Technology Transfer and CRADAs

1. Technology Transfer and CRADAs Local Accountability Training January 13 & 14, 2009 Baltimore Jeff Moore Amy Centanni Acting Deputy Director Director Technology Transfer Program (TTP) Office of Research and Development (ORD) Department of Veterans Affairs

2. What is Technology Transfer? • The process of converting scientific findings from research laboratories into useful products by the commercial or non profit sector. • Can involve: Industry Public and Private foundations Nonprofit Organizations University Federal, state, and local governments Department of Veterans Affairs

3. Who has a duty to disclose an Invention? All VA employees must disclose any invention which includes: - VA salaried employee - Without Compensation (WOC) employee who has signed a WOC IP (intellectual property) agreement - IPA (Intergovernmental Personnel Act) Employee Authority:38 C.F.R. §§1.651(e) and 1.662. Department of Veterans Affairs

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 (ID) form • ACOS reviews Certification and ID form *proper signatures attained - Director of medical center sends a memo to the Director of TTP submitting the ID Department of Veterans Affairs

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). Department of Veterans Affairs

6. Ownership Chart: Three possible outcomes for an invention disclosure Sole University Co-owned VA-University Sole VA owned Managed under CTAA if there is one University owns outright, VA is not involved. VA owns outright and University is not involved. University has right to patent, market and license If University decides not to patent, market and license; VA has the right to do so. Department of Veterans Affairs

7. Chart on invention disclosures submitted to TTP *Number of DORs received from OGC PSG IV (1-09-09). Department of Veterans Affairs

8. VA sole owned or VA the lead on a CTTA invention TTP actively manages inventions - patent - market seek licensees sponsored research agreements - license Department of Veterans Affairs

9. VA TTP Royalty Breakdown VA sole owned Personal Royalties Funds to VA TTP Funds to VAMC 30% Inventors Lab 15% VAMC Research budget (ACOS/R) 5% VAMC (Director’s budget) Inventor First $2,000 and 40% thereafter inventor 10% TTP Adm. overhead University Lead (co-owned VA and university) 60% Inventors Lab 20% VAMC Research budget (ACOS/R) 10% VAMC (Director’s budget) 10 % TTP Adm. overhead • - University pays inventor per its policy • Deducts admin fee (15%) • - Rest of money split 50-50 Money paid to VA Department of Veterans Affairs

10. 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 • Used Federal government wide Department of Veterans Affairs

11. 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 Department of Veterans Affairs

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 Department of Veterans Affairs

13. VA CRADA Models • Clinical Trial Phase I & II and III & IV (CT CRADA) • Investigational Device CRADA • Principal Investigator Initiated Clinical Study CRADA • Material Transfer CRADA • Data Collection Agreement (NEW) • Basic Department of Veterans Affairs

14. Models can be found on the TTP Internet Website • TTP’s intranet website http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm SOPs and Annotations are also posted there Department of Veterans Affairs

15. CRADA SOPs • One SOP for following (all reviewed locally) CT CRADA I&II CT CRADA I&IV Device CRADA Principal Investigator Initiated CRADA • Separate SOPs exist for MT CRADA (reviewed locally) Basic CRADA (consult TTP) Data Collection Agreement (consult TTP) • MTAs? Reviewed locally, consult TTP as necessary - signed by ACOS Department of Veterans Affairs

16. Who is involved in negotiating CRADAs Follow SOPs on the TTP website for the specific CRADA Possible characters: • VA Nonprofit Research Corporation (NPC) • VA Regional Counsel (RC) • Principal Investigator (PI) • VA Medical Center (VAMC) R&D Office • TTP (if it is a Basic CRADA) Department of Veterans Affairs

17. 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 - agreed upon at central office - used locally without review (CRADA body) - expedites CRADA process - 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 budge Department of Veterans Affairs

18. Process and Roles for Using Model CRADAs Confusion remains 1) NPC is the lead (gate keeper) * - read through redline prior to submitting to Regional Counsel (RC) - highlight obvious problem areas - many times changes pertain directly to NPCs - ask if other VAMCs are being considered 2) NPC submits to RC - RC reviews *What if there is no NPC? Department of Veterans Affairs

19. Process for Using Model CRADAs • RC reviews (two possibilities) - if no “substantive” changes send back to NPC for execution (skip to #6 below) - if substantive changes send to TTP for review copy to Renee Szybala (OGC PSG III) 4) TTP Reviews - Works with OGC PSG III and prepares a response back to NPC and RC • NPC and possibly RC work with the company on any needed changes (enlist TTP help as necessary) • CRADA is agreed on by both company and VA 7) Upon execution send copy to TTP and fill out CRADA registry Department of Veterans Affairs

20. Process for Using One CRADA at Multiple VA Sites • No Master template is involved • Company indicates multiple VAMCs are being considered for same protocol • Contact other VA sites and appoint one NPC and RC to take the lead • Lead VA/NPC follows steps as if negotiating a single site CRADA Department of Veterans Affairs

21. Process for Using Master Template CRADAs • NPC the lead • Email TTP for the master template or verify CRADA sent from company is the right master CRADA 3) No legal or TTP review is necessary except for supporting documentation - No changes on actual CRADA body **TTP never negotiates on indirect rates or other elements of the budget Department of Veterans Affairs

22. Current Master Template CRADAs Official masters (phase III/IV): Novartis Sucampo (I&II also) Genentech Roche Sanofi-Aventis Amgen Pfizer Bristol-Myers Squibb Department of Veterans Affairs

23. Unofficial Master Template CRADAs • Lilly and Lilly when Quintiles is the CRO • Avigen • AstraZeneca What does this mean? Templates are available for immediate single site use while undergoing the concurrence process Department of Veterans Affairs

24. Other Templates in the Pipeline • Merck • Schering-Plough  • Johnson & Johnson • Abbott • GlaxoSmithKline • Schering Plough • Few smaller pharmaceutical companies Department of Veterans Affairs

25. Statistics for Masters Masters with 5 of the top 10 Pharmaceutical companies Pfizer, Novartis, Sanofi, Roche, AZ Soon to be 8 of the top 10 GSK, Merck, Abbot Department of Veterans Affairs

26. Monitoring Issue Three solutions to allow clinical trial monitors access to patient medical records (where consent is given) - Stand alone download - VA employee driver - Limited read-only access to select data - Computerized Patient Record System (CPRS) - Permissions can be set to allow access *VA Cyber Security Awareness Training and Sign the National Rules of Behavior Department of Veterans Affairs

27. CRADA Registry • Registration of all in process and executed CRADAs is mandatory • Send email to: Noahline.Stuart@va.gov • Highly useful resource for NPCs and RCs BUT • Remains poorly updated and utilized by field CRADA Registry Website http://www.research.va.gov/programs/tech_transfer/crada/registry.cfm Department of Veterans Affairs

28. Future Plans • Continue to aggressively negotiate master template CRADAs • Field Training • Regional training for NPCs and RCs First training end of January in CA and will continue through spring • Training will be hands on Recommend bringing actual CRADAs to discuss Department of Veterans Affairs

29. Contact Information Questions about Technology Transfer or CRADAs: TTP Website http://www.research.va.gov/programs/tech_transfer/default.cfm VA Technology Transfer Program Amy.Centanni@va.gov (202) 461-1502 Jeffrey.Moore@va.gov (202) 701-7628 Saleem.Sheredos@va.gov (202) 380-5080 Ken.Levin@va.gov (202) 461-1713 VA OGC Group III Renee.Szybala@va.gov (202) 461-7644 Jane.Gutcher@va.gov (202) 461-7619 Maryam.Azarion@va.gov (202) 461-7616 Department of Veterans Affairs