1. NIH Technology Transfer and Ethics Pat Lake, Deputy Director Extramural Technology Transfer NIDDK, NIH FLC – Mid Atlantic Regional Meeting, Rocky Gap, Maryland September 15, 2005

2. National Institutes of Health Mission: The National Institutes of Health is the steward of medical and behavioral research for the Nation. 27 Institutes, Centers and Divisions 18,000 employees Total FY 2004 budget 27 billion dollars

3. NIH IC Offices of Technology Transfer Evaluates new inventions generated by scientists Assists in marketing Institute patents/ inventions to industry Assists scientists in implementing transactional agreements, i.e. Material Transfer Agreements (MTAs), Confidential Disclosure Agreements (CDAs)

4. NIH IC Offices of Technology Transfer (Cont’d) Assists scientists in setting up collaborations with profit and not for profit entities through CRADAs and Clinical Trial Agreements (CTAs) Acts as a resource to our scientists for a wide variety of technology transfer & intellectual property matters

5. CRADAs & Ethics

6. NIH CRADA Review Process Institute & Collaborator PIs develop Research Plan Institute performs actual negotiations with CRADA Collaborator NIH Office of Technology Transfer, IC Ethics Office and Office General Counsel review the CRADA Internal NIH CRADA Subcommittee reviews and makes the recommendation for approval

7. Conflict of Interest & Fair Access Review COIFA Form PIs complete and Ethics Office reviews Questions include: Financial or Personal relationships PI has with CRADA Collaborator Fair Access Issues-why was this Collaborator chosen

8. Other Case Studies\Examples

9. Royalties going directly to a Charity Sorry! According to HHS OGC not possible Royalties must go directly to inventor Inventor can then make arrangements with a charity of choice

10. Employee Owned Inventions New employee hired by NIH from European research institute He personally was prosecuting his own patent application Wanted to continue research in this area covered in patent PI assigned IP rights to NIH who assumed patent prosecution costs

11. Sponsored Travel Sponsored travel is handled differently amongst the NIH institutes. Some Institutes don’t allow their scientists to accept sponsored travel from industry without a one year cooling-off period before a collaboration can begin. Since sponsored travel is technically a gift to the Institute and not the scientist, it is not a conflict. This is a policy issue for the institutes.

12. Recap of NIH’s New Ethics Rules No consulting in personal capacity Scientist are encouraged to consult with industry in their official capacity!!! See our ethics website for summary of new rules…. Http://www.nih.gov/about/ethics/summary_ ammendments

13. Please feel free to contact: Pat Lake Deputy Director Extramural Technology Transfer NIDDK, NIH Office of Technology Transfer and Development 6707 Democracy Plaza, Suite 906B, MSC 5343 Bethesda, MD 20892-5343 Ph. 301-594-6762 Fax: 301-480-7546 Email: LakeP@mail.nih.gov