Introduction - UNM Health Sciences Center

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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
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Principal Investigators for these pilot awards must be members of the UNM HSC faculty.
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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
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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
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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
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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.
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