Division of Extramural Activities Annual Report 2004 National Cancer Institute National Cancer U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Molecular Imaging for Cancer The NCI has made a significant committment to support the discovery, development, and delivery of cutting- edge molecular imaging agents and technologies. The field of molecular imaging has grown rapidly in response to this committment, and the applications being developed will have a far-reaching impact on the detection, diagnosis, and treatment of cancer patients. The images on the cover demonstrate the power of two different types of molecular imaging techniques applied to cancer detection. The image on the top is generated using positron emission tomography-computed tomog- raphy (PET-CT) fusion imaging (image reproduced with permission from David W. Townsend, Ph.D., Department of Radiology, University of Tennessee). Computed-tomography (CT) alone, a technique based on the use of x-rays, is capable of generating images with exquisite anatomical detail, but does not provide the clinician with physiologic information about lesions that are detected. Conversely, positron emission tomogra- phy (PET) alone, a technique based on the use of radiolabeled imaging agents, provides the clinician with func- tional information about whether a lesion is cancerous or not, but the resulting images do not contain the anatomic detail necessary to determine exact location within the body. In the image shown, the radiolabeled agent being used is 2-[18F]fluoro-2-deoxy-D-glucose ([18F] FDG), an agent that reports on the increased metabolism occuring in a cancer cell. In the past, these two types of images were acquired using two sepa- rate machines at two different times. Each of the resulting images was subsequently superimposed on the other, resulting in inaccuracies. Through NCI funding, an imaging technology was developed that allows cli- nicians to acquire both types of images and fuse them automatically into a single image. The combined PET- CT image shown now accurately reflects the precise anatomic location of the lung cancer lesion (as shown by the arrow) as well as the physiologic information about that lesion, greatly enhancing the ability of the clini- cian to effectively treat the patient. Another example of a cutting-edge molecular imaging technology is shown by the image on the bottom of the cover. In this example, magnetic resonance images (MRI) using a superparamagentic imaging agent [monocrystalline iron oxide nanoparticle (MION)] that selectively detects metastatic lymph nodes (colored in red) are acquired, in this case from a series of patients with metastatic prostate cancer (image reproduced with permission from Ralph Weissleder, M.D., Ph.D., and Mukesh Harisinghani, M.D., Harvard University). Those images are superimposed upon the CT image of the pelvis. Importantly, this technique results in 3D represen- tation of the images, allowing for even more precise anatomical localization of the cancerous lesion. The work described was supported by the Cancer Imaging Program, NCI. Division of Extramural Activities Annual Report 2004 National Cancer Institute National Cancer U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health iii Contents Foreword. v Introduction. 1 Overview of the Division of Extramural Activities . 3 Special Activities in the Office of the Director, DEA . 5 Grant Referral: The First Point of Contact with the NCI Grantee. 7 Peer Review—The Next Step . 9 Supporting Peer-Review Consultants . 23 DEA’s Role in Advisory Activities . 25 Committee Management Activities . 29 Portfolio Tracking and Analysis. 31 Information Resources Management . 33 Organizational Structure of the Division of Extramural Activities . 35 Table 1. Applications Received for Referral by the NCI/DEA (by Mechanism), FY2004. 49 Table 2. Grant and Cooperative Agreement Applications Reviewed by the NCI/DEA (by Mechanism), FY2004. 51 Table 3. Applications Reviewed by NCI IRG Subcommittees and SEPs*, FY2004 . 52 Table 4. Summary of Investigator-Initiated P01 Applications Reviewed for Each NCAB Meeting, FY2004 . 53 Table 5. Summary of Review Formats for Unsolicited Program Project Applications, FY2004 . 53 Table 6. Summary of Unsolicited P01 Applications Reviewed by NCI Program Division, FY2004 . 53 Table 7a. Requests for Applications (RFAs) Published by the NCI in FY2004 Sorted by Date of Publication . 54 Table 7b. Requests for Applications (RFAs) Published by the NCI in FY2004 Sorted by Division and Office . 55 Table 8a. Program Announcements (PAs) Published by the NCI in FY2004 Sorted by Date of Publication. 56 Table 8b. Program Announcements (PAs) Published by the NCI in FY2004 Sorted by Division and Office . 57 Table 9a. Program Announcements with Special Receipt Dates Published by the NCI in FY2004 Sorted by Date of Publication. 58 Table 9b. Program Announcements with Special Receipt Dates Published by the NCI in FY2004 Sorted by Division and Office. 58 Table 10. Requests for Applications (RFAs) Reviewed by the NCI/DEA, FY2004 . 59 Table 11. PA/PAR Applications Reviewed by the NCI/DEA, FY2004 . 61 Table 12. Average Total Cost and Number of RPG† Awards by Division, FY2002-FY2004 . 64 Table 13. Summary of NCI Grant Awards (by Mechanism), FY2004 . 67 Table 14. NCI Special Interest Category (SIC) Dollars for FY2004—Percent Change from FY2003. 70 Table 15. NCI Organ Site-Specific Dollars for FY2004—Percent Change from FY2003 . 73 Table 16. Requests for Proposals (RFPs) Reviewed by NCI/DEA in FY2004 . 75 Appendix A: Activities of the National Cancer Advisory Board . 77 Appendix B: Activities of the Board of Scientific Advisors . 81 Appendix C: List of Chartered Committees, FY2004 . 85 Appendix D: NCI Initial Review Group Consultants, FY2004 . 101 Appendix E: NCI Grant Guidelines and Descriptions . 145 Appendix F: Glossary of Acronyms . 153 Appendix G: Cancer Information Sources on the Internet . 155 * Special Emphasis Panel. † Research Project Grant. NCI/DEA Annual Report 2004 v Foreword Since Congress passed the National Cancer Act in 1971, we have been experiencing exponential growth in our knowledge of cancer. That scien- tific knowledge base, which is a primary responsibility of the National Cancer Institute (NCI), is the first stage along a continuum of discovery, development, and delivery that will ultimately take us to the goal I have challenged myself and the entire cancer community to reach by the year 2015—the elimination of suffering and death from cancer. The knowl- edge we discover—whether at the level of the gene, molecule, cell, tissue, organ, individual, or population—must feed the development of strategies and interventions, which can then be delivered in a fashion that not only reduces the cancer burden, but also yields new knowl- edge of the biology of human cancers. The NCI is committed to exploiting that discovery-development-delivery strategy to achieve the 2015 challenge goal. In large measure, this will be accomplished through the efforts of outstanding NCI extramural scientists who have and will continue to enhance the scientific knowledge base. The NCI Division of Extramural Activities (DEA) carries a major responsibility for strengthening that base by conducting the scientific review of applications for support of extramural research, assisting in the development of research Requests for Applications (RFAs) and Requests for Proposals (RFPs), disseminating operating policies pertaining to extramural programs, and analyzing and reporting on all extramural research programs funded by the NCI. The DEA Annual Report provides a comprehensive look at each of the major areas of responsibili- ty within the DEA, including program coordination, referral, review, advisory activities, information resources, portfolio tracking and analysis, management, and extramural policy. I am pleased to endorse this annual report and congratulate the many staff who contributed to its development. It not only describes the DEA’s activities and accomplishments and its work in the context of achieving the NCI’s overall scientific goal of reducing the burden of cancer, but also gratefully acknowledges the hundreds of researchers who have contributed to the success of our peer-review and advisory activities. Andrew C. von Eschenbach, M.D. Director, National Cancer Institute NCI/DEA Annual Report 2004 1 Introduction The Division of Extramural Activities (DEA) is centrally involved in establishing and disseminating extramural policy and all aspects of grant development and tracking, from original conception of re- search and training programs, to issuance of announcements of such programs, receipt and referral of incoming applications, review and final approval of the applications, coding and tracking awards after disbursement of funds and coordinating relevant advisory boards. In brief, the DEA was established to: Provide advice and guidance to potential applicants; Coordinate and assist in the development of extramural research funding initiatives; Refer incoming grant applications to appropriate programs within the NCI; Provide the highest quality and most effective scientific peer review and oversight of extramu- ral grant and contract research; Coordinate and administer advisory committee activities, such as the National Cancer Advisory Board (NCAB) and Board of Scientific Advisors (BSA), as they relate to the various aspects of the NCI mission; Establish and disseminate extramural policies and procedures, such as requirements