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Technology Transfer - the NIH Experience
1. TECHNOLOGY TRANSFER
• • •
The NIH Experience
Steven M. Ferguson, CLP
Special Advisor
NIH Office of Technology Transfer
sf8h@nih.gov
Science. Ideas. Breakthroughs.
2. National Institutes of Health
The Nation’s Steward of Medical & Behavioral Research
Engine for Research & Innovation
Premier biomedical
research institution
in the United
States
Annual Budget =
$32.3 billion
NIH Technology Transfer: Science. Ideas. Breakthroughs. 2
3. National Institutes of Health
Funding
Training
Basic
Research
Clinical
Trials
Inventions
Policies
NIH Technology Transfer: Science. Ideas. Breakthroughs. 3
Biomedical Research
in Support of
the Public Health
4. Technology Transfer Supports
NIH Fundamental Mission
Enhance
health
Reduce
illness
Lengthen
life
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5. • Extramural Research Supporting research of non-Federal scientists in
universities, medical schools, hospitals, and research institutions
throughout United States and overseas
• Intramural Research Conducting research in its own laboratories
• Training Helping train research investigators
• Communication Fostering communication of medical information
Core Components of the NIH Mission
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6. Extramural Research
Supporting Research Worldwide
Over 80%
of the NIH budget
Almost
50,000 awards
annually
300,000 extramural
researchers
(mostly universities)
Over 2,500
research
organizations
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7. Impact of NIH-Supported Research
on U.S. Economy
• In 2015, NIH research supported 352,349 jobs at more
than 2,500 institutions, small businesses nationwide
• In 2015, NIH funding generated $60.171 billion in new
economic activity–double taxpayers’
investment
• NIH serves as foundation for entire U.S.
medical innovation sector that:
– Employs 1 million U.S. citizens
– Generates $84 billion in wages, salaries
– Exports $90 billion in goods, services
NIH Technology Transfer: Science. Ideas. Breakthroughs. 7
“NIH’s Role In Sustaining The U.S. Economy: 2016 Update”
Authored by Dr. Everett Ehrlich
United for Medical Research, 2016
8. Importance of Global Health Research
Globalization of
Health Problems
and Their
Relevance to
Domestic Health
Economic
Development
and Political
Stability
Humanitarian
Objectives
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9. Scientists Funded Globally
(Areas in green denote NIH funding outside of the U.S.)
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10. Intramural Research
Biomedical Research and Training
Approximately 10%
of NIH budget
More than
2,000 active projects
More than
6,000 scientists
Collaborative
research
Patent/License
technologies
NIH Technology Transfer: Science. Ideas. Breakthroughs. 10
11. Technology Transfer
What Does This
Mean?
• Movement of information,
materials, and technologies from
the research laboratories to the
commercial enterprise
• To support further research and
develop new products to improve
public health
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12. NIH Technology Transfer
Since 1887
NIH Founder (1887) and
Tech Transfer Superstar!
Dr. Joseph Kinyoun
Director
Hygienic Laboratory
Marine Hospital Service
Staten Island NY
Joseph J. Kinyoun – One Man TTO
• Day Job = Starting the NIH (when not busy developing and
transferring technology)
• Invented & patented multiple industrial disinfecting machines used
in quarantine operations
• “Kinyoun Portable Bed Disinfectors”
• First smallpox immune serum
• “Kinyoun Method” of smallpox vaccination used until the 1960s
• “Kinyoun Stain” for TB, still used today
• Put Teddy Roosevelt & the “Rough Riders” into quarantine when
they returned from Cuba
• Later worked in pharma (predecessor of Merck)
Read more about the “Forgotten Forefather” at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3388889/.
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13. Technology Transfer Goals
Utilize IP appropriately as incentive for commercial
development of technologies
Attract new R&D resources
Obtain return on public investment
Stimulate economic development
Benefit the public health
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14. Technology Transfer Activities
NIH
Technology
Transfer
Clinical Trial
Agreements
Collaborative
Research
Agreements
Material
Transfer
Agreements
Invention
Evaluation
Patenting &
Licensing
Marketing
Monitoring &
Enforcement
Royalties
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15. NIH Compared to Universities
Like universities,
NIH does:
Value partnerships
with academic and
corporate partners
Collaborate along
the full spectrum of
the developmental
pipeline
Unlike
universities,
NIH does not:
Take equity in
companies
Spin out companies
(but does license to
start ups)
Does not accept
work-for-hire
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16. Characteristics of the NIH Intramural
Research Program “Pipeline”
Novel,
fundamental
research
discoveries
Research
tools
CRADA
partnerships
for basic or
clinical
studies
Selected
products in
early clinical
studies
358 licensees
do over
$7 billion
annually
in sales
~600+
products
27 vaccines
&
therapeutics
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17. CRADA – Cooperative Research
and Development Agreement
Collaboration between Government lab and outside party
Provides
Collaborator with
right to elect
option to exclusive
license to new
inventions
Collaborator
provides
same and
possibly
money
Government
provides
expertise,
equipment,
materials
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18. Examples of Products Developed
Under NIH CRADAs
Product Company Use
FluMist®* MedImmune Influenza vaccine
Havrix® GlaxoSmithKline Vaccine against hepatitis A
Taxol® Bristol-Myers Squibb Treatment of solid tumors
and Kaposi’s cancer
Thyrogen® Genzyme Therapeutics Adjunct to thyroid cancer
treatment
Velcade® Millennium
Pharmaceuticals
Treatment of multiple
melanoma
*Not based on NIH IP
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19. Patenting Policy
Seek patent protection if:
Facilitates availability of the technology for preventive,
diagnostic, therapeutic, or other commercial use
Further research and development is necessary to realize
the technology’s primary use
Commercial or public health value of the technology
warrants the expenditure of funds
Research has a practical utility or a reasonable
expectation of future practical utility
Do not seek patent protection if:
Commercialization and technology transfer can best be
accomplished without patent protection
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20. NIH Product Licensing Principles
Granting only the appropriate scope of rights
Permit research uses
Preference for non- or partial exclusivity
Specified fields of use
Enforceable milestones and benchmarks
Maximize development of products for the public health
Ensure appropriate return on public investment
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27. Licensed Products – Other
• Consumer Products
• Devices/Instrumentation/Software
• Research Reagents
• Veterinary Products
We invite you to view the HHS Intramural Research Product Showcase
to learn more about these licensed products, as well as many others
not listed in the preceding slides. Look for the link on the NIH-OTT
homepage.
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29. NCI and NIAID Fellowships
in Technology Transfer
NCI TTC FELLOWSHIP PROGRAM
This Fellowship is designed to develop the unique skills associated with negotiating
technology transfer agreements as well as marketing a portfolio of exciting, cutting
edge technologies being developed within the National Cancer Institute.
Additional details may be found at
https://techtransfer.cancer.gov/aboutttc/jointtc.
NIAID TTIPO FELLOWSHIP PROGRAM
This Fellowship provides training in drafting and negotiating various technology
transfer agreements, developing technology transfer educational programs for
scientists, and overseeing patent-related issues for NIAID scientists.
Additional details may be found at
https://www.niaid.nih.gov/research/technology-transfer-fellowship-program.
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30. Technology Transfer
Training Programs – FAES
Advanced Studies in Technology Transfer
• Certificate program at FAES Graduate School at NIH for
scientists or engineers who wish to gain expertise in
patenting, licensing, and various tech transfer agreement
transactions.
• For additional details about this program (including a course
listing) visit: https://faes.org/content/advanced-studies-in-
technology-transfer.
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31. Technology Transfer
Training Programs – FLC
Federal Laboratory Consortium for
Technology Transfer
Learning Center
• Overview of federal technology transfer for those new to
the process.
• Offers “On Demand” e-learning courses, webinars, and
reference materials.
• Calendar of upcoming Training Events.
https://www.federallabs.org/Learning-Center
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32. Technology Transfer
Toolkit – FLC
Federal Laboratory Consortium for
Technology Transfer
T2 Toolkit
• T2 Playbook – resource highlighting best technology transfer practices and
strategies at federal labs
• FLC Business & Available Technologies – a one-stop shop for federal lab
information (available technologies, funding, programs, facilities, etc.)
• Technology Locator Service – matches technology seekers with federal labs
that can provide the needed expertise/capabilities
• T2 Mechanisms database – types/examples of agreements used by federal
tech transfer offices
https://www.federallabs.org/T2-Toolkit
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33. For Further Reading...
“Partnering with the NIH: Now part of the ‘Value
Proposition’ for start-ups”
Journal of Commercial Biotechnology. 2012 Apr 1;
18(2):60-67.
“Licensing the Technology: Biotechnology
Commercialization Strategies Using University and Federal
Labs”
In: Craig Shimasaki, ed. Biotechnology Entrepreneurship:
Starting, Managing, and Leading Biotech
Companies. (Elsevier Inc.) 2014:185-206 (Chapter 14).
Available on OTT web site at
https://www.ott.nih.gov/presentations-articles
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34. For Additional Information
To learn more about the NIH,
the NIH Intramural Research Program,
and Technology Transfer at the NIH, visit:
• NIH
https://www.nih.gov
• NIH Intramural Research Program
https://irp.nih.gov
• NIH Office of Technology Transfer
https://www.ott.nih.gov
• Technology Transfer Offices and Contacts
https://www.ott.nih.gov/tdcs
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