Phase 2: Business Plan
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Phase 2 Overview and Submission Requirements

  • Business Plan Phase Overview: Challenge semi-finalists from Phase 1 will develop a 10-page business plan or business model canvas; and a twenty minute "live" pitch via video conference (WebEx)
  • What Constitutes a Complete Submission (estimated 20 pages PPT and Word (not including appendices)):
    • 10 page business plan with potential funding sources; put in 11 point font or larger.  The title page and table of content pages are not counted in the 10 page count 
    • A financial model (P&L, Balance Sheet, Valuation Table) in excel format only
    • 10 page pitch deck in PowerPoint or Prezi.  The title page is not included in the page count for the pitch deck
    • 20 minute (5 minute presentation, 5 minute Q&A, 10 minute preparation time) live pitch via WebEx, to the Challenge judges and to potential funders
    • Optional: Appendices, business model canvas
    • Signed "Founder Agreement:" Click on the button below for a DRAFT version of this agreement   
download FOUNDER'S AGREEMENT here
  • How to Submit: Deliverables will be submitted on our submission platform used in Phase 1.  Please log back in to your pitchburner account and the phase 2 submission will be at the end of the form
  • Winners and Prizes:  Winners will be determined and announced on July 18th.  The winners of this phase will receive a $2000 cash award, per team from CAI.  Prizes will be awarded separately for NIH selected inventions versus external; no set number of prizes has been decided
Phase 2 Timeline
Business plan phase: The official business plan phase will begin on April 11th 2016, promptly after the ending of Phase 1.  Teams are welcome and encouraged to begin their deliverables for Phase 2 earlier than this date, however, only the Phase 1 semi-finalists will be allowed official participation starting April 11th.  Business plan documentation/deliverables are due on June 26th, 2016.  Live pitches will be conducted from June 27th, 2016 to July 1st, 2016.  Finalists and Winners will be announced by July 18th, 2016
  • Official Start Date into Phase 2: April 11th, 2016
  • Final Deliverables Due: June 26th, 2016
  • Pitches Occur: June 27th - July 1st, 2016 as scheduled through the Center for Advancing Innovation
  • Finalists and Winners Announced: July 18th, 2016
Business Plan Phase Steps for Challenge Teams
  1. Review the Business Plan template and guidance.  More information can be found here
  2. Please DO NOT contact NIH inventors directly.  All contact to NIH inventors should be made through the CAI team
  3. Add CAI to your schedules; there will be meetings with CAI twice a month every Friday afternoon for 30-45 min. There will be no meetings during the week of official holidays; these meetings will be conducted on the following week.  Challenge Teams are not required to participate in any meetings; they are for your benefit and for any additional questions and guidance
  4. Start working on deliverables outlined above in Business Plan Overview and Submission Requirements above
  5. Submit all deliverables on June 26th, 2016. Post your Team's business plan and business model canvas on the pitchburner platform
  6. Submit availability for pitches by June 10th via communications with CAI.  If CAI has not received dates for your Team's availability, CAI will assign a date/time to your Team.  CAI will only be conducting business plan and pitch reviews starting on June 27th, 2016 through July 1st, 2016.  Please indicate if your Team has VOIP and Webcam capability
Criteria and Guidelines
Criteria I: Comprehensive and Complete:
  • Defined commercialization and development plan over the appropriate time period and have included specific milestone events (note: milestone events should include go/no-go decisions for potential investors).  For example, therapeutics will take a longer period of time to get approved unless they are addressing a rare disease/orphan indication
  • Clearly articulated all potential addressable target customer segments and the market/competitive landscape
  • Identified additional plans required, for example, Intellectual Property (IP) plan
  • Evaluated the entire lifecycle of your invention, both branded and generic products, if relevant
  • Identified medical/scientific experiments and developed your overall clinical trials plan in development plan. For the next invention tests required, outlined a very high level protocol with the correct number and type of samples and tests that need to be completed with specific goals for statistical significance. Created a plan for reproducing the results (if relevant)
  • Documentation provided is of high quality and includes sources, assumptions.  Overall plans are pragmatic yet optimistic

Criteria II: Ability to Attract Investors/Collaborators:
  • Identified specific differentiators and novelty of your Team's product/service to all key stakeholders. Novelty will indicate why the invention is unique from a scientific perspective.  Differentiation will indicate how the invention is better than anything else currently available e.g., better standard of care (e.g., one drug versus several for a shorter period of time with fewer side effects), cheaper, easier to use (e.g., at home diagnostic test), etc.  Note: stakeholders will be defined in your stakeholder engagement plan but should include the end patient, doctors, payers, VCs, etc.
  • Identified a specific exit or liquidity event, e.g., IPO, out-licensing/sub-licensing, funding partners (both dilutive and non-dilutive), revenue from a viable product, M&A, etc.
  • Creatively defined a quick revenue and profit model through your Team's commercialization and development plans that will assist your Team in reducing investment risk, e.g., do you have a way to bootstrap larger investments via, for example, R&D services; do you know if you can get a priority review voucher; can your invention be fast-tracked and approved in Phase II Clinical Trials, etc.
  • Identified how your Team's invention will be reimbursed through payers
  • Created realistic financial models that illustrate how to achieve profitability that is sustainable and growing

Criteria III: Operational Feasibility:
  • Created practical plans and financial and valuation models estimating revenue, investment requirements and profitability
  • Presented a clear idea of clinical applicability and how to manufacture/market/sell products
  • Outlined specific collaborators that will help your Team at different stages of development
  • Defined a clear regulatory path for any regulatory body, in particular, the FDA

Criteria IV: Strong Collaborators, Management Team and Board of Advisors:
  • Competent team that works together cohesively
  • Identified dilutive and non-dilutive funders as part of your Management/Board of Advisors/Directors team
  • Comprehensively identified all capabilities (either as collaborators, management team members, business advisors and/or scientific advisors) that will allow you to be successful, e.g., Business Development, Scientific leadership, R&D, Manufacturing, Sales, etc.
  • Clearly described how the management team will be compensated
  • Identified the legal form of ownership of the company

Criteria V: Risk Mitigation:
  • Identified risks, the impact of these risks and the probability that these risks have of occurring
  • Created a feasible mitigation plan for all the risks that have the highest probability of negative impact and occurrence