University of California Center for Accelerated Innovation

Funding Opportunities

University of California Center for Accelerated Innovation (UC CAI)

NHLBI 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 up to $200,000* in grant ($100,000 in direct costs) and matching ($100,000 in direct costs) support** 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.

  • *Most technologies will be awarded at $200,000. However, if you feel your technology would substantially benefit from up to $400,000, please submit a budget, milestones and timelines at both funding levels.

  • **Awards must be matched 1:1 with non-federal funds. See Budgets, below.

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.

Medical Device Retreat: UC CAI is hosting the 2nd Annual Medical Device Retreat and Lunch & Learn at UC Irvine on Oct. 24, 2016. The event provides an opportunity for medical device applicants to pitch their project and receive feedback from UC CAI leadership and industry experts, and to learn more about UC resources available to accelerate projects. Private sessions for project feedback will be available either in-person or by webcast. For additional details or to RSVP, please visit the event page.

Application Webinar Series: To assist applicants on required components of their proposals, a webinar series was offered on the topics below. Applicants are strongly advised to review webinar content at: https://ctsi.ucla.edu/cai/pages/ncai_application

  • Market size and competitive landscape
  • Intellectual property
  • Reimbursement
  • Regulatory strategies

Consultations: The UC CAI offers expert consultations to assist applicants with their proposals. In preparation for their submission, we strongly encourage applicants to schedule a consultation with the site leader on their campus. Contact information for campus site leaders can be found below.

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


Letter of intent (highly recommended): Please submit a letter of intent to your campus administrator or project manager by November 18, 2016. The letter of intent should include the name of the PI and tentative title of the proposal. Contact information for campus administrators and project managers can be found below.

The pre-application may be submitted from Dec. 5 to Dec. 9 only. Submission closes at 5 pm on Dec. 9. 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
  9. Product Profile (optional)

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 (three pages for proposals requesting up to $400,000), 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 milestones. 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). Proposals requesting up to $400,000 must submit milestones and timelines at both funding levels of $200,000 and $400,000.

Resubmissions: Resubmitted pre-applications must contain an introduction that precedes the proposal narrative, of no more than one page, that responds to comments from the previous review. Note: this one-page 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 five-page maximum for each biosketch.

Budgets: Refer to the table below for allowable costs. Total costs (direct plus indirect costs) for subawards to other institutions must be included within the total $200,000 direct cost budget maximum. Applicants must submit separate budgets and budget justifications for years 1 and 2 (use PHS 398 Form Pg. 4 “Detailed Budget for Initial Period), and a budget for the entire proposed project period (use PHS 398 Form Pg. 5 “Budget for Entire Proposed Project Period). Separate budgets and budget justifications for years 1 and 2 must also be submitted for subawards. Proposals requesting up to $400,000 must provide budgets at both funding levels of $200,000 and $400,000. Budget forms can be found here: http://grants.nih.gov/grants/f unding/phs398/phs398.html.

Product Profiles (optional)

Download and complete the appropriate product profile. Please note, product profiles will not be counted towards the proposal narrative page limit.

Product Profile Template

Download Link

Device Product Profile

Diagnostic Product Profile

Therapeutic Product Profile


It is required that each grant be matched 1:1 with non-federal funds at the time of the award. APPLICANTS MUST MEET WITH THEIR SITE ADMINISTRATION PRIOR TO SUBMISSION TO DISCUSS THE REQUIREMENT FOR THE MATCHING SUPPORT.

 

Allowable

Not Allowable

PI Salary and Benefits *† X  
Post Doc Salary and Benefits X  
K career development awardees – salary support   X
Consultants and Sub-contracting** 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

† Proposals requesting large salary support are discouraged and will be carefully reviewed

** Applicants are strongly encouraged to utilize consultants and contracted services

*** 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 is the associated prevention, 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

Application components are listed below. Items 1-8 are required. Item 9 is optional.

  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 (eight-page maximum)
  6. Commercial Assessment (to be completed by the campus TTO; see below)
  7. Budget (see Budgets, below)
  8. NIH biosketch
  9. Letters of Support (optional)

Technical requirements: Items 5-9 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, Budget and Biosketches used in the pre- application if the information is unchanged.

Instructions for full-application proposal-narrative: The full application narrative will consist of eight pages (nine pages for proposals requesting up to $400,000), including figures and tables. References and product profiles are excluded from the page count. The narrative should be organized using the headings below. Each area must be addressed.

I. Basis for Project

  1. Background – Describe the scope and nature of the problem the technology will address, and give a briefdescription of the solution. Some elements to include are: disease burden, market space in which the product would operate, and comparison of your solution to the current and predicted standard of care, including target product profile if applicable.
  2. Unmet Need – Clearly state the unmet need being addressed by the technology and provide evidence to support the need from multiple stakeholder perspectives (e.g., patient, clinician, payer).
  3. Proposed Product/Solution – Describe your proposed solution and what is innovative about it. Identify the setting in which it will be utilized (ICU, in- patient, out-patient, primary care physician, etc.), and the primary patient population / indication for use. Characterize the expected benefit from the technology and how it will enhance current or predicted (when this product will be on the market) standard of care or replace the current standard of care. What is the evidence to support the expected benefit? Provide a brief synopsis of your preliminary data.
  4. Market Size and Strategy – Define the total and addressable market size, and target price of the technology. Support your market size and descriptions with evidence about current technologies or approaches to address this indication. Define a specific patient segment of those suffering from the specific targeted disease. What are the market population trends and projections? Webinar available.
  5. Competitive Landscape – Define the competition mix (companies, products, substitutes and shifting landscape) for the technology. Think particularly about how the disease will be treated when the technology/product gets to market. How is the landscape shifting or projected to shift? Webinar available.
  6. Intellectual Property –Describe the extent of interactions with the technology transfer office and how the IP is connected to the commercialization plan. Please include a list of the various types of IP filed or granted, which should include the following information: (1) Patent application number, issued patent number, trademark registration number, copyright number, etc; (2) Title: status and date; (3) For a patent/patent application, the major types of claims (e.g., device and method of treating asthma; independent claim to the generic compound and dependent claims to specific species of the compound). Webinar available.

II. Pathways and Requirements for Bringing Product to Market

  1. Differentiation – Explain how the proposed technology is better than current options/technologies and is anadvancement in the current market direction. Provide data to support this, and in lieu of actual data, describe what data would be needed to justify the differentiation. Describe how it’s better than current options/technologies, including those currently in clinical trials.
  2. Regulatory Path (if applicable) – Describe the expected regulatory pathway for the technology and identify which FDA division will regulate the technology. Describe foreseeable regulatory risks or accelerated programs that could impact the technology development. Comment on the clinical trials considerations and how those might impact the regulatory approach. Please also include information on technologies that are currently in development. Webinar available.
  3. Reimbursement Path (if applicable) –  Define similar product(s)/service(s) that is (are) currently being covered forthe indication your technology targets and identify relevant CPT/DRG/APC Codes and their reimbursement rates. If no code exists, how will the technology be paid for? Webinar available.
  4. Funding Requirements –  Identify how much funding is needed to get the technology to a viable ‘exit’ or inflection point for commercial investment. Define the funding requirements to achieve each milestone and each go/no-go decision point for the proposed project. Projecting beyond the completion of the proposed project, estimate the key milestones that need to be achieved and the total funding required to bring the product to a commercial exit. Include an estimate of the long-term return on the overall investment.

III. Project Plan for Bringing Technology Through the NCAI

  1. Product Profiles

    Download and complete the appropriate product profile. Please note, product profiles will not be counted towards the proposal narrative eight-page limit.

    Product Profile Template

    Download Link

    Device Product Profile

    Diagnostic Product Profile

    Therapeutic Product Profile


  2. Product Development Plan – Describe your overall project plan including key intermediate milestones and the final goal to be achieved at the completion of the project. Identify go/no-go decision points and potential pivot points within the plan. Explain how this project plan fits into the overall product development plan. Explain how achievement of each milestone increases the value of the technology. For each milestone, provide a target date for completion. Proposals requesting up to $400,000 must submit milestones and timelines at both funding levels of $200,000 and $400,000. Clearly define what additional value would be obtained at the higher funding level (e.g. specific changes in inflection point).
  3. Potential Risks and Mitigations – Describe the cost and revenue streams associated with commercializing the technology. Identify how much funding is needed to get the technology to a viable ‘exit’ or inflection point for commercial investment. Define the funding requirements to achieve each milestone for the proposed project.  Include reimbursement issues. Discuss the potential for developing the technology for additional unmet needs.
  4. Personnel – Provide the institutional affiliation, relevant background and expertise of the individuals on the team and explain how their backgrounds inform their ability to succeed at this stage of the product development. Consider how they will impact future product development. What will be needed for future product development?
  5. References

Resubmissions: Resubmitted full applications must contain an introduction that precedes the proposal narrative, of no more than two pages, that responds to comments from the previous review. Note: this two-page introduction will not be counted towards the proposal narrative eight-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.

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

Budget: Refer to the table below for allowable costs. Total costs (direct plus indirect costs) for subawards to other institutions must be included within the total $200,000 direct cost budget maximum. Applicants must submit separate budgets and budget justifications for years 1 and 2 (use PHS 398 Form Pg. 4 “Detailed Budget for Initial Period), and a budget for the entire proposed project period (use PHS 398 Form Pg. 5 “Budget for Entire Proposed Project Period). Separate budgets and budget justifications for years 1 and 2 must be submitted for subawards. Proposals requesting up to $400,000 must provide budgets at both funding levels of $200,000 and $400,000. Budget forms can be found here: http://grants.nih.gov/grants/funding/phs398/phs398.html.

It is required that each grant be matched 1:1 with non-federal funds at the time of the award. APPLICANTS MUST MEET WITH THEIR SITE ADMINISTRATION PRIOR TO SUBMISSION TO DISCUSS THE REQUIREMENT FOR THE MATCHING SUPPORT.

 

Allowable

Not Allowable

PI Salary and Benefits *† X  
Post Doc Salary and Benefits X  
K career development awardees – salary support   X
Consultants and Sub-contracting** 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

† Proposals requesting large salary support are discouraged and will be carefully reviewed

** Applicants are strongly encouraged to utilize consultants and contracted services

*** 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

Background

  • Has sufficient background been provided to help evaluate the need and the solution? What is the market “space” in which this product would operate? What is the current standard of care?

Unmet Need

  • Has the need been clearly stated?
  • Has evidence of the need been provided?
  • Has the expected need from the perspectives of the relevant stakeholders been articulated?

Proposed Product/Solution

  • What is the proposed product/solution, and to what patient subset is this applicable?
  • How is this proposed product/solution innovative?
  • What is the expected benefit with this product/solution, and what is the evidence to support the expected benefit?
  • Is the benefit a major advance or incremental in terms of speed, size, cost- saving, ease of use, safety, efficacy, accuracy or a combination of areas?
  • How would use of the product/solution fit with current physician practice/standard of care?

Market Size
Webinar available

  • Has the total market been identified? 3-year trends and projections? Is thereadequate justification for the market size?
  • Is the specific addressable target market size defined?
  • What is the expected pricing of the product/solution? How can it be justified (comparable, value/price trade-offs)?
  • What is the peak revenue projection?

Competitive Landscape
Webinar available

  • Are the current and anticipated players in the space identified? What competitive products are they developing and/or selling?
  • Are the adjacent spaces and substitution options identified?
  • How is the landscape shifting or projected to shift?

Intellectual Property
Webinar available

  • Has the applicant described its IP protection strategy in sufficient detail?
  • Are the types of IP proposed, or filed, appropriate to protect the invention?
  • Are there other forms of IP protection that the applicant should consider that may be more appropriate (e.g., protecting by trade secret instead of filing patent applications)?
  • How is the IP tied to the commercialization plan?

Differentiation

  • How is the product/solution better than others that are currently in use?
  • How is the product/solution better than what is expected to come to the market?
  • What data needs to be generated to support the differentiation?

Regulatory Path
Webinar available

  • Is the expected regulatory pathway identified?
  • Is the branch/division within the FDA this product would fit into identified?
  • Are regulatory uncertainties or risks identified and addressed?

Reimbursement Path
Webinar available

  • What product/service is currently being covered? What would be comparable?
  • What are the relevant CPT/DRG/APC codes?
  • What are the reimbursement rates for the relevant CPT codes? Has the applicant considered Physician and facility reimbursement? What have the reimbursement rates been over the last year?
  • If no code exists, what do you think are the appropriate next steps to obtain reimbursement?

Funding Requirements

  • Are the financing requirements identified? Are they tied to Go/No-go decisions?
  • Has the applicant defined the funding required to get to the next inflection point?

Product Development Plan

  • What is the ultimate goal of the product development plan and when will that goal be achieved?
  • What are the 2-4 major milestones that need to be achieved in order for the plan to be successful? What is the timing for each milestone?
  • Explain how achievement of each milestone increases the value of the product? Explain how you have validated the accuracy of these milestones? What stakeholders or customers have been referenced for this validation?
  • Have Go/No-Go decision points in the plan been established?
  • Where is the money going to be utilized? How much of it is for project costs?
  • Will the work advance the technology to a significant value point (e.g., licensing, investment, target validation, prototype generation)?
  • Are the project milestones relevant to establishing commercial viability of the projects?

Potential Risks and Mitigations

  • Has the applicant identified potential risks (e.g., scientifically, technically,personnel, market, commercialization) and risk mitigation strategies?

 Personnel

  • Do investigators have the necessary strengths and expertise to accomplish the work plan and aims?
  • Can investigators adapt to changing circumstances and advice?
  • Is the quality of the team appropriate for the work that needs to be done? Why is this the correct team for the present stage of the technology?

SUBMISSION DATES AND TIMES

RFA release: Aug 15, 2016
Letter of intent due: Nov 18, 2016
Pre-application due: Dec 9, 2016 5 PM PT
Pre-application notification: Jan 17, 2017
Full application due: Mar 3, 2017 5 PM PT
Earliest start date: Aug 1, 2017

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
Elliot Botvinick
Site Leader
elliot.botvinick@uci.edu

Andria Pontello
Project Manager
apontell@uci.edu

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

Breanna Davis
Project Manager
bjdavis@mednet.ucla.edu

Linda Taba
Site Administrator
ltaba@mednet.ucla.edu

UC San Diego
Robert Ross
Site Leader
rross@ucsd.edu

Su-Yin Chang
Site Administrator
suc014@ucsd.edu

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

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

Roopa Ramamoorthi
Project Manager
Roopa.Ramamoorthi@ucsf.edu

About the website and online submission tool:
Maryam Ariannejad
Technical Support
uccai-support@ctsi.ucla.edu

University of California Center for Accelerated Innovation (UC CAI)

NHLBI Stimulus Funding Award

PURPOSE
The goal of the UC CAI Stimulus Grant Program is to provide seed funding to allow technologies to obtain a level of maturity that could allow a more robust application for a UC CAI Technology Development Award. Eligible technologies 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).

Awardees will be mentored through key go/no go milestone(s) to help develop an improved project that could have greater success at achieving UC CAI funding than at its present stage. Applicants with early-stage technologies needing additional data or a key experiment to further a project’s progress would benefit from this grant. Completion of key go/no go milestone(s) with this stimulus grant may help projects become more competitive for additional NIH NHLBI UC CAI funding.

BACKGROUND
Biomedical companies are attracted to later-stage technologies for licensing and development. The NHLBI-funded UC CAI Stimulus Grant Program will incubate promising early-stage technologies from UC innovators with the goal of advancing them toward a UC CAI NHLBI Technology Development Award.

The Award: Stimulus Funding Awards provide up to $50,000 in grant support for a period of up to six months, as well as mentoring and project management support. 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. Project and research scientists and 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 and Review: All applications will be reviewed by a UC CAI committee consisting of disease and platform experts from academia and industry. The committee will review any concerns or gaps that need to be addressed to increase the likelihood of reaching the proposed milestone and eventual success of the project. The review committee then decides which applicants will receive a Stimulus Funding Award of up to $50,000. Applicants who successfully complete the agreed key go/no go milestone(s) and develop the technology to the appropriate level of maturity will qualify to submit an application for a UC CAI Technology Development Award worth up to $200,000. UC CAI Technology Development Awards are awarded annually for the development of novel technologies that address heart, lung and blood diseases and have a high potential of becoming commercially viable products that address an unmet need.

APPLICATION

The application may be submitted from Nov. 14 to Nov. 23 only. Submission closes at 5 pm on Nov 23. 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). 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. Clearly state the unmet need being addressed by the technology and provide evidence to support the need from multiple stakeholder perspectives (e.g., patient, clinician, payer).
    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, including specific milestone(s) and clear go/no-go decision point(s) and target completion date(s). Describe how funding will develop the technology to a maturity appropriate to apply for a UC CAI Technology Development Award. Estimate the key milestones and timelines that would be achieved if additional funding was awarded in the form of a UC CAI Technology Development Award.
    5. Potential Risks and Mitigations – Describe the cost and revenue streams associated with commercializing the technology. Identify how much funding is needed to get the technology to a viable ‘exit’ or inflection point for commercial investment. Define the funding requirements to achieve each milestone for the proposed project. Include reimbursement issues. Discuss the potential for developing the technology for additional unmet needs.
    6. Intellectual Property – Describe the extent of interactions with the technology transfer office and how the IP is connected to the commercialization plan. Please include a list of the various types of IP filed or granted, which should include the following information: (1) Patent application number, issued patent number, trademark registration number, copyright number, etc; (2) Title: status and date; (3) For a patent/patent application, the major types of claims (e.g., device and method of treating asthma; independent claim to the generic compound and dependent claims to specific species of the compound). Webinar available.
  6. Commercial Assessment (to be completed by the campus TTO)
    • 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.
  7. NIH 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 five-page maximum for each biosketch.
  8. Budget and justification
    • Refer to the table below for allowable costs. Total costs (direct plus indirect costs) for subawards to other institutions must be included within the total $50,000 direct cost budget maximum. Applicants must submit a budget and budget justifications for the 6-month period (use PHS 398 Form Pg. 4 “Detailed Budget for Initial Period). Budget forms can be found here: http://grants.nih.gov/grants/f unding/phs398/phs398.html

       

       

      Allowable

      Not Allowable

      PI Salary and Benefits *† X  
      Post Doc Salary and Benefits X  
      K career development awardees – salary support   X
      Consultants and Sub-contracting** 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

      † Proposals requesting large salary support are discouraged and will be carefully reviewed

      ** Applicants are strongly encouraged to utilize consultants and contracted services

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

  9. Product Profiles
    Download the appropriate product profile and complete all applicable portions. Please note, product profiles will not be counted towards the proposal page limit. If you have questions about how to complete the product profile, please request a consultation with your site leader. Site leader contact information can be found in the “Questions” section at the bottom.

    Product Profile Template

    Download Link

    Device Product Profile

    Diagnostic Product Profile

    Therapeutic Product Profile

Technical requirements: Items 5-9 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 here. Letters of Support are not accepted for pre-applications.  Please note, references and abstracts will not be counted towards the proposal two-page limit

REVIEW CRITERIA

Review Criteria

Review Questions

Location within the Proposal

Unmet Need

  • Why is this a significant problem?
  • What is the associated prevention, 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 maturity appropriate for application of a UC CAI Technology Development Award?
  • Will the work advance the technology to a significant value point (e.g., licensing, investment, target validation, prototype generation)?
  • Work Plan
  • Potential Risks and Mitigations
  • 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
SUBMISSION DATES AND TIMES

RFA release: Oct 17, 2016
Application due: Nov 23, 2016 5 PM PT
Application notification: Dec 22, 2016
Earliest start date: Jan 1, 2017

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
Elliot Botvinick
Site Leader
elliot.botvinick@uci.edu

Andria Pontello
Project Manager
apontell@uci.edu

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

Breanna Davis
Project Manager
bjdavis@mednet.ucla.edu

Linda Taba
Site Administrator
ltaba@mednet.ucla.edu

UC San Diego
Robert Ross
Site Leader
rross@ucsd.edu

Su-Yin Chang
Site Administrator
suc014@ucsd.edu

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

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

Roopa Ramamoorthi
Project Manager
Roopa.Ramamoorthi@ucsf.edu

About the website and online submission tool:
Maryam Ariannejad
Technical Support
uccai-support@ctsi.ucla.edu

 

NHLBI Introduction to the UC CAI

UC CAI Webinar

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NIDA Introduction to the UC CAI

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Click here to download the slides from the webinar.

Awardees

Visit our UC CAI Funded Technologies page to see the full list of awardees.

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

Elliot Botvinick, PhD
Site Leader
elliot.botvinick@uci.edu

Andria Pontello
Site Administrator
apontell@uci.edu

UCLA Team

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

Breanna Davis
Project Manager
bjdavis@mednet.ucla.edu

Linda Taba
Site Administrator
ltaba@mednet.ucla.edu

Research Navigator
Elvira Liclican, PhD
CTSI Science Officer
eliclican@mednet.ucla.edu

UC San Diego Team

Robert Ross, MD
Site leader
rross@ucsd.edu

Su-Yin Chang
Site Administrator
suc014@ucsd.edu

UC San Francisco Team

June Lee, MD
Site Leader
june.lee@ucsf.edu

Research Navigator
Catherine Tralau-Stewart, PhD
Project Manager and 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 Technology Development Award budget capped at $200,000?

Most Technology Development Awards provide up to $200,000 for direct costs. However, if you feel your technology would substantially benefit from up to $400,000, please submit a budget, milestones and timelines at both funding levels. The award may be used over one or two years.

Is the Stimulus Funding Award budget capped at $50,000?

Stimulus Funding Awards provide up to $50,000 for direct costs. The award may be used over six months

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.

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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