Partnering with Federal Labs: A Panel Discussion

1. Partnering with Federal Labs:A Panel Discussion FLC Mid-Atlantic Region Annual Meeting October 24, 2007

2. Traversing the Maze!

3. Panel Members • Department of Commerce • George Arnold, Ph.D., National Institute of Standards and Technology • Department of Agricultural   • Rick Brenner, Ph.D., Agricultural Resource Services • Department of Defense • Paul Mele , Army Medical Research and Materiel Command • National Aeronautics and Space Administration • Ray Turcotte, Ph.D., Langley Research Center • Department of Health and Human Services • Tom Stackhouse, Ph.D., National Cancer Institute, NIH

4. Collaborative R & D with the National Institutes of Health Tom Stackhouse, Ph.D. Assistant Director Technology Transfer Center National Cancer Institute National Institutes of Health FLC Mid-Atlantic Region Annual Meeting October 24, 2007

5. National Institutes of Health The National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services, is the primary U.S. Federal agency for conducting and supporting medical research.

6. 27 Institutes & Centers at NIH

7. NIH/FDA Intramural Portfolios(2006) 􀂄 383 invention disclosures (168 from NCI) 􀂄 101 U.S. patents issued (50 from NCI) 􀂄 3,400+ total pending/issued patents 􀂄 254 licenses executed (122 from NCI) 􀂄 364 technologies (inventions) were licensed (167 from NCI) 􀂄 1300+ active licenses 􀂄 $82.7 million in royalties collected 􀂄 51 CRADAs executed (NIH only) 􀂄 222 active CRADAs (NIH only)

8. Interactive Offices • Patent Prosecution via 14 contract patent law firms • Licenses The Institute Technology Transfer/Development Offices: • Transactional Agreements • Collaborative Research Agreements • Specialized Agreements The NIH Office ofTechnology Transfer:

9. Licenses Licensing is centralized : NIH Office of Technology Transfer (OTT) • Commercial Evaluation Licenses • Internal Commercial Use Licenses • Nonexclusive Patent Licenses • Exclusive Patent Licenses • Biological Materials Licenses • NIH Technologies available for licensing: http://ott.od.nih.gov/db/tech.asp

10. Resources to Collaborate with NCI • Unique research and clinical grade materials • Unique expertise for mutual projects • Unique testing capabilities • Extensive clinical trials network for cancer • Specific projects to develop NCI’s patented technologies • http://ttc.nci.nih.gov

11. Mechanisms for Collaboration • Material Transfer Agreements • Confidential Disclosure Agreement • Cooperative Research And Development Agreement (CRADA) • Clinical Trials CRADA • Collaboration Agreement • Clinical Trial Agreements • Beta Testing Agreement • Screening Agreement • Others

12. http://ttc.nci.nih.gov Collaborative Opportunities The following links provide more information about identified areas where the NCI is seeking collaborators to enter into research partnerships. • Software (3) • Therapeutics (35) • Vaccines (1) • Devices (9) • Diagnostics (13) • Research Reagents (6) • Other Technologies (5) • NOTE: These are just for NCI, one of the 27!!

13. Resource Examples from NCI • Discovery and Developmental Programs • Clinical Trials Program • NCI-Frederick, a Federally Funded Research and Development Center (FFRDC) • Alliance for Nanotechnology in Cancer

14. Identifying the Unique NIH Programs to fit your needs What are the appropriate NIH programs? • Disease(s) and Applications • prevention, diagnosis, treatment • Stage of Development • Type of agent • small molecule, biologic • Eligible organizations • academic/government, industry

15. Discovery Compounds (repositories) informatics (public database) cell lines screening services Natural Products Development formulation In vivo testing Pharmacology toxicology NCI Developmental Therapeutic Program (DTP) provides resources for: • Rapid Access to Intervention Development (RAID) • Clinical "proof of principle“ that a new molecule or approach is a viable candidate for expanded clinical evaluation. • Provides NCI resources including our contract resources: • - Small- medium scale production • - Bulk supply • - GMP manufacturing • - formulation • - Toxicology • http://dtp.nci.nih.gov/docs/raid

16. Pre-Clinical through Clinical NCI Drug Development Group Cancer Therapy Evaluation Program (CTEP) • Pre-clinical development and clinical development of cancer therapeutics • National Network of Clinical Centers • http://ctep.cancer.gov/

17. NCI-Frederick • Federal Funded Research and Development Center • Government-Owned Contactor-operated facility • Contractor is currently SAIC-Frederick, Inc.

18. Services and Support:NCI-Frederick • biopharmaceutical development program • a high-performance IT center dedicated to biomedical research and informatics • advanced technology programs: • genomics • proteomics • imaging • nanotechnology • histopathology • molecular biology • clinical trial laboratory services

19. NCI Nanotechnology Characterization Laboratory (NCL) • Characterization of physical attributes, pre-clinical toxicology and efficacy testing of nanoparticles intended for cancer therapy, imaging and diagnostics. • Partners with NIST and the FDA • http://ncl.cancer.gov/working_application-process.asp

20. Check Handout and links for more information • Description of program • Eligibility requirements • Types of services • Application procedures • Intellectual property considerations • Funded projects and outcomes

21. Questions? Thomas M. Stackhouse, Ph.D. Assistant Director Technology Transfer Center National Cancer Institute stackhot@mail.nih.gov NIH Technology Development Coordinators http://ott.od.nih.gov/nih_staff/tdc.html