AAPM SBIR - PowerPoint PPT Presentation

Loading...

PPT – AAPM SBIR PowerPoint presentation | free to download - id: 604fa4-Zjg3N



Loading


The Adobe Flash plugin is needed to view this content

Get the plugin now

View by Category
About This Presentation
Title:

AAPM SBIR

Description:

NCI SBIR and STTR: Advancing the Commercialization of New Cancer Innovations North Carolina Biotechnology Center October 16, 2012 Deepa Narayanan – PowerPoint PPT presentation

Number of Views:154
Avg rating:3.0/5.0
Slides: 66
Provided by: Jennif219
Learn more at: http://www.ncbiotech.org
Category:

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: AAPM SBIR


1
NCI SBIR and STTR Advancing the Commercializati
on of New Cancer Innovations North Carolina
Biotechnology Center October 16, 2012 Deepa
Narayanan Program Director, NCI SBIR Development
Center http//sbir.cancer.gov
2
Todays 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
  • NCIs SBIR Program
  • NCI SBIR Development Center
  • Phase II Bridge Award
  • Investor Forum
  • Tips on Preparing a Successful SBIR Application

2
3
Congressionally Mandated Programs
Set-Aside (FY13)
  • Small Business Innovation Research (SBIR)
  • Set-aside program for small business concerns to
    engage in Federal RD with the potential for
    commercialization
  • Federal agencies with an extramural RD budget
    gt 100M
  • Small Business Technology Transfer (STTR)
  • Set-aside program to facilitate cooperative RD
    between small business concerns and U.S. research
    institutions with the potential for
    commercialization
  • Federal agencies with an extramural RD
    budget gt 1B

2.7
0.35
3
4
SBIR/STTR Funding Levels
2010 Budget SBIR STTR SBIRSTTR
NIH 616 M 74 M 690 M
NCI 99 M 12 M 111 M
? The annual SBIR/STTR budget for each
participating Institute or Center (IC) is
proportional to the total annual budget
appropriation for that IC
4
NIGMS
NIDDK
5
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 NIHs rigorous scientific peer
    review

6
SBIR Eligibility
  • Applicant must be a Small Business Concern (SBC)
  • Organized for-profit U.S. business
  • 500 or fewer employees, including affiliates
  • PD/PIs primary employment (i.e., gt50) 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
7
STTR Eligibility
  • Applicant is a Small Business Concern
  • Formal Cooperative RD 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 RD Center (FFRDC)
  • Intellectual Property Agreement
  • Should provide the necessary IP rights (to the
    SBC) in order to carry out follow-on RD and
    commercialization
  • Principal Investigators primary employment may
    be with either the Small Business Concern or the
    research institution

7
8
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 Combined Phase I II
Phase III COMMERCIALIZATION
Phase II DEVELOPMENT
Phase I FEASIBILITY
  • Research Development
  • Commercialization plan required
  • 1 million over 2 years

8
9
SBIR/STTR Reauthorization Key Changes
9
10
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
11
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
12
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
13
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
14
Implementation Timeline
Effective New Program Element
Now Set-aside increases, FY12 SBIR 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/reauthor
ization.htm
15
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/r
    eauthorization.htm
  • Speak with your program officer

16
SBIR/STTR Funding Opportunities
16
17
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
    (PAs) and Requests for Application (RFAs), i.e.
    grants
  • Release Weekly
  • Receipt Dates Various

http//grants.nih.gov/grants/guide
17
18
http//sbir.nih.gov
18
19
http//sbir.cancer.gov
19
20
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-deri
    ved 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

21
SBIR Contracts
21
22
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
23
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
NCI SBIR contracts (thousands) of total NCI
SBIR
25
17
13
8
23
24
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 NCIs topic areas
  • http//sbir.cancer.gov/funding/contracts/

25
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 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)

25
26
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 Oxide-Releasing Materials
  • 318 Test to Predict Effectiveness of Docetaxel
    Treatment for Prostate Cancer

26
27
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
28
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
    microenvironmentvalidated 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

28
29
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
30
Questions About Contracts?
Ms. Bette Shanahan eshanahan_at_mail.nih.gov 301.435.
3782
http//sbir.cancer.gov/funding/contracts/
30
31
New Paradigm for Managing SBIR at NCI
32
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

33
NCI SBIR Development Center Program Staff
  • Andrew J. Kurtz, PhD (Lead Program Director)
  • Previous
  • NIH AAAS Science Technology Policy Fellow
  • Cedra Corporation Research Associate,
    Bio-Analytical Assays and Pharmacokinetics
    Analysis
  • Michael Weingarten, MA (Director)
  • Previous
  • NASA Program Manager, NASA Technology
    Commercialization Program
  • Jian Lou, PhD (Program Director)
  • Previous
  • Johnson Johnson Research Scientist, Target
    Validation Biomarker Development
  • Lumicyte, Inc. Director, Molecular Biology
    Systems Analysis
  • Greg Evans, PhD (Lead Program Director)
  • Previous
  • NHLBI/NIH Program Director, Translational and
    Multicenter Clinical Research in
    Hemoglobinopathies
  • NHGRI/NIH Senior Staff Fellow
  • 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
  • Patti Weber, DrPH (Program Director)
  • Previous
  • International Heart Institute of Montana Tissue
    Engineering and Surgical Research
  • Ribi ImmunoChem Research, Inc. Team Leader,
    Cardiovascular Pharmacology
  • 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)
  • 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
  • Ming Zhao, PhD (Program Director)
  • Previous
  • NCI Program Director, Center to Reduce Cancer
    Health Disparities
  • GE Global Research Senior Scientist
  • Pfizer Scientist
  • Jennifer Shieh, PhD (AAAS Science Technology
    Policy Fellow)
  • Previous
  • National Academy of Sciences Christine Mirzayan
    Science and Technology Policy Fellow
  • Syapse, Inc. Biology Associate

33
34
SBIR Phase IIB Bridge Award
34
35
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., 11 match)

36
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 applicants 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
37
Partnership Benefits
  • Benefits to the NCI
  • Opportunity to leverage millions of dollars in
    external resources
  • Valuable input from third-party investors
  • Rigorous commercialization due diligence prior to
    award
  • Commercialization guidance during the award
  • Additional financing beyond the Bridge Award
    project period
  • Benefits to third-party investors
  • Opportunity to partner with small businesses to
    develop commercialize
  • Technologies that have been vetted by NIH
    peer-review, AND
  • Projects for which substantial proof-of-concept
    data already exists
  • Opportunity to share in the early-stage
    investment risk with the NCI

37
37
38
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
39
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
39
40
12 Bridge Awards (to date)
NCI Total 31,401,156
Third-Party Investments 72,695,374
Leverage gt 2 to 1
Venture Capital ?1/3 Strategic Partners
?1/3 Individuals Other ?1/3
40
41
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 gt150
    investors and potential strategic partners
  • Features NCIs top portfolio companies with
    innovative technologies
  • Exclusive one-on-one meetings
  • Previous Presenters
  • Zacharon Pharmaceuticals, Inc.
  • Omniox, Inc.
  • ImaginAb, Inc.
  • Fluxion Biosciences

41
42
What Does It Take to Get Funded? Tips on Applying
43
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

44
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 competitors
    capabilities
  • Basic Research - commercial and clinical value is
    not clear

45
Before You Write an Application
  • Consider your companys strengths
  • Consider your companys 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

46
Search Previous Awards
RePORTER http//projectreporter.nih.gov
47
Key Application Tips
  • Start Early
  • Strong proposals take time to develop
  • Take care of the administrative registrations
    (SF424)
  • http//sbir.nih.gov gt 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

48
Know NIH Review Criteria
  • Does the product address an important problem,
    and have commercial potential? Is there a market
    pull for the proposed product?

Significance
  • Are design and methods well-developed and
    appropriate? Are problem areas addressed?

Approach
  • How novel is the product and the approaches
    proposed to test its feasibility?

Innovation
  • Is the investigator appropriately trained and
    capable of managing the project?

Investigator
  • Does the scientific environment contribute to the
    probability of success? Is the environment unique?

Environment
  • Is the companys business strategy one that has a
    high potential for success?

Commercialization
48
49
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
50
If you arent 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 didnt get your proposal
  • Customers, investors, and employees may not get
    it either
  • Fix errors, improve your presentation
  • Its always painful not to be funded, but at
    least you get the feedback
  • Explore opportunities to serve on NIH peer review
    panels

51
Deepa Narayanan SBIR Program Director Cancer
Imaging and Radiation Therapy NCI SBIR
Development Center Phone 301.594.0212 narayanand_at_
mail.nih.gov http//sbir.cancer.gov
52
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
  • RD activities needed to complete an IND
    application

52
53
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
    microenvironmentvalidated 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

53
54
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
55
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 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

55
56
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
57
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 CYP1B13
    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
    CYP1B13 variant
  • Phase II Activities Deliverables Include
  • Clinical trial
  • Develop commercially-viable prototype

57
58
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 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

58
59
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
60
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
61
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

61
Re-issue
62
Topic 322 Real-Time Integration of Sensor and
Self-Report 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
63
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
64
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

64
Re-issue
65
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

65
Re-issue
About PowerShow.com