Innovation Fund 2020 RFP & LOI Narrative Template



CCHMC Innovation Fund and Adare Pharmaceuticals Drug Optimization and Repurposing Innovation Award - Request for Proposals (RFP)Cincinnati Children’s researchers discover dozens of health innovations every year. Whether they are prospective molecular targets for treating or diagnosing disease or concepts for new medical devices, many discoveries encounter a critical funding gap before being ready to obtain outside commercial investment. CCHMC Innovation Fund (internal funding): The Innovation Fund is designed to fill that gap by enabling product development and commercialization. Awarded annually, the Innovation Fund provides $5,000 - $100,000 in total direct funding for one-year, to an innovator (or innovation team) to advance the development of technologies toward the commercial market. This award is intended to add value to the technology to increase the probability of licensing to an established company or start-up. Priority will be given to technologies that show a strong probability of return on investment. Grant funds are to be used for a) concept development of an unmet medical need, e.g., prototypes and proof of concept demonstration and/or b) product development and commercialization.Adare PharmaceuticalsTM Drug Optimization and Repurposing Innovation Fund: Adare will fund projects that either optimize (e.g., a delivery route, onset of action and/or length of efficacy) an existing drug for its approved indication or repurpose a known drug for a new indication. Proposals that study known therapeutics that could benefit from improved efficacy, improved adverse event/tolerability profiles, improved pharmacokinetic/pharmacodynamic relationships or be developed for an entirely new purpose will be a priority Therapeutics must be available for optimizing or repurposing with no more than 5 years of patent exclusivity remaining. Adare offers up to $200,000 in funding over two, one-year installments. (Year 2 funding is contingent upon the successful completion of milestones.)Following completion of the funded research program, Adare will have an exclusive option to enter into a licensing agreement for these projects/intellectual property. Please contact Ginny Van Horne (virginia.vanhorne@) directly for application instructions for the Adare opportunity.Innovation Fund Proposal Categories Biologic, Cell & Gene TherapiesDiagnostics Digital Health and Care DeliveryMedical DevicesSmall Molecule TherapiesInnovation Fund Application ProcessSubmit a one-page Letter of Intent (LOI) narrative, and if needed, an invention disclosure form. Selected applicants will be invited (by February 28, 2020) to submit a full proposal and briefly present their project (i.e., 3-5 minutes) to reviewers as well as answer questions.Innovation Fund LOI Submission Guidelines -- Due by 1:00 p.m., February 5, 2020If you have NOT submitted an invention disclosure for this technology in the past, please do so via the CCHMC Inventor Portal. A CCHMC employee must be the primary innovator on the project.Prepare a one-page LOI Narrative using the LOI Narrative template. Your narrative should include:Project Name and PI Name Unmet Need: describe the unmet need or problem (e.g. disease population; and prevalence/incidence) your innovation will solve or address.Innovation: describe the innovation, including: a) medical need/research significance, b) current standard of care/current products and limitations, and c) plans for ultimate clinical utility (i.e., who is the specific patient population (end user) impacted by the technology? What is the ultimate product that will provide a distinct intellectual property or market position?)Project Milestones: provide specific aims or development goals along with estimated completion timeframe for each. You’ll have an opportunity to refine these milestones later should you be invited to make a full proposal.Use the following link to login to Planbox and access the online LOI Submission form… your completed LOI Narrative where instructed and complete remaining fields.Submit the completed LOI form by 1:00 p.m. on February 5, 2020Innovation Fund LOIs will be examined by Innovation Ventures staff and subject matter experts as needed for:Clarity and credibilityStrength of intellectual property (IP)Market need: what is the ultimate product that will provide a distinct IP or market position; how is the proposed project distinct from what currently exists in the market; who is the customer for this project; who is the specific patient population impacted? Clear research methods Qualifications of the project teamInnovation Fund Proposal Submission Guidelines – Due by Noon, April 8, 2019Proposals cannot exceed 6-7 pages; single spaced, one-inch margins, 11-point font or largerAccess and complete the category-specific Proposal Templates and Instructions in PlanboxReferences are not included in the page countA letter of support from the applicant’s Division Director is mandatory. Other letters of support from strategic partners, customers, and/or potential investors, etc., are optional. Do not attach biosketchesInnovation Fund Budget/Funding Cycle: July 1, 2020 - June 30, 2021 Budget cannot exceed $100,000.00 total costs. No more than 15% of the total project budget can be allocated toward PI(s) or Co-I(s) salaries and the funds cannot be used for travel. Normally, funds are not available for the purchase of large items of equipment. However, under exceptional circumstances, equipment purchases will be considered. The applicant must justify a) the purchase will only be used to advance/foster commercialization for the technology proposed (e.g., validate results to move toward commercialization) and b) verify there are no other funding sources (e.g., Division funds) available for this purchase.The possibility of funding for an additional 12 months will be considered, assuming mutually agreed upon milestones and deliverables have been met by June 30, 2021, and further work is needed. The Innovation Fund proposal must include:A detailed budget for the work proposedA brief summary of funding received for this technology to dateFunds are to be used for concept development of an unmet medical need and/or to enable product development and commercialization. Examples…Funds CANNOT be used for…Proof of principle – early concept design Unmet need validationDesign research: review of state-of-the-art technologies, solutions (e.g., understanding what is being done)Needs identificationBiomedical engineering consultCustomer discovery: qualitative market researchPrototype developmentHuman clinical dataPre-clinical dataPharmacokinetic/pharmacodynamic modelingFormulationsDrug delivery systems/platform development Large animal studiesOther advanced pre-commercial researchAlgorithmic diagnostics as opposed to single biomarker associationsTarget validationPreliminary/Pilot data to apply for other fundingHealth services and implementation researchHuman pluripotent stem cell and organoid biologyPublished Content (e.g., guidelines, best practices, training manuals)Core services (e.g., drug discovery core)Basic science (this is considered too far from the clinic, hence, limited commercial potential at this stage)Travel to conferences/presentationsInnovation Fund Mandatory Reporting/Fund DistributionInnovation Ventures staff will meet with awardees to finalize quarterly milestones. Thereafter, awardees will be required to meet with Innovation Ventures staff quarterly to provide progress updates.Award funding will be distributed in quarterly segments, based on completion of milestones. A continuation evaluation will be made 6 months into the project. Projects deemed commercially unfeasible may be redirected or discontinued.If work is not progressing on a timely basis, funding may be pulledAt the end of the funding period, awardees will be required to submit a final report. A final meeting with each awardee will be held to discuss project results.Innovation Fund EligibilityA Cincinnati Children’s employee must be the primary innovator/principal investigator on the project. An invention disclosure must be associated with the technology.Before funding begins, applicants must have or obtain IRB or IACUC approval, if applicable. If invited to submit a full proposal, a letter of support from the applicant’s Division Director is required.Innovation Fund Review Process and CriteriaThe reviewers will read proposals prior to the PI presentations. Final scoring will take place after PI presentations. Significance/clinical impact. What will be the research outcome impact AND will it address a significant unmet clinical need? The proposal should clearly state the problem, the product/service, and how the outcome will provide a solution.Novelty of idea/approach and Intellectual Property status. Do patents already exist or have applications been filed? Have invention disclosures been submitted? If not patentable, might other proprietary protection be possible? Can an assessment be made as to how well the IP is protected?Feasibility. Is the science based on solid principles and is the research plan appropriate? Are the timeline and milestones proposed feasible? Is there a commercially reasonable path to market entry of first product? Commercial potential. Does the proposed research envision a commercial product? What is the expected timeframe for the product to reach the market (in years)? What is the specific patient population impacted by the technology? Who is the customer (client) for this technology? What is the ultimate product that will provide a distinct intellectual property position? What is the commercialization stage? In addition to answering the above questions, each project will be screened against the following criteria: clinical/regulatory/reimbursement, market profile, and exit package profile/landscape. Mission impact/intangibles. Will the proposed project improve child health?Budget: Is the proposed budget reasonable?Innovation Fund ReviewersEach review panel will be comprised of CCHMC scientists, CCHMC clinicians, experts from industry, investors, and entrepreneurs. Relevant Innovation Ventures staff will assist reviewers as needed. Jeffrey Robbins, PhD, Innovation Ventures Chief Science Officer, will chair each panel.2020 Key Dates for CCHMC Innovation FundJanuary 2: RFP released.February 5, (1:00 p.m.): Deadline for receipt of Letters of Intent (LOIs) February 28: Applicants are notified as to their selection to submit proposalApril 8, (noon): Deadline for receipt of full proposals. Applicants selected for further consideration will be notified by May 14.Mandatory PI Presentation Dates for Selected PIs: Presentations to the Reviewer Panel are limited to 5 minutes followed by Q&A with reviewers. May 21 – Biologic Cell & Tissue Therapies May 27 – Digital Health & Care Delivery* May 28 – Small Molecule TherapiesJune 2 – Diagnostics June 3 – Medical Device Late June: Applicants notified of funding decisions.June 24: Innovation Fund Awardees Group Photo/Celebration EventEarly July: Kick-off meetings with PIs, business managers and Innovation Ventures staff.*Digital applicants may have the option to briefly demo their product within the time limit.2020 Key Dates for AdareJanuary 2: RFP released.January 2 – April 1: Contact Ginny Van Horne for application instructions.April 21: Applicants to present projects to Adare staff.Early July: Applicants notified about next steps.Questions? Please contact Ginny Van Horne at 3-1175 or virginia.vanhorne@ ................
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