nci sbir and sttr: advancing the commercialization of new cancer innovations

NCI SBIR and STTR: Advancing theCommercialization of New Cancer Innovations

North Carolina Biotechnology Center October 16, 2012

Deepa NarayananProgram Director, NCI SBIR Development Center

http://sbir.cancer.gov

Today’s Presentation

• SBIR/STTR Overview & Eligibility

• Congressional Reauthorization & Policy Directives• Key Changes• Update on SBA Policy Directives for Implementing Changes

• Funding Opportunities at NCI/NIH• Priority Areas & Focused Solicitations

• NCI’s SBIR Program• NCI SBIR Development Center• Phase II Bridge Award• Investor Forum

• Tips on Preparing a Successful SBIR Application2

Congressionally Mandated Programs

2.7%

0.35%

Set-Aside (FY13) Small Business Innovation Research (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

Small Business Technology Transfer (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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SBIR/STTR Funding Levels

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2010 Budget SBIR STTR SBIR+STTR

NIH $616 M $74 M $690 M

NCI $99 M $12 M $111 M

NIDDKNIGMS

← The annual SBIR/STTR budget for each participating Institute or Center (IC) is proportional to the total annual budget appropriation for that IC

• One of the largest sources of early stage 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

• Funding is non-dilutive capital

• Can be a leveraging tool to attract other funding

• Projects undergo NIH’s rigorous scientific peer review

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

≥ 51% U.S.- owned by individuals and independently operated *

OR ≥ 51% owned and controlled by another (one) business concern that is ≥ 51% owned and controlled by one or more individuals *

* Recent reauthorization includes some exceptions to this rule

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STTR Eligibility

Applicant is a Small Business Concern

Formal Cooperative R&D Effort

• Minimum 40% by small business concern

• 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

• Should provide the necessary IP rights (to the SBC) in order 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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SBIR & STTR: Three-Phase Program

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Phase IIICOMMERCIALIZATION

Phase IIDEVELOPMENT

Phase IFEASIBILITY

• Proof-of-Concept study• $150,000 over * 6 months (SBIR) or 1 year (STTR)

• Research & Development• Commercialization plan required• $1 million over 2 years*

• Commercialization stage• Use of non-SBIR/STTR funds

Fast-Track ApplicationCombined Phase I & II

Fast-Track ApplicationCombined Phase I & II

SBIR/STTR Reauthorization:Key Changes

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

• New law includes a range of important changes to the programs

• US Small Business Administration (SBA) is responsible for providing policy guidance on how to implement changes

• Increases SBIR set-aside (incrementally) from 2.5% to 3.2% by 2017.

• Increases STTR set-aside from 0.30% to 0.45% by 2017• Establishes hard caps on funding levels for Phase I & II

awards• $225K for Phase I• $1,500K for Phase II

Congressional Reauthorization

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Changes to Eligibility

Venture Capital Participation

NIH 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 Awards

STTR Phase I awardees can receive SBIR Phase II awards, and vice versa

Cross-Agency Awards

Phase I awardee may receive a Phase II award from a different agency

Direct to Phase II pilot

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

…and other proposed eligibility changes

Focus on Commercialization

Expanded Technical Assistance• Increased funding for technical assistance ($5000 per award)• This can be provided through NIH technical assistance programs,

i.e. Niche Assessment Program (Phase I), or Commercialization Assistance Program (Phase II), or requested by the awardee

• STTR awardees now eligible (previously not allowed)

Commercialization Readiness Program• Allows NIH up to 10% of SBIR/STTR funds to support

commercialization and Phase III efforts

Company Commercialization Record• Applicants will be required to provide information on

commercialization of prior SBIR/STTR awards

…and other proposed commercialization initiatives

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

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

For More Information

• Sign up for NCI mailing list for updates at: http://sbir.cancer.gov

• Visit: http://sbir.gov

• For more info about NIH-specific implementation visit: http://grants.nih.gov/grants/funding/sbir/reauthorizati

on.htm

• Speak with your program officer

SBIR/STTR Funding Opportunities

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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: AugustReceipt Date: Early November

See the NIH Guide for other Program Announcements (PA’s) and Requests for Application (RFA’s), i.e. grants

Release: WeeklyReceipt Dates: Various

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Multiple Funding SolicitationsKnow the Application Deadlines

http://grants.nih.gov/grants/guide

http://sbir.nih.gov

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NCI Program Announcements

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

Goal: Accelerate development & commercialization of evidence-based consumer health IT to (1) Prevent or reduce the risk of cancer (2) Facilitate patient-provider communication (3) Improve disease outcomes in consumer & clinical settings

• Next receipt date December 5, 2012, April 5 2013, August 5 2013

Image Guided Cancer Interventions (PA-10-079 & PA-10-080, SBIR/STTR)

Goal: Accelerate development & optimization of integrated image guided intervention systems for cancer imaging, monitoring, therapy.

• Next receipt date December 5, 2012

Cancer Diagnostic &Therapeutic Agents Enabled by Nanotechnology

(PAR-10-286)

Goal: Accelerate the translation and commercialization of promising nanotechnology-derived cancer therapeutics and in vivo diagnostics from the advanced discovery phase to the end of preclinical characterization.

• Next receipt date November 9 2012, March 8. 2013, July 8 2013

SBIR Contracts

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SBIR Contracts vs. Grants

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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NCI SBIR Contracts

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NCI scientific & technologypriorities

Areas of interest to the commercial sector,

based on market opportunity

Contract topics in areas with strong potential for commercial success

13%8%

17%25%

NCI SBIR contracts(thousands)

% of total NCI SBIR

Contract Opportunities Now Available

PHS-2013-1 “Solicitation of NIH and CDC for SBIR Contract Proposals”

Published August 15, 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/

Proposals Due: November 13, 2012

FY13 NCI SBIR Contract 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)

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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

FY13 NCI SBIR Contract Topics

Topic 323: Development of Radiation Modulators for Use During Radiotherapy*

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Budget: Phase I $300,000; Phase II $1.5M Number of Anticipated Awards: 3 - 5

Goal: Development of radiosensitizers, radioprotectants, or radiomitigators that decrease normal tissue injury and/or enhance tumor killing.

Phase I Activities & Deliverables Include:•In vitro testing•Clonogenic survival studies•Preliminary in vivo toxicity studies

Phase II Activities & Deliverables Include:•In vivo experiments•PK/PD in rodent model•GMP drug production/sourcing•IND approval

*Re-issue

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

Questions About Contracts?

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Ms. Bette Shanahan

[email protected]

301.435.3782

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

New Paradigm for Managing SBIR at NCI

Activities of Center

• Active outreach to bring in a new class of commercially viable applicants

• Coaching companies on developing stronger applications

• Active management of projects and better oversight

• Mentor and guide companies throughout the award period

• Matchmaking with investors

NCI SBIR Development Center Program Staff

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

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

Andrew J. Kurtz, PhD (Lead Program Director)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

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

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

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

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

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Ming Zhao, PhD (Program Director)Previous•NCI– Program Director, Center to Reduce Cancer Health Disparities•GE Global Research – Senior Scientist•Pfizer – Scientist

SBIR Phase IIB Bridge Award

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NCI SBIR Phase IIB Bridge Award

CROSSING THE VALLEY OF DEATH

Phase IIICOMMERCIALIZATION

Phase IIDEVELOPMENT

Phase IFEASIBILITY

NCI SBIR Phase IIB Bridge Award

• Incentivize partnerships with third-party investors & strategic partners earlier in the development process

• Involves another peer-review cycle to evaluate progress & future plans

• Up to $1M per year for up to 3 years to extend selected projects

• Open to any NIH-funded Phase II awardees

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

FY13 Receipt Dates: November 6, 2012 & March 6, 2013

Program Funding Solicitation

Eligibility• Current Phase II awards & and those that ended within the last 2 years

• Cancer-related Phase II projects initially funded by other NIH institutes

• Special Review to Evaluate Technical and Commercial Merits

•Reviewers are academics, clinicians, industry professionals, venture capitalists

•Emphasizes important commercialization considerations such as intellectual property (e.g., patents) and strategy for gaining FDA approval

•Requires complete disclosure of applicant’s SBIR commercialization history

Third-Party Fundraising plan

• Preferred Types of Funds: Cash, liquid assets, convertible debt

• Sources of Funds: Another company, venture capital firm, individual “angel” investor, foundation, university, state or local government, or any combination

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Partnership Benefits

Benefits to the NCI

• Opportunity to leverage millions of dollars in external resources

• Valuable input from third-party investors:

1. Rigorous commercialization due diligence prior to award

2. Commercialization guidance during the award

3. Additional financing beyond the Bridge Award project period

Benefits to third-party investors

• Opportunity to partner with small businesses to develop & commercialize:

1. Technologies that have been vetted by NIH peer-review, AND

2. Projects for which substantial proof-of-concept data already exists

Opportunity to share in the early-stage investment risk with the NCI

“Valley of Death”

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Applicants must provide a concise “Statement of Need” that includes answers to the following questions:

•What is the perceived “Valley of Death” for the product/technology?

•Why is additional government funding critically needed to accelerate the development of the product or technology toward commercialization?

•What activities are being proposed that would not otherwise be possible through independent third-party investments OR would be significantly delayed without additional NIH support?

•To what extent would a possible award advance the product or technology far enough to attract sufficient, independent third-party financing and/or strategic partnerships to carry out full commercialization?

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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 1

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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

What Does It Take to Get Funded?

Tips on Applying

When is an SBIR/STTR application appropriate?

• Innovative solution to significant clinical and/or research need (e.g. Rx, Dx, research tools)

• Significant commercial potential

• Collaboration with SBC: Need involvement of a commercial partner

• Start-up: Too early for private investment

• Established SBC: No resources to try new approach, but board supports SBIR

• Leverages company/PI expertise

When NOT to apply

• Need cash urgently

• SBIRs take 8-16 months or more to get and you must start with Phase I (~$225K)

• Incremental upgrade: no change to clinical paradigm

• “Me too” product matching competitor’s capabilities

• Basic Research - commercial and clinical value is not clear

• Consider your company’s strengths

• Consider your company’s weaknesses

• Contact NIH Program Director in advance (more than 1 week before due date!) to discuss your proposal concept and receive feedback

• Review similar, currently funded NIH projects

Before You Write an Application

RePORTER http://projectreporter.nih.gov

Search Previous Awards

Key Application Tips

• Start Early• Strong proposals take time to develop

• Take care of the administrative registrations (SF424)

• http://sbir.nih.gov > Electronic Submission

• Take Time to Refine the Vision• Start informal discussions with potential customers, technical experts, investors,

commercialization experts to clarify the product vision

• Assemble the right team• Assemble a strong scientific team

• Get outside partners to fill knowledge and expertise gaps (academic collaborators, consultants, other companies)

• Know your Reviewers• Identify the most appropriate Institute/Center• Identify the most appropriate study section BEFORE you submit your

application

• Review your Application before you Submit

Know NIH Review Criteria

Significance• Does the product address an important

problem, and have commercial potential? Is there a market pull for the proposed product?

Innovation• How novel is the product and the approaches

proposed to test its feasibility?

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?

Commercialization• Is the company’s business strategy one that has

a high potential for success? 48

Other Tips for a Strong Application

• Significant, innovative, and focused science

• Make the SBIR/STTR application product-focused, as distinct from an R01

• Generate preliminary data, if possible

• Include letters of support from KOLs, end-users, possible investors.

• Explain the key issues and controversies in the product space; describe the competition and your value proposition

• Identify any unanswered questions, and then contact NCI SBIR program staff for help

• Write clearly

• Prepare your application early!

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Use peer review to improve your technology and presentation

Reviewers often spot errors in the proposal

Reviewers will let you know if what you are proposing has been done before

If peer reviewers “didn’t get your proposal”

Customers, investors, and employees may not get it either

Fix errors, improve your presentation

It’s always painful not to be funded, but at least you get the feedback

Explore opportunities to serve on NIH peer review panels

If you aren’t funded …

Deepa NarayananSBIR Program Director

Cancer Imaging and Radiation Therapy

NCI SBIR Development CenterPhone: 301.594.0212

[email protected]


Topic 313: RNAi Cancer Therapeutics Using Nanotechnology

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Goal: …design, fabrication, characterization, and preclinical evaluation of novel nanoparticle-based drug formulations capable of delivering candidate RNAi therapeutics for the treatment of cancer

Phase I Activities & Deliverables Include:•Demonstrate nanoconstruct stability in vitro, and demonstrate controlled release of RNAi therapeutic agent(s)•In vitro efficacy studies in relevant cancer cell line(s)•Establish specificity of RNAi therapeutic and its phenotypic effects•Small in vivo efficacy study in relevant animal model of cancer

Phase II Activities & Deliverables Include:•In vivo preclinical efficacy•Safety, pharmacokinetics and pharmacodynamics•R&D activities needed to complete an IND application

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

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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 315 Companion Diagnostics*

Budget: Phase I $300,000 ; Phase II $1,500,000

Number of Anticipated Awards: 4

Goal:

Companion diagnostics for selecting patients for which a particular therapeutic regimen, including existing drugs and those in clinical development and radiation, will be safe and effective

Phase I Activities & Deliverables Include:

•Test development and analytical validation

•If the drug is not commercially available, establish partnership w/ developer

Phase II Activities & Deliverables Include:

•Full clinical validation

*Re-issue

Topic 316: Development of CTC Isolation Technologies Enabling Downstream Single Cell Molecular Analysis

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Budget: Phase I $300,000; Phase II $1.5M Number of Anticipated Awards: 4

Goal: Demonstrate technical viability of technology to isolate and analyze CTCs at the single-cell level in an experimental setting.

Phase I Activities & Deliverables Include:•Method for CTC isolation or identification amenable to downstream single-cell analysis•Isolate or identify CTCs from samples with counts as low as 1 cell/ml of blood•Provide CTCs for molecular analysis at the single-cell level

Phase II Activities & Deliverables Include:•Prototype demonstrating applications with significant clinical utility, such as whole genome sequencing, molecular phenotyping, or culture for ex vivo analysis•Test device with patient samples•Establish marketing partnership

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.


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 318: Test to Predict Effectiveness of Docetaxel Treatment for Prostate Cancer (NIH Technology Transfer)

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Budget: Phase I $300,000; Phase II $2M Number of Anticipated Awards: 1Fast-Track proposals not accepted

Goal: Develop genetic test based on CYP1B1*3 variant to predict clinical outcome of docetaxel patients and guide therapeutic strategy.


Phase I Activities & Deliverables Include:•Develop array-based genotyping technique•Retrospective validation•Identify percentage of patient samples with CYP1B1*3 variant

Phase II Activities & Deliverables Include:•Clinical trial•Develop commercially-viable prototype

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

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Budget: Phase I $200,000; Phase II $1M Number of Anticipated Awards: 4

Goal: New technologies that generate reproducible, well-characterized anti-peptide capture reagents for use in affinity-enriched proteomic studies.

Phase I Activities & Deliverables Include:•Capture reagents that reliably immunoprecipitate target peptides•Affinity reagents to at least 10 proteotypic peptides•Coordination with the Clinical Proteomic Technologies for Cancer (CPTC) community

Phase II Activities & Deliverables Include:•Develop at least 100 anti-peptide capture reagents•Demonstration whether antibodies can immunoprecipitate full-length proteins•Benchmark performance criteria against current technology

Topic 320: High Quality Cancer-Related Standards for Metabolomics Research

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Budget: Phase I $200,000; Phase II $1M Number of Anticipated Awards: 3 – 5

Goal: Develop labeled and unlabeled metabolite standards for use with mass spectrometry (MS) and/or nuclear magnetic resonance (NMR) spectroscopy.

Phase I Activities & Deliverables Include:•Synthesize 10-1000 labeled or unlabeled compounds on a pilot scale for a given metabolic pathway•Verify structures of synthesized compounds•Run pilot MS or NMR validation tests

Phase II Activities & Deliverables Include:•Scale up synthesis, purification, and formulation of Phase I deliverables•Validate metabolite standards set for reproducible performance in MS or NMR as appropriate•Provide letters of interest from potential customers

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

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Goal: Synthesis & commercial distribution of robust, well-characterized new carbohydrate libraries for use as standards.

Phase I Activities & Deliverables Include:•Synthesize defined library (20-50 compounds) of representative glycans•Verify structures of synthesized compounds by NMR•Provide samples to NIGMS-designated screening center for validation testing

Phase II Activities & Deliverables Include:•Expand glycan library to at least 100 compounds•Scale up synthesis, purification, structural verification, and packaging•Provide letters of interest from potential customers to purchase the product

Topic 324: Novel Imaging Agents to Expand the Clinical Toolkit for Cancer Diagnosis, Staging, and Treatment*

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Goal: Development of novel imaging agents for:• Early detection & diagnosis of cancer• Differentiation of benign disease from malignancy• Stratification of patients for the purpose of selecting a cancer therapy• Surgical planning• Evaluation of tumor response to chemotherapy & radiation therapy• Detection of cancer recurrence

Phase I Activities & Deliverables Include:•Prepare imaging agent with high signal-to-noise ratio•Proof-of-concept preclinical studies•Preliminary toxicological studies

Phase II Activities & Deliverables Include:•Demonstrate fast in vivo clearance, stability, bioavailability, etc. •Demonstrate high reproducibility & accuracy in several animal models

*Re-issue

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

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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

Topic 323: Development of Radiation Modulators for Use During Radiotherapy*

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Goal: Development of radiosensitizers, radioprotectants, or radiomitigators that decrease normal tissue injury and/or enhance tumor killing.

Phase I Activities & Deliverables Include:•In vitro testing•Clonogenic survival studies•Preliminary in vivo toxicity studies

Phase II Activities & Deliverables Include:•In vivo experiments•PK/PD in rodent model•GMP drug production/sourcing•IND approval

*Re-issue

Topic 324: Novel Imaging Agents to Expand the Clinical Toolkit for Cancer Diagnosis, Staging, and Treatment*

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Goal: Development of novel imaging agents for:• Early detection & diagnosis of cancer• Differentiation of benign disease from malignancy• Stratification of patients for the purpose of selecting a cancer therapy• Surgical planning• Evaluation of tumor response to chemotherapy & radiation therapy• Detection of cancer recurrence

Phase I Activities & Deliverables Include:•Prepare imaging agent with high signal-to-noise ratio•Proof-of-concept preclinical studies•Preliminary toxicological studies

Phase II Activities & Deliverables Include:•Demonstrate fast in vivo clearance, stability, bioavailability, etc. •Demonstrate high reproducibility & accuracy in several animal models

*Re-issue

Topic 325: Innovative Radiation Sources for Advanced Radiotherapy Equipment

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Goal: Development of innovative radiation sources that could reduce the cost and footprint of radiation treatment systems.

Phase I Activities & Deliverables Include:•Design and build proof-of-principle prototype system•Characterize beam parameters

Phase II Activities & Deliverables Include:•Prototype radiation source with clinically acceptable parameters•Demonstrate that system is capable of delivering treatment dose in clinically acceptable period of time in an anthropomorphic system

*Re-issue

nci sbir and sttr: advancing the commercialization of new cancer innovations

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