Wallace H. Coulter Center for Translational Research 2016 Commercialization Grant RFP Issued: Nov 17, 2014 Due Date: 8:00 a.m. Tuesday Jan 6, 2015 Oral presentations: March, 2015 Award Notification: April, 2015 Funding Start Date: June 1, 2015 Principal Investigator Name (signature) Name (print) Title Department Phone Number Department Chair or Center Director Name (signature) Name (print) Title Department Departmental Administrator (Name) Departmental Administrator Email & Phone Project Title, Funds Requested and Executive Summary (350 word limit) Project Title: Funds Requested: Executive Summary: In accordance with the requirements of this proposal, the signator offers and agrees, if their proposal is accepted, to comply with the terms specified in this proposal.
Mission Statement The mission of the Wallace H. Coulter Center ( WHCC ) at the University of Miami is to promote translational research in biomedical science and engineering by capitalizing on research projects that address an unmet clinical need and have commercial potential. This will be achieved by providing the investigator with the core capabilities and expertise to carry the project from an experimental finding to a tangible application that enhances quality of life and has significant impact on public health. Eligibility The PI must be a permanent, full time faculty member of the University of Miami Leonard M. Miller School of Medicine primarily and be readily available during the funding period. Applicants must 1. Attend the Coulter information session on December 2, 2014, 2. OR contact Andrew Vinard (avinard@med.miami.edu) prior to December 2, 2014 to set up an in-person meeting. All PIs and Co-PIs are required to be active participants in the process. Please note that our typical process includes several conversations with the applicants prior to the application deadline to help improve your proposal and increase the chance of successful funding. Applicants who have worked closely with the Coulter Center before the proposal deadline have had better funding outcomes. Application Criteria WHCC's resources are not intended to support basic research, but aim to commercialize UM intellectual property (IP) by funding translational projects that are post discovery phase and require specialized expertise in technology transfer and commercialization activities i.e. identification of corporate partners, investors, and licensees; assessment of market value or regulatory approval pathway; testing in pre-clinical models or translation to human cells and reagents. In order to be considered for WHCC funding and support, the proposed product must: a) Be patentable or otherwise protectable b) Have IP belonging to the University of Miami c) Address an unmet clinical need d) Have commercial potential Commercial potential is the likelihood of investment or licensing by a company with adequate resources. e) Have the potential to be licensed to an established company, or become a professionally funded and managed start-up within 2-4 years. Budget Guidelines Up to $125,000/year direct costs can be requested; no facilities and administration funds are associated with these grants. Applicants are strongly encouraged to minimize fund requests for faculty salary support. 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. Project period Approved projects will be funded for one year beginning June 1, 2015. Additional years of funding can be obtained via competitive renewal.
Proposal Format All proposals should be prepared on 8½ X 11 paper size with 1 margins, Arial 11 font, single spacing, line breaks between paragraphs, and left alignment. Only proposals meeting format guidelines will be evaluated. Incomplete applications will not be reviewed. The proposal body should be no more than 5 pages in length excluding cover page, provided appendices, biosketches, budget, approvals or references. See application instructions on subsequent pages for full guidelines Proposal Submission Submission Deadline: 8:00 a.m., Tuesday, January 6, 2015 Proposals with signatures should be submitted in one electronic pdf document to Andrew Vinard (Avinard@med.miami.edu), copied to Melda Uzbil (melda@miami.edu) and Tamara Levine at tlevine@med.miami.edu. Questions should be submitted via email to the attention of Melda Uzbil and Andrew Vinard. Additional Instructions We are here to help. Please contact us with questions regarding the format or content of this application. If you are selected for final presentations to the Oversight Committee (OC), these presentations should be rehearsed with Melda Uzbil and Andrew Vinard at least once. Coulter Contacts Applicants must 1. Attend the Coulter information session on December 2, 2014, 2. OR contact Andrew Vinard (avinard@med.miami.edu) prior to December 2, 2014 to set up an in-person meeting. 3. Applicants will be strongly encouraged to attend training sessions December 9 & 16 Please note that our typical process includes several conversations with the applicants prior to the application deadline to help improve your proposal and increase the chance of successful funding. Applicants who have worked closely with the Coulter Center before the proposal deadline have had better funding outcomes. Please contact: Melda Uzbil, MEM Senior Coulter Project Director Email: melda@miami.edu Mobile: 919-641-4335 Andrew Vinard Coulter Project Director Email: avinard@med.miami.edu Phone: 305-243-3446
WALLACE H. COULTER CENTER COMMERCIALIZATION GRANT APPLICATION INSTRUCTIONS 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 person for the final funding decision. All proposals should be prepared on 8½ X 11 paper size with 1 margins, Arial 11 font, single spacing, line breaks between paragraphs and left alignment. Only proposals meeting format guidelines will be evaluated. Incomplete applications will not be reviewed. I. Cover Page (1 page) a. Project title b. PIs including departments c. Funds requested d. Executive summary. This is the most important paragraph since most reviewers will use the executive summary, the Clinical Impact Chart, and the Gantt Chart to decide whether they will give the application any further consideration. Sections II-VII are strictly limited to 5 pages. Proposals not meeting the criteria will not be reviewed. II. III. IV. Unmet Clinical Need (½ page) a. What is the unmet clinical need? b. Who and how many are affected each year (i.e., what is the patient population)? c. Summarize the clinical problem with a one or two sentence needs statement that includes what the solution will require for performance in order to successfully address the unmet clinical need. E.g., There is a clinical need for the development of a low-cost, rapid influenza test that can reduce unnecessary diagnostic testing, decrease inappropriate antibiotic use, and reduce the duration of treatment during hospitalization compared to currently available solutions. Standard Of Care And Currently Available Solutions (½ page) a. What is the current standard of care? b. What are two or three other solutions available today or in development that are intended to impact the same clinical need? What stage of development are they at? c. Who is administering the current standard of care? (E.g., surgeon, pathologist, breast cancer specialist, clinical nurse, etc.) Your New Solution (½ page) a. What is the end product? How does it address the unmet clinical need? b. Is it a new product or an improvement of existing products? c. Who is the end user of your product? Who will prescribe/administer the product if it is a drug, or who will be the user if it is a device, diagnostic, software, or method? d. How will your solution be better than the current gold standard? How is it novel? e. Who will buy this product and who will pay for it (E.g., the surgeon will request the product, but the hospital pays for it.)? f. Will it replace an existing product in the market?
g. Is it a platform technology? What is the first application you will focus on? h. If there are additional future applications, list briefly within one sentence. V. Preliminary Results (½ page) a. Include results from preliminary testing and data that demonstrates the feasibility of your solution. b. Describe the current stage of the technology/product. VI. Research Plan and Quarterly Milestones (1 ½ page) a. Describe specific research aims b. Fill out the below milestone table to describe quarterly milestones for the activities that need to be undertaken during the one year of funding. Also fill out the Gantt Chart provided in section IX. The milestones and timelines in the Gantt Chart must be consistent with this section. The chart is obtainable in excel format by contacting Andrew Vinard (avinard@med.miami.edu). c. How will the results of the Coulter funding help you convince subsequent investors or licensees to further invest into your idea (i.e., Explain how these specific aims and milestones will get you closer to finding a commercial partner)? d. Briefly list the technical and business milestones for the 2 years following the end of the Coulter grant. Milestones & Tasks Qtr 1 Qtr 2 Qtr 3 Qtr 4 VII. Commercialization Plan and Intellectual Property Status (1 ½ page) This section focuses on the IP status, potential competition, and plan for commercialization. a. Intellectual Property: Are there any concerning patents in the space that might block you from filing IP (patentability)? Does the IP belong to UM? If you have disclosed your project to tech transfer, include your case manager, case number, filings to date (provisional, full) and key upcoming decision points. b. Regulatory Strategy: What regulatory pathway will this project require to reach the market? What preclinical studies and clinical trials are required? What are the associated timelines and costs? If there are similar products that have been approved by the FDA, please list. (You can find relevant clinical studies on www.clinicaltrials.gov) c. Market Size: What is the US market size (i.e., how many patients could use the resulting therapeutic, device or diagnostic)? How many procedures or tests are currently being done in the US per year? (e.g., If your device will be used during lumpectomy, your market size is the number if lumpectomy procedures, NOT the total number of all breast cancer patients). It is more important to list an accurate number than it is to list a large number for your market size. d. Reimbursement: Is there existing reimbursement code for your product or will it require a new code? If existing, what is the current reimbursement code and amount ($)? e. Exit Strategy: i. List companies or organizations that currently have or are likely to have interest in your technology.
ii. List company names and divisions and why they would be interested (e.g., they sell similar products, sell to similar markets, or this item will fill a gap in their product portfolio) iii. List information you have obtained from potential licensees or investors related to this particular project. Have they commented on the value proposition? iv. Any quotes or letters of support would greatly strengthen the application. To protect your rights and UM s rights, conversations with companies or investors should be conducted with the help of the tech transfer office and the Coulter Center. We are here to help. Please contact us if you plan to talk or are currently talking with any commercial partners. f. Competition and Commercial Partners: List names of start-up companies and established companies that are currently developing or selling products targeted at solving the same problem. If they are using a different technology bur are solving the same clinical problem, you should still list them. Remember that competitors are potential future commercial partners for your technology. g. Follow-on funding: Our experience from the past 10 years shows that successful Coulter projects are the ones that start applying to other sources of funding as soon as they receive the Coulter grant. The Coulter grant provides a bridge to other types of commercial and federal funding to get your product closer to the market. It is not enough by itself to get your product all the way to the market. It is very important that you have a plan for obtaining follow-on funding to continue the project after the Coulter award expires. List potential sources of funding in bullets and the associated deadlines. (i.e. NIH-R01 due June 5, 2015, apply for SBIR/STTR in 2016, work with foundations to seek grants throughout 2015). Please contact Melda Uzbil, Senior Coulter Project Director, and Andrew Vinard, Coulter Project Director to discuss this section. Applications that do not specifically address this section in detail will not be considered for funding. VIII. Team (½ page) a. Name, institutional affiliation, title and role (e.g., PI, Co-PI, collaborator, etc.) of each team member b. Two sentences on each team member s experience relevant to this project c. Please mention all team members expected to play a role in this project
IX. CLINICAL IMPACT CHART This document can be obtained in word format by contacting Andrew Vinard (avinard@med.miami.edu) What is the proposed end product/solution? (Describe in one line) What is the market size (how many people are afflicted each year?) Who will be prescribing (drugs) or using (devices/diagnostics/software) the proposed end product? Who are the competitors? List the 5 distinguishing characteristics of your end product (Examples are shape, viscosity, quantity or frequency needed for treatment, delivery method, accuracy, sensitivity/specificity, size, % of patients called back for repeat surgery): What does the current gold standard do and how can your product do it better? Proposed Product/Solution Example 1: Peptide drug for drug resistant colon cancer Example 2: Imaging device to detect tumor margins during lumpectomy Example 3: Genome sequencing software Example: # of colon cancer patients whose tumors are drug-resistant Example 2: # of lumpectomy surgeries (NOT the # of breast cancer patients) Example 3: # of tests that are currently done or would be done with your products Example: breast cancer specialist, clinical research nurse, gastroenterologist, surgeon, physical therapist, pathologist, interventional cardiologist etc. List the emerging research at other academic institutions as well as the emerging and established companies that are working on solving the same problem. Even if they are using an entirely different method/compound/technology that is not similar to yours, if they are solving or trying to solve the same clinical problem that you are trying to solve, you should list the names of the investigators and companies. List how your solution is performing on these characteristics 1. 2. 3. 4. 5. How can your product do it better? Current Gold Standard What is current gold standard treatment? The gold standard can be a drug, use of a device, use of a diagnostic, use of software, a procedure or simply a method. Who is currently using/prescribing the gold standard. Example: surgeon, pathologist, interventional radiologist. List the methods/treatments/devices/diagnostics that are currently available but may not be first line treatment. List how the current gold standard is performing on these characteristics 1. 2. 3. 4. 5. What does the current gold standard do?
X. PROJECT MILESTONE GANTT CHART This chart can be obtained in Excel format by contacting Andrew Vinard (avinard@med.miami.edu)
XI. XII. XIII. XIV. XV. XVI. Project Budget a. Utilize the NIH form page 4 (see last page) to detail the direct costs for the year including personnel, supplies, animals, etc. b. Provide a description of key personnel and their responsibilities. c. 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. d. Travel, and facilities and administration costs, will not be supported. e. In general, funds for equipment or computers will not be supported. Equipment that is minor and highly specific and essential to the project should be accompanied by a justification. f. Provide a detailed budget justification for personnel and supplies. List of Sponsored Research Agreements (½ page) List in bullets all sponsored research agreements related to this project, even if they are only remotely related to this project. For example: If you are using the proposed underlying technology/treatment for a different application area and have a sponsored research agreement for that different area, you should list it here. Include title of agreement and name of the sponsor. Approvals Provide approval date and number for all human subjects or animal protocols. For human subjects, include IRB and applicable IND numbers. If funded, hard copies of approval letters will be required prior to initiation of work. Supplementary Materials and Letters a. Letter of interest from commercial partners or other organizations. PLEASE contact tech transfer and the Coulter Center before attempting to obtain such letters to make sure your rights and UM s rights are protected. b. Letter describing resources available, including funds, that will be employed alongside the Coulter funds to make this project successful. References & Literature Cited 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. Contact Information: Melda Uzbil, M.E.M Coulter Project Director Wallace H. Coulter Center for Translational Research melda@miami.edu 919-641-4335 Andrew Vinard Coulter Project Director Wallace H. Coulter Center for Translational Research avinard@med.miami.edu 305-243-3446 Norma S. Kenyon, Ph.D. Martin Kleiman Professor of Surgery Executive Director, Wallace H. Coulter Center for Translational Research Chief Innovation Officer, Leonard M. Miller School of Medicine Vice Provost for Innovation, University of Miami nkenyon@miami.edu 305-243-5346
Program Director/Principal Investigator (Last, First, Middle): DETAILED BUDGET FOR INITIAL BUDGET PERIOD DIRECT COSTS ONLY 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 FROM THROUGH 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 $ PHS 398 (Rev. 6/09) Page Form Page 4