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Partnering with Federal Labs:
A Panel Discussion
FLC Mid-Atlantic Region Annual
Meeting
October 24, 2007
Traversing the Maze!
Panel Members
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Department of Commerce
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Department of Agricultural
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Paul Mele , Army Medical Research and Materiel Command
National Aeronautics and Space Administration
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Rick Brenner, Ph.D., Agricultural Resource Services
Department of Defense
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George Arnold, Ph.D., National Institute of Standards and Technology
Ray Turcotte, Ph.D., Langley Research Center
Department of Health and Human Services
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Tom Stackhouse, Ph.D., National Cancer Institute, NIH
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
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.
27 Institutes & Centers at NIH
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)
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
Licenses
Licensing is centralized :
NIH Office of Technology Transfer (OTT)
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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
Resources to Collaborate with NCI
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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
Mechanisms for Collaboration
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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
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.
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Software (3)
Therapeutics (35)
Vaccines (1)
Devices (9)
Diagnostics (13)
Research Reagents (6)
Other Technologies (5)
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NOTE: These are just for NCI, one of the 27!!
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Resource Examples from NCI
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Discovery and Developmental Programs
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Clinical Trials Program
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NCI-Frederick, a Federally Funded Research and
Development Center (FFRDC)
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Alliance for Nanotechnology in Cancer
Identifying the Unique NIH
Programs to fit your needs
What are the appropriate NIH programs?
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Disease(s) and Applications
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Stage of Development
Type of agent
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prevention, diagnosis, treatment
small molecule, biologic
Eligible organizations
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academic/government, industry
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
Pre-Clinical through Clinical
NCI Drug Development Group
Cancer Therapy Evaluation Program (CTEP)
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Pre-clinical development and clinical development of
cancer therapeutics
National Network of Clinical Centers
http://ctep.cancer.gov/
NCI-Frederick
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Federal Funded Research and Development
Center
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Government-Owned Contactor-operated
facility
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Contractor is currently SAIC-Frederick, Inc.
Services and Support:
NCI-Frederick
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biopharmaceutical development program
a high-performance IT center dedicated to biomedical
research and informatics
advanced technology programs:
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genomics
proteomics
imaging
nanotechnology
histopathology
molecular biology
clinical trial laboratory services
NCI Nanotechnology Characterization
Laboratory (NCL)
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Characterization of physical attributes, pre-clinical
toxicology and efficacy testing of nanoparticles intended
for cancer therapy, imaging and diagnostics.
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Partners with NIST and the FDA
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http://ncl.cancer.gov/working_application-process.asp
Check Handout and links for more
information
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Description of program
Eligibility requirements
Types of services
Application procedures
Intellectual property considerations
Funded projects and outcomes
Questions?
Thomas M. Stackhouse, Ph.D.
Assistant Director
Technology Transfer Center
National Cancer Institute
[email protected]
NIH Technology Development Coordinators
http://ott.od.nih.gov/nih_staff/tdc.html