Funding Overview and Application Instructions Deadline: January 15, 2016 FUNDING OVERVIEW The objective of the University of Michigan Coulter Translational Research Partnership Program (Coulter Program) is to bring medical innovations into healthcare through a commercial entity. As such, projects funded through Coulter will need to demonstrate: Clearly envisioned medical product concepts that meet unmet medical needs Translational research plans to de-risk key technical hurdles and address commercial questions Industry or investor interest Clear path to company formation with angel or venture capital funding or to direct licensing of technology IP by a medical device, pharma or diagnostics company who complete development and commercialization of the envisioned product. Proposals demonstrating the ability to meet these objectives will receive greater consideration for funding. APPLICATION INSTRUCTIONS Funding application submission packets for Coulter Program funding must be submitted to Coulter Program Director, Thomas Marten (tmarten@umich.edu) as a single PDF document. Funding application submissions need to include the proposal, budget, literature references, and NIH style biosketches. The proposal and budget will also need to be submitted as separate documents. It is strongly suggested that applicants discuss their proposal with the Coulter Program Director Thomas Marten (tmarten@umich.edu; 734-647-1680) prior to submission. Proposals are due by 5 pm on Friday, January 15th, 2016. Each proposal must have Co-PI’s, at least one of whom has an appointment in the College of Engineering (COE) at the University of Michigan and at least one clinical investigator from a clinical department at the University of Michigan. The research must relate directly to the development of new products with applications in health care. The objectives of the project should include milestones that provide technical and commercial de-risking to generate professional investor interest. Each proposal will be evaluated on the basis of scientific merit, potential health care impact and significance, and the potential for commercialization and successfully obtaining angel or venture capital financing of a new company formed around the technology or licensing of the IP to a medical device, pharmaceutical or diagnostics company. FUNDING SUBMISSION PACKET – This will include the following information compiled into a single pdf document. 1. Proposal (7 pages) Please follow the template for the research proposal which can be downloaded on the Coulter Website here: http://www.bme.umich.edu/research/coulter_apply.php and do not use smaller than 10 pt font. The Proposal must also be submitted as a separate Word document. 1 2. Budget Spreadsheet Please follow the template for the budget which can be downloaded on the Coulter Website here: http://www.bme.umich.edu/research/coulter_apply.php . The budget must also be submitted as a separate Excel document. Projects are funded for 1-year time periods at at the $100,000 range, though larger and smaller requests will be considered. o Requests for larger amounts should be discussed with Thomas Marten, Coulter Program Director. o Seed grants not exceeding $25,000 may also be considered for projects requiring finite achievements (i.e. generation of data or a prototype necessary to apply for subsequent translational funding). Allowable budget expenditures include: salary and fringe benefits for project personnel, materials and supplies, equipment, and pre-negotiated travel. Budget line items for outside consultants (i.e. regulatory and market research) and prototype manufacturing are allowable, but will be managed through the Coulter CPD short code. The clinical co-PI must be included in the budget and his/her budget percentage MAY be cost-shared with the clinical department. Typically 5% to 10% of a clinical collaborator’s salary is budgeted, of which up to half will be charged to the Coulter grant and at least half will be cost shared with the clinical department. There are no guidelines for acceptable percent effort for the COE co-PI. Combined co-PI salaries and benefits should not exceed 20% of the total project budget. Tuition for graduate students is allowable based on graduate student effort level on the project. Large tuition line items on budgets are discouraged. See budget template for additional details. Large capital purchases are prohibited. Funds may not be used for construction or renovation. A department signature is required on the bottom of the budget, for the cost share commitment. 3. References/Literature cited 4. NIH-style Biosketches Biosketches for PIs and key personnel involved in the materials should be attached to this document as supplemental material. 2 REVIEW PROCESS Proposals will be triaged internally, and successful candidates will be invited to make a five minute “elevator pitch“ to the UM Coulter Oversight Committee at a meeting in March. Finalists will be notified by mid-March as to whether they will be invited to participate in the C3i program. The C3i program is an 8-week commercialization planning program (see below). A final presentation to the Oversight Committee at the Final Review Meeting in late May/early June. Funding will begin July 1, 2016. Michigan C3i (Coulter College Commercializing Innovation) Planning Program The objective of the Michigan C3i Program is to help Coulter proposal applicants build their full proposal and pitch deck, as well as answer three fundamental questions: 1) Does their envisioned product address a true unmet clinical need that health care providers and payors are willing to solve? 2) Is there a viable business opportunity? 3) Will the proposed research derisk the project to the point of generating investor or industry interest in the product concept? These are the same questions that the Coulter Oversight Committee will have in mind when evaluating project pitches for funding at the Coulter Project Selection meeting. C3i is designed to provide Coulter Proposal Teams with the specialized business frameworks and essential tools for successful translation of biomedical technologies from lab to market. Teams are guided through a series of lectures and interactive exercises, pressure-testing commercial viability of ideas using universal business criteria as well as the unique requirements of biomedical product commercialization. Teams will also work with medical device industry business development directors, outside regulatory and reimbursement consultants, venture capitalists, and IP attorneys who provide insights into the market sector, new product planning, IP, regulatory, and reimbursement requirements specific for their projects. 3