Clinical & Translational Science Center CTSC New Technology & Commercialization Award REQUEST FOR APPLICATIONS {revised} Re-Issue Date: July 26, 2011 Introduction The Clinical and Translational Science Center (CTSC) of the University of New Mexico (UNM) Health Sciences Center (HSC) is soliciting applications from all HSC faculty members- senior as well as junior investigators- for the development of new technology and its commercialization. These technologies should help fulfill the CTSC mission of developing novel approaches to translational research and to promote and support the bench-tobedside-to-community goal of the NIH. The purpose of this RFA is to support innovative, high-risk/high-reward pilot projects to produce preliminary data for competitive NIH proposals in clinical and translational research. Most awards will be expected to seek NIH funding probably through an SBIR/STTR mechanism. These projects are intended to provide the preliminary data and initial corporate relationships to develop technology and move it towards successful commercialization. Clinical research is defined, in accordance with the NIH definition, as research conducted with human subjects or on material collected from humans for which an investigator directly interacts with a human subject to broaden knowledge about mechanisms of disease, therapeutic interventions, or clinical trials, or to develop new technology. Epidemiological population-based, behavioral studies and community interventions, as well as outcomes and health services research, are considered clinical research. Translational research is defined to include four emphases: 1. Phase 1 translational research (T1) includes the process of applying basic research discoveries to develop trials and other studies in humans (i.e., case series, phase I and II clinical trials). 2. Phase 2 translational research (T2) is directed at better patient outcomes and the development of evidence-based guidelines. 3. Phase 3 translational research (T3) implements evidence-based guidelines into health practice through community practice (delivery, dissemination, and diffusion research). 4. Phase 4 translational research (T4) evaluates the health outcomes of applications of translational research in the community. We will award several grants ranging from $5,000 to $25,000 to be spent between 01 October 2011 and 30 September 2012. Please note: All funds not spent by the end date of the New Technology & Commercialization Award (30 September 2012) will be returned to the CTSC and NIH. No extensions will be granted. Investigators are strongly encouraged to have IRB approval in place prior to the beginning of the funding cycle so that pilot award funds may be spent during the funding period. Application Deadline, Notice of Awards and Funding Cycle Application Deadline: 01 September 2011 Notice of Awards: 26 September 2011 Funding Cycle: 01 October 2011 to 30 September 2012 Eligibility and Project Requirements Principal Investigators for these pilot awards must be members of the UNM HSC faculty. 1 Eligible projects will cover a wide range of translational science from the development of novel devices or drugs, strategies for commercialization of translational technologies, novel approaches to clinical investigations, and development of novel methodologies for translation of science to communities. However, in all cases we are looking for products that will ultimately be commercializeable and lead to better health care. Collaborative proposals should be considered with corporate partnerships which have demonstrated working success, due to the short timeframe of these proposals. All investigators selected to receive funding will be expected to submit a Final Progress Report at the end of the funded project and an additional report one year later, detailing progress to date, expenditures, and all submitted publications and grant applications (pending or funded) relating to the pilot project. Evaluation Criteria Applications should be well written, precise, and succinct. Applications will be subject to both scientific and programmatic review and will receive scientific review by the CTSC Review Committee. The following criteria will be used in evaluating these proposals: 1. Scientific merit/quality of research plan 2. Impact, Innovation and Novelty of approach; importance of reward/benefit to clinical or translational science 3. Probability of extramural funding through the usual NIH or SBIR/STTR mechanisms (Please include a paragraph on the qualifications of the investigator, as well.) 4. Utilization of CTSC resources – Development of devices, technology, or drugs that are successfully developed through this proposal are expected to utilize CTSC resources, such as the Clinical Research Unit, when applicable. Presentations and Publications Awardees are expected to publish their findings in scholarly peer-reviewed journals and present their research at professional meetings. All publications, grants, and presentations resulting from research funded by the CTSC or using CTSC resources should cite the CTSC as a contributing source of support and indicate the CTSC’s NIH CTSA grant title and number: “University of New Mexico Clinical and Translational Science Center, DHHS/NIH/NCRR #1UL1RR031977-01." Investigators are responsible for submitting any peer-reviewed journal articles resulting from research funded by this award to PubMed Central, the NIH digital archive of biomedical and life sciences journal literature. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html Budget Guidelines Awards may support research costs, as well as CTSC core services in: nursing and trial coordinator services biostatistical services, including o study design assistance o power analysis o data analysis clinical bioinformatics warehouse services RIOSNet biochemical laboratory services and sample processing survey development and implementation development of customized, web-based data collection tools 2 full service bionutrition services, including o metabolic rate assessment o body composition o study meal preparation o DXA bone densitometry assistance with commercialization: pairing investigator with appropriate Angel investor, SBIR guidance, STC liaison access to community liaison services access to CTSC translation technologies: o clinical laboratory support o flow cytometry o high-throughput small molecule screening o microarray analysis o human MRI/MEG imaging Costs not covered under these awards are: faculty salaries graduate student stipends administrative or office costs (e.g., office supplies, telephone, etc.) meals or hospitality (i.e., no food, beverages, or alcohol) travel non-HSC staff salaries other items typically supported by indirect costs How to Apply Proposals should demonstrate the following: 1) rationale—importance of the work to translational science; 2) innovation that will improve clinical and translational research; 3) why the proposed approach is significantly more innovative than existing methodologies; & 4) justification of investigator’s ability to succeed based on historical efforts of taking intellectual risks or challenging paradigms, history of developing successful partnerships to overcome challenges, and persistence using alternative approaches to overcome unanticipated barriers. Emphasis on concise communication of the relevant information will help to demonstrate effective proposal writing and communication skills, and the likelihood of success in developing the full, competitive proposals to follow these pilots. Applications should include in this order: 1. A completed Cover Sheet Form (the “CTSC Pilot and Collaborative Research Projects Program Grants Application” form). This form can be found at: http://hsc.unm.edu/research/ctsc/docs/CTSC_pilot_project_application_9Dec2010.pdf 2. Your Research Plan ( 5 pages, in the following order): a. significance (½ page) b. innovation/novelty – describe high risk/high reward aspects of project and applicant’s record of success with other high-risk projects (1 page) c. background and approach 3. NIH Biographical Sketches for the significant participants (maximum of 3 sketches, 4 pages each). a. The NIH biographical sketch form can be found at: http://grants.nih.gov/grants/funding/phs398/biosketch.doc b. A sample NIH biographical sketch form can be found at: http://grants.nih.gov/grants/funding/phs398/biosketchsample.doc 3 4. Detailed budget, budget justification, and justification that funds can be spent by 30 September 2012 ( 2 page; budget in table format, followed by a concise budget justification in narrative form) See Budget Guidelines section for details. 5. Specific plan to obtain extramural funding, including: 1) an outline of planned specific aims of the future NIH application that this CTSC award would support, 2) brief explanation of why the data generated by this CTSC award will significantly strengthen such a future NIH application, 3) a timeline of planned NIH grant submission, and 4) a description of corporate partner relationships ( 2 pages). Projects are expected to submit for extramural funding by the end of the pilot funding phase 6. No appendices are allowed. Applications must adhere to the following formatting specifications: 11-point Arial font Single-spaced ¾” margins on all sides 8 ½” x 11” (i.e., standard size) paper Number all pages Send your completed application via e-mail in one PDF file to Bambi Wolf (BWolf@salud.unm.edu) by 5:00 pm 01 September 2011. Applications that are late or do not adhere to the above instructions may not be reviewed. Please call Bambi Wolf (2-6556) with any questions about this RFA or the application process. 4