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 IIB Bridge Award

3. SBIR Phase II Awards and Commercialization 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. 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. Goal: NCI is in Planning Stages for a New SBIR Phase IIB Bridge Award

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

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

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

8. 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. NCI is in Planning Stages for a New SBIR Phase IIB Bridge Award

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

10. Overview of the SBIR Program

11. SBIR & STTR: Three-Phase Program PHASE I – R41, R43 Feasibility Study $100K and 6-month (SBIR) * or 12-month (STTR) Award * Note: Actual funding levels may differ by topic. 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

12. 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.) Reasons to Seek SBIR & STTR Funding

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 Significance Does the study address an important problem and have commercial potential? Innovation Are there novel concepts or approaches? Are the aims original and innovative? Investigator Is the investigator appropriately trained and capable of managing the project? Approach Are design and methods well-developed and appropriate? Are problem areas addressed? Environment Does the scientific environment contribute to the probability of success? Is the environment unique?

16. Electronic Submission Process (Grants Only) 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 http://era.nih.gov/ElectronicReceipt

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

18. Eligibility Requirements

19. 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 operated or 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 SBIR Eligibility Requirements

20. 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’s primary employment may be with either the Small Business Concern or the research institution STTR Eligibility Requirements

21. SBIR SBIR and STTR Programs (Critical Differences) Award always made to small business 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)

22. NCI SBIR Funding Opportunities

23. 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 NIH Issues Multiple SBIR Solicitations

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. 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 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-07-242) 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 Examples of SBIR Grant Topics Division of Cancer Biology

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. 29 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 NCI Creating an SBIR Development Center to Optimally Manage the Program

30. 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 NCI Creating an SBIR Development Center to Optimally Manage the Program

31. 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 New NCI SBIR Development Center

32. 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. 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 http://sbir.cancer.gov