I. “You Have Been Given an Opportunity” A local consortium of angel investors has agreed to review proposals for new Bio

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I You Have Been Given An Opportunity A Local Consortium Of Angel Investors Has Agreed To Review Proposals For New Bio 1 (142.86 KiB) Viewed 53 times

I. “You Have Been Given an Opportunity” A local consortium of angel investors has agreed to review proposals for new Biomedical-related start-up entrepreneurial ventures, of graduates of ENTR 481/581. As such they want a written proposal that covers the elements outlined below. If you are convincing and innovative, both in your write-up and product concept, they will likely provide seed funding. They have asked that you prepare the following... Identify an Unmet Medical Need – Describe background, population affected, market size, present diagnostics or therapy (SOMETHING DIFFERENT THAN THE MIDTERM). Convince them why this is important. Devise a solution - i.e. a New Device, Drug or Combo Therapeutic – may be truly new or “real enough” to complete the exercise. (for non-Science majors in the class you can invent a technology even if not real, use your imagination) Describe the device, drug, or combo completely. They want details as to size, materials and technology to fabricate the device, drug or combo, how it works, sterile/non-sterile, etc. Productize this solution - what will the final product look like, be like, who will buy it, how will it be sold, what will it cost to make, what will it sell for, how will it be marketed, distribution?
Create IP for this – if truly new will be no issue, if IP partially exists - for the purpose of this exercise assume that no IP exists. Write a brief patent disclosure - be sure to include summary of invention, some detailed description of the invention, examples of demonstration of efficacy and draft claims (this is the key aspect of this exercise) need a minimum of 2 independent claims and 3 dependent claims, Maximum of 20 claims overall. Describe the Regulatory strategy to bring this product forward. Please include - what class is the device, drug or combo is it. If a device, construct a Device Master Record. What regulatory pathway will it undergo? If 510(k) how will you proceed, who needs to be involved? If PMA- what pre-clinical studies will be needed, Will animal studies be needed, if so outline. What will the human trial be like? Need to be specific here - what will be the question, the endpoint variables, control, trial design, and statistical approach. (refer to FDA web site for prior examples). What will be the biggest performance hurdle – either pre-clinical or clinical. What if the device does NOT get approval –what will your recourse be? Create a budget – how much money will be needed to create prototype, for regulatory, manufacturing, clinical trials, pilot market testing, sales and marketing, insurance. How will you get this funded? How will investors see a return on investment? Please respond in essay format - create a dossier. Separate all issues, organization and clarity are key.