The NCI Technology Transfer and SBIR Programs: Creating An Internal Partnership

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1 The NCI Technology Transfer and SBIR Programs: Creating An Internal Partnership Karen Maurey Chief, Technology Transfer Thomas Branch M. Stackhouse, PhD National Cancer Institute Associate Director National Instutes Technology of Health Transfer Center September 21, 2006 National Cancer Institute, NIH FLC National Meeting, Nashville, TN May, 2011

2 Combining the SBIR and TT is in Line with Congressional Intent Stimulate technological innovation Use small business to meet Federal R&D needs Increase private-sector commercialization innovations derived from Federal R&D Foster participation by minority and disadvantaged persons in technological innovation Small Business Innovation Development Act of 1982 Small Business Technology Transfer Act of 1992

3 Where to Start?: Information Gathering Long-term goal commercialize NCI inventions which are backed by intellectual property protection using the funding of the NCI-SBIR Program. Is this something NCI wants to do? Has it been done before? How? NIST precedent (2 year experience) Clara. Asmail, Use of Small Business Innovation (SBIR) Program in Support of Technology Transfer, les Nouvelles, vol. XLV, No. 3, pp Sept 2010

4 Creating Critical Mass - The Internal Partners: NIH Office of Technology Transfer NCI SBIR Development Center NCI Technology Transfer Center NCI Office of Acquisitions NCI CCR Inventors NCI CCR Scientific Director

5 General Flow of Activities Key Steps: Choose intramural technologies (Team) * Approach inventors (Scientific Directors Office) Develop, refine SBIR Phase I and II workscope, contract deliverables (Team) Review by SBIR Selection Committee SBIR Program s Technology Assessment Group (TAG) Develop strategy for targeted contract solicitation Write solicitation (NCI SBIR and NIH OTT) Publish solicitation Market solicitation

6 General Flow of Activities, Part 2 Public briefing/webinar to advertise and explain solicitation (SBIR and tech transfer aspects; most stakeholders participate) Receipt of SBIR proposals (November 2010) Receipt of commercialization license applications (NIH OTT) Peer review of SBIR Phase I contract proposals (Jan - Feb 2011) SBIR contract negotiations with offerors in competitive range Review, negotiation of commercialization license Award of 1 SBIR Phase I contract (Sept 2011)

7 Next Steps: Review progress of work performed under Phase I contract Decide whether to invite follow on SBIR Phase II contract, including in this assessment the status of the application for a commercialization license If contract invited, repeat proposal receipt, peer review, negotiation for 2-year Phase II award Phase IIB Bridge award may follow if company is successful in Phase II Commercialization activities to follow (not supported by federal SBIR funds)

8 Solicitation Excerpts - Unique Aspects Description of the Invention(s) The NCI Center for Cancer Research (CCR) has developed two inventions that may address this shortcoming. One invention is a low-frequency coil design suitable for. This invention is fully described in U.S. Patent Number 5,865,746 and is the subject of HHS Reference Number E /0. A second invention is an image-formation method for in vivo imaging of physiological function. It emphasizes image resolution and quantitative assessment of in vivo tissue oxygen. This invention is fully described in PCT Patent Application Number PCT/US2009/65956 and is the subject of HHS Reference Number E /0

9 Solicitation Excerpts - Unique Aspects Program Goals and Inventor Access: This is an NIH TT (Technology Transfer) contract topic from the NCI. This is a new program whereby inventions from the NCI Intramural Research Program (Center for Cancer Research, CCR) are licensed to qualified small businesses with the intent that those businesses develop these inventions into commercial products that benefit the public. The contractor funded under this contract topic shall work closely with the NCI CCR inventor of this technology, who will provide access to operational scanners and hardware as well as image-formation and reconstruction algorithms. The inventor will provide assistance in a collaborative manner with reagents and discussions during the entire award period. Between the time this contract topic is published and the time an offeror submits a contract proposal for this topic, no contact will be allowed between the offeror and the NCI CCR inventor. However, a pre-submission public briefing and/or webinar will be given by NCI staff to explain in greater detail the technical and licensing aspects of this program (for further information, see In addition, a list of relevant technical, invention, and licensing-related questions and answers (including those from the public briefing) will be posted, maintained, and updated online ( during this time period.

10 Solicitation Excerpts - Unique Aspects Licensing The awarded contractor will automatically be granted a royalty-free, non-exclusive license to use NIH-owned and patented background inventions only within the scope and term of the award. However, an SBIR offeror or SBIR contractor can apply for an exclusive or nonexclusive commercialization license to make, use, and sell products or services incorporating the NIH background invention. Offerors submitting an SBIR contract proposal in response to this topic are strongly encouraged to submit concurrently an application for a commercialization license to such background inventions. Under the NCI NIH TT program, the SBIR contract award process will be conducted in parallel with, but distinct from, the review of any applications for a commercialization license. A Phase II proposal will typically/generally only be invited by NCI if the Phase I contractor has been granted a commercialization license via the NIH license application process described herein.

11 Lessons Learned The Team is Critical! Must be balanced and each team member must have ownership in effort so that it becomes a priority Timelines, Timelines, Timelines! We had to comply with the strict proposal and review processes of the SBIR Contract Program.

12 Lessons Learned Scientific and Marketing Criteria - needed to be developed more rigorously and used to select the NCI invention portfolio for selection of SBIR-TT topics. Uniqueness of the technology/interest to date Patent lifetime Therapeutic versus diagnostic use Stage of Development Opportunity for innovation Potential Market Impact Can the technology be matured in accordance with the SBIR phase I and phase II criteria by a small business (building a prototype/kit, etc; developing a unique model for testing)

13 And We Decided to Do it all Over Again! Potential Topics for 2012 We have selected 5 new SBIR-TT topics for next round Currently prepared technical marketing write-up To be reviewed end of May month by the SBIR Technology Advisory Group (TAG) Already had a unique issue arise with one of the five.

14 NCI SBIR-TT Program: The Team NIH Office of Technology Transfer Sue Ano Mojdeh Bahar Bonny Harbinger Jeffrey Clark Klein Richard Rodriguez Mark Rohrbaugh Elicia Rothschild NCI SBIR Ali Andalibi Greg Evans Michael Weingarten NCI Center for Cancer Research Eric Hale Bob Wiltrout Grace Yeh NCI Technology Transfer Center John Hewes Karen Maurey Tom Stackhouse Special Thanks to Clara Asmail, NIST