TECHNOLOGY TRANSFER • • • The NIH Experience

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Presentation transcript:

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

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.

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.

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

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.

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.

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’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.

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.

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

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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

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.

Some Products based on NIH technologies 27

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 NIH Technology Transfer: Science. Ideas. Breakthroughs.