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Technology Transfer Process at CU

Technology Transfer Process at CU. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Devices Platforms Startups Successes Summary. Rick Silva, PhD Assistant Director Rick.Silva@cu.edu. Susana Read, DVM, MBA

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Technology Transfer Process at CU

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  1. Technology Transfer Process at CU Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Devices Platforms Startups Successes Summary Rick Silva, PhD Assistant Director Rick.Silva@cu.edu Susana Read, DVM, MBA Licensing Associate Susana.read@cu.edu Kate Tallman, MBA Assistant Director Kate.Tallman@cu.edu

  2. Technology Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary The ideal… The inventor has thought about a problem in the context of product development for a lucrative market Proof of concept work is done Infrastructure in place to exploit technology The commercial partner in is the queue …the blockbuster drug or the killer app

  3. Technology Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary The reality… Raw technologies Not directed to a market problem Product has not been defined or conceived Data directed at curiosity, publication, and next grant cycle Lack of infrastructure for revolutionary advances …a solution looking for a problem

  4. Technology - the “gap” Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary The risk gap: this is not venture capital SBIR/STTR CAPCO/CVCA RAID and RAPID programs at NIH Gap funds Birdseed funds

  5. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  6. Invention disclosure Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Evidence for patent - Novelty - Non-obviousness - Utility Stage of development Expert opinions Public disclosure Sponsorship

  7. First inventor interview Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Technical feasibility Patentability Applications and marketability Inventor interest and motivation Benefits, as inventor sees them Inventor’s industry contacts Future resources Commitment to technology validation Commitment to technology development Expectations Pending publications, collaborations, joint ownership

  8. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  9. Commercial feasibility analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Basic Questions for Physical Sciences What does it do? What is the problem to be solved? How does the technology solve it? What are the alternatives? (How is the problem currently solved?) How is the technology better than alternatives?

  10. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  11. Legal analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Are there legal constraints? Ownership, preexisting obligations Regulatory path Healthcare policy Reimbursement Government rights Disclosure obligation of the University Publication rights

  12. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  13. Market analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Is there a market? Who is the customer Market drivers Epidemiology, incidence, prevalence Reimbursement by third-party payers, validated payer Demographics/trends Competitive landscape

  14. Market analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Disruptive vs. incremental technology What does the ideal partner look like? Does it stand alone? What are the risks? Is the infrastructure in place?

  15. Market analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Physical Sciences: Is it a big enough market? Does the problem really need to be solved? Are the only customers a few specialized University labs?

  16. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  17. IP position analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Are there patent constraints? Publications Patentability Enforceability Freedom to operate Freedom to exclude Prior art

  18. IP position analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Obviousness Licensing - exclusivity, sublicensing, payment model Fields of use Geographical distinctions

  19. IP position analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Enforceability – Physical Sciences Can you prove infringement easily? Is it difficult to design-around?

  20. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  21. Technical analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Are there technical risks? Stage of development Is the technology validated? Is the product validated? What can go wrong? Is the inventor funded? Is the inventor interested in the development work? How to fund development?

  22. Technical analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary How to fund development? What are the milestones/checkpoints? Regulatory environment Analytical, biological, clinical development needs Licensing - exclusivity, sublicensing, payment model Fields of use Geographical distinctions

  23. Technical analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Physical Sciences Is it technically sound? Does data exist to show it works? Is it far enough along in development? Is there a prototype? Any barriers to scaling-up? Can it be produced profitably?

  24. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  25. Licensing Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Product IP Typically exclusive, rarely a startup Platform IP Startup or existing company, sometimes divided uses Process IP Often nonexclusive to existing companies

  26. Attracting potential licensees Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary What is the technology? Why is the technology useful in the organization’s product, process, or markets? How mature is the technology? What is the “value proposition”? What do I need to use the technology? Will it stand alone? What will it cost? What is the net benefit?

  27. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  28. Patent costs Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Simple, mechanical application = $8-10k Complex chemical or software = $20-25k Pharmaceutical = $30k + Prosecution = $4k per office action Issue/maintenance fees for life of patent $1.4k + $0.9k + $2.3k +$3.8k = $8.4k

  29. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  30. Marketing strategy Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Know the channels that fit the technology Look for the partners that will develop or use the product/technology The inventors will get inquiries Summarize the critical info Get in touch with the right people Document marketing, show inventors the efforts Exposure can lead to critical mass Seek feedback, refine the pitch Make adjustments as necessary

  31. Confidential Disclosure Agreements Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Used during the marketing stage Protect international patent rights Signed by a TTO Director

  32. Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Internal processing Receive disclosure Data incomplete- On Hold Accept disclosure Create case add to database Assign manager Internal Analysis Release rights to inventor Rights Determination Review of Related contracts Notification of other owners Agreement clarifying rights Commercial feasibility analysis Legal Market IP Technical Release rights to inventor 4 months Business plan Management IP Terms Startup -or - licensing Patent Filing Advise Inventor (s) of commercial plan Marketing Interest? Yes Negotiation External Development No Release rights to inventor

  33. Feasibility Analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary • Will anyone buy it? • Opportunity/need • Product description • Target market • Unique benefits • Competitive Analysis • Can it make a profit? • Sustainable competitive advantage • Risks • Profitability

  34. Feasibility Analysis Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary

  35. Take-home points Introduction Capabilities Process Approaches Biomaterials Biomarkers Targets Therapeutics Device Platforms Startups Successes Summary Take detailed notes, always; ask questions frequently Don’t sign anything, don’t make any actionable decisions Submit written summaries and recommendations, decisions are made by committees - make your case Don’t do everything by yourself; don’t reinvent the wheel Nobody is an expert in everything; work as a team Keep all of the written resources made available to you Mistakes are easier to fix early, don’t wait Organization is critical; keep a notebook and a calendar Communicate with your mentor/licensing associate Read all of the TTO materials, understand our values Call your inventors, be patient with them

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