Andrew J. Kurtz, Ph.D. Cancer Health Disparities Summit

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1 Andrew J. Kurtz, Ph.D. AAAS Science & Technology Policy Fellow NCI SBIR & STTR Programs Cancer Health Disparities Summit Bethesda, MD (July 18, 2007)

2 Today s Presentation Overview Eligibility Requirements SBIR Funding Opportunities Submitting an Application

3 Overview

4 Congressional Goals of SBIR 1. Stimulate technological innovation 2. Use small business to meet Federal R&D needs 3. Increase private-sector commercialization innovations derived from Federal R&D 4. Foster participation by minority and disadvantaged persons in technological innovation Small Business Innovation Development Act of 1982 P.L (Signed 12/21/2000 extends program through 09/30/2008) Small Business Technology Transfer Act of 1992 P.L (Signed 10/15/2001 extends program through 09/30/2009)

5 Percentage of NIH Extramural Research Budget Set Aside SBIR: Set-aside program for small business concerns to engage in Federal R&D with potential for commercialization 2.5% STTR: Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions with potential for commercialization 0.3% FY 2006 (SBIR & STTR) National Cancer Institute = $105 million All NIH Institutes and Centers = $640 million

6 Reasons to Seek SBIR & STTR Funding Provides seed funding for innovative technology development projects Provides recognition, verification and visibility Helps provide leverage in attracting additional funding or support (e.g., venture capital, strategic partner) Not a loan No repayment is required Doesn t impact stock or shares in any way (non dilutive capital) Intellectual property rights are retained by the small business

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

8 Eligibility Requirements

9 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 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

10 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 s primary employment may be with either the Small Business Concern or the research institution

11 SBIR Funding Opportunities

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

13 Upcoming SBIR Contract Topics (August 2007, NIH-Wide) Examples 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 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 Portable e-technology Diet and Physical Activity Tools for Consumers To support the development of a portable intervention tool to monitor energy imbalance in obesityrelated health behaviors that are linked to cancer Goal is to assess and modify diet and physical activity among groups at high risk of obesity and cancer, including ethnic minorities and socio-economically disadvantaged groups

14 More Information on NCI SBIR & STTR Website

15 Submitting an Application

16 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

17 Application and Award Process Solicitation Topics NCI describes topics in solicitation Proposal Submission Evaluation About 6-9 months 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 Award NCI makes awards

18 Advice from Successful Awardees Understand NCI s mission and needs Explore the funding opportunities on the Web site(s) Seek guidance from SBIR & STTR program staff If you are new to the NIH SBIR program and/or the peer review process, consider collaborating with someone who has been successful in receiving awards Win or lose, request and review evaluations Don t depend solely on SBIR funding

19 NCI s SBIR & STTR Program Successful NCI-Supported Projects A number of products commercialized In areas ranging from devices, to research tools, to software, to educational materials: MarkPap Test Kit (System) Image Guided Cancer Therapy Based on a unique biomarker that in clinical trials has improved the cytoscreeners ability to detect abnormal specimens (50% more than control) and has assisted them in reducing false negative readings (50% less than control) A system for the accurate localization and fixation of the prostate during the planning and treatment of prostate cancer using radiation therapy Interactive multimedia CD- ROM entitled Kidz with Leukemia: A Space Adventure For 4- to 11-year-old youth with leukemia, their friends, and families; with the help of games, voiceover, videos, animation, graphics, and music, children learn about their illness, diagnosis, treatment, as well as some helpful coping skills Source: 2003 National Survey to Evaluate the NIH SBIR program

20 Michael Weingarten Director NCI SBIR & STTR Programs Phone: Andrew Kurtz, Ph.D. AAAS Science & Technology Policy Fellow NCI SBIR & STTR Programs Phone: