An Overview of the SBIR Program at the National Cancer Institute Prepared by Michael Weingarten

1. An Overview of the SBIR Program at the National Cancer Institute Prepared by Michael Weingarten Director of NCI SBIR Development Center January 17, 2007

2. New SBIR Phase IIBBridge Award

3. SBIR Phase II Awards andCommercialization Success • Significant resources are required for getting through the FDA approval process Today, many NIH SBIR awardees complete the SBIR Phase II award without advancing the technology far enough to attract private investment

4. NCI is in Planning Stages for a New SBIR Phase IIB Bridge Award Goal: • 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 • It would require the SBIR company to either raise matching funds from the investment community or industry partners • Leverage private investor’s due diligence process • Modeled after the National Science Foundation’s “SBIR Phase IIB Option” program. • Recent data from the NSF show that Phase IIB awards significantly accelerate the commercialization process.

5. Example: How the Bridge Award Might 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

6. Example: How the Bridge Award Might 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 Awardwould allow NIH to share investment risk by incentivizing investors or strategic partners to evaluate projects and commit funds much earlier

7. Example: How the Bridge Award Might 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

8. NCI is in Planning Stages for a New SBIR Phase IIB Bridge Award • NCI is in the important stage of developing and gaining approval for this new funding opportunity. • Our goal is to launch this within the next several months. • Further details will be spelled out in the Funding Opportunity Announcement. • To receive more information, please go to http://sbir.cancer.gov and enter your email in “Sign up for updates.” • We will email out information on this funding opportunity once its available.

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

10. Overviewof the SBIR Program

11. 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.

12. 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.)

13. Tips on Submitting an Application

14. 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

15. 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

16. 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

17. 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

18. Eligibility Requirements

19. 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

20. 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

21. 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 must 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

22. NCI SBIR Funding Opportunities

23. 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: Sbir.cancer.gov

24. 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.

25. Current NCI Priority Areas • Development of Anti-Cancer Agents • Development of Molecular Pharmacodynamic Assays for Targeted Therapies • Nanotechnology Imaging and Sensing Platforms for Improved Diagnosis of Cancer • Multifunctional Therapeutics Based on Nanotechnology • Antibody Array for Cancer Detection • Biosensors for Early Cancer Detection and Risk Assessment • Novel and Improved Methods to Measure Cancer Epigenetic Biomarkers • High-Throughput Assays for Isolation and Characterization of Cancer Stem Cells • Assay Systems for Drug Efficacy Using Cancer Stem Cells • Integrating Patient-Reported Outcomes in Hospice and Palliative Care Practices • Portable e-Technology Diet and Physical Activity Tools for Consumers • Patient-Centered Coordinated Cancer Care System • System to Analyze and Support Biomarker Research and Development Strategies • Biopsy Instruments and Devices that Preserve Molecular Profiles in Tumors • Advances in Protein Expression of Post-Translationally Modified Cancer Related Proteins • Development of Clinical Quantitative Multiplex High-Throughput Mass Spectrometric Immunoassay for Detecting Low Abundance Cancer Related Proteins/Peptides in Bodily Fluids

26. Examples of SBIR Grant TopicsDivision of Cancer Biology SBIR Program Announcement (PAS-07-240) Technology Development for the Detection and Evaluation of Chemical and Biological Carcinogens (R43/R44) http://grants.nih.gov/grants/guide/pa-files/PAS-07-240.html Receipt Dates: April 5, August 5, December 5, 2007 SBIR Program Announcement (PAS-07-241) Technology for the Detection and Characterization of Low Abundance Proteins, Peptides, or micro RNAs (R43/R44) http://grants.nih.gov/grants/guide/pa-files/PAS-07-241.html Receipt Dates: April 5, August 5, December 5, 2007 SBIR Program Announcement (PAS-07-242) Technologies and Software to Support Integrative Cancer Biology Research (R43/R44) http://grants.nih.gov/grants/guide/pa-files/PAS-07-242.html Receipt Dates: April 5, August 5, December 5, 2007

27. Omnibus Solicitations for Grants SBIR Omnibus Solicitation PHS 2006-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) http://grants.nih.gov/grants/guide/pa-files/PA-06-120.html Receipt Dates: April 5, August 5, December 5, 2007 STTR Omnibus Solicitation PHS 2006-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent SBIR [R41/R42]) http://grants.nih.gov/grants/guide/pa-files/PA-06-121.html Receipt Dates: April 5, August 5, December 5, 2007

28. Changes in Program Management

29. 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 29

30. 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 • Recruit internally and externally • These would be full time dedicated SBIR management teams • Integrate all SBIR initiatives with NCI’s program priorities • Foster collaborations with other Institutes 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 30

31. 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 31

32. 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”

33. 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