An Overview of the NCI SBIR Program

1. An Overview of the NCI SBIR Program Michael Weingarten Director, NCI SBIR Development Center April 14, 2008

2. Today’s Presentation • Overview • Eligibility Requirements • Move to More Focused Solicitations • New SBIR Bridge Award • Submitting An Application • SBIR Development Center

3. Overview

4. Charge from the NIH Director October 2006-- request from Dr. Zerhouni to Dr. Niederhuber for NCI to lead an effort to examine the $650 million NIH SBIR Program with a target of enhancing the program’s outcomes NCI’s Response • December 2006-- Dr. Niederhuber presented recommendations to Dr. Zerhouni • Presentations followed to the NIH Steering Committee and Institute Directors • Dr. Zerhouni asked that all recommendations be implemented on a pilot basis at NCI with interested Institutes to work with NCI • Since February 2007, NCI has been working to implement the recommendations 4

5. Recommendations • Specific Recommendations Being Implemented • Establish SBIR Development Centers • Focus Solicitations on Commercially Viable Technologies • Co-invest With the Private Sector to Bridge SBIR Projects Toward Commercialization 5

6. Why are SBIR and STTR Important? • NIH’s primary resource for enabling commercialization of innovative high impact technologies, such as: • Research tools • Medical devices • Therapeutics • Provides incentive to academic investigators to translate technology (new company formation) • One of the largest sources of early-stage life sciences financing 6

7. Reasons to Seek SBIR & STTR Funding • Provides seed funding for innovative technology development projects • Intellectual property rights are retained by the small business concern • Not a loan – no repayment is required • Doesn’t impact stock or shares in any way (no dilution of capital) • Provides recognition, verification and visibility • Can be a leveraging tool to attract other funding (VC, etc.)

8. SBIR & STTR: Three-Phase Program • PHASE II – R42, R44 • Full Research/R&D • $750K and 2-year Award (SBIR & STTR) * • Commercialization plan required • PHASE III • Commercialization Stage • Use of non-SBIR/STTR Funds PHASE I – R41, R43 • Feasibility Study • $100K and 6-month (SBIR) * • or 12-month (STTR) Award * Note: Actual funding levels may differ by topic.

9. Program Descriptions • SBIR: Set-aside Program for Small Business Concerns to engage in Federal R&D with potential for commercialization • STTR: Set-aside Program to facilitate Cooperative R&D between Small Business Concerns and U.S. Research Institutions with potential for commercialization Set Aside 2.5% 0.3% A $100M Program at the NCI

10. Eligibility Requirements

11. SBIR Eligibility Requirements • Small Business Concern • Organized for-profit U.S. business • 500 or fewer employees, including affiliates • Must be: • At least 51% U.S.- owned by individuals and independently operatedor • At least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals • Principal Investigator’s primary employment must be with the Small Business Concern at the time of award and for the duration of the project period

12. STTR Eligibility Requirements • Applicant is a Small Business Concern • Formal Cooperative R&D Effort • Minimum 40% by small business • Minimum 30% by U.S. research institution • U.S. Research Institution • College or University • Other non-profit research organization • Federal R&D center • Intellectual Property Agreement • Allocation of IP rights and rights to carry out follow-on R&D and commercialization • Principal Investigator’sprimary employment may be with either the Small Business Concern or the research institution

13. SBIR and STTR Programs(Critical Differences) SBIR • Permits research institution partners (e.g., universities) • Small business concern may outsource ~33% of Phase I activities and 50% of Phase II activities STTR • Requires research institution partners (e.g., universities) • 40% of the work should be conducted by the small business concern (for profit) and 30% by a U.S. research institution (non-profit) Award always made to small business

14. NCI SBIR Funding Opportunities

15. NIH Issues Multiple SBIR Solicitations • SBIR/STTR Omnibus Grant Solicitation • Release:January • Receipt Dates:April 5, August 5, and December 5 • SBIR Contract Solicitation (NIH, CDC) • Release:August • Receipt Date:Early November NIH Guide for Grants and Contracts Release:Weekly Receipt Dates:Various For more information visit: http://sbir.cancer.gov

16. NCI is Moving to More Focused Solicitations • Goal is to improve success in commercialization by focusing on more directed research. • Invest in the technology priorities of NCI that also have potential for commercialization • Catalyze targeted technology development and draw private sector investment in areas such as drug development and assays that measure treatment response • Significantly increase the use of SBIR contracts.

17. Examples of NCI SBIR Technology Priorities • To support the investigation of candidate therapeutic agents to establish the rationale for continued development to the point of filing an IND • Compounds may be chosen from a list provided by NCI or by the small business Nanotechnology Imaging and Sensing Platforms for Improved Diagnosis of Cancer • To support the development of nano-enabled platforms for early detection and/or imaging, or for post-treatment monitoring to detect recurrence of disease • Goal is to enhance clinical diagnosis of cancer Development of Anti-Cancer Agents Antibody Array for Cancer • To support the development of high-throughput antibody arrays for the quantitative analysis of multiple biomarkers • Goal is to provide new tools for the early detection and diagnosis of cancer Biopsy Instruments and Devices that Preserve Molecular Profiles in Tumors • To support the development of devices with potential for stabilizing the molecular profile of cancerous lesions in visceral tissue sites during clinical biopsy procedures • To improve the accuracy of biomarker assessment for diagnosis and prognosis

18. Request for Information • We will be announcing a Request for Information in a couple of weeks. • Opportunity to put forward your ideas on topics that the NCI should solicit. • Please address why the topic is important in advancing the science in cancer research. • Critical to also address the commercial potential and market opportunities in the area.

19. More Information onNCI SBIR & STTR Website http://sbir.cancer.gov

20. New SBIR Bridge Award

21. Phase II SBIR andCommercialization Success • Significant resources are required for getting through the FDA approval process • This funding gap is known as the “Valley of Death” Today, many awardees complete the SBIR Phase II award without advancing the technology far enough to attract private investment

22. New SBIR BridgeAward Strategy: • Accelerate projects to commercialization by: • Filling the funding gaps that currently exist • Sharing in the investment risk and incentivizing private investors to fund earlier stage projects • Expectation that the SBIR company will raise raise matching funds from the investment community or industry partners • Opportunity to leverage external resources • Leverage private investor’s due diligence process • Modeled after NSF’s “Phase IIB Option” program • In FY 06, NSF invested $18M in this program and raised $58M in matching funds from the investment community

23. Example: How the Bridge Award Would Apply in the Area of Drug Development Phase I & Phase II SBIR The “Valley of Death” is the problem Preclinical Development (Lead Development, Animal Studies, File IND) Target Identification & Validation Safety Review Clinical Trials NDA Review Commercialization Private Investment

24. Example: How the Bridge Award Would Apply in the Area of Drug Development Phase I & Phase II SBIR Preclinical Development (Lead Development, Animal Studies, File IND) Target Identification & Validation Safety Review Clinical Trials NDA Review Commercialization SBIR Bridge Award Private Investment SBIR Bridge Award addresses the problem by bridging the “Valley of Death” SBIR Bridge Awardallows NIH to share investment risk by incentivizing investors or strategic partners to evaluate projects and commit funds much earlier

25. Example: How the Bridge Award Would Apply in the Area of Drug Development Phase I & Phase II SBIR SBIR Bridge Award STOP STOP 2nd Year 1/3 of funds 1st Year 1/3 of funds 3rd Year 1/3 of funds YES YES • Milestones reached? • Matching Funds? • Milestones reached? • Matching Funds? • Milestones reached? • Matching Funds? NO NO Preclinical Development (Lead Development, Animal Studies, File IND) Target Identification & Validation Safety Review Clinical Trials NDA Review Commercialization SBIR Bridge Award Private Investment

26. Submitting an Application

27. Keys to a Strong Application • Significant, innovative, and focused science • Significant product and/or commercial potential • A product-focused application is more likely to have support of business reviewers • A project with sound financial projections is more likely to attract a partner • Translational research/clinical applications projects should involve the appropriate collaborators • Oncologists • Pathologists • Statisticians

28. Know NIH Review Criteria • Does the study address an important problem and have commercial potential? Significance • Are design and methods well-developed and appropriate? Are problem areas addressed? Approach • Are there novel concepts or approaches? Are the aims original and innovative? Innovation • Is the investigator appropriately trained and capable of managing the project? Investigator • Does the scientific environment contribute to the probability of success? Is the environment unique? Environment • Is the company’s business strategy one that has a high potential for success? Commercialization

29. Preliminary Data • Solicitation states “Preliminary data are not required” • Reviewers like to see preliminary data • Preliminary data should support your proposal and the feasibility of the project • Preliminary data may consist of your own publications and unpublished data from your laboratory

30. Electronic Submission Process(Grants Only) http://era.nih.gov/ElectronicReceipt • The PHS398 grant application form is being phased out and replaced with the SF424 Research and Related (R&R) application • NIH has transitioned from paper submission of SBIR/STTR grant applications to electronic submission • Company and company official must be registered in Grants.gov • PI and company official must be registered in the eRA Commons

31. Application and Award Process About 6-9 months Award Solicitation Topics • NCI describes topics in solicitation Proposal Submission • Small business concerns prepareshort (usually 25-page) proposals • Unsolicited proposals are not accepted Evaluation • NCI evaluates proposals based on technical merit, applicant qualifications, and commercial potential/societal benefit • NCI makes awards

32. Changes in Program Management

33. NCI Creating an SBIR Development Center to Optimally Manage the Program Today, SBIR program management is generally dispersed across NIH, with few full-time SBIR program managers • For example, at NCI, SBIR awards are managed by ~40 people who each spend only a fraction of their time managing small business awards • Few NIH SBIR program managers have significant industry or commercialization experience 33

34. NCI Creating an SBIR Development Center to Optimally Manage the Program Development Center Goals • Assemble the scientific and business expertise needed to optimally manage the SBIR program at the NCI • These will be full time dedicated SBIR management teams • Integrate all SBIR initiatives with NCI’s program priorities • Foster collaborations with other ICs at NIH which share common technology needs • Enhance the return on investment for the SBIR program for the benefit of the cancer community and the public health in general 34

35. New NCI SBIR Development Center • Center will offer a menu of services: • Assess commercial potential of NIH technology priorities • Write solicitation topics/post-solicitation activities • Market program to attract the best companies • Evaluate commercialization potential of proposals • Provide awardee management & support • More active monitoring of awards • Program managers will have expertise and networks to mentor emerging SBIR companies in commercialization strategy and process 35

36. Employment Opportunities Employment Opportunities • Positions to be announced soon looking for expertise in: • Biomarkers and Diagnostic Assays • Cancer Imaging • Radiation Therapy • Cancer Prevention • Cancer Biology • Cancer Control and Population Sciences • To receive job announcement information, go to sbir.cancer.gov and click on “Sign up for Updates”

37. http://sbir.cancer.gov Michael Weingarten Director NCI SBIR Development Center Phone: 301-496-4413 weingartenm@mail.nih.gov Andrew Kurtz, Ph.D. Program Manager NCI SBIR & STTR Programs Phone: 301-594-6846 kurtza@mail.nih.gov