an overview of the sbir program at the national cancer institute prepared by michael weingarten

An Overview of the SBIR Program at the National Cancer

InstitutePrepared by

Michael WeingartenDirector of NCI SBIR Development Center

January 17, 2007

New SBIR Phase IIBBridge Award

SBIR Phase II Awards andCommercialization 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

• 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

Example: How the Bridge Award Might Apply in the Area of Drug Development

CommercializationNDAReview

ClinicalTrials

SafetyReview

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


Phase I & Phase II SBIR


ClinicalTrials

SafetyReview




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 InvestmentSBIR Bridge Award



ClinicalTrials

SafetyReview




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

• 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

More Information onNCI SBIR & STTR Website

http://sbir.cancer.gov

Overviewof the SBIR Program

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

• 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

Tips on Submitting an Application

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

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?

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

• NCI describes topics in solicitation

Evaluation

Award

ProposalSubmission

• Small business concerns prepareshort (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

SolicitationTopics

Abo

ut 6

-9 m

onth

s

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

SBIR 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

STTR Eligibility Requirements

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)

NCI SBIR Funding Opportunities

SBIR/STTR Omnibus Grant SolicitationRelease: JanuaryReceipt Dates: April 5, August 5, and December 5

SBIR Contract Solicitation (NIH, CDC)Release: AugustReceipt Date: Early November

NIH Guide for Grants and ContractsRelease: WeeklyReceipt Dates: Various

For more information visit:Sbir.cancer.gov

NIH Issues Multiple SBIR Solicitations

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.

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

Technologies and Software to Support Integrative Cancer Biology Research (R43/R44)http://grants.nih.gov/grants/guide/pa-files/PAS-07-242.htmlReceipt 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.htmlReceipt Dates: April 5, August 5, December 5, 2007



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.htmlReceipt Dates: April 5, August 5, December 5, 2007

Examples of SBIR Grant TopicsDivision of Cancer Biology

http://grants.nih.gov/grants/guide/pa-files/PAS-07-242.html



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.htmlReceipt 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.htmlReceipt Dates: April 5, August 5, December 5, 2007

http://grants.nih.gov/grants/guide/pa-files/PA-06-120.html

http://grants.nih.gov/grants/guide/pa-files/PA-06-121.html

Changes in Program Management

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

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

• 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

Employment Opportunities

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”

Michael WeingartenDirector

NCI SBIR Development CenterPhone: 301-496-4413

[email protected]

Andrew Kurtz, Ph.D. Program Manager

NCI SBIR & STTR ProgramsPhone: [email protected]

http://sbir.cancer.gov

an overview of the sbir program at the national cancer institute prepared by michael weingarten

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