. SGE.pdf asp NIH Ethics Program: http://ethics.od.nih.gov/ Ethics Rules for Advisory Committee Members default.htm and Other Individuals Appointed as Special Government Employees (SGEs): https://ethics. Bioethics Resources on the Web: https://bioethics. od.nih.gov/topics/SGE-Training-Oct-04.pdf nih.gov/resources/index.shtml
NIH Administrative Fact Sheet for Special Government Employees: http://ofacp.od.nih.gov/
Foreign Activities: • U.S. Constitution Emoluments Clause: http:// ofacp.od.nih.gov/ethics/pdfs/EmolClause.pdf • Foreign Activities Questionnaire: https:// intranet.hhs.gov/forms/hhs_forms/hhs-697.pdf
66 NCI FNLAC Orientation Book APPENDIX K RELATED DOCUMENTS
Cancer DEA Annual Report http://www.cancer.gov http://deainfo.nci.nih.gov
NCI Budget Fact Book NCI Office of Grants Administration http://www.cancer.gov/about-nci/budget/fact- http://www.cancer.gov/about-nci/organization/ book oga
Bypass Budgets Grants and Contracts http://plan.cancer.gov https://www.cancer.gov/grants-training/ grants-funding/funding-opportunities Cancer Centers http://cancercenters.cancer.gov Grant Mechanisms and Descriptions http://deainfo.nci.nih.gov/flash/awards.htm Clinical Trials http://www.cancer.gov/clinicaltrials Center for Cancer Training http://www.cancer.gov/grants-training/training/ NCAB Orientation Book about https://deainfo.nci.nih.gov/advisory/ncab/ OrientationBook.pdf Center for Scientific Review (CSR) Reviewer Resources BSA Orientation Book http://public.csr.nih.gov/ReviewerResources/ https://deainfo.nci.nih.gov/advisory/bsa/ Pages/default.aspx OrientationBook/OrientationBook.pdf Surveillance CTAC Member’s Manual http://seer.cancer.gov https://deainfo.nci.nih.gov/advisory/ctac/ OrientationBook.pdf • NIH Grant Review Process YouTube Videos http://public.csr.nih.gov/aboutcsr/contactcsr/ NCI Division of Extramural Activities pages/contactorvisitcsrpages/nih-grant- http://deainfo.nci.nih.gov review-process-youtube-videos.aspx
NCI FNLAC Orientation Book 67 APPENDIX L WEBSITES OF INTEREST
DEA Websites Charter of the Initial Review Group (IRG); subcommittee rosters. DEA home page. Includes links to individual http://deainfo.nci.nih.gov/advisory/irg/irg.htm DEA Web Pages, the mission of the Division, and contact information for DEA staff. Charter of the Special Emphasis Panel (SEP); http://deainfo.nci.nih.gov rosters of recent meetings. http://deainfo.nci.nih.gov/advisory/sep/sep.htm
Frederick National Laboratory Advisory Committee (FNLAC) charter, members, meeting information. http://deainfo.nci.nih.gov/advisory/fac/fac.htm
Charter of the NCI Council of Research Advocates; meeting schedules, agendas, minutes, and meeting summaries. http://deainfo.nci.nih.gov/advisory/ncra/ncra.htm
Links to grant-related NCI and NIH policies, such as guidelines on the inclusion of women and Links to the home pages of NCI’s advisory boards. minorities in clinical trials and instructions for http://deainfo.nci.nih.gov/advisory/boards.htm evaluating research involving human subjects. http://deainfo.nci.nih.gov/grantspolicies/index. President’s Cancer Panel (PCP) charter; meeting htm agendas and meeting minutes; annual reports. https://deainfo.nci.nih.gov/advisory/pcp/index. Comprehensive information about funding for htm cancer research; lists of active PAs and RFAs; grant policies and guidelines; downloadable application National Cancer Advisory Board charter; rosters; forms. meeting agendas, minutes, presentation slides. http://deainfo.nci.nih.gov/funding.htm http://deainfo.nci.nih.gov/advisory/ncab/ncab. htm Active PAs, with links to detailed descriptions. https://deais.nci.nih.gov/foastatus/?nt=P Board of Scientific Advisors (BSA) charter; subcommittee rosters; meeting agendas, minutes, Active RFAs, with links to detailed descriptions. presentation slides. https://deais.nci.nih.gov/foastatus/? http://deainfo.nci.nih.gov/advisory/bsa/bsa.htm Grants Guidelines and Descriptions (descriptions Charter of the Board of Scientific Counselors of NCI funding mechanisms, with links to (BSC), Clinical Sciences and Epidemiology. Program Announcements (PAs), RFAs, guidelines, http://deainfo.nci.nih.gov/advisory/bsc/cse/ and supplemental materials). charter.pdf http://deainfo.nci.nih.gov/flash/awards.htm
Charter of the Board of Scientific Counselors NCI Glossary of Terms. (BSC), Basic Sciences. http://deais.nci.nih.gov/glossary http://deainfo.nci.nih.gov/advisory/bsc/bs/ charter.pdf NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/ Clinical Trials and Translational Research cancer-terms/ Advisory Committee. http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm
68 NCI FNLAC Orientation Book NCI Websites The NCI Office of Advocacy Relations (OAR) uses a variety of methods to engage cancer research The NCI maintains numerous sites containing advocates in NCI activities. information about the Institute and its programs. http://www.cancer.gov/about-nci/organization/ All NCI websites, including those designed to oar provide cancer-related information to the general public and physicians, can be reached from the The Cancer Moonshot Initiative aims to make NCI home page. more therapies available to more patients, while https://www.cancer.gov also improving our ability to prevent cancer and detect it at an early stage. Descriptions of NCI’s Divisions, Offices, and http://www.cancer.gov/research/key-initiatives/ Centers. moonshot-cancer-initiative http://www.cancer.gov/aboutnci/organization NCI Cancer Information Websites NCI’s website for the press, managed by the NCI Office of Media Relations; contains news and Links to a wide variety of NCI’s Web-based information on cancer research and NCI programs information resources for health professionals and and resources. the general public. http://www.cancer.gov/newscenter http://www.cancer.gov/cancerinfo
A wide variety of information sources on A comprehensive resource for definitions of obtaining funding for cancer research, including cancer-related terms, as well as links to additional assistance in applying for grants; descriptions of online dictionaries of medical and health-related NCI-sponsored research initiatives; review panel terms. rosters and schedules; training opportunities; and http://cancer.gov/dictionary links to other funding resources. http://deainfo.nci.nih.gov/funding.htm The NCI Contact Center, or Cancer Information Service (CIS), is a free public service providing The essentials of the NCI grants process are accurate, up-to-date, and reliable information available on this website. on cancer that is easy to understand. The http://www.cancer.gov/grants-training/grants- Cancer Information Specialists respond to calls process in English and Spanish and can be reached at 1-800-4-CANCER (1-800-422-6237). Hearing- The Biorepositories and Biospecimens Research impaired callers with TTY equipment may call Branch is responsible for promoting a common 1-800-332-8615. biorepository infrastructure that promotes http://www.cancer.gov/contact/contact-center resource sharing and team science. http://biospecimens.cancer.gov/researchnetwork/ The Cancer Trials website provides information default.asp and news about cancer research studies. The site is designed to answer basic questions about clinical Links to NCI’s partnerships with the cancer trials; provide resources for people considering research, advocacy, and support communities. participating in clinical trials; help people learn http://www.cancer.gov/researchprograms/ what clinical trials are available; and publish partners current, accurate information about clinical trial results and advances in cancer care. Technology Transfer Center (TTC). The NCI TTC’s http://www.cancer.gov/clinicaltrials mission is to speed the progress of cancer research by encouraging development of new technologies and promoting scientific collaborations between the NCI and the private sector. https://ttc.nci.nih.gov
NCI FNLAC Orientation Book 69 The NCI Surveillance, Epidemiology, and End The Center for Information Technology (CIT) Results (SEER) Program is the most authoritative makes special NIH events, seminars, and lectures source of information on cancer incidence and available to viewers on the NIH network and survival in the United States. Information on more the Internet from the NIH VideoCasting and than 2.5 million cancer cases is included in the SEER Podcasting website. database, and approximately 160,000 new cases are http://videocast.nih.gov added each year within the SEER catchment areas. http://seer.cancer.gov Information on Electronic Review of Grant Applications. NIH Websites https://era.nih.gov/reviewer/index.cfm
National Institutes of Health home page. Information on grants policy statements and http://www.nih.gov notices, grant awards and NIH appropriations, policy resources, and other guidance resources. National Institutes of Health Almanac. http://grants1.nih.gov/grants/policy/policy.htm https://www.nih.gov/about-nih/what-we-do/nih- almanac Information on Extramural Training Mechanisms. http://grants.nih.gov/training/extramural.htm NIH Research Portfolio Online Reporting Tool (RePORT). NIH RePORT provides access to The NIH Event Calendar is a scheduling system reports, data, and analyses of NIH research for cancer-related scientific meetings and events. activities, including information on NIH http://calendar.nih.gov expenditures and the results of NIH-supported research. The NIH Precision Medicine Initiative (PMI) http://report.nih.gov Cohort Program will seek to extend precision medicine to all diseases by building a national Office of Federal Advisory Committee Policy research cohort of 1 million or more (OFACP). This site features downloadable U.S. participants. guidelines, reference tools, and training materials. https://www.nih.gov/precision-medicine- It also contains advisory committee membership initiative-cohort-program lists; laws, regulations, and policies related to Federal advisory committees; and other resources. PubMed comprises more than 26 million citations http://ofacp.od.nih.gov from Medline, life science journals, and online books. NIH Office of Extramural Research. Includes an https://www.ncbi.nlm.nih.gov/pubmed overview of the grants process. http://grants.nih.gov/grants/oer.htm General Government-Related Websites
NIH Guide for Grants and Contracts for NIH The official U.S. Government portal to 30 million grants and funding opportunities. pages of Government information, services, and http://grants.nih.gov/grants/guide/index.html online transactions. FirstGov offers a powerful search engine that searches every word of every NIH Center for Scientific Review. U.S. Government document. The site also features http://www.csr.nih.gov a topical index, options to contact Government agencies, links to state and local agencies, and Definitions of NIH Acronyms and Glossary. other tools, so the user does not have to know the http://grants.nih.gov/grants/glossary.htm name of the agency to get needed information. https://www.usa.gov eRA Commons is an online interface where grant applicants and Federal staff at the NIH Centers for Disease Control and Prevention. and grantee institutions can access and share http://www.cdc.gov administrative information relating to research grants. U.S. Food and Drug Administration. http://commons.era.nih.gov/commons https://www.fda.gov
70 NCI FNLAC Orientation Book APPENDIX M LIST OF ABBREVIATIONS
AIDS Acquired Immune Deficiency DHS Department of Homeland Security Syndrome DoD Department of Defense BSA Board of Scientific Advisors DOE Department of Energy BSC Board of Scientific Counselors eRA Electronic Research Administration CBIIT Center for Biomedical Informatics and Information Technology FAR Federal Acquisition Regulations
CCCT Coordinating Center for Clinical Trials FDA Food and Drug Administration
CCR Center for Cancer Research FOIA Freedom of Information Act
CCSG Cancer Center Support Grant GMP Good Manufacturing Practice
CDC Centers for Disease Control and HHS Department of Health and Human Prevention Services
CFR Code of Federal Regulations IAR Internet Assisted Review
CIS Cancer Information Service IHS Indian Health Service
CIT Center for Information Technology IRG Initial Review Group
CMO Committee Management Office IRP Intramural Research Program
CMS Centers of Medicare and Medicaid NASA National Aeronautics and Space Services Administration
COG Children’s Oncology Group NCAB National Cancer Advisory Board
COI Conflict of Interest NCI National Cancer Institute
CSR Center for Scientific Review NCRA NCI Council of Research Advocates
CTAC Clinical Trials and Translational NCTN NCI Clinical Trials Network Research Advisory Committee NExT NCI Experimental Therapeutics DCB Division of Cancer Biology NHGRI National Human Genome Research DCCPS Division of Cancer Control and Institute Population Sciences NIAID National Institute of Allergy and DCEG Division of Cancer Epidemiology and Infectious Diseases Genetics NIGMS National Institute of General Medical DCP Division of Cancer Prevention Sciences
DCTD Division of Cancer Treatment and NIH National Institutes of Health Diagnosis NSF National Science Foundation DEA Division of Extramural Activities OAR Office of Advocacy Relations DFO Designated Federal Official OFACP Office of Federal Advisory Committee Policy
NCI FNLAC Orientation Book 71 OGA Office of Grants Administration SBIR Small Business Innovative Research Program OHAM Office of HIV and AIDS Malignancy SEER Surveillance, Epidemiology, and End P30 Cancer Center Support Grant Results Program
P50 Specialized Center Grant SEP Special Emphasis Panel
PA Program Announcement SIC Special Interest Category
PCP President’s Cancer Panel SPL Scientific Program Leaders
PI Principal Investigator SPORE Specialized Program of Research Excellence PMI Precision Medicine Initiative STTR Small Business Technology Transfer RePORT Research Portfolio Online Reporting Tool TARGET Therapeutically Applicable Research to Generate Effective Treatment RFA Request for Application TCGA The Cancer Genome Atlas Project SAMHSA Substance Abuse and Mental Health Services Administration TTC Technology Transfer Center
72 NCI FNLAC Orientation Book NCI FNLAC Orientation Book 73
MARCH 2020