1. TECHNOLOGY TRANSFER • • • The NIH Experience
Ajoy Prabhu, MS, MBA
Head, Marketing Operations Office of Technology Transfer National Institutes of Health
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.

3. National Institutes of Health
Funding
Training
Basic Research
Clinical Trials
Inventions
Policies
Biomedical Research in Support of the Public Health
NIH Technology Transfer: Science. Ideas. Breakthroughs.

4. Technology Transfer Supports NIH Fundamental Mission
Enhance health
Reduce illness
Lengthen life
NIH Technology Transfer: Science. Ideas. Breakthroughs.

5. Core Components of the NIH Mission
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
NIH Technology Transfer: Science. Ideas. Breakthroughs.

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
NIH Technology Transfer: Science. Ideas. Breakthroughs.

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 $ 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’s Role In Sustaining The U.S. Economy: 2016 Update” Authored by Dr. Everett Ehrlich United for Medical Research, 2016
NIH Technology Transfer: Science. Ideas. Breakthroughs.

8. Importance of Global Health Research
Globalization of Health Problems and Their Relevance to Domestic Health
Economic Development and Political Stability
Humanitarian Objectives
NIH Technology Transfer: Science. Ideas. Breakthroughs.

9. Scientists Funded Globally (Areas in green denote NIH funding outside of the U.S.)
NIH Technology Transfer: Science. Ideas. Breakthroughs.

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.

11. NIH Organization U.S. Department of Health and Human Services
National Institutes of Health
Office of the Director
Office of Intramural Research Office of Technology Transfer
27 Institutes and Centers
NIH Office of Technology Transfer

12. 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
NIH Technology Transfer: Science. Ideas. Breakthroughs.

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
NIH Technology Transfer: Science. Ideas. Breakthroughs.

14. Technology Transfer Activities
NIH Technology Transfer
Clinical Trial Agreements
Collaborative Research Agreements
Material Transfer Agreements
Invention Evaluation
Patenting & Licensing
Marketing
Monitoring & Enforcement
Royalties
NIH Technology Transfer: Science. Ideas. Breakthroughs.

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
NIH Technology Transfer: Science. Ideas. Breakthroughs.

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
NIH Technology Transfer: Science. Ideas. Breakthroughs.

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
NIH Technology Transfer: Science. Ideas. Breakthroughs.

18. Examples of Products Developed Under NIH CRADAs
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
NIH Technology Transfer: Science. Ideas. Breakthroughs.

19. 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
NIH Technology Transfer: Science. Ideas. Breakthroughs.

20. NIH License Types Exclusive Patent Commercialization
Non-exclusive Patent Commercialization
Non-exclusive Patent Internal Use
Start-Up Exclusive Evaluation Option
Start-Up Exclusive Patent Commercialization
Commercial Evaluation License
Biological Material Commercialization
Biological Material Internal Use
Interference or Dispute Settlement
Inter-institutional
NIH Technology Transfer: Science. Ideas. Breakthroughs.

21. Licensing to University Start-Ups
NIH Technology Transfer: Science. Ideas. Breakthroughs.

22. NIH Intramural Portfolios FY-2016
Invention disclosures
320
Patents issued
152
Licenses executed
285
Active licenses
1,300+
Royalties collected
$137.8 million
CRADAs executed (NIH only)
115
Active CRADAs (NIH only)
367
Products developed to date (27 vaccines and therapeutics)
~600
Royalties collected to date
$1.58 billion
NIH Technology Transfer: Science. Ideas. Breakthroughs.

23. Licensed Products – Diagnostics
Parvovirus B19 Immunoassay
PathVysion® HER-2 DNA Probe Kit
Pathway® Her-2/neu (4B5)
Thyrogen®
AcuTect®
BRACAnalysis®
HIV Test Kits
NeoTect®
NIH Technology Transfer: Science. Ideas. Breakthroughs.

24. Licensed Products – Therapeutics
Didanosine
Fludara®
Hivid®
Kepivance®
NeuTrexin®
Prezcobix™
Prezista®
Sporanax Oral®
Synagis®
Taxol®
Velcade®
Videx®
Vitravene®
Zenapax®
Zevalin®
Zinbryta™
NIH Technology Transfer: Science. Ideas. Breakthroughs.

25. Licensed Products – Vaccines
Certiva®
Cervarix®
Gardasil®
Havrix®
Hepatyrix®
LYMErix™
RotaShield®
Twinrix®
NIH Technology Transfer: Science. Ideas. Breakthroughs.

26. 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.
NIH Technology Transfer: Science. Ideas. Breakthroughs.

27. Some Products based on NIH technologies27

28. For Additional Information
To learn more about the NIH, the NIH Intramural Research Program, and Technology Transfer at the NIH, visit:
NIH
NIH Intramural Research Program
NIH Office of Technology Transfer
Technology Transfer Offices and Contacts
NIH Technology Transfer: Science. Ideas. Breakthroughs.