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NCI SBIR and STTR: Advancing the Commercialization of New Cancer Innovations North Carolina Biotechnology Center October 16, 2012 Deepa Narayanan Program Director, NCI SBIR Development Center http://sbir.cancer.gov. Today’s Presentation. SBIR/STTR Overview & Eligibility - PowerPoint PPT Presentation
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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
3
SBIR/STTR Funding Levels
4
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
6
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
7
SBIR & STTR: Three-Phase Program
8
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
9
• 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
10
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
16
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
17
Multiple Funding SolicitationsKnow the Application Deadlines
http://grants.nih.gov/grants/guide
http://sbir.nih.gov
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http://sbir.cancer.gov
19
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
21
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
22
NCI SBIR Contracts
23
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
25
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)
26
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*
27
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
28
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)
29
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?
30
Ms. Bette Shanahan
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
33
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
34
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
36
3737
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”
38
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?
3939
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
40
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
41
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!
49
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
http://sbir.cancer.gov
Topic 313: RNAi Cancer Therapeutics Using Nanotechnology
52
Budget: Phase I $200,000; Phase II $1M Number of Anticipated Awards: 3 - 5
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
53
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 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
55
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)
56
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 318: Test to Predict Effectiveness of Docetaxel Treatment for Prostate Cancer (NIH Technology Transfer)
57
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.
*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:•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
58
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
59
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)
60
Budget: Phase I $300,000; Phase II $1M Number of Anticipated Awards: 4 – 6
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*
61
Budget: Phase I $250,000; Phase II $1.5M Number of Anticipated Awards: 3 - 5
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
62
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
Topic 323: Development of Radiation Modulators for Use During Radiotherapy*
63
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 324: Novel Imaging Agents to Expand the Clinical Toolkit for Cancer Diagnosis, Staging, and Treatment*
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Budget: Phase I $250,000; Phase II $1.5M Number of Anticipated Awards: 3 - 5
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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Budget: Phase I $300,000; Phase II $2M Number of Anticipated Awards: 2 - 3
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