CTSI Request for Applications for the Incubator Program by dbfQd67


									                       University of Rochester Medical Center
                    Clinical and Translational Science Institute
              Request for Applications for the Incubator Program - 2011

         The University of Rochester Clinical and Translational Science Institute (CTSI) is
pleased to announce this Request for Applications for the Incubator Program. This initiative is
an expansive pilot program that might be termed a “superpilot” award and may be thought of as
a “program project pilot” mechanism. Like traditional program project grants, the award is
meant to fund two or more individual pilot projects by collaborating investigators linked to a
scientific or clinical theme. The program seeks to solicit areas for development of the most
promising clinical and translational research within the institution, where larger, carefully
targeted investments can accelerate progress. The scope of these awards will create stand-
alone research programs, and will go through a two-step preliminary and final application
process. These applications will receive a high level of input and guidance by the CTSI Core
Expert Team to help shape and refine the applications during the application process. A CTSI
Project Officer will work with the funded investigators and facilitate engagement with the Core
Expert Team subsequently during the conduct of the research. The intention is to fully engage
the new Incubator Projects and investigators with the scope of resources available from the
CTSI, and will provide a new facilitative role to develop new research programs using the well
established pilot studies key function of the University of Rochester CTSI.
         The goal of the RFA is to identify research collaborations at the institution with
tremendous potential for developing programs that will catalyze breakthrough treatments,
diagnostic techniques, or quantum leaps in community health. We would anticipate that
successful Incubator Projects would utilize the award to provide the groundwork to ultimately
achieve programmatic levels of extramural funding in the research area. Several programs will
be chosen each year, with a goal of creating a balanced portfolio of programs across the
translational spectrum of biomedical research. These “superpilot” programs will be eligible for
awards of up to $125,000 per year, and will be made for two years of support per research
program. This substantial level of funding and two-year duration will enable greater forward
progress and momentum in programmatic directions, and higher ultimate impact than we are
able to achieve with the smaller, one-year pilot awards. For especially promising and productive
Incubator projects following their initial funding year, the option of a third year of funding will be
         Examples of Incubator Projects might include basic mechanistic studies of a disorder
linked with clinical diagnostic or therapeutic projects, or studies of a pathway, therapy, or
outcome measure applicable to a range of related disorders to enhance the research impact.
Providing support for collaborative research to create a project needed to complement other
existing projects in preparation for a Program Project or Center type of extramural grant
application would be another supported use of Incubator Project funding. A key feature of the
Incubator Program is the involvement of the Core Expert Team. The Team not only aids in
identification of the most promising applications to the Incubator program for potential funding,
but also provides recommendations and guidance to enhance the final applications selected to
submit full proposals as a result of the initial review of abstracts that respond to this RFA. The
recommendations and guidance that are part of the process of preparing the final full proposals
contributes URMC expertise to improve the science and ultimate outcome of the proposed
Incubator projects. To this end the Core Expert Team is comprised of individuals able to
contribute key expertise to project and trial design and implementation, and is intended to
engage the Incubator Project Investigators more directly with the consultants and mentors as
well as other assets of our CTSI. We expect this process to result in enhanced integration of
the different resources that are available across the institution and beyond.
         This approach will enable us to focus CTSI resources more broadly on the most
promising translational research programs. We will provide pilot funding to allow for collection
of key data needed to advance translational research, as well as assist in development of novel

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                                                                   Incubator Program RFA 2011

research methodologies and clinical trial design specifically targeted to overcoming barriers
identified as preventing progress in the Incubator Projects. The Core Expert Team will interact
with the individual Incubator Project Investigators through periodic workshops that will occur
every 4-8 weeks during preparation of applications from those programs selected for
submission of full proposals. The CTSI will assign a staff member to serve as a Project Officer
for each funded Incubator project team. During the award period, the Project Officer will
facilitate ongoing engagement with members of the Core Expert Team and with other CTSI,
institutional and CTSA Consortium resources, as appropriate. These are mandatory features
of the Incubator Program. This process will provide ongoing resources and expertise for
modification and improvement of research. The specific details of implementing these
resources will be provided to each applicant whose abstract was chosen for submission of a full
proposal. For the selected research programs, the Incubator Program will be able to:
         a. Provide bioinformatics expertise necessary to support the Incubator project.
         b. Provide needed research equipment and access to laboratory technologies.
         c. Provide expertise and connections to foster connections with targeted segments of
            the community.
         d. Provide regulatory support, intellectual property support, project management and
            team facilitation support.
         e. Provide research facilities and space necessary to advance the Incubator project,
         f. Provide expertise in biostatistics, epidemiology, and ethics tailored to the needs of the
         g. Encourage TL1 trainees and KL2 scholars to develop their research projects around
            current or past Incubator projects.
         h. Provide mentoring support, including mentor development consultations and support
            for senior mentors for Incubator project directors.
         i. Provide assistance with respect to searching for and acquiring other sources of funds
            to support the Incubator Project after the period of CTSI support, which will be an
            expectation of all Incubator Projects.

Eligibility for Incubator Program: Two or more linked projects, analogous to a program
project, will be required, with faculty PIs for each project, and identification of the overall
Incubator Project leader. Ability of interaction among the projects to accelerate progress toward
clinical applications and achieve high biomedical impact rapidly are crucial determinants, as are
multidisciplinary interactions. Moreover, progress on developing novel therapeutics affecting
significant numbers of patients needs to be evident. All principal investigators of proposals must
be faculty at the University of Rochester, and must have written consent of the Department
Chair and/or Center Director. Co-investigators may be from other institutions.

Selection Process: A preliminary 2-page abstract describing the Incubator Project will initially
be submitted, which should clearly identify the short and long term goals and the linkages
between the individual projects involved, highlighting innovative aspects and clinical impact of
the proposed research. The Pilot Translational and Clinical Studies Incubator Program Key
Function Coordination Committee, with input from the Core Expert Team, will evaluate, score
and discuss all the preliminary applications, and with guidance from the CTSI Director (Dr.
Thomas Pearson, Senior Associate Dean for Clinical Research) and Co-director (Dr. J. Edward
Puzas, Senior Associate Dean for Basic Research) will invite the most meritorious proposals for
an in person oral presentation to the Committees by the teams of investigators for feedback to
refine their proposals. In addition, all preliminary applications not scored well enough to qualify
for solicitation of a full proposal will receive feedback comments from the combined review
committees to help them in improving potential future submissions or changing research
directions. The Core Expert Team then will work closely with the selected applicant teams to

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                                                                   Incubator Program RFA 2011

determine how CTSI and other resources can be best deployed to advance the proposed
projects. Resources can include additional effort on the part of Core Expert Team members,
additional effort provided by other UR researchers, funds for equipment or services, etc. The
result will be a full application for Incubator support developed and submitted over a 3 month
         The Coordination Committee, again with input from the Core Expert Team, will then
subject the full applications to rigorous scientific review using the Committee and drawing from
its large pool of committed ad hoc expert reviewers representing essentially every scientific field
and School within the University community. Following the review process and a formal study
section style discussion and scoring meeting, recommendations will be made to the Executive
Committee of the CTSI for funding of the most meritorious programs, based on:
         1. Scientific merit
         2. Likelihood that CTSI resources will make a dramatic difference in the Incubator
             Program’s ability to discover and disseminate new knowledge that improves human
         3. Demonstrated investigator expertise and commitment to the research program
         4. Likelihood of sustaining the proposed research program through other resources
             before and after the CTSI award is complete.
         5. Commercialization potential or public health benefit, depending upon the nature of
             the program.
         6. Involvement of a multidisciplinary team that cuts across Schools, departments,
             centers, and UNYTRN institutions
         7. Involvement of students and trainees in the research team.

Project Officer: At least monthly during the two years of funding all Incubator project teams will
meet with the assigned CTSI Project Officer to review obstacles and difficulties related to their
projects, and to receive advice on how to overcome such problems. The Project Officer will
facilitate the engagement of a diversity of high-level expertise in the areas of research protocol
and clinical trial design, epidemiology, clinical research ethics, subject recruitment and retention,
biostatistical design, bioinformatics, regulatory support, laboratory support services/research
technology resources. In addition, this will serve to much more strongly engage the
investigators assisted by the Incubator Program in the CTSI overall, and potentially establish
new programmatic levels of collaboration as well.

Allowable Costs: The Incubator Program will support costs normally allowable for NIH-funded
research projects, including faculty and other salaries. Facilities and administrative costs or
“indirects” will not be supported, either internally or for subcontracts with other institutions.

Application Process:
Applicants will submit a two-page abstract of their proposal, which will be reviewed by the
Coordinating Committee and Core Expert Team as described above, and a limited number of
projects will subsequently be invited for oral presentations of the Projects to the Committees.
Following the oral presentations, a selected number of programs will be invited for full proposal
submissions, and will meet with the Core Expert Team during the 3 months allotted for
application preparation to refine the proposals. If selected for a full proposal, additional
application materials will be required and details will be supplied at that time.

Deadlines: Initial abstracts of proposals must be received by August 19, 2011. Applicants from
whom oral presentations to the Committees are invited will be notified in mid-September, 2011,
and the presentations will be scheduled during early October with applicants subsequently
invited for full proposals notified by November 1, 2011. Final applications will be due by March

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                                                                Incubator Program RFA 2011

1, 2012, and awards will be made by May 1, 2012, with an anticipated start date of July 1, 2012.
Note: All animal and human subject protocols must be approved prior to the start date.
No funds will be released until these approvals have been documented.

Format for Abstract Submission: Abstracts are to be limited to 2 pages with no smaller than
an 11 point font, and should use the attached application form. The information to be provided
(1)    Title of the Incubator Project
(2)    Investigators, with clear identification of PI and full contact information. Both the
       lead principal investigator of the Project and the PI’s and co-investigators of the
       individual sub-projects should be included.
(3)    Total amount of money requested
(4)    Indication as to whether the application is new or a revision
(5)    A description of how the proposal is responsive to the Incubator Program RFA
(6)    Overall goals of the Project
(7)    A brief description of the specific aims and research plan for each sub-project
(8)    A signed attestation statement that the project is not funded through another mechanism
(9)    A signed statement indicating that the Department Chair and/or Center Director is
       supportive of the application

Submission: Proposals must be submitted electronically by email to Mary Little at
Mary_Little@urmc.rochester.edu .

Details of the full proposal application procedure will be provided at the time of
notification of invitation.

Contacts: If you have questions regarding this RFP, please contact one of the following.

General inquiries:
Mary Little

Scientific and Peer Review contacts:
Randy Rosier, MD PhD
Richard Moxley III, MD

Financial contact:
Kathleen Jensen, MHSA

Other questions:
Thomas Fogg, MS MPH

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                                                                     Incubator Program RFA 2011

                         CTSI Incubator Program Application Face Page

                              Submission deadline: August 19, 2011

Proposal Title

Principle Investigator

       Department           Area of Research

       E-mail address


Co-Investigator(s) (if applicable)                            Co-Investigator(s) (if applicable)

Department          Area of Research                    Department          Area of Research

       E-mail address                                      E-mail address

       Phone                                               Phone

       Institution (if not URMC)                         Institution (if not URMC)

Amount Requested $

     New Application                   Human subjects involved

     Revised Application               Vertebrate animals involved

I attest there is no current funding of this proposal through any other funding source.

PI       Date

Please include page number and name of PI in the footer of the application.

Please include any additional Co-Investigators at the footer of the application as well.

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