REVIEW CRITERIA (click to expand)

Is my invention too early for a pitch?

Do I need to have physicians on my team?

How do I assess the market potential of the invention?

Do I need an issued patent to be allowed to pitch?

Can I pitch an invention if I already started a company based on that invention and licensed the invention to this company?

Does the pitch have to be in the areas of heart, lung and blood diseases?

What makes for a good pitch?

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

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

Vish Krishnan
Skills Development Leader
vkrishnan@ucsd.edu

UC San Francisco 
Roopa Ramamoorthi
Project Manager
Roopa.Ramamoorthi@ucsf.edu

Nathaniel Prorok
Site Administrator
Nathaniel.Prorok@ucsf.edu

About the website and online submission tool:

Rey Encarnacion
Technical Support
rfpsupport@mednet.ucla.edu

The pre-application may be submitted from March 19 to March 23 only. Submission closes at 5 pm on March 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. Statement of IP Position
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. 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.

Statement of IP Position: Consider the novelty of your technology and patent eligibility. Describe the extent of interactions with the technology transfer office. Please include a list of the various types of IP filed or granted (including patent application number, issued patent number, title, status and date) and the major types of claims (e.g., composition of matter claims, use claims, process of manufacturing claims). Also list the IP events anticipated during development.

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.

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.

strong>Allowable Budget Costs

* 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

Review Criteria

A select number of pre-applicants will be invited to participate in a pitch day hosted at UC Irvine. This will involve a presentation to UC CAI leadership and industry experts. Panelists will evaluate the status of your technology and development, business plan, and commercial viability. Full applicants will be invited following pitch day. Resources for creating a pitch deck can be found at: https://ctsi.ucla.edu/cai/pages/ncai_application#pitch.

Format:

1. Presentations will be in person or by webcast.
2. For medical devices it is best to bring in a prototype or webcast with it in hand

Additional details will be provided to invited applicants.

The full application may be submitted from April 23-30 only. Submission closes at 5 pm on April 30.

Application components are listed below. Items 1-9 are required. Item 10 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. Product Profile
10. Letters of Support (optional)

Technical requirements: Items 5-10 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 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	DOWNLOAD
   Diagnostic Product Profile	DOWNLOAD
   Digital Health Product Profile	DOWNLOAD
   Therapeutic Product Profile	DOWNLOAD

   
   
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. 

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.

* 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.

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	DOWNLOAD
   Diagnostic Product Profile	DOWNLOAD
   Therapeutic Product Profile	DOWNLOAD

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. 

• 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?

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

Are indirect costs allowed?

Can the proposed budget be a non-binding estimate?

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

Is the application process confidential?

Can I submit a lung cancer project?

Which diseases are in NHLBI’s portfolio?

Who is eligible to submit an application?

Are post docs eligible?

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

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

May I submit more than one application?

Does the pre-application require an institutional signature?

Can I view my application after it is submitted?

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