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

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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

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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

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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

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"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

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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