University of California Center for Accelerated Innovation

Funding Opportunities

University of California Center for Accelerated Innovation (UC CAI)

Technology Development Award

Purpose: The UC CAI invites applications for development of novel technologies that address heart, lung and blood diseases. This opportunity will support a broad range of drugs, devices (including wireless devices), diagnostics and tools with high potential of becoming commercially viable products that address an unmet need.

BACKGROUND
Cardiovascular, lung and blood diseases affect nearly 145 million Americans and account for three of the four leading causes of death. The University of California medical campuses at Davis, Irvine, Los Angeles, San Diego and San Francisco have a rich research base to support a robust pipeline of technologies to improve human health. Biomedical companies increasingly seek later-stage technologies for licensing and development. UC CAI will incubate promising technologies from UC innovators with the goal of advancing them toward licensing and commercialization for patient benefit. UC CAI anticipates offering this opportunity annually through FY2020.

The Award: Technology Development Awards provide grant and local support worth up to $200,000 for a period of up to two years, as well as mentoring and project management support. It is anticipated that five to six awards will be made. NIH guidelines for annual and end-of-project reporting will apply. Carry forward of funds is not allowed.

Eligibility: Faculty in all series and ranks at UC Davis, UC Irvine, UCLA, UC San Diego, and UC San Francisco are eligible. Postdoctoral scholars are eligible to submit applications as Co-PI with a faculty PI.

Requirements: Projects must have existing or imminent target validation in animal systems or human cell lines and a clear clinical indication. Therapeutic areas can cover any health condition within NIH NHLBI disease domains (heart, lung and sleep, blood) where there is an unmet medical need or the potential for significant improvement over current treatments, diagnostics, devices, tools or services. (Click here for list of targeted health conditions.) Note: If you are targeting an infectious disease, please discuss eligibility with your site leader before submitting a pre-application. If patents or patent applications have not been filed, there should be a strong potential for obtaining defensible intellectual property. If the proposal is a continuation of an existing project, the applicant must demonstrate an impact on translation beyond current efforts.

Selection Process: UC CAI will invite full applications on the basis of a pre-application. Following peer-review, UC CAI will recommend high-scoring proposals to NHLBI for funding.

PRE-APPLICATION

The pre-application may be submitted Aug. 18-22 only. Submission closes 5pm on Aug. 22. The following information is required:

  1. Title of research proposal
  2. Names, institutions, telephone numbers and emails of PIs and Co-PIs
  3. IRB, IACUC, Stem Cell information, if applicable
  4. Abstract
  5. Proposal narrative (two-page maximum)
  6. Commercial Assessment (to be completed by the campus TTO; see below)
  7. NIH biosketch
  8. Budget

Technical requirements: Items 5-8 above are document uploads (doc or pdf). Minimum specifications are Arial, 11-points, half-inch margins on all sides, 8 x 11 paper. Commercial Assessment form can be downloaded from this funding announcement (see below). Letters of Support are not accepted for pre-applications.

Instructions for pre-application proposal narrative: The pre-application narrative will consist of two pages, including figures and tables. References are excluded from the page count. The narrative should be organized using the headings below. Each area must be addressed.

  1. Significance - Describe the scope and nature of the problem you are trying to solve. Define customers (e.g., patients, practitioners, researchers) and the context in which they want the problem solved.
  2. Innovation and Impact - Describe your proposed solution and what is innovative about it. Define the impact you hope to accomplish using metrics most appropriate for you (e.g., morbidity, mortality, costs).
  3. Competition - List the competing approaches customers can use to address the problem, including products, services and compensating behaviors (e.g., work-arounds)
  4. Work Plan and Aims - Describe the proposed project and specific aims. Describe how successful completion of the project will advance the technology (e.g., licensing, investment, or value inflection point, such as target validation or prototype generation).

Resubmissions: Resubmitted pre-applications must contain a half-page introduction to the proposal that responds to comments from the previous review. Note: This introduction will not be counted towards the proposal narrative two-page limit.

Commercial Assessment Form: A commercial assessment form must be completed and signed by your campus technology licensing office. The completed form must be uploaded as part of your application. Applicants are encouraged to complete this form two weeks before the application deadline to ensure they will meet the application deadline. Click here to download the form.

Biosketch: Provide biosketches of PI and Co-PIs. Use PHS 398 NIH Biographical Sketch Format Page form found at http://grants.nih.gov/grants/funding/phs398/phs398.html. There is a four-page maximum for each biosketch.

Budgets: Use PHS 398 Form Pg. 4 “Detailed Budget for Initial Period,” found here: http://grants.nih.gov/grants/funding/phs398/phs398.html. Refer to the table below for allowable costs. Applicants must submit separate budgets for years 1 and 2. Applicants are strongly advised to meet with their site leaders to determine grant and local support.

Budget Justification:  Address the following: (1) FTE requirement (number, percent effort, type, and budget for project duration), (2) R&D requirement (total R&D, budget phases per milestone/deliverable), (3) Contract or outsource requirements (e.g., internal core facilities or external CROs), (4) Other required costs. 


Allowable Not Allowable
PI Salary and Benefits * X
Post Doc Salary and Benefits X
K career development awardees - salary support
X
Consultants X
Administrative Support
X
Supplies X
Equipment X
Software X
Personal Computers
X
Mailing
X
Tuition**
X
Travel*** X
Research Staff Support (e.g., SRA, Lab Tech) - salary and benefits X
Patient Care
X

* NIH base salary cap

** Strongly discouraged. Justification must be provided.

*** Travel is restricted to local travel between project sites.

Selection and Scoring: Pre-applications will be scored by a study section on the applicant’s campus using the criteria below. Pre-applications will receive an impact score. The NIH 9-point scoring scale (1=exceptional; 9=poor; see section C ) will be used. High-scoring proposals (about 20% of total submissions) will be invited to submit full applications.

REVIEW CRITERIA REVIEW QUESTIONS LOCATION WITHIN THE PROPOSAL
Unmet Need
  • Why is this a significant problem?
  • What are the associated morbidities, mortality or costs?
  • Have the users of this technology been identified?
  • Significance
  • Innovation and Impact
Innovation and Impact
  • Is the proposed solution linked to an unmet need?
  • How is this proposed solution innovative?
  • If successful, will the proposed solution be transformative?
  • Innovation and Impact
  • Competition
Competition
  • Are competitive technologies addressed?
  • Competition
Work Plan and Specific Aims
  • Is the plan well described?
  • Is the plan feasible and consistent with the budget?
  • Does the proposal build on prior work or data?
  • Will the work advance the technology to a significant value point (e.g., licensing, investment, target validation, prototype generation)?
  • Work Plan
  • Budget
Investigators
  • Do investigators have the necessary strengths and expertise to accomplish the work plan and aims?
  • Biosketches
Intellectual Property
  • Has invention disclosure occurred?
  • Has a patent application been filed?
  • Has a patent been approved?
  • Is there a previous licensing event and how does this affect the IP strategy?
  • Commercial Assessment

FULL APPLICATION

The full application may be submitted from Oct. 6 to Oct. 10 only. Submission closes at 5 pm on Oct. 10. Application components are listed below. Items 1-9 are required. Items 10-11 are optional. Item 10 is strongly encouraged.

  1. Title of research proposal
  2. Names, institutions, telephone numbers and emails of PIs and Co-PIs
  3. IRB, IACUC, Stem Cell information, if applicable
  4. Abstract
  5. Proposal narrative (six-page maximum)
  6. Commercial Assessment (to be completed by the campus TTO; see below)
  7. Budget (see Budgets, below)
  8. NIH biosketch
  9. NHLBI Technology Review Committee (TRC) form (see below)
  10. Consultation Letter (optional, see below)
  11. Letters of Support (optional)

Technical requirements: Items 5-11 above are document uploads (doc or pdf). Minimum specifications are Arial, 11-points, half-inch margins on all sides, 8 x 11 paper. Applicants must submit a Commercial Assessment, Budget and Biosketches. Applicants may resubmit the Commercial Assessment, Biosketches and Budget used in the pre-application if the information is unchanged. TRC form can be downloaded from this funding announcement (see below).

Webinar: CAI will conduct a webinar on "technology readiness and go-to-market decision-making" on Sept. 11 from noon to 1 p.m. PDT. Webinar topics will include (1) assessment of technology readiness for commercialization, (2) interfacing campus technology transfer offices, (3) go-to-market options, including licensing and company formation, and (4) matching technology with go-to-market decisions. To register, please go here.

Instructions for full-application proposal-narrative: The full application narrative will consist of six pages, including figures and tables. References are excluded from the page count. The narrative should be organized using the headings below. Each area must be addressed.

  1. Significance - Describe the scope and nature of the problem you are trying to solve. Define customers (e.g., patients, practitioners, researchers) and the context in which they want the problem solved.
  2. Innovation and Impact - Describe your proposed solution and what is innovative about it. Define the impact you hope to accomplish using metrics most appropriate for you (e.g., morbidity, mortality, costs).
  3. Competition - List the competing approaches customers can use to address the problem, including products, services and compensating behaviors (e.g., work-arounds). Explain the advantages of your technology over competing approaches.
  4. Work Plan and Aims - Describe the proposed project and specific aims. Describe how successful completion of the project will advance the technology (e.g., licensing, investment, or value inflection point, such as target validation or prototype generation). For each Aim, provide milestones and a target date for completion.
  5. Market Size and Strategy - Define your potential market and its size. Include any evidence you have (e.g., surveys, market research) that validates the market. Describe how you would introduce your product to this market. What are your potential challenges and opportunities?
  6. Strategic Partnerships - Provide a brief description of existing partnerships with organizations related to the research. List any companies that may be interested in licensing or co-developing your technology.
  7. Regulations – Describe the regulatory requirements that exist for your technology.
  8. Business Model - Describe the cost and revenue streams associated with commercializing the technology, include reimbursement issues.  Discuss the potential for developing the technology for additional unmet needs.

Resubmissions: Resubmitted full applications must contain an introduction of no more than one page that responds to comments from the previous review. Note: This introduction will not be counted towards the proposal narrative six-page limit.

Commercial Assessment Form: A commercial assessment form must be completed and signed by your campus technology licensing office. The completed form must be uploaded as part of your application. Applicants are encouraged to complete this form two weeks before the application deadline to ensure they will meet the application deadline. Click here to download the form. Applicants may resubmit the Commercial Assessment used in the pre-application if the information is unchanged.

NHLBI Technology Review Committee (TRC) Form: Applicants must complete and upload the TRC form, which can be accessed here.

Consultation Letter: The UC CAI offers expert consultations to assist applicants with their proposals. Applicants may schedule a consultation by contacting the site leader, site administrator or project manager on their campuses. Consultants will provide written summaries of their advice, which the applicants may submit as a separate upload in the applications. Summaries should be dated and signed by the consultant and submitted in a separate upload as a pdf.

Biosketch: Provide biosketches of PI and Co-PIs. Use PHS 398 NIH Biographical Sketch Format Page form found at http://grants.nih.gov/grants/funding/phs398/phs398.html. There is a four-page maximum for each biosketch.

Budget: Use PHS 398 Form Pg. 4 “Detailed Budget for Initial Period,” found here: http://grants.nih.gov/grants/funding/phs398/phs398.html. Refer to the table below for allowable costs. Applicants must submit separate budgets for years 1 and 2. APPLICANTS MUST MEET WITH THEIR SITE LEADERS TO DETERMINE GRANT AND LOCAL SUPPORT. Applicants may resubmit the Budget used in the pre-application if the information is unchanged.

Budget Justification:  Address the following: (1) FTE requirement (number, percent effort, type, and budget for project duration), (2) R&D requirement (total R&D, budget phases per milestone/deliverable), (3) Contract or outsource requirements (e.g., internal core facilities or external CROs), (4) Other required costs. 


Allowable Not Allowable
PI Salary and Benefits * X
Post Doc Salary and Benefits X
K career development awardees - salary support
X
Consultants X
Administrative Support
X
Supplies X
Equipment X
Software X
Personal Computers
X
Mailing
X
Tuition**
X
Travel*** X
Research Staff Support (e.g., SRA, Lab Tech) - salary and benefits X
Patient Care
X

* NIH base salary cap

** Strongly discouraged. Justification must be provided.

*** Travel is restricted to local travel between project sites.

Selection and Scoring: Full applications will be scored by a study section that includes disease and platform experts from academia and industry. The NIH 9-point scoring scale (1=exceptional; 9=poor; see section C ) will be used. Full applications will receive an impact score calculated using the NIH scoring system. High-scoring proposals will be forwarded to NHLBI for review. Review criteria are below.

REVIEW CRITERIA REVIEW QUESTIONS LOCATION WITHIN THE PROPOSAL
Unmet Need
  • Why is this a significant problem?
  • What are the associated morbidities, mortality or costs?
  • Have the users of this technology been identified?
  • Significance
  • Innovation and Impact
Innovation and Impact
  • Is the proposed solution linked to an unmet need?
  • How is this proposed solution innovative?
  • If successful, will the proposed solution be transformative?
  • Innovation and Impact
  • Competition
Competition
  • Are competitive technologies described and addressed?
  • Who else is working on the target, pathway or mechanism?
  • Competition
  • Commercial Assessment
Work Plan and Specific Aims
  • Is the plan well described?
  • Is the plan feasible and consistent with the budget and timelines?
  • Does the proposal build on prior work or data?
  • Will the work advance the technology to a significant value point (e.g., licensing, investment, target validation, prototype generation)?
  • Work Plan
  • Budget
Investigators
  • Do investigators have the necessary strengths and expertise to accomplish the work plan and aims?
  • Can investigators adapt to changing circumstances and advice?
  • Biosketches
  • Consultation Letter (optional)
Intellectual Property
  • Has invention disclosure occurred?
  • Has a patent application been filed?
  • Has a patent been approved?
  • Is there a previous licensing event and how does this affect the IP strategy?
  • Commercial Assessment
Market Attractiveness
  • Is the market segment for the proposed technology well-defined?
  • Have technology costs and margins been considered in the context of analogous products?
  • Have market penetration and timing issues been considered?
  • Commercial Assessment
  • Market Size and Strategy
  • Competition
Regulatory and Reimbursement Risk
  • Is FDA allowance or approval required?
  • Has a preliminary regulatory strategy been articulated?
  • Are regulatory uncertainties or risks identified and addressed?
  • Does the product reimbursement for successful market penetration? If so, has a reimbursement strategy been considered?
  • Regulations
  • Business Model
Business Development
  • Is a business model proposed?
  • Are strategic partnerships needed to complete the project?
  • Is additional capital required? If so, are potential sources identified?
  • Are product distribution channels and access uncertainties identified?
  • Is manufacturing scale-up proposed?
  • Strategic Partnerships
  • Business Model

SUBMISSION DATES AND TIMES

RFA release: July 18, 2014
Pre-application due: Aug. 22, 2014 5 PM PT
Pre-application notification: Sept. 15, 2014
Full application due: Oct. 10, 2014 5 PM PT
Earliest start date: Feb. 1, 2015

Additional Information: Successful applicant co-PIs must provide their field of specialization, their NIH Commons ID and their IRB and/or IACUC protocol numbers, if applicable, before funds are released. Recipients must credit NHLBI and cite grant number U54HL119893 in publications that result from this funding.

QUESTIONS

About application requirements and process:

UC Davis
Laura Marcu
Site Leader
lmarcu@ucdavis.edu

Anuurad Erdembileg
Site Administrator
anuerdem@ucdavis.edu

UC Irvine
Steve Cramer
Site Leader
scramer@uci.edu

Andria Pontello
Site Administrator
apontell@uci.edu

UCLA
Tomas Ganz
Site Leader
tganz@mednet.ucla.edu

Elvira Liclican
Project Manager
eliclican@mednet.ucla.edu

UC San Diego
Kirk U. Knowlton
Site Leader
kknowlton@ucsd.edu

Robert Ross
Site Leader
rross@ucsd.edu

Caesar Dispo
Site Administrator
cdispo@ucsd.edu

UC San Francisco
June Lee
Site Leader
june.lee@ucsf.edu

Catherine Tralau-Stewart
Project Manager
Catherine.Tralau-Stewart@ucsf.edu

About the website and online submission tool:

Maryam Ariannejad
Technical Support
uccai-support@ctsi.ucla.edu

Introduction to the UC CAI

UC CAI Webinar

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2014 Awardees

Ian Kennedy, PhD
Professor
Department of Mechanical and Aerospace Engineering
UC Davis

Project title: Nanophotonic Detection of Bacterial and Fungal Infections

Tomas Ganz, MD, PhD
Professor of Medicine and Pathology
Director, Will Rogers Pulmonary Research Laboratory
Co-Director, Center for Iron Disorders
UC Los Angeles

Project title: Diagnostic Antibodies for Erythroferrone

Stephen Nishimura, MD
Associate Professor
Department of Pathology
UC San Francisco

Project title: Therapeutic Antibodies for TGF-Beta

Charles Chiu, MD, PhD
Assistant Professor
Department of Laboratory Medicine
UC San Francisco


Project title: NextGen Sequencing for Pulmonary Differential Diagnosis

UC Davis Team

Laura Marcu, PhD
Site Leader
lmarcu@ucdavis.edu

Research Navigator
Anuurad Erdembileg, MD, PhD, MAS
Site Administrator and UCD Assistant Adjunct Professor
anuerdem@ucdavis.edu

UC Irvine Team

Steve Cramer, MD
Site Leader
scramer@uci.edu

Andria Pontello
Site Administrator
apontell@uci.edu

UCLA Team

Tomas Ganz, MD, PhD
Site Leader
tganz@mednet.ucla.edu

Denise Gellene
Site Administrator and UC CAI Communications Lead
dgellene@mednet.ucla.edu

Research Navigator
Elvira Liclican, PhD
CTSI Science Officer and Technology Transfer Program Administrator
eliclican@mednet.ucla.edu

UC San Diego Team

Kirk U. Knowlton
Site Leader
kknowlton@ucsd.edu

Robert Ross
Site leader
rross@ucsd.edu

Caesar Dispo
Site Administrator
cdispo@ucsd.edu

UC San Francisco Team

Shaun R. Coughlin, MD, PhD
Site Co-leader
coughlin@cvrimail.ucsf.edu

June Lee, MD
Site Co-leader
june.lee@ucsf.edu

Research Navigator
Catherine Tralau-Stewart, PhD
Site Administrator
Catherine.Tralau-Stewart@ucsf.edu

Understanding the Selection Process

Background

  • Annual solicitation across three platforms
    1. Therapeutics
    2. Devices (including digital/wireless health)
    3. Diagnostics
    4. Tools
  • Awards of up to $200K for two years
  • Eligibility
    1. Faculty in all series and ranks at UC Davis, UC Irvine, UCLA, UC San Diego, and UC San Francisco
    2. Postdoctoral scholars are eligible to submit applications as Co-PI with a faculty PI
    3. Projects with existing or imminent target validation and a clear clinical indication
    4. Patents or patent applications are filed or potential for obtaining defensible intellectual property is strong
  • There is a two-stage submission process consisting of a pre-application and an invitation-only full application

Is the budget capped at $200,000?

Technology Development Awards provide up to $200,000 for direct costs. The award may be used over one or two years.

Are indirect costs allowed?

Indirect costs do not need to be addressed in the budget for your proposal. Please contact your site administrator for additional guidance.

Can the proposed budget be a non-binding estimate?

Yes.

What if my IP is held by a UC campus that is not participating in the Center?

You may still apply. The important questions for reviewers are whether you have freedom to operate and whether your work in the Center will result in creation of new IP.

Is the application process confidential?

The application process is completely confidential. The Center is committed to protecting existing IP and new IP that is developed as a project moves forward.

Can I submit a lung cancer project?

Because cancer is not in NHLBI’s disease portfolio, the Center will not review applications that specifically target cancer, including lung and blood cancers. Projects that target a disease in NHLBI’s portfolio but have potential utility against cancer are acceptable.

Which diseases are in NHLBI’s portfolio?

A list of diseases targeted by this opportunity can be viewed here.

Who is eligible to submit an application?

All faculty in all ranks at UC Davis, Irvine, Los Angeles, San Diego and San Francisco are eligible. Faculty at affiliated institutions are not eligible

Are post docs eligible?

Post docs may submit with a faculty Co-PI.

I am a UCSF PI with a UC Santa Cruz co-PI. Am I eligible to apply?

Yes. You may partner with a UC investigator at another UC campus.

When are pre-applications due?

Pre-applications must be submitted at uccai.ctsi.ucla.edu by 5 pm Aug 22.

Who do I contact if I have problems with the online submission tool?

Please email uccai-support@ctsi.ucla.edu for assistance. Allow 24 hours for a response.

May I submit more than one application?

Yes. There is no limit on the number of pre-applications you may submit.

Does the pre-application require an institutional signature?

No.

Can I view my application after it is submitted?

Yes. You may view your submitted application but you cannot make changes to it. If you want to change a submitted application, you must delete your applications and upload an new one.

I received outside funding for my project. Can I withdraw my proposal?

Yes, you may delete your proposal by clicking the “delete” button.

Questions?

Click the links below to contact your Research Navigator.


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