NCI SBIR Program Overview

The Montana Bioscience AllianceAugust 28, 2012

Patricia A Weber, DrPHProgram Director

Today’s Presentation

• Program Overview & Eligibility

• SBIR/STTR Reauthrization

• General Funding Information

• SBIR Phase II Bridge Award (NCI)

• Managing NCI’s Small Business Portfolio

• SBIR Development Center

• New Funding Opportunities

• Investor Forum

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Congressionally Mandated Programs

2.6%

0.35%

Set-Aside (FY12)

SBIR: Set-aside program for small business concerns to engage in Federal R&D with the potential for commercialization Federal agencies with an extramural R&D budget > $100M

STTR: Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions with the potential for commercialization Federal agencies with an extramural R&D budget > $1B

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NIH = 27 Institutes & Centers23 Participate in the SBIR/STTR Program

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The Office of the Director (OD)

National Instituteon Alcohol Abuse

& Alcoholism(NIAAA)

National Instituteof Arthritis &

Musculoskeletal &Skin Diseases (NIAMS)

National CancerInstitute (NCI)

National Instituteon Aging

(NIA)

National Instituteof Child Health &

Human Development(NICHD)

National Instituteof Allergy &

Infectious Diseases(NIAID)

National Instituteof Diabetes &

Digestive & KidneyDiseases (NIDDK)

National Instituteof Dental andCraniofacial

Research (NIDCR)

National Instituteon Drug Abuse

(NIDA)

National Instituteof Environmental Health Sciences

(NIEHS)

National Institute onDeafness & OtherCommunication

Disorders (NIDCD)

National EyeInstitute

(NEI)

National HumanGenome ResearchInstitute (NHGRI)

National Heart,Lung, & Blood

Institute (NHLBI)

National Instituteof Mental Health

(NIMH)

National Instituteof Neurological

Disorders &Stroke (NINDS)

National Instituteof General

Medical Sciences(NIGMS)

National Instituteof Nursing Research

(NINR)

No funding authority

National Institute on Minority Health &Health Disparities

(NIMHD)

National Libraryof Medicine (NLM)

National Centerfor Complementary

& AlternativeMedicine (NCCAM)

FogartyInternationalCenter (FIC)

National Instituteof Biomedical

Imaging & Bioengineering (NIBIB)

National Centerfor Advancing

Translational Sciences(NCATS)

Center for InformationTechnology (CIT)

Center for ScientificReview (CSR)

NIH ClinicalCenter (CC)

• Provides seed funding for innovative technology development

• 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 (i.e. non-dilutive)

• Intellectual property rights retained by the small business

• Bayh-Dole Act (1980)

Reasons to Seek SBIR/STTR Funding

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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

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STTR Eligibility

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; Non-profit research organization; Federally-Funded R&D Center (FFRDC)

Intellectual Property Agreement

• Allocation SBC of IP rights (to SBC) 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

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Note: Actual funding levels may differ by topic.

PHASE I – R41, R43• Feasibility Study • $150K, 6-months (SBIR)• $100K, 12-months (STTR)

PHASE II – R42, R44• Full Research/R&D• $1M (SBIR) / $750K (STTR), 2-years• Commercialization plan required

PHASE III• Commercialization Stage• Use of non-SBIR/STTR Funds

Three-Phase Programs

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Fast-TrackApplication

Combined Phase I & II

SBIR/STTR programs were re-authorized through FY2017 by the 2012 Defense Authorization Act (P.L.112-81)

•Increases SBIR set-aside (incrementally) to 3.2% by 2017

• FY2012 set-aside is 2.6%

•Increases STTR set-aside to 0.45% by 2017

• FY2012 set-aside is 0.35%

•Establishes hard caps on funding levels for Phase I & II awards

•Allows companies majority owned by multiple VC firms, hedge funds, and private equity firms to compete for up to 25% of NIH SBIR funds

•Allows ability to switch between the SBIR and STTR mechanisms

Congressional Reauthorization

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Public Comment Period Open Now

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SBA published SBIR & STTR policy directives August 6.

Public Comment period open until October 5, 2012

Submit comments at http://regulations.gov RIN: 3245-AF84 (SBIR)RIN: 3245-AF45 (STTR)

Public Webinars

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Wednesday, August 29, 20122 pm EDT

To attend, email technology@sba.gov with:

Send questions & comments to SBIRComments@sba.gov

SBIR/STTR Reauthorization

Key Changes

FY SBIR Set-aside STTR Set-aside

2011 2.5% 0.30%

2012 (current) 2.6% 0.35%

2013 2.7% 0.35%

2014 2.8% 0.40%

2015 2.9% 0.40%

2016 3.0% 0.45%

2017 3.2% 0.45%

Increase in Set-Aside

Hard Limits* on Award Sizes

Program Phase I Phase II Current

SBIR $225,000 $1,500,000 Flexible

STTR $225,000 $1,500,000 Flexible

This will impact current NIH practices on awards.Comment on policy directives!

*NIH will request waivers on limits for specific topics

Changes to Eligibility

Venture Capital ParticipationNIH will be allowed to spend up to 25% of SBIR funds on small businesses majority owned by multiple VCs, hedge funds, or private equity firms. Previously not allowed. In effect after Size Rules are finalized, expected 1/1/13.

Cross-Program AwardsSTTR Phase I awardees can receive SBIR Phase II awards, and vice versa

Cross-Agency AwardsPhase I awardee may receive a Phase II award from a different agency

Changes to Eligibility

Open Phase II competitionInvitations for Phase II contract proposals will be open to all Phase I contract awardees.

Second Phase II AwardA sequential Phase II award may be given to continue a Phase II project.

Collaborations with Federal LabsWaivers no longer required for partnership with Federal Labs and Centers

Direct to Phase II pilotPhase II SBIR awards may be awarded without requiring Phase I award. Not yet clear what NIH implementation will be.

Improving the SBIR/STTR Programs

Streamlining the Award ProcessWorking to shorten timelines from application to award decision. NIH given 1 year from solicitation close date.

Administrative Funding Pilot3% of SBIR funds for agencies to provide support to improve:

• Outreach• Commercialization• Streamlining & Simplifying the Award Process

What can we do to make the program better for you? Comment on Policy Directives & tell your Program Officers

Implementation Timeline

Effective New Program Element

Now Set-aside increases, FY12SBIR = 2.6% STTR = 0.35%

With next issued solicitation • 150% award caps• Open Phase II competitions• SBIR to STTR/STTR to SBIR • Cross-agency awards

January 1, 2013 (expected) • Size Rule finalized• Company Registry registration

required• New eligibility requirements re:

ownership & affiliation

More Info

• Sign up for NCI mailing list for updates

• http://sbir.cancer.gov

• NIH will soon have more info about NIH-specific

implementation at http://sbir.nih.gov

• Public Comments on Policy Directives open until

October 5, 2013

Get your voice heard!

How to Find NIH and NCI Funding Opportunities

http://grants.nih.gov/grants/funding/sbir.htm

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http://sbir.cancer.gov

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NIH SBIR/STTR Omnibus Solicitations for Grant Applications

Release: JanuaryReceipt Dates: April 5, August 5, and December 5

Solicitation of the NIH & CDC for SBIR Contract Proposals

Release: August 15, 2012Receipt Date: November 13, 2012

RFP can be found at: http://grants.nih.gov/grants/funding/SBIRContract/PHS2013-1.pdf

More info about NCI’s topic areas: http://sbir.cancer.gov/funding/contracts/

Multiple Funding Solicitations

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http://projectreporter.nih.gov/reporter.cfm

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SBIR Success Rates(1998 – 2010)

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Source: NIH IMPAC, Success Rate FileContact: Division of Information Services, ORIS/OER

SBIR Success Rates(1998 – 2010)

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FY 2013SBIR Contract Solicitation

Targeted Funding Opportunities

• Goal is to improve commercialization success by focusing on more directed research in targeted areas

• Invest in the technology priorities of NCI that also have greatest potential for commercialization

• Catalyze technology development and draw private sector investment in specific areas

20% of NCI’s SBIR budget is now invested in contracts

NCI has set aside $10M to support new Phase I contracts in 13 different topic areas in FY2013

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SBIR Contracts vs. Grants: What's the difference?

Funding Solicitations for

SBIR Grants

Funding Solicitation for

SBIR Contracts

Scope of the proposal

Investigator-defined within the mission of NIH

Defined by the NIH (focused)

Questions during solicitation period?

May speak with any Program Officer

MUST contact the contracting officer

Receipt Dates 3 times/year for Omnibus Only ONCE per year

Basis for AwardBased on score during peer review

If proposal scores well during peer review, must then negotiate to finalize deliverables with NIH

ReportingOne final report (Phase I);

Annual reports (Phase II)Monthly or quarterly progress reports

Set-aside of funds for particular areas?

NO YES

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FY13 NCI Contract Funding Topics

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313 RNAi Cancer Therapeutics using Nanotechnology 314 Development of Human Tissue Culture Systems that Mimic the Tumor

Microenvironment 315 Development of Companion Diagnostics: Enabling Precision Medicine in Cancer

Therapy 316 Development of CTC Isolation Technologies Enabling Downstream Single Cell

Molecular Analysis 317 Wound Healing Preparations Incorporating Nitric Oxide-Releasing Materials 318 Test to Predict Effectiveness of Docetaxel Treatment for Prostate Cancer 319 Technology to Generate Anti-Peptide Capture Reagents for Affinity-Enriched

Proteomic Studies 320 High Quality Cancer-Related Standards for Metabolomics Research 321 Chemically Defined Glycan Libraries for Reference Standards and Glycomics

Research (Joint NCI-NIGMS Program) 322 Real-Time Integration of Sensor and Self-Report Data for Clinical and Research

Applications 323 Development of Radiation Modulators for Use During Radiotherapy 324 Novel Imaging Agents to Expand the Clinical Toolkit for Cancer Diagnosis, Staging,

and Treatment 325 Innovative Radiation Sources for Advanced Radiotherapy Equipment

FY13 NCI Contract Funding Topics

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Therapeutics & Diagnostics

Advancing Cancer Research

• 313 RNAi Cancer Therapeutics using Nanotechnology• 315 Development of Companion Diagnostics: Enabling Precision

Medicine in Cancer Therapy• 316 Development of CTC Isolation Technologies Enabling Downstream

Single Cell Molecular Analysis

• 314 Development of Human Tissue Culture Systems that Mimic the Tumor Microenvironment

• 319 Technology to Generate Anti-Peptide Capture Reagents for Affinity-Enriched Proteomic Studies

• 320 High Quality Cancer-Related Standards for Metabolomics Research

• 321 Chemically Defined Glycan Libraries for Reference Standards and Glycomics Research (Joint NCI-NIGMS Program)

FY13 NCI Contract Funding Topics (cont’d)

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Health IT

Imaging & Radiation Therapy

NIH Technology Transfer

• 323 Development of Radiation Modulators for Use During Radiotherapy• 324 Novel Imaging Agents to Expand the Clinical Toolkit for Cancer

Diagnosis, Staging, and Treatment• 325 Innovative Radiation Sources for Advanced Radiotherapy

Equipment

• 322 Real-Time Integration of Sensor and Self-Report Data for Clinical and Research Applications

• 317 Wound Healing Preparations Incorporating Nitric Oxide-Releasing Materials

• 318 Test to Predict Effectiveness of Docetaxel Treatment for Prostate Cancer

Topic 314: Development of Human Tissue Culture Systems that Mimic the Tumor Microenvironment

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Budget: Phase I $300,000; Phase II $2M Number of Anticipated Awards: 3 - 5

Goal: Development of 3D human tissue model culture systems that accurately mimic the tumor microenvironment…validated against known effective anti-cancer agents

Phase I Activities & Deliverables Include:•Develop 3D culture system prototype that incorporates human tumor cells using or easily adapted for use with high content screening platforms•Demonstrate accurate prediction of clinical efficacy in the developed prototype benchmarked against 2D and currently available 3D systems

Phase II Activities & Deliverables Include:•Benchmark performance against known in vivo effects•Demonstrate ability to scale-up system

Topic 317: Wound Healing Preparations Incorporating Nitric Oxide-Releasing Materials (NIH Technology Transfer)

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Budget: Phase I $200,000; Phase II $1.5M Number of Anticipated Awards: 1Fast-Track proposals not accepted

Goal: Develop a wound-healing dressing using NCI-developed NO-releasing material technology.

*Contractor will be granted royalty-free, non-exclusive license but is encouraged to submit an application for a commercialization license to NIH OTT

Phase I Activities & Deliverables Include:•Prototype development•Material characterization•Proof of concept in vitro studies•In vivo efficacy studies

Phase II Activities & Deliverables Include:•Stability studies•Capacity for commercial production & manufacture

Topic 322: Real-Time Integration of Sensor and Self-Report Data for Clinical and Research Applications

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Budget: Phase I $200,000; Phase II $1M Number of Anticipated Awards: 2 – 3

Goal: Secure, privacy-compliant mobile applications and paired analytic systems to control the collection, transfer, integration, analysis, and reporting of objective and self-reported health-related measures.

Phase I Activities & Deliverables Include:•Establish project team with broad expertise•Prototype including front-end mobile application(s), integration with sensors, and back-end user-interface controls for data integration

Phase II Activities & Deliverables Include:•Beta-test and finalize:

• Front-end mobile application• File transfer, screening, data importation protocols and systems• Data integration and visualization tools• User-interface systems

•Usability testing

Questions About Contracts?

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Ms. Anita Hughes

Anita.Hughes@nih.gov

301.435.3805

http://sbir.cancer.gov/funding/contracts/

More Information on NCI SBIR & STTR Website

http://sbir.cancer.gov

Application Deadline: November 13, 2012

Innovative Health IT for Broad Adoption by Healthcare Systems & Consumers (PA-12-196)

Goal: Accelerate development & commercialization of evidence-based consumer health IT to:

• Prevent or reduce the risk of cancer

• Facilitate patient-provider communication

• Improve disease outcomes in consumer & clinical settings

•Phase II or Fast-Track applications only

•Strong applicants will have a partnership with large business (e.g. commercial IT firm, EMR vendor, healthcare systems, etc.)

Next receipt date December 5, 2012

http://sbir.cancer.gov/resource/hit/

Contact Dr. Patricia Weber, weberpa@mail.nih.gov

Innovative Health IT for Broad Adoption by Healthcare Systems & Consumers (PA-12-196)

NCI is responding to the goals of the IOM and ONC by publishing a funding opportunity that encourages small businesses to partner with larger businesses or health organizations to develop user-centered health IT products.

Does not promote the development of healthcare delivery systems that would compete with the over arching infrastructure for EMRs being developed by the ONC.

Instead the focus is on patient-centered, evidence-based health IT tools that are interoperable with existing EMRs

Overall goal is to engage health providers and consumers in the prevention and management of chronic diseases

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NCI SBIR Phase IIBridge Award

Note: Actual funding levels may differ by topic.

PHASE I – R41, R43• Feasibility Study • $150K, 6-months (SBIR)• $100K, 12-months (STTR)

PHASE II – R42, R44• Full Research/R&D• $1M (SBIR) / $750K (STTR), 2-years• Commercialization plan required

PHASE III• Commercialization Stage• Use of non-SBIR/STTR Funds

Three-Phase Programs

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Phase II Bridge Award

Phase II Bridge Award

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• Follow-on to the SBIR Phase II Award• Goal is to extend SBIR Phase II awards to help cross the “Valley of Death”

• Provides up to $3M in additional SBIR funding over 3 years

• Strategy is to help early-stage projects by:• Incentivizing partnerships between SBIR grantees and third-party investors

• Giving competitive preference and funding priority to applicants that can raise substantial third-party funds (i.e., minimum 1:1 match)

• Benefits• Affords NCI the opportunity to leverage millions in external resources

• Provides NCI added confidence based on due diligence by outside investors

• Provides the small business with commercialization guidance during the award

• Ideally, the small business will establish a strong relationship with an investor or strategic partner that will provide additional financing beyond the Bridge Award

CommercializationNDA

ReviewClinicalTrials

SafetyReview(IND)

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

EXAMPLE: Drug Development

Phase I & Phase II SBIR

Private Investment / Strategic Partner

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The “Valley of Death” is the problem

CommercializationNDA

ReviewClinicalTrials

SafetyReview(IND)

Preclinical Development(Lead Development,

Animal Studies, File IND)

Target Identification& Validation

SBIR Bridge Award

EXAMPLE: Drug Development

SBIR Bridge Award allows NIH to share investment risk by incentivizingPrivate Investors to evaluate projects and commit funds much earlier

Phase I & Phase II SBIR

Private Investment / Strategic Partner

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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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EXAMPLE: Drug Development

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12 Bridge Awards (to date)

FY Company Technology/Product Award Size

2009 Lpath Therapeutics Humanized monoclonal antibody for treatment of prostate cancer $3,000,000

2009 Optosonics Photoacoustic CT for preclinical molecular imaging $2,997,247

2009 Guided Therapeutics Fluorescence/reflectance spectroscopy for detection of cervical cancer $2,517,125

2009 Koning Corporation High-performance breast CT as diagnostic adjunct to mammography $2,986,453

2009 Gamma Medica-Ideas Molecular imaging to detect metabolic activity of breast lesions $3,000,000

2009 Altor BioScience Tumor-targeted immunotherapy for treatment of p53-positive cancers $2,969,291

2010 20/20 GeneSystems mTOR companion diagnostic assay $2,750,000

2010 Advanced Cell Diagnostics In situ RNA detection assay for analyzing circulating tumor cells $2,996,450

2010 Ambergen Expression-based prognostic assay for recurrence of colorectal cancer $2,998,830

2010 Praevium Research High-performance imaging engine for optical coherence tomography $1,180,420

2011 Wilson Wolf Manufacturing Moving TIL therapy past the Valley of Death $1,006,256

2011 Oncoscope Validation & commercialization of a/LCI for detection of esophageal neoplasia $2,999,084

3 therapeutics6 imaging technologies3 molecular diagnostics http://projectreporter.nih.gov/reporter.cfm

12 Bridge Awards (to date)

Venture Capital: 1/3

Strategic Partners: 1/3

Individuals & Other: 1/3

NCI Total $31,401,156

Third-Party Investments $72,695,374

Leverage > 2 to 148

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New Approach for Managing SBIR at NCI

Managing NCI’s SBIR/STTR Portfolio

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Old Management Model

• Awards were managed by 40-50 program staff from across the NCI who each spent a small percentage of their time on SBIR

• Few of these program directors had significant industry experience or commercialization expertise

New SBIR Development Center

• 10-member management team exclusively focused on the administration of NCI’s SBIR/STTR portfolio

• Center staffed by program directors with industry experience and a broad range of scientific expertise

• Center collaborates with staff from across other NCI divisions to integrate the small business initiatives with the Institute’s priorities

SBIR Development Center Staff

Michael Weingarten, MA (Director)Previous•NASA – Program Manager, NASA Technology Commercialization Program

Greg Evans, PhD (Branch Chief)Previous•NHLBI/NIH – Program Director, Translational and Multicenter Clinical Research in Hemoglobinopathies•NHGRI/NIH – Senior Staff Fellow

Andrew J. Kurtz, PhD (Branch Chief)Previous•NIH – AAAS Science & Technology Policy Fellow•Cedra Corporation – Research Associate, Bio-Analytical Assays and Pharmacokinetics Analysis

Deepa Narayanan, MS (Program Director)Previous•Naviscan PET Systems, Inc., Director, Clinical Data Management (Oncology Imaging & Clinical Trials)•Fox Chase Cancer Center, Scientific Associate (Molecular Imaging Lab)

Jian Lou, PhD (Program Director)Previous•Johnson & Johnson – Research Scientist, Target Validation & Biomarker Development•Lumicyte, Inc. – Director, Molecular Biology Systems Analysis

Patricia Weber, DrPH (Program Director)Previous•International Heart Institute of Montana –Tissue Engineering and Surgical Research•Ribi ImmunoChem Research, Inc. – Team Leader, Cardiovascular Pharmacology•Trega Biosciences Inc. – Director, Microbiology & Immunology

Todd Haim, PhD (Program Manager)Previous•National Academy of Sciences – Christine Mirzayan Science and Technology Policy Fellow•Pfizer Research Laboratories – Postdoctoral Fellow, Cardiac Pathogenesis & Metabolic Disorders

Julienne Willis (Program Specialist)

Amir Rahbar, PhD, MBA (Program Director)Previous•NCI– Program Director, Center for Strategic Scientific Initiatives•BioInformatics, LLC – Senior Science Market Analyst•Naval Research Laboratory – Research Scientist

Jennifer Shieh, PhD (AAAS Science & Technology Policy Fellow)Previous•National Academy of Sciences – Christine Mirzayan Science and Technology Policy Fellow•Syapse, Inc. – Biology Associate

Catherine Langston, MA (Program Analyst)

NCI SBIR Investor Forum

Exclusive opportunity for some of the most promising NCI-funded companies to showcase their technologies

http://sbir.cancer.gov/investorforum/

• Opportunity to pitch and network with >150 investors and potential strategic partners

• Features NCI’s top portfolio companies with innovative technologies

• Exclusive one-on-one meetings

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Previous Presenters• Zacharon Pharmaceuticals, Inc.

• Omniox, Inc.

• ImaginAb, Inc.

• Fluxion Biosciences

Patricia Weber, DrPH Program Director

SBIR Development CenterPhone: 301-594-8106

weberpa@mail.nih.gov

http://sbir.cancer.gov

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