Wallace H. Coulter Center for Translational Research

RFP Issued: Nov 5th, 2013

Due Date: Jan 6, 2014

Initial Review: Mid February 2014

Oral presentations:Last week of March or first half of April2014

Funding Start Date:June 1, 2014

Principal InvestigatorDepartment Chair or Center Director

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Name (signature) Name (signature)

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Name (print) Name (print)

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TitleTitle

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DepartmentDepartment

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Phone Number

Project Title, Funds Requested and One paragraph Summary (350 word limit)

In accordance with the requirements of this proposal, the undersigned offers and agrees, if their proposal is accepted, to comply with the terms specified in this proposal.
Mission Statement

TheWallace H. Coulter Center (“WHCC”) at the University of Miami is focused on turning translational research in biomedical science and engineering into products by commercializing research projects that address an unmet clinical need and have market potential. We work with investigators as a team to help them carry the project from a translational stage to a tangible product that impacts public health. The success metrics for our center include either successful licensing to an established company or creation of new professionally managed and financed UM start-ups. Emphasis is placed on ability to secure follow-on funding and translate into a successful license or start-up in less than 3 years.

Eligibility

The PI must be a permanent, full time faculty member of the University of Miami Leonard M. Miller School of Medicine. Applicants should contact Melda Uzbil, Coulter Project Director, ()and Dr. Robert Zivin ()to discuss potential projects and criteria. Working closely with the Coulter Team before the RFP deadline has resulted in increased likelihood of funding for the PIs.

Criteria

In order to be considered for WHCC funding and support, the proposed product must:

a) address an unmet clinical need,

b) have commercial potential,

c) be patentable or otherwise protectable

d) be able to raise follow-on funding, and

d) have the potential to get licensed to an established company or a professionally funded and managed start-up in less than3years.

Availability of matching funds for the project is not required buthighly desirable.Matching funds could be derived from a government grant related to the project or from corporate, philanthropic or foundation sources. WHCC resources are not available to pay for work performed to obtain regulatory approvals for a clinical product that is owned by a third party, nor is support provided to fund projects for which intellectual property revenue will be directed solely to another party (university, company, etc). Up to $125,000/year direct costs can be requested; no facilities and administration funds are associated with these grants.

WHCC's resources are not intended tosupport basic research, but aim to commercialize UM intellectual property (IP) by funding translational projects that are post discovery phase and require specialized expertise intechnology transfer and commercialization activities i.e. identification of corporate partners, investors, and licensees, assessment of market value, regulatory approval, testing in pre-clinical models or translation to human cells and reagents.

Milestones and timeline must describe the plan for bringing the project to a point where it can be licensed to an established company or a professionally funded and managed start-up in less than 3 years. Approved projects will be fundedforone year; additional years of funding can be obtained via competitive renewal. Any applications that include requests for funding of PI salaries will be limited to the NIH salary cap presently in effect. Due to the award period of one year, TBA positions should not be included in these applications.

The proposal body should be no more than 5pages in length excluding cover page, biosketches, budget, approvals or references.

CENTER PROJECT APPLICATION

Projects will be reviewed for scientific strength, but the primary focus will be on commercial potential. Projects that pass initial review by the Oversight Committee will be invited to present in personfor the final funding decision.

All proposals should be prepared based on an 8½ X 11” paper size: 1” margin, Arial 11 font and left alignment.Incomplete applications will not be reviewed.

  1. Cover Page (1page)
  2. Project title
  3. PIs including departments
  4. Project title, funds requested and short paragraph of project description.
  1. Unmet Clinical Need and the Solution (1 page)–Describe the unmet clinical need and the current standard of care (or current solutions) for the unmet need you are proposing to address with your technology/product. Discuss the patient population, doctors or other users who will benefit from your product. Who will buy this product and who will pay for it? Clearly describe the end product and the target application (Please identify a clear target application for your proposal). What is the underlying technology? Describe the current stage of the technology/product.Briefly discuss other potential future applicationsbesides your target application.
  1. Background and Significance (1 page) - An overview of the research field with emphasis on the significance of the proposed work. Include preliminary results.
  1. Research Plan(1 page) - Provide a detailed plan for the research activities that need to be undertaken during the Coulter grant and also briefly discuss the plan for the 2 years following theCoulter grant. Concisely describe the specific aims and the activities to be accomplished to achieve these aims. Include key areas where WHCC expertise will be needed; note potential pitfalls and alternatives.
  1. Quarterly Milestones (1/2 page) – Include a table of quarterly research and commercialmilestones and a plan for achieving them. These should align with the research plan.
  1. Commercialization Plan and Intellectual Property Status (1.5 page)– This section focuses on the IP status, potential competition, and plan for commercialization.
  1. Compare the envisaged product resulting from this project to the current standard of care as well asother technologies/solutions that are currently available and/or under development by the research community for the specific problem you are trying to solve. Are any of these competing solutions currently in clinical trials? Please list.
  2. Describe the advantages of your technology over existing solutions or other solutions under development.
  3. Will the proposed research lead to a new product or to improvements of existing products? Will it replace an existing product and/or service in the market? Is this a disruptive product/technology?
  4. What is the US market size i.e. how many patients could use the resulting therapeutic, device or diagnostic? How many procedures or tests currently being done per year in the US (if applicable)?
  5. What is the regulatory path? Are there similar products that have been approved by the FDA?
  6. Is there existing reimbursement for your product? Or would it require a new reimbursement code?
  7. How will this research attract a commercial licensee or investor looking to invest into a start-up around it within 3 years? List the start-ups companies or established companies that are developing similar products. List the companies that could be interested in licensing your product.
  8. Provide a description of any relevant intellectual property, including patents, patent applications, invention disclosures, copyrights, know-how, etc. Are there existing patents that the PI is aware of that could have an impact on this project? Does the PI have existing corporate relationships pertinent to this project? Has the IP already been licensed or encumbered, e.g., by an industry sponsored research agreement? Does the IP belong to UM? If you have worked with UM’s technology transfer office, who is your case manager? This section must be clearly addressed
  9. Plan for follow-on funding after Coulter award expires. (i.e. NIH-R01, SBIR/STTR, Venture Capital, license, etc.).

Please contact Melda Uzbil, Coulter Project Director, to discuss this section. Applications that do not specifically address this section in detail will not be considered for funding.

Sections II-VIshould not exceed 6 pages.

  1. ProjectBudget–Utilizing the NIH form page 4 (see last page), detail the direct costs for the year including personnel, supplies, animals, etc. Provide a description of key personnel and their responsibilities. Describe the resources needed to move the project forward; articulate the need for additional personnel, supplies, regulatory expertise, etc. to make the work progress in a timely fashion. Travel, and facilities and administration costs, will not be supported. In general, funds for equipment or computers will not be supported, unless highly specific and essential to the project. Provide a detailed budget justification for personnel and supplies.
  2. Approvals - Provide approval date and number for all human subjects or animal protocols. For human subjects, include IRB and applicable IND numbers. If the project is selected, hard copies of approval letters will be required prior to initiation of work.
  3. Current sources of support - Provide NIH biosketch for PI and key personnel (4 page NIH format). Indicate whether or not support for this project is being sought elsewhere.

Additional Submission Details

Proposals with signatures should be submitted in one electronic pdf documentto Melda Uzbil (), copied to Tamara Levine at .

Questions should be submitted via email to the attention of Melda Uzbil and Robert Zivin.

Utilize NIH form page 4 for the budget (see last page of RFP).

Reporting

Writtenquarterly progress reports will be submitted after project initiation andinclude the following. A report template will be provided by the Coulter Center. For projects that have reached an end, a complete report is due within 60 days of completion.

1) progress towards milestones and objectives,

2) significant changes to the research plan,

3) presentations or manuscripts submitted or published,

4) invention disclosure or patent activity,

5) commercialization, licensing or technology transfer/progress activity,

6) follow-on funding including grants, other funded applications andawards.

The Coulter Center Team will meet with funded PIs on a quarterly basis.

The Coulter process is a team effort that involves the PI, his/her team, the technology case manager from the technology transfer office, as well as the director of the office, and Coulter Center personnel. This team approach allows for maximal support of the project towards commercialization. In addition, the scientist will involve a clinician or clinician scientist who can advise on current practices and clinical applications of the potential product.

Contact Information:

Melda Uzbil, M.E.M

Coulter Project Director

Coulter Center

Norma S. Kenyon, Ph.D.

Martin Kleiman Professor of Surgery

Chief Innovation Officer, Leonard M. Miller School of Medicine

Vice Provost for Innovation, University of Miami

305-243-5346

Robert Zivin, Ph.D.

Research Associate Professor of Medicine

Senior Fellow, Coulter Center

305-243-0284

Tamara Levine, M.S.

Director, Business Operations

305-243-5346

Program Director/Principal Investigator (Last, First, Middle):

DETAILED BUDGET FOR INITIAL BUDGET PERIOD

DIRECT COSTS ONLY

/ FROM / THROUGH

List PERSONNEL(Applicant organization only)

Use Cal, Acad, or Summer to Enter Months Devoted to Project

Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

NAME / ROLE ON
PROJECT / Cal.
Mnths / Acad.
Mnths / Summer
Mnths / INST.BASE
SALARY / SALARY
REQUESTED / FRINGE
BENEFITS / TOTAL
PD/PI
SUBTOTALS
CONSULTANT COSTS
EQUIPMENT (Itemize)
SUPPLIES (Itemize by category)
TRAVEL
INPATIENT CARE COSTS
OUTPATIENT CARE COSTS
ALTERATIONS AND RENOVATIONS (Itemize by category)
OTHER EXPENSES (Itemize by category)
CONSORTIUM/CONTRACTUAL COSTS / DIRECT COSTS
SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 7a, Face Page) / $
CONSORTIUM/CONTRACTUAL COSTS / FACILITIES AND ADMINISTRATIVE COSTS
TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD / $

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