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Bringing Science to the Market:
The NCI SBIR ProgramMarch 4, 2011
Ali Andalibi, PhDNCI SBIR Development Center
Today’s Presentation
• Program Background
• Helping Companies Bridge the “Valley of Death” -- SBIR Phase II Bridge Award
• New Initiatives:
• NCI Investor Forum
• Regulatory Assistance Program
Percent of NCI and NIH Budget
2.5%
0.3%
Set Aside
~$110 million annually at the NCI~$650 million annually at the NIH
SBIR: Set-aside program for small business concerns to engage in Federal R&D with the 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
• One of the largest sources of early stage of life sciences funding in the country.
• A stable and predictable source of funding
• 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
SBIR Eligibility
Applicant must be a Small Business Concern (SBC)
Organized for-profit U.S. business
500 or fewer employees, including affiliates
PD/PI’s primary employment (i.e., >50%) must be with SBC at the time of award and for duration of the project period
At least 51% U.S.- owned by individuals and independently operated
ORAt least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals
NCI Efforts and Programs Focused on Improving Commercialization
SBIR Development Center
Established in 2008
• Goal: Enhance commercialization success of SBIR-funded projects
Old SBIR Management Model at NCI
• Awards were managed by 40-50 Program Directors with an academic focus, whose portfolios were comprised mainly of academic awards (currently the model at other NIH Institutes)
SBIR Development Center at NCI
• Team of 8 Program Directors focused on the management of NCI’s SBIR/STTR portfolio
• Many of the Center’s Program Directors have previous industry experience and professional networks to help mentor awardees in commercialization strategy and process
• Center is developing a range of new activities to help small businesses
Mentoring and Facilitation
Goal• To work closely with promising SBIR Phase awardees in order
to advance their technologies towards the clinic
Path • Active outreach to bring in a new class of commercially viable
applicants
• Mentor and guide companies throughout the award period.
• When appropriate, act as a liaison to bring investors (VC, angels, strategic partners) and NCI SBIR companies together
• Use the Bridge Award as an incentive to involve investors in Phase II companies
• NCI SBIR Investor Forum
The Bridge Award
SBIR & STTR: Three-Phase Program
* Note: Actual funding levels may differ by topic. 10
PHASE I – R41, R43• Feasibility Study • $150K and 6-month (SBIR) *• or 12-month (STTR) Award
PHASE II – R42, R44• Full Research/R&D• $1 million and 2-year Award (SBIR & STTR) *• Commercialization plan required
PHASE III• Commercialization Stage• Use of non-SBIR/STTR Funds
Phase II Bridge Award
Follow-on to SBIR Phase II
• Helps early-stage companies cross the “Valley of Death” by:
• Facilitating partnerships with third-party investors & strategic partners
• Incentivizing third-party investments earlier in the development process
NCI is sharing in the investment risk with other investors
Incentive Structure
• Gives competitive preference and funding priority to applicants that can raise third-party funds (i.e., 1:1 match)
• Affords NIH the opportunity to leverage millions in external resources
• Provides valuable input from third-party investors in several ways:
1. Rigorous commercialization due diligence prior to award
2. Commercialization guidance during the award
3. Additional financing beyond the Bridge Award project period
SBIR Phase II Bridge Award
11
Example: How the Bridge Award Would Apply in the Area of Drug Development
Phase I & Phase II SBIR
CommercializationNDA
ReviewClinicalTrials
SafetyReview
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 allows NIH to share investment risk by incentivizing investors or strategic partners to evaluate projects and commit funds much earlier
Private InvestmentSBIR Bridge Award
12
Example: How the Bridge Award Would Apply in the Area of Drug Development
CommercializationNDA
ReviewClinicalTrials
SafetyReview
Preclinical Development(Lead Development,
Animal Studies, File IND)
Target Identification& Validation
Private InvestmentPhase I & Phase II
SBIR
SBIR Bridge Award
2nd Year1/3 of funds
3rd Year1/3 of funds
1st Year1/3 of funds
Milestones reached?Matching Funds?
YES
STOP
NO
YES
STOP
NOMilestones reached?Matching Funds?
Milestones reached?Matching Funds?
SBIR Bridge Award
13
Bridge Awards
Company Name
Location Technology
20/20 GeneSystems
Maryland Diagnostic immunohistochemistry that permits 10 or more biomarkers to be measured simultaneously from a single section of biopsied tissue while maintaining morphology.
Advanced Cell Diagnostics
California Automated system (CTCscope) for the detection, enumeration, and molecular analysis of circulating tumor cells (CTC) in cancer patients
AmberGen Massachusetts Prognostic assay that monitors the recurrence and response to treatment of colorectal cancer (CRC)
Praevium Research
California High-speed engine for Fourier-domain Optical Coherence Tomography (OCT) for cancer detection
Altor BioScience Florida Bifunctional T cell receptor-based immunotherapeutic directed against cancer
Gamma Medica-Ideas
California Molecular Breast Imaging (MBI) technique to guide clinical management of breast cancer
Guided Therapeutics
Georgia Rapid and painless test for HPV
Koning Corporation
New York Cone-beam computed tomography (CBCT) for breast cancer diagnosis and surgical planning
Lpath Therapeutics
California Lipidomics-based therapeutics
OptoSonics North Carolina The first preclinical photoacoustic computed-tomography (PCT) scanner
Investor Forum
NCI SBIR Investor Forum
2010 Investor Forum: November 9, Stanford , CA
http://sbir.cancer.gov/investorforum/
Featured Small Businesses• Exclusive opportunity for 14 NCI awardees to showcase their
companies to investors• Present to and network with >150 investors & strategic partners• Participate in panel discussion with successful Bridge awardees
and their investors
Investors• Opportunity to evaluate NCI’s top companies with
innovative technologies• Exclusive one-on-one meetings
16
"The Forum was a great opportunity to get exposed to new companies in oncology." - Ankit Mahadevia, M.D., MBA, Life Sciences Associate, Atlas Venture
"I was very impressed with your choice of companies.The mix of stages was ideal." - Sarah Bodary, Ph.D., Venture Partner, SV Life Sciences
Regulatory Assistance
Regulatory Assistance
Goal • Provide Phase II awardees access to regulatory consultants to
accelerate the FDA approval process for drugs, biologics and devices
Path• Provide appropriate Phase II awardees ≥30 hours of consulting time
and activities, including:
1. A preliminary conversation with the company regarding the writing of a regulatory plan
2. Review and editing of the regulatory plan
3. Post review discussion
18
NCI Has Moved to More Targeted Funding Opportunities
• Goal is to improve success in commercialization by focusing on more directed research.
• Invest in the technology priorities of NCI that also have greatest potential for commercialization
• Catalyze targeted technology development and draw private sector investment in specific areas
Approximately $10M in new funding opportunities was announced in November.
Contact
Ali Andalibi, PhD andalibia@mail.nih.govAndy Kurtz, PhD kurtza@mail.nih.gov
Greg Evans, PhD evansg@mail.nih.govMichael Weingarten weingartenm@mail.nih.gov
David Beylin beylind@mail.nih.govAmir Rahbar, PhD rahbaram@mail.nih.gov
Jian Lou, PhD loux@mail.nih.govPatti Weber, DrPH weberpa@mail.nih.gov
Deepa Narayanan narayanand@mail.nih.gov
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