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

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Presentation on theme: "Partnering with Federal Labs: A Panel Discussion FLC Mid-Atlantic Region Annual Meeting October 24, 2007."— Presentation transcript:

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 Department of Commerce George Arnold, Ph.D., National Institute of Standards and Technology George Arnold, Ph.D., National Institute of Standards and Technology Department of Agricultural Department of Agricultural Rick Brenner, Ph.D., Agricultural Resource Services Rick Brenner, Ph.D., Agricultural Resource Services Department of Defense Department of Defense Paul Mele, Army Medical Research and Materiel Command Paul Mele, Army Medical Research and Materiel Command National Aeronautics and Space Administration National Aeronautics and Space Administration Ray Turcotte, Ph.D., Langley Research Center Ray Turcotte, Ph.D., Langley Research Center Department of Health and Human Services Department of Health and Human Services Tom Stackhouse, Ph.D., National Cancer Institute, NIH 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 firmsPatent Prosecution via 14 contract patent law firms LicensesLicenses Transactional Agreements Collaborative Research Agreements Specialized Agreements The Institute Technology Transfer/Development Offices: The NIH Office of Technology Transfer:

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

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

11 Mechanisms for Collaboration Material Transfer Agreements Material Transfer Agreements Confidential Disclosure Agreement Confidential Disclosure Agreement Cooperative Research And Development Agreement (CRADA) Cooperative Research And Development Agreement (CRADA) Clinical Trials CRADA Clinical Trials CRADA Collaboration Agreement Collaboration Agreement Clinical Trial Agreements Clinical Trial Agreements Beta Testing Agreement Beta Testing Agreement Screening Agreement Screening Agreement Others 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) Software (3) Software Therapeutics (35) Therapeutics (35) Therapeutics Vaccines (1) Vaccines (1) Vaccines Devices (9) Devices (9) Devices Diagnostics (13) Diagnostics (13) Diagnostics Research Reagents (6) Research Reagents (6) Research Reagents Research Reagents Other Technologies (5) Other Technologies (5) Other Technologies Other Technologies NOTE: These are just for NCI, one of the 27!! NOTE: These are just for NCI, one of the 27!!

13 Resource Examples from NCI Discovery and Developmental Programs Discovery and Developmental Programs Clinical Trials Program Clinical Trials Program NCI-Frederick, a Federally Funded Research and Development Center (FFRDC) NCI-Frederick, a Federally Funded Research and Development Center (FFRDC) Alliance for Nanotechnology in Cancer 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 Disease(s) and Applications prevention, diagnosis, treatment prevention, diagnosis, treatment Stage of Development Stage of Development Type of agent Type of agent small molecule, biologic small molecule, biologic Eligible organizations Eligible organizations academic/government, industry academic/government, industry

15 NCI Developmental Therapeutic Program (DTP) provides resources for: Discovery Compounds (repositories) Compounds (repositories) informatics (public database) informatics (public database) cell lines cell lines screening services screening services Natural Products Natural Products Development formulation In vivo testing Pharmacology toxicology 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 Pre-clinical development and clinical development of cancer therapeutics National Network of Clinical Centers National Network of Clinical Centers http://ctep.cancer.gov/ http://ctep.cancer.gov/

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

18 Services and Support: NCI-Frederick biopharmaceutical development program biopharmaceutical development program a high-performance IT center dedicated to biomedical research and informatics a high-performance IT center dedicated to biomedical research and informatics advanced technology programs: advanced technology programs: genomics genomics proteomics proteomics imaging imaging nanotechnology nanotechnology histopathology histopathology molecular biology molecular biology clinical trial laboratory services 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. 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 Partners with NIST and the FDA http://ncl.cancer.gov/working_application-process.asp http://ncl.cancer.gov/working_application-process.asp

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

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