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An Industry Guide to Partnering with the National Cancer Institute, NIH

An Industry Guide to Partnering with the National Cancer Institute, NIH. Tom Stackhouse, Ph.D. Technology Transfer Branch National Cancer Institute National Institutes of Health. December 09, 2003.

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An Industry Guide to Partnering with the National Cancer Institute, NIH

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  1. An Industry Guide to Partnering with the National Cancer Institute, NIH Tom Stackhouse, Ph.D. Technology Transfer Branch National Cancer Institute National Institutes of Health December 09, 2003

  2. To establish partnerships between the National Institutes of Health and non-federal partners to develop leading-edge technologies into products that improve public health.

  3. Formal Agreements with the NCI, NIH Programs  Licenses • Transactional Agreements • Collaborative Research Agreements • Specialized Agreements

  4. Transactional Agreements • Material Transfer Agreements • Confidential Disclosure Agreements • Collaborative Research Agreements

  5. Material Transfer Agreement • Identifies research material • Generally prohibits human use • Specifies permitted use(s) • Makes no promises regarding inventions made using the materials • Addresses publication(s) • Addresses liability

  6. Confidential Disclosure Agreement • Identifies the confidential information generally, and requires that actual information exchanged be clearly marked as “Confidential” • Specifies permitted use(s) • Specifies a term of the confidentiality obligation • Addresses required release of information under law, court order or FOIA. • Makes no promises regarding inventions made through the use of the information

  7. Collaborative Research Agreements • Clinical Trial Agreement • Cooperative Research and Development Agreement

  8. NCI’s Cancer Therapy Evaluation Program (CTEP) • Currently sponsors over 150 INDs. • Nearly 10,000 registered investigators at approximately 2000 institutions. • 500 new protocols/year. • ~25,000 patients accrued/year. • Over 80 collaborative agreements (CRADAs, CTAs) with pharmaceutical companies.

  9. The Advantages of Collaborating with CTEP • Regulatory expertise. • Ability to evaluate agent in wide variety of tumor types and disease settings. • Expedite trials through extensive clinical trials network of cooperative groups, cancer centers, and phase 1 & 2 contracts. • Exclusive access to primary data concerning a particular agent

  10. Clinical Trial Agreement • Specifies transfer and use of materials in research using human subjects • Specifies a clinical protocol • Assigns responsibility for drug supply, data monitoring, and addressing regulatory requirements • Addresses data rights • Addresses publication • Makes no promises regarding inventions made through the use of the materials

  11. What is CRADA? Cooperative Research and Development Agreement (CRADA) CRADAs are collaborative agreements designed to facilitate the commercialization of technology arising in Federal laboratories. The intent of the CRADA is always to link the strengths of NIH with those of industry in order to commercialize Federally funded research to benefit the public health.

  12. CRADAs • A focused collaboration • Duration 1-5 years • A CRADA provides the Collaborator with an option to an exclusive license to CRADA subject inventions • A CRADA is the only mechanism the NIH has to promise intellectual property rights in advance

  13. CRADA exchanges • The Federal laboratory may provide • Personnel • Services • Facilities, equipment, or other resources • The Collaborator may provide • Funds • Personnel • Services • Facilities, equipment, or

  14. The CRADA Research Plan Scientists (NCI & company) jointly draft Research Plan. • Provide necessary scientific background • Define scope of the Research Plan which in turn defines scope of the licensing option. • Clearly specify roles/responsibilities of each party

  15. Clinical Trial-CRADA • Intellectual Collaboration with one or more outside Collaborators • Collaboration involves Clinical Trials • Collaborator requires Exclusive Access to Drug, Technology, Data, Expertise • Collaborator(s) wants Rights to Future Inventions by NIH Scientist • Funding may be received by NIH

  16. CRADA between NCI and Bristol-Myers Squibb - for the clinical development of paclitaxel - development of a semi-synthetic form manufactured from renewable resources - development of methods of administration - 29,000 patients treated through the end of CRADA - FDA approval for 5 indications, including refractory ovarian and breast cancers

  17. NCI CRADAs That Have Generated Inventions • Development of Treatments for Vascular and Cardiovascular Restenosis • Development of a Clinical Pathology Laser Capture Microdissection System for Routine Clinical Use • Development of Anti-Cancer Vaccines Using the Accell Gene Delivery System • Development of Poxvirus Based Cancer Vaccine • Determination of Binding Sites and Design of New HIV Integrase Inhibitors • Development of PMZ-1 • Evaluation of Raloxifene by Itself or in Combination with a Retinoid for Prevention of Breast Cancer and Prostate Cancer • Identification of Neutrophil and Monocyte Chemokines Induced by Interleukin-8 and Monocyte Chemotactic Protein-1

  18. Developmental Therapeutic Program (DTP) DTP provides resources for: • discovery • compounds (repositories) • informatics (public database) • cell lines • screening (60 cell line panel, etc..) • development • formulation • In vivo testing • pharmacology • toxicology

  19. Rapid Access to Intervention Development (RAID) • No funding • Tied to a Academic applicant • Provides NCI resources including our contract resources: • Small- medium scale production • Bulk supply • GMP manufacturing • formulation • Toxicology • Most IP developed flows to Government to allow it to be unencumbered by such third party contracts for use by the RAID Recipient.

  20. Academic Public Private Partnership Program (AP4) • To stimulate cancer intervention discovery and development research at academic centers in partnership with industry, non-profits and government • Focus on: • Incorporation of the latest technologies and • novel, mechanistically targeted drugs and other intervention strategies for underserved diseases • To bring together the necessary expertise to reduce the time required to translate novel drug discoveries into therapies.

  21. AP4 Interactive Flow Academic Director (College, USA) Funding Funding Partner 1 Voting Member & Coordinator Evaluations Voting Members Advice (Non- Voting) NCI Program Director Steering Committee Partner 2 Requests For Support/ Progress Reports Review & Approvals Partner 3 Project 1 Project 2 Project 3

  22. Specialized Agreements • Specialized MTAs for Repositories • Screening Agreements • Memorandum of Understanding • Letters of Collection • Modified IP Clause(s) in a Contracts • Special IP Term(s) of Award in a Grant • Any Agreement Referring to Patent Rights

  23. Licenses • The NIH Office of Technology Transfer negotiates licenses on behalf of all of the Institutes and Centers at NIH, and the FDA • NIH licensing policy issues

  24. Types ofCommercialUse Licenses • Commercial Evaluation Licenses grant the right to make and use the technology for the purpose of evaluating its commercial potential. • Internal Commercial Use Licenses grant the right to make and use the invention for the purpose of internal use by the licensee. No sales or distribution. • Full Commercial License grant the right (non-exclusive or co-exclusive or exclusive) to make, use and sell the invention. • Bilogical Materials License for inventions desired for commercial purposes but not claimed in a patent or patent application; typically non-exclusive.

  25. NCI-Technology Transfer Fellowship • Introductory TTB “University”, including lectures, policy and procedures manual, and negotiation sourcebooks • Individualized training plans • Ongoing training program alternating between tech transfer speakers, and NCI and CSC scientist speakers • “On the job” training • Details to other technology transfer offices (e.g. NIH Office of Technology Transfer)

  26. Institute Program http://www.nci.nih.gov/ • RAID and AP4: http://dtp.nci.nih.gov • For CTEP: http://ctep.cancer.gov • Institute Technology Development Coordinator • http://ott.od.nih.gov/NewPages/tdc.html • NIH Office of Technology Transfer • http://ott.od.nih.gov • NIH Clinical Trials Information • http://www.clinicaltrials.gov/

  27. Contact Information Thomas M. Stackhouse, Ph.D. Associate Chief, Technology Transfer Branch National Cancer Institute at Frederick Fairview Center, Suite 500 1003 W. 7th Street Frederick, MD 21701 Telephone: 301-846-5465 Facsimile: 301-846-6820 Email stackhot@mail.nih.gov

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