Under the specifications of the WHCC grant, preference for funding will be given to permanent, full time faculty members of the Diabetes Research Institute, the Sylvester Cancer Center, the Bascom-Palmer Eye Institute, the Miami Project to Cure Paralysis, and the Department of Biomedical Engineering; however, medical school faculty from other departments and programs with projects that may be suitable for WHCC are invited to submit applications in response to this RFP. A letter of intent is required and should include PI name and contact information, department, project title, brief project description, projected budget request and source of PI funds, as well as IP status (e.g., invention disclosure or patent submitted or not).
Project Criteria: In order to be considered for entry into the Center, the project must meet the following criteria:
address an unmet clinical need,
have the potential to be in a phase one trial within 3-5 years, or in the case of a device, will be marketable within 5 years,
patent or similar protection can be obtained for such product by the Center, and
the product has commercial potential.
Note: Some applicants will receive non-fiscal support, which could include input on commercialization details, regulatory guidance and expertise, and access to the Center’s facilities and equipment.
In addition to the above criteria, the applicant must bring funding with the project (this can include, e.g., funded personnel or supplies), either from grants, contracts or foundations. PI salary will not be supported by WHCC and does not count towards a match. Indirect costs, if available from the funding source, will go to the WHCC for that part of the project that is carried out in WHCC or with WHCC resources. WHCC funds of up to 50% of the project costs (exclusive of PI salary) may be committed to selected projects. Please note that corporate sources of funding are acceptable, but WHCC resources are not available to pay for a company to obtain approvals for a clinical product that the PI has worked with. Clinical trials will not be carried out by WHCC but will stay in the PI's department; WHCC will, as examples, participate in production of cells and reagents needed to undertake a clinical trial and provide relevant regulatory expertise. Assistance with Intellectual Property Strategy and Licensing, regulatory issues, preclinical models, laboratory space and equipment for projects in the preclinical or clinical phase (cGMP facility for processing of cells to be used in clinical trials), as well as assay, reagent and biomarker development, will be available. WHCC space is meant to serve as a flexible laboratory facility, and portions of the project that are supported by WHCC will physically move into the Center.
Primary objectives of the Center are to capitalize on UM intellectual property (IP) by assisting the PI in carrying forward projects that have already been through the discovery phase and that have, as examples, reached a stage that requires specialized expertise in: Intellectual Property Strategy and Licensing (e.g., identification of corporate partners, assessment of potential market value), regulatory issues, in vivo pre-clinical models, translation to human cells and reagents, cGMP production of cells and reagents for clinical trials or GLP conduct of pre-clinical research. WHCC's resources are not designed to support basic research efforts. Please contact Dr. Bin Yan (BYan@med.miami.edu; 305-243-8931) to discuss potential projects, IP status and eligibility for entry into WHCC. Under special circumstances, it may be possible to utilize a fee for service mechanism.
Projects will be approved for a period of one year. A second year, with clearly stated milestones and objectives can be applied for and ultimately be funded if year 1 milestones are met. Please use the following format for the application. The proposal should be no more than 10 pages for parts I-VI of the application. Confirmation of receipt will be e-mailed to the PI.
