1 / 29

Technology Transfer and CRADAs Office of Research and Development Department of Veterans Affairs

Technology Transfer and CRADAs Office of Research and Development Department of Veterans Affairs. Jeff Moore Technology Transfer Program, ORD Local Accountability Training Chicago. What is Technology Transfer?.

holden
Télécharger la présentation

Technology Transfer and CRADAs Office of Research and Development Department of Veterans Affairs

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Technology Transfer and CRADAs Office of Research and DevelopmentDepartment of Veterans Affairs Jeff Moore Technology Transfer Program, ORD Local Accountability Training Chicago

  2. What is Technology Transfer? • The process of converting scientific findings from research laboratories into useful products by the commercial sector. • Can involve Federal Labs Industry University Federal, state, and local governments - Industry is encouraged to develop that technology via new products, processes, or materials.

  3. Who has a duty to disclose an Invention? - VA salaried employee - Without Compensation (WOC) employee who has signed a WOC IP (intellectual property) agreement - IPA (Intergovernmental Personnel Act) Employee

  4. Disclosure Process - Go to the VA TTP website (Reporting of Invention button): www.research.va.gov/programs/tech_transfer/ - Inventor fills out the Certification and Invention Disclosure form. - Attain proper signatures i.e., immediate supervisor and ACOS. - Prepare a memo to the Director of TTP through the Director of the medical center.

  5. What does TTP do with the disclosure? - Review disclosure for scientific/patentability and for contribution VA made to invention. - TTP provides a recommendation to OGC - retain rights. - VA leaves right, title & interest to the invention with the inventor. - VA leaves entire right, title, & interest to the invention with the inventor subject to the VA retaining a non-exclusive, govt. use license. - OGC issues determination of rights (DOR).

  6. What if TTP asserts ownership? - Invention is managed pursuant to the Cooperative Technology Administration Agreement (CTAA). or - If VA owns solely VA Technology Transfer Program patents, markets, and looks for potential licensees.

  7. Licenses - Central office (TTP) negotiates Licenses CRADAs and Licenses should not be confused - A license is a contract between licensor (e.g., VA holder of the patent) and a licensee (e.g., an industry partner) which gives the licensee certain rights - Per Federal statue (37 CFR 404) terms below must be in a Federal license development or marketing plan company agrees to commercialize in a set time period reports on efforts

  8. VA TTP Royalty Breakdown VA Sole owned - First $2,000 to inventor(s) - 40% goes to inventor(s) - Rest of money (other 60%) - 85% goes back to VAMC - 50% to lab where invented - 25% to ACOS budget - 10% to Director budget - 15% goes to TTP for admin costs • University Lead • - University pays inventor • - Deducts admin fee (15%) • Spilt remaining money per • employment of inventors VA Split

  9. Introduction to CRADAs • What is a Cooperative Research and Development Agreement (CRADA)? • 15 USC § 3710a - A legal agreement between a federal agency and one or more non-federal parties. • Purpose is to foster federal/private collaborations to bring new technology to the marketplace. • Government owns the invention rights of government employees made during work hours, using government resources or that bear a direct relation to the official duties of the inventor (Executive Order 10096).

  10. Introduction to CRADAs (cont’) • Government may provide personnel, services, facilities, equipment, intellectual property, and other resources, but not funds. • Non-federal party may provide funds, personnel, services, facilities, equipment, intellectual property, or other resources. • Allows government to negotiate licensing agreements and may agree to grant in advance: - Exclusive patent licenses; or - Non-exclusive patent licenses; or - Assignments; or - Options to CRADA subject inventions

  11. Introduction to CRADAs (cont’) Protections to Collaborators • Protect background inventions, trade secrets and confidential information. • Establish intellectual property ownership and licensing options in advance of an invention. • Ensure enforceable terms. • Government-wide, readily understood and accepted mechanism for establishing collaborative relationships .

  12. Introduction to CRADAs (cont’)VA requirements • Agency must review for conflicts of interest. • For CRADAs with foreign companies, agency must “consult” with US Trade Representative. • Must be reviewed and signed by the federal laboratory director – VA Medical Center Director. • Consists of CRADA, Statement of Work (SOW), Budget, and Appendix C.

  13. The New VA CRADA models VA listened to the VA research field and sponsors. • shorter (15 pages or less) • easier to read • streamlined definitions and language • better organized • reflects more flexible interpretation of the law by OGC

  14. New VA CRADA Models (cont’) • Clinical Trial Phase I & II CRADA • Clinical Trial Phase III & IV CRADA • Clinical Trial Investigational Device CRADA • Material Transfer CRADA • Basic CRADA • In development: Principal Investigator Initiated Clinical Study CRADA

  15. Where to find the new CRADA models VA intranet website http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm Or go to the TTP CRADA model page and replace the first “w” with “va”.

  16. When to use the CT CRADA for Phase I & II and Phase III & IV clinical trials? When the collaborator: 1. Owns the investigational new drug (IND); 2. Designs the protocol; and 3. Funds the project.

  17. When to use the Investigational Device CT CRADA. When to use the Investigational Device CT CRADA CRADA: • When the research involves a collaborative research, development, engineering, testing or evaluation studies involving devices. • Maybe PI initiated or not.

  18. Basic Research CRADA When to use the Basic Research CRADA: • Used only for collaborative research, development, engineering, testing or evaluation studies. • VA investigator designs or contributes substantively to the design of the statement of work. • Study does not involve human subjects VA.

  19. MT CRADA When to use the MT CRADA: • VA is the recipient of a material and the company would like the right to license any improvement or intellectual property (IP) that stems from the research. • If IP is not an issue please use the basic MTA.

  20. VA CRADACommon Provisions Throughout Article 2: Definitions • Background Invention • CRADA Subject Invention • CRADA Data • Clinical Investigator = PI • Statement of Work (maybe protocol)

  21. VA CRADA (cont’) Article 5. Inventions and Intellectual Property 5.2 Ownership of CRADA Subject Inventions – VA Retains Ownership. 5.3 Reporting – VA and Collaborator invention disclosure obligations. Article 6. Licensing continued 6.1 License Options. VA grants to Collaborator an option to elect a nonexclusive, partially exclusive or exclusive license on any CRADA Subject Invention made solely by VA Employee(s) or made jointly by VA and Collaborator employees. * In the CT III & IV CRADA a nonexclusive license is granted up front

  22. VA CRADA (cont’) Article 7. Ownership and Rights of Access to Data and Publication. 7.1 Case Report Forms and Records For CT CRADAs. 7.2 CRADA Data and CRADA Materials. 7.3 Presentations and Publications.

  23. VA CRADA (cont’) Article 8. Confidentiality 8.1 Confidential Information. 8.2 Disclosure of Confidential Information. 8.3 Duration of Confidential Information.

  24. VA CRADA (cont’) Article 12. Liability 12.1 Collaborator’s Indemnification and Liability 12.2 VA’s Indemnity and Liability

  25. VA CRADA Options • Single-study CRADA Negotiated for a single study at a single site; signed locally. Over time, single-study CRADAs may become de facto templates. • Master/template CRADA - negotiations are in process with major pharmaceuticals companies. - Could apply to all Phase I & II or III & IV clinical trials with a specific sponsor. - Only variables are the Statement of Work (may be the protocol) and budget.

  26. Process for negotiating CRADAs Follow the SOPs that are on the TTP website for the specific CRADA. Who is involved: • Principal Investigator (PI) • VA Medical Center (VAMC) R&D Office • VA Nonprofit Research Corporation (NPC) • VA Regional Counsel (RC) • TTP if it is a Basic CRADA

  27. The Role of the NPC in CRADAs • PI and NPC jointly negotiate CRADA. • PI and NPC jointly negotiate budget. • NPC coordinates VA approvals (R&D Committee, IRB, RC, MCD, etc.). • NPC administers the study and funds. • NPC manages receipts and expenditures. • Contact NPC personnel for assistance in identifying PIs and assessing potential VAMC subject pool.

  28. VA CRADA Closing the Deal • Agency review within 15 to 30 days if needed. • PI signs acknowledgement. • Parties sign CRADA. - Collaborator - NPC - Medical Center Director (last to sign) • Disseminate originals to all parties and provide a copy to PI. • Send a copy to TTP to enter into the CRADA Registry

  29. Contact Information and Resources Questions about Technology Transfer or CRADAs: TTP Website http://www.research.va.gov/programs/tech_transfer/default.cfm CRADA Registry http://www.research.va.gov/programs/tech_transfer/crada/registry.cfm VA Technology Transfer Program Amy.Centanni@va.gov (202) 254-0224 Jeffrey.Moore@va.gov (202) 701-7628 Saleem.Sheredos@va.gov (410) 302-0989 Kris.Burton@va.gov (202) 254-0256 Ken.Levin@va.gov (202) 254-0256 VA OGC Group III Renee.Szybala@va.gov (202) 273-6334 Jane.Gutcher@va.gov (202) 273-6348

More Related