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Guidelines and Advice for Bioscience Discovery and Evaluation Grant applications
1. Pre-Proposal
The Pre-Proposal need be no more than one paragraph and should reference or accompany an IDF to be on file with the Technology Transfer Office that identifies the intellectual property and development program that is going to be advanced. The Pre-Proposal should summarize data or key experimental systems that have been generated to date for the project if there is background data, and should clearly articulate how the funds will advance the project in a clinically relevant direction. These funds are not intended for pure research or discovery research. It will be imperative to explain how the funds will help the project take the next step towards a commercially/clinically relevant product or process. Devices may not yet have been generated but a sufficient description of a proposed device should make it clear the device can be produced and tested using the funds. For diagnostics, ideally an analyte and assay methodology will be identified or in vivo proof of concept for clinical utility of the diagnostic will be proposed. For therapeutic projects, investigators should already have identified and ideally have on hand the compound(s) of interest and not have pre-existing obligations for the use of those compounds, though some target validation studies have been funded in past years.
2. Project Narrative
Project Summary
Include the title of the invention submitted to the TTO. Should be a high-level description of the proposed project and not assume detailed knowledge in the field. Briefly describe the problem to be solved and shortcomings of existing solutions (i.e. the unmet need). Do not focus on the technical background of your technology. The relevance and feasibility of addressing a market, clinical, and societal problem are more important than the scientific merit. This section should be readable by a technically inclined person who has general familiarity with your field. Audience will be investors, biotech executives, in addition to doctors, scientists. Do not disclose any proprietary or confidential information in the project summary. Contents of this section may be summarized and will be submitted to the State of Colorado Office of Economic Development and may appear on the TTO web site. Must not exceed 1 page.
Project Plan
Describe the proposed project (key experiment(s), specific aims milestones and strategic objectives) with a statement of the problem to be solved and how the proposed project will lend credibility to a solution that addresses this problem. Include identification (name and key inventors), brief description and significance of the invention(s) disclosed to TTO that this work is based upon. Discuss the background and technical objectives of the research. If successful, what will this project prove/disprove? Be as specific as possible about key technical or clinical feasibility issues addressed. Ensure fundamentally sound experimental design and controls. Use the most validated and accepted model systems and experimental tools practical. Avoid the temptation to apply a peer review philosophy to experimental approaches and defining endpoints. Strive to address commercially relevant endpoints. The key issue to address is whether it works, not how it works. If you are subcontracting any of this work to another group or entity, explain what they will do, why they are necessary and how you will integrate their work product into the overall development of the commercial concept. Must not exceed 3 pages.
Commercialization
Be sure to articulate the value proposition for users of the technology. How does this technology compare to existing alternatives to solving the same problem? What are the unique benefits and disadvantages relative to the current approach or standard of care? Who are the customer and what are the benefits to those customers? Don’t confuse benefits with features. What will next steps be in the commercial roadmap after this project is completed? Define short term specific aims in the context of long term project milestones, beyond the BDEG grant. Specify the product model, business model (drug or surgical procedure or disposable product), financing model, and revenue model (patient pays, 3rd party payer, hospital buyer, etc) for commercialization where possible. Provide comparisons and contrasts/novelty relative to similar commercial models. Understand potential regulatory pathways, at a high level and be prepared to address regulatory strategy in broad strokes. State patent status, but be honest about nascent IP. The panel will want to see a credible market opportunity and value proposition. For example, global oncology spending does not create a relevant sense of opportunity, but the incidence of and treatment for tamoxafen refractory ER positive breast cancers is a reasonable definition of addressable market or patient population. Does not have to be quantitative, but does have to be based in some form of verifiable rationale. The proposal should paint a picture of how the BDEG project promotes the more expansive commercial development program and drives investment in the opportunity. Speak to scalability (jobs and capital) and value inflection (value creation); specify the scale of scope of peer products and companies formed to develop them. Address issues of technical risk, clinical risk, regulatory risk, financial risk, and market risk where possible. Must not exceed 2 pages.
3. Work plan
Be concise and specific with respect to what you plan to accomplish. The most successful proposals will have clearly defined deliverables, experimental endpoints, with clear commercial and economic implications. A single graphic (Gantt chart) with milestones, budgets, project objectives, and project elements is an ideal representation of budget and return on investment. Be capital efficient. For example, bank animal blood and tissues for pharmacological analysis later (post-BDEG) if practical.
4. Budget
Consult TTO or OEDIT information sources for allowable and preferred uses of proceeds. Matching fund commitments are viewed favorably. Must not exceed 1 page. Please note, matching funds simply means that the final budget shall consist of funds supplied by the State of Colorado and the University of Colorado, therefore for each line item, simply divide the total request in half. If you have additional funds you can supply through a departmental match or other match of some kind, they need not but can be listed as supplemental information.
5. Biographies
The scientific credentials of the Principle Investigator are important, but experienced, credible commercial advisors can add merit to a project. Use business advisors and include business advisors credentials where appropriate.
Summary of Suggestions
- Advice: Seek advice from your technology transfer case manager and industry advisors. You will be asked to pitch your proposal to a panel of industry executives, investors, and applied scientists. You will have to hit the important points in a 15 minute presentation.
- Opportunity and value proposition: Define unmet need and clinical/commercial relevance addressed.
- Business model: Stick to the beaten path, if practical.
- Milestones: Clearly state specific aims of proposed project in the context of commercial development roadmap.
- Follow-on funding: Speak to the long term financing of the development plan (i.e. venture capital, grants, and corporate partnerships), since follow-on funding is a key goal of the BDEG program
- Program fit: Seek TTO advice to ensure use of proceeds is in accordance and well-aligned with program policy and program objectives.
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