NOT-CA-04-022: CREATING CANCER NANOTECHNOLOGY PLATFORMS THROUGH DIRECTED RESEARCH PROGRAMS: REQUEST FOR INFORMATION (RFI)

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CREATING CANCER NANOTECHNOLOGY PLATFORMS THROUGH DIRECTED RESEARCH PROGRAMS: REQUEST FOR INFORMATION (RFI) RELEASE DATE: June 24, 2004 NOTICE: NOT-CA-04-022 National Cancer Institute (NCI) (http://www.nci.nih.gov) The National Cancer Institute (NCI) is interested in attracting ideas for directed research programs that will ultimately deploy nanotechnology platforms for the diagnosis or treatment of cancer. The goals of such programs are twofold: to increase the visibility and availability of nanomaterials and nanoscale devices within the cancer research community and to catalyze those targeted discovery and development efforts that offer the greatest opportunities for translation into the clinic. The NCI would like to identify opportunities, programs, and contracts for specified nanotechnology platforms in cancer research where nanotechnology can have the biggest and fastest impact, including molecular imaging and early detection, in vivo imaging, reporters of treatment efficacy, multifunctional therapeutics, cancer prevention and control, and research enablers. Areas for consideration may include, but are not limited to: o Early imaging agents and diagnostics that will allow clinicians to detect cancer in its earliest, most easily treatable, presymptomatic stage; o Systems that will provide real-time assessments of therapeutic and surgical efficacy for accelerating clinical translation; o Multifunctional, targeted devices capable of bypassing biological barriers to deliver multiple therapeutic agents at high local concentrations, with physiologically appropriate timing, directly to cancer cells and those tissues in the microenvironment that play a critical role in the growth and metastasis of cancer; o Agents capable of monitoring predictive molecular changes and preventing precancerous cells from becoming malignant; o Novel methods for managing the symptoms of cancer that adversely impact quality of life; o New approaches to help understand the complex interactions between cellular molecules ultimately affecting their use as potential markers or targets; and o Research tools that will enable investigators to quickly identify new targets for clinical development and the prediction of drug resistance. Although suggestions may focus on specific technology needs or on cancer biology problems, they must incorporate the application of nanotechnologies to address cancer-specific issues. NCI is aware of the growing interest and involvement of the academic community in the development of nanotechnology for the diagnosis and treatment of cancer. This RFI is commensurate with the NCI Cancer Nanotechnology Plan (see http://otir.cancer.gov), an integrated program of activities that uses nanotechnology to enable rapid clinical and basic research advances and to lower the barriers to technology development and commercialization by the private sector. It is expected that efforts that arise from the Cancer Nanotechnology Plan will generate products in clinical trials or clinical use within the next 5 years. This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a cooperative agreement on the basis of responses to this RFI nor otherwise pay for the preparation of any information submitted or for the Government’s use of such information. Background The NCI wishes to facilitate the use of nanotechnology to develop diagnostic tools and therapeutic interventions for cancer. Nanotechnology offers a wide range of tools, from chip-based nanolabs that are capable of monitoring and manipulating individual cells to nanoscale probes that can track the movements of individual cells and molecules. Such tools will enable cancer biologists to study, monitor, and alter the multiple systems that define cancer processes as well as to identify the key biochemical and genetic focus points for the development of future molecular therapies. As such, nanotechnology can serve as the perfect complement to other technology platforms, such as proteomics and bioinformatics, that are critical components of the discovery and development engine that will power both near- and long- term advances in cancer diagnosis, treatment, and prevention. More importantly, nanotechnology serves as a versatile development platform to rapidly translate biological insights into clinically useful products. Current clinical cancer-related nanotechnology research has demonstrated advances in laboratory-based diagnostics (e.g., nanowires, quantum dots, lab-on-a-chip applications), in vivo diagnostic imaging (e.g., contrast agents, implantable biosensors), and therapeutics (e.g., dendrimers, engineered virus particles, multifunctional nanodevices). These developments will provide insights into the understanding and measurement of numerous aspects of the tumor microenvironment, including the production of growth signals and the regulation of apoptosis, angiogenesis, replication, metastasis, and genomic instabilities. Nanotechnology encompasses a broad range of novel materials, strategies, and devices, and the intent of this RFI is to benefit basic biological research and preclinical research by increasing the variety of available nanotechnologies for cancer and to catalyze their development and commercialization by the public or private sector. The NCI Cancer Nanotechnology Plan is designed to empower multi- disciplinary academic teams to discover and develop nanotechnologies that can be used in basic biological and biomedical studies and clinical trials. The sharing of information on nanomaterials and nanodevices supported by the NCI Cancer Nanotechnology Plan will be promoted through links with public databases available through the Cancer Biomedical Informatics Grid (CaBIG). This paradigm promises to facilitate the understanding of how nanomaterials and nanodevices interact with biological systems and to shorten the timeline for drug development, with resulting benefits to individual patients and to public health. The NCI will use input received in response to this RFI to develop concepts for individual Requests for Applications (RFAs) and Requests for Proposals (RFPs) that focus on directed research programs for specific nanotechnology platforms in cancer. The NCI plans to issue the resulting RFAs in the fall of 2004. The NCI will also fund 3-year nanotechnology projects through a contract mechanism overseen by project specialists. This initiative will target Cancer Centers, small businesses, and Federal laboratories that can support technology programs to create platforms that are aimed at deployment of nanotechnologies for clinical application in cancer research. Applicants will be required to team with NCI Cancer Centers, Specialized Programs of Research Excellence (SPOREs), or other NCI- funded technology development programs with a plan to disseminate the technologies thus developed. Information Requested Information in the following areas will aid the NCI in the design of the announcements for cancer nanotechnology research platforms. We ask that interested organizations identify critical criteria that should be included in the announcements and to describe their interests as well as their current and potential capabilities to meet these criteria. Information presented need not be limited to these areas. Please limit your responses to 10 pages or fewer. 1. Capabilities for Nanotechnology Development and Testing (note: Respondents should address those areas that are applicable) a. Describe your capabilities, or means of acquiring the capabilities, to fabricate, synthesize, and test nanomaterials. Materials that you have developed may be listed, as well as the technical capabilities of personnel and the capacity available in your organization. b. Describe your capabilities to engage multidisciplinary research teams to address cancer nanotechnology issues (e.g., affiliations with university or research centers of engineering or physical sciences, well-developed modules for integrative training in key areas relevant to the enterprise [such as biomaterials and clinical applications of nanotechnology], and relevant private technology development partnerships). c. Describe your laboratory information management system (LIMS) and your capabilities for data analysis and biocomputing. d. Describe your technology assessment capabilities to identify and bring in new nanomaterials and nanotechnologies for cancer research. e. Describe the criteria by which you would judge the usefulness of a nanotechnology research platform for cancer, and how you think that a center should prioritize and coordinate its resources. 2. Equipment/Techniques a. Describe your current facilities and equipment, or plans to acquire the appropriate infrastructure support, and discuss the range of techniques and technologies available in your organization (e.g., animal models, small animal in vivo imaging, materials synthesis and fabrication facilities). 3. Capacity a. Describe the highest level of throughput likely to be obtainable by your organization and discuss the timeline, staff, and equipment additions you believe would be necessary to reach this level. 4. Personnel a. Describe the personnel who would be required to carry out a directed research program in a specific nanotechnology platform relevant to your organization. Include an estimate for the level of effort of each. Responses Responses should be identified with the Notice No. (NOT-CA-04-022) and are due by August 2, 2004. Please submit three (3) copies of your response to Gregory J. Downing, D.O., Ph.D.; Director, Office of Technology and Industrial Relations, National Cancer Institute, NIH, Building 31, Room 10A-52, MSC 2580, 31 Center Drive, Bethesda, MD 20892-2580. Email responses will also be accepted at downingg@mail.nih.gov. For further information on this or other NCI nanotechnology initiatives, please see http://otir.cancer.gov or contact the Office of Technology and Industrial Relations at the address above. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government’s assessment of the information received. However, should such an announcement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government’s use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement. Responses will be held in a confidential manner. Any proprietary information should be so marked.

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