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
• 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 Application
2
Congressionally Mandated Programs
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
2.7%
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
0.35%
Federal agencies with an extramural R&D budget > $1B
3
SBIR/STTR Funding Levels
2010 Budget
SBIR
STTR
SBIR+STTR
NIH
$616M
$74M
$690M
NCI
$99M
$12M
$111M
← The annual SBIR/STTR budget
for each participating Institute
or Center (IC) is proportional
to the total annual budget
appropriation for that IC
NIGMS
NIDDK
4
Reasons to Seek SBIR/STTR Funding
• 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
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
• Proof-of-Concept study
• $150,000 over *
6 months (SBIR)
or 1 year (STTR)
• Commercialization stage
• Use of non-SBIR/STTR funds
Fast-Track
Application
Phase
I
Phase II
Combined Phase
I & II
FEASIBILITY
DEVELOPMENT
Phase III
COMMERCIALIZATION
• Research & Development
• Commercialization plan required
• $1 million over 2 years*
8
SBIR/STTR Reauthorization:
Key Changes
9
Congressional Reauthorization
• 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
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 Process
Working to shorten timelines from application to
award decision. NIH given 1 year from solicitation
close date.
Administrative Funding Pilot
3% 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, FY12
SBIR = 2.6%
STTR = 0.35%
With next issued solicitation
•
•
•
•
January 1, 2013 (expected)
• Size Rule finalized
• Company Registry registration
required
• New eligibility requirements re:
ownership & affiliation
150% award caps
Open Phase II competitions
SBIR to STTR/STTR to SBIR
Cross-agency awards
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/reauthori
zation.htm
• Speak with your program officer
SBIR/STTR Funding
Opportunities
16
Multiple Funding Solicitations
Know the Application Deadlines
 SBIR & STTR Omnibus Solicitations for Grant Applications
Release: January
Receipt Dates: April 5, August 5, and December 5
 Solicitation of the NIH & CDC for SBIR Contract Proposals
Release: August
Receipt Date: Early November
 See the NIH Guide for other Program Announcements (PA’s)
and Requests for Application (RFA’s), i.e. grants
Release: Weekly
Receipt Dates: Various
http://grants.nih.gov/grants/guide
17
http://sbir.nih.gov
18
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 nanotechnologyderived 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 Award
Based on score during peer
review
If proposal scores well during
peer review, must then negotiate
to finalize deliverables with NIH
Reporting
One 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
Areas of interest to the
commercial sector,
based on market
opportunity
NCI scientific &
technology
priorities
Contract topics in areas with strong potential for
commercial success
$25,020
NCI SBIR contracts
(thousands)
$16,665
$12,387
13%
2007
25%
$7,757
17%
% of total NCI SBIR
8%
2008
2009
2010
23
Contract Opportunities Now Available
 PHS-2013-1 “Solicitation of NIH and CDC for SBIR Contract
Proposals”
 Published August 15, 2012:
Proposals Due: 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/
FY13 NCI SBIR Contract Topics
Therapeutics & Diagnostics
• 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
Advancing Cancer Research
• 314 Development of Human Tissue Culture Systems that Mimic the
Tumor Microenvironment
• 319 Technology to Generate Anti-Peptide Capture Reagents for AffinityEnriched 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)
25
FY13 NCI SBIR Contract Topics
Imaging & Radiation Therapy
• 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
Health IT
• 322 Real-Time Integration of Sensor and Self-Report Data for
Clinical and Research Applications
NIH Technology Transfer
• 317 Wound Healing Preparations Incorporating Nitric OxideReleasing Materials
• 318 Test to Predict Effectiveness of Docetaxel Treatment for Prostate
Cancer
26
Topic 323: Development of Radiation
Modulators for Use During Radiotherapy*
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
27
Topic 314: Development of Human Tissue Culture
Systems that Mimic the Tumor Microenvironment
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 anticancer 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
28
Topic 317: Wound Healing Preparations Incorporating Nitric
Oxide-Releasing Materials (NIH Technology Transfer)
Budget: Phase I $200,000; Phase II $1.5M
Number of Anticipated Awards: 1
Fast-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
29
Questions About Contracts?
Ms. Bette Shanahan
eshanahan@mail.nih.gov
301.435.3782
http://sbir.cancer.gov/funding/contracts/
30
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)
Andrew J. Kurtz, PhD (Lead Program Director)
Previous
• NASA – Program Manager, NASA Technology
Commercialization Program
Previous
• NIH – AAAS Science & Technology Policy Fellow
• Cedra Corporation – Research Associate, BioAnalytical Assays and Pharmacokinetics Analysis
Greg Evans, PhD (Lead Program Director)
Jian Lou, PhD (Program Director)
Previous
• NHLBI/NIH – Program Director, Translational and
Multicenter Clinical Research in Hemoglobinopathies
• NHGRI/NIH – Senior Staff Fellow
Previous
• Johnson & Johnson – Research Scientist,
Target Validation & Biomarker Development
• Lumicyte, Inc. – Director, Molecular Biology
Systems Analysis
Patti Weber, DrPH (Program Director)
Todd Haim, PhD (Program Director)
Previous
• International Heart Institute of Montana –
Tissue Engineering and Surgical Research
• Ribi ImmunoChem Research, Inc. – Team
Leader, Cardiovascular Pharmacology
Previous
• National Academy of Sciences – Christine Mirzayan
Science and Technology Policy Fellow
• Pfizer Research Laboratories – Postdoctoral Fellow,
Cardiac Pathogenesis & Metabolic Disorders
Deepa Narayanan, MS (Program Director)
Amir Rahbar, PhD, MBA (Program Director)
Previous
• Naviscan PET Systems, Inc., Director, Clinical Data
Management (Oncology Imaging & Clinical Trials)
• Fox Chase Cancer Center, Scientific Associate (Molecular
Imaging Lab)
Previous
• NCI– Program Manager, Center for Strategic Scientific
Initiatives
• BioInformatics, LLC – Senior Science Market Analyst
• Naval Research Laboratory – Research Scientist
Jennifer Shieh, PhD (AAAS Science &
Ming Zhao, PhD (Program Director)
Technology Policy Fellow)
Previous
Previous
• National Academy of Sciences – Christine Mirzayan
Science and Technology Policy Fellow
• Syapse, Inc. – Biology Associate
• NCI– Program Director, Center to Reduce Cancer Health
Disparities
• GE Global Research – Senior Scientist
• Pfizer – Scientist
33
SBIR Phase IIB Bridge Award
34
NCI SBIR Phase IIB Bridge Award
Phase I
FEASIBILITY
Phase II
DEVELOPMENT
NCI SBIR Phase IIB Bridge Award
CROSSING THE VALLEY OF DEATH
Phase III
COMMERCIALIZATION
• 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
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
37
“Valley of Death”
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?
38
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 therapeutics
6 imaging technologies
3 molecular diagnostics
http://projectreporter.nih.gov/reporter.cfm
39
12 Bridge Awards (to date)
$20,000,000
NCI Funding
Third-Party Funding
$15,000,000
$10,000,000
$5,000,000
$0
NCI Total
$31,401,156
Venture Capital:
Third-Party Investments
$72,695,374
Strategic Partners: 1/3
> 2 to 1
Individuals & Other: 1/3
Leverage
1/3
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
Previous Presenters
• Zacharon Pharmaceuticals, Inc.
• Omniox, Inc.
• ImaginAb, Inc.
• Fluxion Biosciences
• Exclusive one-on-one meetings
41
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
Before You Write an Application
• 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
Search Previous Awards
RePORTER
http://projectreporter.nih.gov
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?
Approach
• Are design and methods well-developed and
appropriate? Are problem areas addressed?
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?
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
If you aren’t funded …
 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
Deepa Narayanan
SBIR Program Director
Cancer Imaging and Radiation Therapy
NCI SBIR Development Center
Phone: 301.594.0212
narayanand@mail.nih.gov
http://sbir.cancer.gov
Topic 313: RNAi Cancer Therapeutics
Using Nanotechnology
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
52
Topic 314: Development of Human Tissue Culture
Systems that Mimic the Tumor Microenvironment
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 anticancer 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
53
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
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 singlecell 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
55
Topic 317: Wound Healing Preparations Incorporating Nitric
Oxide-Releasing Materials (NIH Technology Transfer)
Budget: Phase I $200,000; Phase II $1.5M
Number of Anticipated Awards: 1
Fast-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
56
Topic 318: Test to Predict Effectiveness of Docetaxel
Treatment for Prostate Cancer (NIH Technology Transfer)
Budget: Phase I $300,000; Phase II $2M
Number of Anticipated Awards: 1
Fast-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
57
Topic 319: Technology to Generate Anti-Peptide Capture
Reagents for Affinity-Enriched Proteomic Studies
Budget: Phase I $200,000; Phase II $1M
Number of Anticipated Awards: 4
Goal: New technologies that generate reproducible, well-characterized antipeptide 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
58
Topic 320: High Quality Cancer-Related Standards for
Metabolomics Research
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
59
Topic 321: Chemically Defined Glycan Libraries for
Reference Standards and Glycomics Research
(Joint NCI-NIGMS Program)
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
60
Topic 324: Novel Imaging Agents to Expand the
Clinical Toolkit for Cancer Diagnosis, Staging, and
Treatment*
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 61
Topic 322: Real-Time Integration of Sensor and SelfReport Data for Clinical and Research Applications
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
62
Topic 323: Development of Radiation
Modulators for Use During Radiotherapy*
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
63
Topic 324: Novel Imaging Agents to Expand the
Clinical Toolkit for Cancer Diagnosis, Staging, and
Treatment*
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 64
Topic 325: Innovative Radiation Sources for
Advanced Radiotherapy Equipment
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 65