Partnering with Federal Labs: A Panel Discussion

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Partnering with Federal LabsA Panel Discussion

• FLC Mid-Atlantic Region Annual Meeting
• October 24, 2007

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Traversing the Maze!
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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

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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
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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.

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27 Institutes Centers at NIH
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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)

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Interactive Offices
The Institute Technology Transfer/Development
Offices

• Transactional Agreements
• Collaborative Research Agreements
• Specialized Agreements

The NIH Office of Technology Transfer

• Patent Prosecution via 14 contract patent law
  firms
• Licenses

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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

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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 NCIs patented
  technologies
• http//ttc.nci.nih.gov

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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

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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!!

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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

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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

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NCI Developmental Therapeutic Program (DTP)
provides resources for

• Discovery
• Compounds (repositories)
• informatics (public database)
• cell lines
• screening services
• 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
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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/

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NCI-Frederick

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

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Services and SupportNCI-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

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• 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

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Check Handout and links for more information

• Description of program
• Eligibility requirements
• Types of services
• Application procedures
• Intellectual property considerations
• Funded projects and outcomes

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Questions?

• Thomas M. Stackhouse, Ph.D.
• Assistant Director
• Technology Transfer Center
• National Cancer Institute
• stackhot_at_mail.nih.gov
• NIH Technology Development Coordinators
• http//ott.od.nih.gov/nih_staff/tdc.html