Center for Cancer Nanotechnology Excellence and Translation Department of Radiology, School of Medicine Stanford University http://mips.stanford.edu/grants/ccne-t/ RFA Synopsis: Title: RFA: CCNE-T_P2ACP. Solicitation for Alliance Challenge Project Proposals Release date: December 12, 2011 Application due date: January 20, 2012 (submission window: 1/2/2012-1/20/2012) Amount of Funding: Up to $73,408 total costs for the Stanford portion for 18 months Number of Projects to be Funded: Two projects Project Performance Period: 05/11/2012 – 11/10/2013 (tentative) Contact: Dr. Demir Akin (demir.akin@stanford.edu), T: 650-721-2016 Center Website: http://mips.stanford.edu/grants/ccne-t 1. Purpose: The Center for Cancer Nanotechnology Excellence and Translation (CCNE-T, PI: Sanjiv Sam Gambhir, MD, PhD, co-PI: Shan X. Wang, PhD) is soliciting new trans Alliance Challenge Projects (ACP) from investigators who are participants in the NCI Nanotechnology in Cancer Alliance programs. These ACP proposals will need to be between two or more of the Alliance Programs (http://nano.cancer.gov) such as the CCNEs, CNPPS and CNTCs and must have at least one member from CCNE-T as an investigator and/or PI/co-PI. The ACP proposals are expected to have distinct but complementary research goals to the original grant. The intended goal of these seed projects is to develop new intra-Alliance collaborations between the CCNE-T members and the other NCI Alliance funded program investigators to speed-up the development of nano-based or nano-enabled solutions in the area of Cancer and potentially attract larger funding to facilitate clinical translation of these endeavors. The vision of CCNE-T (http://mips.stanford.edu/grants/ccne-t) is to bring together researchers from various disciplines to form synergistic teams that will make significant advances in developing and validating nanotechnology that will impact cancer diagnosis, therapy and management. Thus, the proposed projects will mainly include those that have a high potential for linking nanotechnology to early detection, therapy response monitoring, diagnostics and pre-clinical imaging models for the improvement of cancer patient management. Potential proposals solely focused on drugs or experimental treatments are strongly discouraged but the proposals with diagnostic or imaging technologies that have therapy components (theranostics) are highly encouraged. If you would like to discuss the suitability of your project for this program funding, please contact Dr. Demir Akin, Deputy Director of the CCNE-T, at 650-721-2016 or demir.akin@stanford.edu before or after the Winter Closure time period. 2. Eligibility: Established investigators (Stanford faculty with UTL, MCL or NTLR appointments or CCNE-T consortium members with PI authorizations). Preference will be given to those investigators who are already involved in the CCNE-T programs or who have strong complementary research areas to the CCNE-T goals and who can synergistically work with the CCNE-T members to form new bridges with the other NCI Alliance funded programs. All applications will undergo the same level of scrutiny before being identified as an appropriate Project. 3. Deadline: January 20, 2012 (see "Submitting an Application" below). 4. Amount of Funding/Budget Information: Applicants may request up to $73,408.00 in total (direct+indirect) costs for 18-month duration of the supplemental Alliance Challenge Projects under this program. Up to two applicants will be selected for funding. Each Alliance Challenge Project will be an 18-month duration project and continuation of a project beyond its first year will be contingent upon the success of the previous year. Once all required documents are received, the selected candidates will have a tentative funding period from 05/11/2012 – 11/10/2013. The exact start and end dates of the research performance periods and the exact amount of the funding will be 1 Center for Cancer Nanotechnology Excellence and Translation Department of Radiology, School of Medicine Stanford University http://mips.stanford.edu/grants/ccne-t/ released by NCI in early 2012. Awards pursuant to this funding opportunity are contingent upon the availability of funds, the receipt of a sufficient number of meritorious applications and the approval of the NCI Program officer of the selected proposals. The selected projects will be required to send all required documents and protocols prior to the initiation of the funding. The due dates will be provided upon selection of the applicants. Attendances to several CCNE meetings are required to show progress of the project. An interim and yearly progress report in NIH format will also be required. In addition, a presentation of progress is required for the annual NCI site visit, which will be held on April 26, 2012 and again in late spring of 2013. 5. Submitting an Application A complete application package consists of the following with the listed page requirements: a. Face page (1 page) b. Project description (3-4 pages including milestones and timetable) c. Budget (1 page) and its justification ( 1/2 page) d. NIH Biographical Sketch of the proposed PI (not to exceed 4 pages) All applications must include a Milestones and Timetable section; these milestones should be descriptive, quantitative and reasonable. This section should clearly provide a timeline and a logical pathway for the development of the proposed technology. The following will be the main evaluation criteria for the proposals. 1. Scientific Value of the Idea(s) and their Relevance to CCNE-T Missions 2. Relevance to Cancer and/or Nanotechnology field 3. Novelty and Clinical Translation Potential 4. Inter Alliance Team and Milestones Proposed 5. Ability to Lead to Extramural Funding after 18 moths 6. Methodology 7. The strength of any preliminary data if exists. 8. Budget—if adequate to accomplish work Applicants should send their individual project proposals as a single e-mail attachment in PDF format to brobles@stanford.edu by Friday, January 20, 2012. Please note that due to the Stanford Winter Closure, the proposal submission period is between January 2 and 20, 2012. Any proposals submitted during the winter closure will not be acknowledged until after 1/3/2012. 5a. FACE PAGE (1 page) Please feel- in the requested information. This information will enable CCNE-T to determine which proposals to fund, which copies of research compliance approvals (human, animal, etc.) will be needed from each awardee before funds can be released. Your department chair and RPM or (for other school faculty-OSR) signatures are not needed for this RFA only. We will collect the full SU-42 forms from only selected projects. Please list the Project Leaders’ and other key personnel (from both CCNE-T and the other Alliance partner) names, titles, departments, and complete contact information. 5b. PROJECT DESCRIPTION (maximum 4 pages) Describe the proposed research, including the following: Research plan. 2 Center for Cancer Nanotechnology Excellence and Translation Department of Radiology, School of Medicine Stanford University http://mips.stanford.edu/grants/ccne-t/ Description of research subjects involved (human or animal). Description of interdisciplinary and trans-Alliance characteristics of this project as to how it utilizes the CCNE-T Resources and the entire range of the NCI's Cancer Nanotechnology Alliance. Explanation of how the proposed research fits into existing CCNE-T (note: illustrations and references are not included in the 6-page limit). 5c. BUDGET (1 PAGE) AND ITS JUSTIFICATION ( 1/2 PAGE) The total allocated funds for Alliance Challenge Projects is $94,600 (direct costs) and each project will be funded for up to 18 months. Please provide a detailed prorated budget up to $47,300 for 18 months in total direct costs at applicable rates. Please note that the CCNE-T Executive Council is likely to choose to fund more than one project therefore, it is highly advised that the budgeted research is appropriate for the funding level. Please provide a ½ page Budget Justification in NIH format. 5d. Biosketch (NIH format) for the Project Leader and Co-Investigators - Other Support (NIH format). Please include both active and pending support SELECTION PROCESS: All applications will be reviewed by the Center Executive Council for their suitability for the goals of CCNE-T and the Alliance. Preference will be given to those investigators who are already involved in the CCNE-T program or who have strong complementary research areas to the CCNE-T goals. All applications will undergo the same level of scrutiny before being identified as an appropriate Project. Example evaluation factors are given below. INQUIRIES/CONTACT PERSON: Applicants are welcome to discuss their plans in response to this solicitation. Please direct all initial inquiries to Dr. Demir Akin at demir.akin@stanford.edu or by phone at 650-721-2016. Please note that the release of funds will be contingent upon verification by CCNE-T of the recipient's human subject, SCRO, and animal subject approvals and compliance with other administrative issues. 3 Center for Cancer Nanotechnology Excellence and Translation Department of Radiology, School of Medicine Stanford University http://mips.stanford.edu/grants/ccne-t/ 5a. FACE PAGE LEAVE BLANK—FOR CCNE USE ONLY. Type: ACP Number: Date Initiated Stanford University Center for Cancer Nanotechnology Excellence and Translation Alliance Challenge Project Grant Application 1. TITLE OF PROJECT 2. STANFORD PRINCIPAL INVESTIGATOR NAME (Last, first, middle) POSITION TITLE MAILING ADDRESS (Street, city, state, zip code) DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT MAJOR SUBDIVISION TELEPHONE AND FAX (Area code, number and extension) TEL: E-MAIL ADDRESS: FAX: 3. HUMAN SUBJECTS 3b. RESEARCH No Yes 3a. Exempt Research No Yes 5. Human Stem Cells No Yes 8. Recombinant DNA No Yes Human Subjects Assurance No. 4. VERTEBRATE ANIMALS 3d. NIH-defined Phase III Clinical Trial No Yes 3c. Clinical Trial No Yes No Yes 4a. If “Yes,” IACUC approval Date 4b. Animal welfare assurance no. 6. Radiological Hazards No Yes 7. Human Blood or Body Fluids No Yes If “Yes,” Exemption No. If Yes, approval number of the Stem Cell Research Oversight Panel : 10. All participating researchers, including postdocs, students and scholars, signed Stanford's Patent & Copyright form (SU-18/18A) 9. Infectious/Biohazardous Agents No Yes 11. DATES OF PROPOSED PERIOD OF SUPPORT (month, day, year—MM/DD/YY) From Through 5/10/2012 11/09/2013 No 12. COSTS REQUESTED FOR BUDGET PERIOD 12a.Direct Costs ($) Yes $ KEY PERSONNEL. List all other key personnel in alphabetical order, last name first. Please list the intra-Alliance Collaborators here. Name and Primary Title Degree(s Organization ) 4 Role on Project Center for Cancer Nanotechnology Excellence and Translation Department of Radiology, School of Medicine Stanford University http://mips.stanford.edu/grants/ccne-t/ 5b. PROJECT DESCRIPTION (maximum 4 pages) State the application’s broad impact, long-term objectives and specific aims. Description of interdisciplinary and trans-Alliance characteristics of this project as to how it utilizes the CCNE-T resources and the entire range of the NCI's Cancer Nanotechnology Alliance. Explanation of how the proposed research fits into existing CCNE-T goals Describe concisely the research design and methods for achieving these goals. Description of research subjects involved (human or animal or in vitro cultured cells). Describe the rationale and techniques you will use to pursue these goals. Describe the path and brief timeline to extramural funding. Note: illustrations and references are not included in the-page limits but should be kept to reasonable minimum. Milestones and Timetable Milestones 2012 1 2 3 4 2013 1 2 3 4 5 Center for Cancer Nanotechnology Excellence and Translation Department of Radiology, School of Medicine Stanford University http://mips.stanford.edu/grants/ccne-t/ 5c. BUDGET (1 Page) and BUDGET JUSTIFICATION (1/2 Page) 5c1. Budget : Principal Investigator (Last, First, Middle): DETAILED BUDGET FOR INITIAL BUDGET PERIOD DIRECT COSTS ONLY PERSONNEL (Applicant organization only) ROLE ON PROJECT Principal Investigator NAME Acad. Mnths Sum. Mnths THROUGH 5/10/2012 12/31/2012 DOLLAR AMOUNT REQUESTED (omit cents) Months Devoted to Project Cal. Mnths FROM INST.BASE SALARY SALARY REQUESTED FRINGE BENEFITS TOTAL SUBTOTALS CONSULTANT COSTS EQUIPMENT (Itemize) SUPPLIES (Itemize by category) TRAVEL PATIENT CARE COSTS INPATIENT OUTPATIENT ALTERATIONS AND RENOVATIONS (Itemize by category) OTHER EXPENSES (Itemize by category) CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS TOTAL DIRECT COSTS $ 6 Center for Cancer Nanotechnology Excellence and Translation Department of Radiology, School of Medicine Stanford University http://mips.stanford.edu/grants/ccne-t/ 5c2. Budget Justification: 7 Center for Cancer Nanotechnology Excellence and Translation Department of Radiology, School of Medicine Stanford University http://mips.stanford.edu/grants/ccne-t/ 5d: NIH BIOSKETCH of the PI. BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE eRA COMMONS USER NAME (credential, e.g., agency login) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) INSTITUTION AND LOCATION DEGREE (if applicable) MM/YY FIELD OF STUDY NOTE: The Biographical Sketch may not exceed four pages. Follow the formats and instructions below. A. Personal Statement Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application. B. Positions and Honors List in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee. C. Selected Peer-reviewed Publications D. Research Support List both selected ongoing and completed research projects for the past three years (Federal or non-Federallysupported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs. 8