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 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

Letter of intent (optional): Please submit a letter of intent to your campus administrator by December 18, 2014. The letter of intent should include the name of the PI and tentative title of the proposal. Contact information for campus administrators can be found below.

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.

The pre-application may be submitted Jan. 19-23 only. Submission closes 5pm on Jan. 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)
  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 an introduction to 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 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. Indirect costs do not need to be addressed in the budget for your proposal. 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.


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 Mar. 16 to Mar. 20 only. Submission closes at 5 pm on Mar. 20. 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 5-11 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 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, 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. Background – Describe the scope and nature of the problem the technology will address, and give a brief description 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 standard of care.
  2. Unmet Need – Clearly state the unmet need being addressed by the technology and provide evidence to support the need. Define customers (e.g., patients, practitioners, researchers) and the context in which they want the problem solved.
  3. Proposed Product/Solution – Describe your proposed solution and what is innovative about it. Identify the primary patient population / indication for use. Define the impact you hope to accomplish using metrics most appropriate for you (e.g., morbidity, mortality, costs).
  4. 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?
  5. Competitive Landscape – Define the competing approaches customers can use to address the problem, including products, services and compensating behaviors (e.g., work-arounds). How is the landscape shifting or projected to shift?
  6. Differentiation – Describe the advantages of your technology over current options/technologies (including those currently in clinical trials), and how they will be demonstrated or validated.
  7. Regulations – Describe the regulatory requirements that exist for your technology.
  8. Product Development Plan – Describe your overall project plan.  Identify within the plan: key intermediate milestones, the final goal to be achieved at the completion of the project, and potential pivot points. 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 milestone, provide a target date for completion.
  9. Business Model – 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.
  10. Intellectual Property – Describe the extent of interactions with the technology transfer office and how the IP is connected to the commercialization plan.
  11. 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?.

Resubmissions: Resubmitted full applications must contain an introduction to 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 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/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. Indirect costs do not need to be addressed in the budget for your proposal. Applicants must submit separate budgets for each milestone. APPLICANTS MUST MEET WITH THEIR SITE LEADERS TO DETERMINE GRANT AND LOCAL SUPPORT. 


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

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

  • Why is this a significant problem?
  • Has evidence of the need been provided?
  • What are the associated morbidities, mortality or costs?
  • Have the users of this technology been identified?

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 and Strategy

  • 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?

Competitive Landscape

  • Are competitive technologies described and addressed?
  • Who else is working on the target, pathway or mechanism?

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?

Regulations

  • Is FDA allowance or approval required?
  • Has a preliminary regulatory strategy been articulated?
  • Are regulatory uncertainties or risks identified and addressed?

Product Development Plan

  • 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)?
  • Are the project milestones relevant to establishing commercial viability of the projects?

Business Model

  • 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?
  • If applicable, has a reimbursement strategy been considered?

 Intellectual Property

  • Has invention disclosure occurred?
  • Are the types of IP proposed, or filed, appropriate to protect the invention?
  • Is the IP tied to the commercialization plan?
  • Has the applicant described its IP protection strategy in sufficient detail?
  • Is there a previous licensing event and how does this affect the IP strategy?
  • 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)?

 Personnel

  • Do investigators have the necessary strengths and expertise to accomplish the work plan and aims?
  • Can investigators adapt to changing circumstances and advice?

SUBMISSION DATES AND TIMES
RFA release: Dec. 8, 2014
Letter of intent due (optional): Dec. 18, 2014
Pre-application due: Jan. 23, 2015 5 PM PT
Pre-application notification: Feb. 17, 2015
Full application due: Mar. 20, 2015 5 PM PT
Earliest start date: Aug. 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

Sylvia Plummer
Site Administrator
stplummer@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

University of California Center for Accelerated Innovation (UC CAI)

NIDA Technology Development Award

PURPOSE
The purpose of this funding opportunity is to support basic researchers with the strong interest and desire to ultimately translate their research discoveries into medications and technologies for the treatment of Substance Use Disorders (SUDs) stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use. UC CAI Technology Development Award serves to enable UC scientists to realize the therapeutic potential of their scientific discoveries and advance them closer to regulatory approval, accelerating innovation. 

This opportunity will support a broad range of approaches (described in Research Focus below) with high potential of becoming commercially viable products that address this unmet public health need. 

The UC CAI offers expert consultations on each campus to assist applicants with their proposals.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 FY2017.

BACKGROUND
Throughout much of the last century, scientists studying drug abuse labored in the shadows of powerful myths and misconceptions about the nature of addiction. Historically, people addicted to drugs were thought to be morally flawed and lacking in willpower. Those views shaped society's responses to drug abuse and led to an emphasis on punitive rather than preventative and therapeutic responses. It also contributed to the market response and SUDs received limited attention and interest from the pharmaceutical industry.  However, contemporary research shows that addiction is a disease from which people can recover, with success rates roughly on par with recovery rates for other chronic disease such as diabetes, asthma and hypertension.  Today, about 22 million Americans need treatment for SUDs, making the development of safe and effective medications for the treatment of SUDs an urgent public health priority.  The U.S Market for substance abuse treatment and diagnosis was estimated to be approximately $2.86B in 2014. While there are medications approved by the US Food and Drug Administration (FDA) for the treatment of nicotine and opiate dependence, there are no FDA approved medications for cocaine, methamphetamine, or cannabis use disorders. 

Dedicated scientists studying fundamental/basic aspects of addiction made major advancements in the field, including the discovery of genes and proteins, receptors, neurotransmitters, neuromodulators, and brain circuits associated with drug abuse, thus, offering extraordinary opportunities for the development of medications to treat SUDs. However, due to historical reasons, fewer resources (including best R&D practices, clear regulatory paths, entrepreneurial and product development education) are available for researchers within the substance abuse market space who are attempting to move their discoveries from the bench towards FDA approval and commercialization. 

The purpose of the UC CAI is to provide those key resources to the addiction researchers of the University of California medical campuses at Davis, Irvine, Los Angeles, San Diego and San Francisco interested in bringing their discoveries closer to the regulatory approval. The UC CAI provides seed funding for feasibility studies; direct access to regulatory, legal, and business development expertise; and entrepreneurial training and mentorship. Additionally, the UC CAI leverages existing federal government resources, including those offered by NIH and by other federal program partners including the U.S. Food and Drug Administration, the United States Patent Office, and the Centers for Medicare & Medicaid Services to advance technologies in the product development continuum.

RESEARCH FOCUS
This Technology Development Award RFA invites applications from UC scientists working and interested in accelerating their translation efforts in the following areas:

  • Discovery and development of medications for the treatment of SUDs stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use. Multiple therapeutic approaches, ranging from small molecules to biologics (e.g., vaccines) are eligible. 
  • Technologies or formulations to improve medication delivery and/or to deter drug abuse.
  • Tools to streamline drug design and preclinical development for SUD.
  • Novel patient adherence monitoring (systems and devices) at the point of care in clinical trials.
  • Technologies and tools with high potential of becoming commercially viable products designed to better inform the diagnosis and treatment of SUD.

THE AWARD

The award: The successful awardee of the UC CAI Technology Development Awards will receive comprehensive support for accelerating the pace of their translational work. It includes technology development/entrepreneurial mentoring, professional project management support, access to UC research and development base, and monetary grant support worth up to $200,000 for a period of up to two years.

It is anticipated that up to three 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: Therapeutic projects must have existing or imminent target validation in animal systems or human cell lines and a clear clinical indication for SUDs stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use. Projects in other areas within NIDA‘s mission must present the clear potential for significant improvement over current treatments, diagnostics, devices, tools or services.

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, together with NIH and NIDA, will make funding decisions.

PRE-APPLICATION

APPLY HERE

The pre-application may be submitted Apr. 27-30 only. Submission closes at 5pm on Thursday, Apr. 30. 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., prevention, 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).

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. Indirect costs do not need to be addressed in the budget for your proposal. Applicants must submit separate budgets for years 1 and 2


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 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

The full application will be submitted online through the Center’s website, uccai.ctsi.ucla.eduThe full application may be submitted from May 18-25 only. Submission closes at 5 pm on May 25. 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 5-11 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, 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, 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. Background – Describe the scope and nature of the problem the technology will address, and give a brief description 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 standard of care.
  2. Unmet Need – Clearly state the unmet need being addressed by the technology and provide evidence to support the need. Define customers (e.g., patients, practitioners, researchers) and the context in which they want the problem solved.
  3. Proposed Product/Solution – Describe your proposed solution and what is innovative about it. Identify the primary patient population / indication for use. Define the impact you hope to accomplish using metrics most appropriate for you (e.g., prevention, mortality, costs).
  4. 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?
  5. Competitive Landscape – Define the competing approaches customers can use to address the problem, including products, services and compensating behaviors (e.g., work-arounds). How is the landscape shifting or projected to shift?
  6. Differentiation – Describe the advantages of your technology over current options/technologies (including those currently in clinical trials), and how they will be demonstrated or validated.
  7. Regulations – Describe the regulatory requirements that exist for your technology.
  8. Product Development Plan – Describe your overall project plan.  Identify within the plan: key intermediate milestones, the final goal to be achieved at the completion of the project, and potential pivot points. 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 milestone, provide a target date for completion.
  9. Business Model – 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.
  10. Intellectual Property – Describe the extent of interactions with the technology transfer office and how the IP is connected to the commercialization plan.
  11. 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?.

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/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. Indirect costs do not need to be addressed in the budget for your proposal. Applicants must submit separate budgets for years 1 and 2.


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

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

  • Why is this a significant problem?
  • Has evidence of the need been provided?
  • What is the associated prevention, mortality or costs?
  • Have the users of this technology been identified?

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 and Strategy

  • 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?

Competitive Landscape

  • Are competitive technologies described and addressed?
  • Who else is working on the target, pathway or mechanism?

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?

Regulations

  • Is FDA allowance or approval required?
  • Has a preliminary regulatory strategy been articulated?
  • Are regulatory uncertainties or risks identified and addressed?

Product Development Plan

  • 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)?
  • Are the project milestones relevant to establishing commercial viability of the projects?

Business Model

  • 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?
  • If applicable, has a reimbursement strategy been considered?

 Intellectual Property

  • Has invention disclosure occurred?
  • Are the types of IP proposed, or filed, appropriate to protect the invention?
  • Is the IP tied to the commercialization plan?
  • Has the applicant described its IP protection strategy in sufficient detail?
  • Is there a previous licensing event and how does this affect the IP strategy?
  • 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)?

 Personnel

  • Do investigators have the necessary strengths and expertise to accomplish the work plan and aims?
  • Can investigators adapt to changing circumstances and advice?

SUBMISSION DATES AND TIMES
RFA release: Mar. 25, 2015 
Pre-application due: Apr. 30, 2015 5 PM PT
Pre-application notification: May 6, 2015
Full application due: May 25, 2015 5 PM PT
Earliest start date: Aug. 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:

Elvira Liclican
Project Manager
eliclican@mednet.ucla.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

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

Sylvia Plummer
Site Administrator
stplummer@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.

What diseases are in NIDA's portfolio?

NIDA invites applications from innovators working and interested in accelerating their translation efforts in the following areas:

  • Discovery and development of medications for the treatment of SUDs stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use. Multiple therapeutic approaches, ranging from small molecules to biologics (e.g., vaccines) are eligible. 
  • Technologies or formulations to improve medication delivery and/or to deter drug abuse.
  • Tools to streamline drug design and preclinical development for SUD.
  • Novel patient adherence monitoring (systems and devices) at the point of care in clinical trials.
  • Technologies and tools with high potential of becoming commercially viable products designed to better inform the diagnosis and treatment of SUD. 

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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