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 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 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 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.

9. A $100M Program at the NCI 2.5% 0.3% Program Descriptions Set Aside
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
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 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

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

13. Award always made to small business
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. For more information visit:
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:

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
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
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 on NCI SBIR & STTR Website

20. New SBIR Bridge Award

21. Phase II SBIR and Commercialization 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 Bridge Award 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
Target Identification
& Validation
Preclinical Development
(Lead Development, Animal Studies, File IND)
Safety
Review
Clinical
Trials
NDA
Review
Commercialization
Phase I & Phase II SBIR
Private Investment
The “Valley of Death” is the problem

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

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)
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
Solicitation
Topics
NCI describes topics in solicitation
Proposal
Submission
About 6-9 months
Small business concerns prepare short (usually 25-page) proposals
Unsolicited proposals are not accepted
Evaluation
NCI evaluates proposals based on technical merit, applicant qualifications, and commercial potential/societal benefit
Award
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
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. NCI SBIR Development Center NCI SBIR & STTR Programs
Michael Weingarten
Director
NCI SBIR Development Center
Phone:
Andrew Kurtz, Ph.D.
Program Manager
NCI SBIR & STTR Programs
Phone: