TECHNOLOGY DEVELOPMENT PROGRAM
REQUEST FOR APPLICATIONS  AUGUST 2014

Request For Applications Released – August 4, 2014
TABLE OF CONTENTS

Letters of Intent Due – September 4, 2014
1.

Selected LOI Submissions Invited to Submit
Applications – October 16, 2014 (revised).

Full Project Applications Due –
November 6, 2014 (revised).

Award Notices – January 2015.

This RFA and appendices are available for download
at www.ncai-cc.ccf.org.
NIH Center for Accelerated Innovations
1.1
1.2
2.
Program Description
2.1
2.2
2.3
2.4
2.5
3.
4.
For information Contact:
Email: NCAIRFA@ccf.org
Telephone: 216-444-5322
Technology Development Program
Request for Applications – August 2014 (Revised 10/16/14)
RFP Release
Letter of Intent
Initial Review
Full Application Review
Funding Decision and Award Implementation
Project Management
Proposal Requirements
4.1.
4.2.
5.
Overview
Eligibility
General Evaluation Criteria
Awards
Reporting Requirements
Program Process
3.1.
3.2.
3.3.
3.4.
3.5.
3.6.
Note: Awards under the program will be matched
with funding from the home institution.
Purpose
Center Organization and Goals
General Instructions
Application Contents
4.2.1. Applicant Information Page
4.2.2. Executive Summary
4.2.3. Development Background
4.2.4. Project Plan
4.2.5. Biographical Information
4.2.6. Budget
4.2.7. Page Limit Guidelines
Technology Review Criteria
Appendices
A.
B.
Application Information Page
Budget Worksheets
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TECHNOLOGY DEVELOPMENT PROGRAM
REQUEST FOR APPLICATIONS  AUGUST 2014
The goals for NCAI-CC program are:
1.
NIH Center for Accelerated Innovations
1.1.
Purpose
The National Institutes of Health has launched a major
initiative to improve how basic science advances and
discoveries are translated into commercially viable
products that improve patient care and advance public
health.
1.
To advance development of commercially
promising projects related to prevention,
diagnosis and treatment of heart, lung, blood and
sleep disorders and diseases by a) selecting
through rigorous peer-review, b) providing
project funding, and c) providing expert project
evaluation and management guidance to projects
spanning the technology range of diagnostics,
devices, therapeutics and tools.
2.
To organize new and existing diverse resources
into a broadly accessible community for
educating and mentoring researchers, clinicians
and developers in biomedical innovation,
entrepreneurism, and commercialization.
The NIH Centers for Accelerated Innovations (NCAI)
program, funded by NIH’s National Heart, Lung, and Blood
Institute (NHLBI), will target technologies to improve the
diagnosis, treatment, management, and prevention of
heart, lung, blood, and sleep disorders and diseases.
According to NHLBI’s Fact Book for the 2012 fiscal year,
the estimated economic cost for cardiovascular, lung, and
blood diseases was $424 billion—23 percent of the total
economic costs of illness, injuries, and death in the United
States. In addition, cardiovascular and lung diseases
accounted for three of the four leading causes of death in
the United States and four of the 10 leading causes of
infant death.
NCAIs will provide an integrated, systematic, and
comprehensive approach to navigating the translation of
early stage biomedical innovations from the research
laboratory to commercial development and successful
deployment to patients. Three inaugural NCAIs have been
established, including the NCAI-Cleveland Clinic.
1.2.
Center Organization and Goals
The NCAI led by Cleveland Clinic (NCAI-CC) is a multiinstitutional consortium of leading Ohio clinical and
academic institutions including Case Western Reserve
University, The Ohio State University, the University of
Cincinnati, and Cincinnati Children’s Hospital Medical
Center. The Center was established in 2013 via a
$10 million grant from NHLBI, complemented with a
$1.5 million grant from the Ohio Third Frontier. In
addition, each participating institution has committed
matching funds to each project selected for funding from
that institution.
Technology Development Program
Request for Applications – August 2014
2. Program Description
2.1.
Overview
The NCAI-CC Technology Development Program is
targeted to assist the evaluation and advancement of
early stage technologies requiring studies to establish
commercial product potential.
The program operates under a periodic Request for
Applications basis to solicit projects from NCAI
partner institutions for funding and project support.
Funds under the program are allocated to specific,
measurable project development activities that are
key to establishing commercial opportunity. Project
scope typically encompasses work which leads to
achieving critical project milestones that can be
accomplished within a period of one to two years, and
which serve to enable follow-on funding from later
stage investment sources such as other federal
programs (e.g., SMARTT, SBIR/STTR), other state
programs (e.g. Ohio Third Frontier, Global
Cardiovascular Innovation Center), venture capital or
industry.
NCAI-CC has formed an independent External
Selection Committee comprised of prominent
clinicians and scientists in cardiovascular and
pulmonary medicine, industry representatives,
business development experts, and members of the
venture capital community. The ESC provides
technical and commercial evaluation and guidance to
the selection of projects for funding.
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NCAI-CC staff includes industry-experienced project
managers and developers who will work closely with
each selected project to provide commercial
assessment, project guidance and access to resources
to help in project planning and successful
achievement of project milestones.
2.2.
Eligibility
Proposals are accepted from investigators at NCAI
partner institutions Cleveland Clinic, Case Western
Reserve University, The Ohio State University, the
University of Cincinnati, and Cincinnati Children’s
Hospital Medical Center.
The NCAI technology development program
encompasses and seeks a broad portfolio of NHLBIrelated projects directed to the prevention, diagnosis,
and treatment of cardiovascular, lung, blood, and
sleep disorders and diseases spanning the technology
range of diagnostics, devices, therapeutics, and tools.
Please contact NCAI-CC for clarification if you are
unsure if your project falls within the NCAI domain.
Proposals submitted should be for projects that
include the achievement of critical development
milestones with the objective of advancing the
technology towards commercialization. Use of NCAI
funds should be allocated to specific, measurable
project activities, key to establishing commercial
opportunity and on a timeline covering a period of
one to two years from grant of the award.
2.3.
General Evaluation Criteria
Proposals will be evaluated based on the following
general criteria:
A. Fit with NHLBI mission, domain and NCAI
program.
 Clinical application area related to
cardiovascular, lung, blood or sleep disorders
 Project directed towards development of
diagnostics, devices, therapeutics or tools.
Technology Development Program
Request for Applications – August 2014
B. Commercialization Focus and Opportunity
 Clinical significance
 Market opportunity
 Commercial value proposition
 Innovation and novelty
 Competitive advantage
 Intellectual property protection
 Regulatory pathway
 Third party reimbursement
C. Project Plan
 Project definition
 Specific project goals for which award funding
will be used
 Research and development to-date
 Development timeline
 Development cost and strategy for follow-on
funding
 Budget
 Project team
More detailed technology review criteria are provided
in Section 5.
2.4.
Awards
Funding awards will be in the form of a grant. Up to
several hundred thousand dollars may be provided,
including cost match from the home institution, based
on the scope of work proposed. Distribution of funds
will be authorized on a phased basis dependent on
achievement of pre-defined project milestones.
2.5.
Reporting Requirements
Awardees are required to participate in periodic
project reviews, and to submit progress reports and
invoices to document achievement of project
milestones and appropriate expenditure of funds.
Progress updates will be required for the duration of
the award period and on an ongoing basis thereafter
to facilitate tracking of technology development. All
reports will be submitted in the form and format
required by NCAI.
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3.
Program Process
The program process consists of the following steps:
1.
2.
3.
Release of RFA.
LOI submission.
Initial review, applicant selection, invitation to
submit full proposal.
Full application review.
Funding decision and award implementation.
4.
5.
Projects funded will then continue the process
through a collaborative project management
engagement with NCAI and NCAI-CC personnel.
3.1.
RFA Release
Requests for Applications (RFA) under the Technology
Development Program are issued once or twice per
year and communicated broadly among the Center’s
partner institutions.
See cover page of this document for specific dates
pertaining to the current funding round.
This RFA is publically available for download at
www.ncai-cc.ccf.org.
3.2.
Letter of Intent
A brief Letter of Intent (LOI), not to exceed 2 pages
plus Biosketches, shall include the following overview
of the project intended for funding:




Relevance to the NHLBI mission and domain.
Vision for the commercial opportunity.
Current state of development
Project plan for year 1.
In addition, an abridged 2-3 page NIH biosketch for
the lead investigator plus up to two (2) coinvestigators shall be attached.
3.3.
Initial Review
NCAI-CC personnel and partner institution
representatives will review the submitted LOIs to
evaluate fit for the NCAI-CC Technology Development
Program funding opportunity including cardiovascular,
lung, blood and sleep disorders domain, phase of
development, project goals and feasibility, clinical
need or opportunity to be addressed, and potential
for commercial success.
Selected projects will then be invited to submit a full
application for the next phase of evaluation. Only
invited applications will be considered for further
evaluation.
3.4.
Full Application Review
Invited applications are subject to an initial review
during which compliance with the criteria and
requirements of this RFA is assessed. Proposals
found not to meet RFA requirements may not be
reviewed further.
Applications will be reviewed by NCAI-CC and partner
institution personnel and by an External Selection
Committee. The process may include making an oral
presentation before the selection committee.
Applications selected as finalists from the ESC review
will then receive a final review by the NCAI
Technology Review Committee.
3.5.
Funding Decision and Award
Implementation
Funding decisions will be communicated via notice of
grant award. Funding awards will be provided 50%
from NCAI funds and 50% from institutional cost
share provided by the home institution. Award
management will be conducted under terms of a
subgrant agreement in the case of funding awards to
partner institutions, or a letter of commitment in the
case of awards made to Cleveland Clinic investigators.
In either case, the agreement will specify terms of
funds distribution, providing of cost share, and
methods for funds disbursement.
A documentation packet consisting of instructions,
forms and agreement guidelines will accompany
notice of an award.
Technology Development Program
Request for Applications – August 2014
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3.6
Project Management
Experienced NCAI-CC project managers will
collaborate with investigators to develop milestone
driven, commercially relevant project plans, and will
engage throughout the project to provide guidance
and support to the project as needed. Progress will
be reviewed and managed using commercial project
management processes and methodologies (e.g.
phase gate process) to facilitate and accelerate
achievement of project milestones. Continued
funding of projects will be based on demonstrated
progress and successful achievement of the defined
project milestones.
4. Proposal Requirements
4.1.
General Instructions

LOIs and invited applications must be received by
NCAI-CC by the appropriate dates and times
indicated on the cover page of this RFA.

Margins must not be less than 0.75 inches on all
sides.

Font must be 10 point or larger.

All pages must be numbered; the institution
name and project title must appear in the footer
of each page.

The order of the sections should follow the order
they are presented in Section 4.2 of this RFA.
The application information page shall be the
proposal cover page.

Only electronic submissions will be accepted. The
proposal will be submitted via upload to the
NCAI-CC website. Specific instructions will be
provided at the time of invitation to submit full
applications.
4.2.
Application Contents
4.2.1.
Application Information Page
The proposal cover page is an information sheet that
includes project title, a brief project description, and
basic contact information. This form is found in
Appendix A, available on the website.
4.2.2.
Executive Summary
The executive summary shall consist of an abstract
defining the proposed project, describing the
commercial rationale and opportunity, and detailing
the goals to be achieved with the proceeds of the
requested funding.
4.2.3.
Development Background
This section should include a statement of the
problem addressed by the proposed project, a
discussion of the scientific and clinical rationale, and
the research/development accomplished to-date.
Please include citations for any scientific publications
relevant to the proposal.
4.2.4.
Project Plan
This section shall include the project definition and
project schedule. Please include the details of the
project plan to be undertaken and specific milestones
to be achieved within the scope of the requested
project funding. The project plan and schedule
should encompass a period of work of approximately
one year duration. The schedule should graphically
display (i.e. Gantt chart) the specific tasks and the
timing of deliverables and other key milestones. It is
recommended that the graphical schedule reflect a
monthly schedule and not be based on fixed dates.
4.2.5.
Biographical Information
NIH Biosketches should be submitted for key
individuals who will contribute to the project. In
addition, please include any information pertaining to
product development and commercialization
experience. Please limit the number of biographical
sketches to the lead investigator plus two (2) coinvestigators.
Technology Development Program
Request for Applications – August 2014
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4.2.6.
Budget
The Budget Worksheets included in Appendix B shall
be used to present the total budget plan for the
proposed project. Include direct costs only. Please
provide one summary budget sheet for the total
project budget, and an individual budget sheet for
each major project milestone identified in the project
plan. A budget narrative must also be included to
provide an explanation of the overall budget by
category and milestones.
Funding awards will be provided 50% from NCAI
funds and 50% from institutional cost share provided
by the home institution.



5.2.

4.2.7.
Page Limit Guidelines
Please limit proposal sections based upon the
guidelines below. Appendices or other augmentations
are not permitted.
 Executive Summary – 1 page

 Development Background – 2 pages
 Project Plan – 5 pages
 Budget – Use Budget Forms; Budget Narrative
limited to 2 pages
 Biographical Information – Up to 3 biosketches

5.
Technology Review Guidance
The following presents additional guidance in the
form of questions that reviewers will use for
evaluating the application, taking into consideration
that technology candidates will present at different
stages of maturity and that certain elements will be
addressed after project approval and initiation.
5.3.

5.1.


Unmet Need/Clinical Benefits and Risks
Considerations
Has the unmet need been clearly defined and the
“customer”, i.e., end user (e.g., physician, nurse)
and/or patient population who will use and/or
benefit from the technology been identified?
Have the end user or patient population
estimates, either U.S. alone or U.S. plus global
(or major markets) been estimated?
Technology Development Program
Request for Applications – August 2014


Does the technology target a rare/orphan disease
population?
Does the envisioned technology outcome/product
concept deliver measurable and unique end
user/patient benefit?
Have the anticipated clinical outcome(s) and
uncertainties (risk) been identified and
addressed? If risks are known, has a risk
mitigation plan been considered?
Competitive Advantage Considerations
Has the applicant identified potential competitive
technologies within the same market space?
Where does the applicant’s technology rank with
respect to the number, quality and stage of
development of competing technologies, and the
capabilities and market dominance of
competitors?
Have the unique end user/patient benefits and
outcomes been considered with respect to overall
reduction of cost of care? Measures could
include (1) a reduction in cost of procedure over
current practice; (2) reduced hospitalization stay;
(3) reduced intensity of care (e.g., an ICU
requirement); (4) and/or replacement by remote
lower-cost-of-care services (e.g., telemedicine,
in-home) as examples.
Does the product concept offer solutions to
additional unmet clinical needs (i.e., a “platform
solution”) beyond the primary indication and
purpose of the current R&D plan? If so, how will
those opportunities be addressed (e.g., serial or
parallel development considerations)?
Market Attractiveness Considerations
Have the market segment and sub-segments
been defined for the prospective technology
(e.g., cardiovascular device/interventional/drug
eluting stent)?
Have technology costs and potential margins
been considered in the context of analogous
products?
Have market penetrance and timing issues been
considered?
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5.4.




Intellectual Property (IP)
Considerations
Is the novelty and impact of the IP considered
(1) an incremental improvement, preserving
market opportunity and share, (2) next
generation, expanding utility and markets, or (3)
breakthrough, transformative, creating new
markets?
Is the current IP status clearly described e.g., (1)
invention disclosure has/has not occurred and if
not, when; (2) a provisional application for patent
and/or patent application has been filed; (3) a
patent was approved; (4) were there prior
licensing events and if so how that effects the IP
strategy; and (5) has a patentability study and/or
a freedom-to-operate study (FTO) been
conducted?
Does the technology opportunity offer additional
intellectual property opportunities in trademark
or copyright and were these described?
Did the applicant access or describe plans to
access the resources within the NCAI USPTO
Partner?

5.6.

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
5.5.



Development Plan: Technical
Feasibility, Risk and Core Competencies
Leverage Considerations
Does the plan contain (1) sufficient detail linking
the technology development plan to the
anticipated product profile; (2) any prior proofof-concept research findings; (3) a targeted
product profile (TPP), in part or in whole; (4)
clear milestones with go/no-go criteria; (5) clear
deliverables achievable within time proposed; (6)
timely access to all required resources; and (7) a
budget that aligns with R&D objectives?
Have any significant technical gaps been
identified and addressed (i.e., how reasonably
straightforward to accomplish within current
state-of -the-art); and (2) any significant
technical complexities identified and addressed
(e.g., the technology requires multiple complex
milestones for completion)?
Were other novel solutions considered (simpler,
less costly, broader applicability, etc.) and why
these were not pursued?
Technology Development Program
Request for Applications – August 2014



Within the technology domain, does the project
team demonstrate core competencies and
strengths in (1) scientific and/or technological
expertise; (2) technology development
experience; (3) clinical evaluation expertise; (4)
business development experience; (5) regulatory
strategy experience; (6) marketing experience;
and (7) IP strategy experience? If deficiencies
exist, is there a mitigation plan?
Regulatory & Reimbursement Risk
Considerations
Is FDA regulatory allowance or approval required
for the commercialization of the proposed
technology?
Has a preliminary regulatory strategy been
articulated including the final anticipated
regulatory class and allowance/approval action
(e.g., biologic therapeutic/BLA) for the proposed
technology been described?
Were any uncertainties/risks for regulatory
approval identified?
Are any regulatory related actions required within
the timeframe of the proposed technology
development?
Were discussions conducted or planned with the
NCAI FDA Partner with regard to regulatory
strategy?
Does the anticipated technology/product concept
require reimbursement for successful end user
adoption and market penetrance? If so, has a
preliminary reimbursement strategy been
considered?
Were discussions conducted or planned with the
NCAI Payor Partner (CMS/Kaiser) regarding
reimbursement strategy?
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5.7.

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Business Development & Financial
Benefit Considerations
Are strategic partnership(s) with outside entities
(relevant industry, contract organizations, other
academic institutions, etc.) required to complete
the project? If so, how will this be addressed?
Was a preliminary business model proposed
using comparatives or other methods?
Was the magnitude of financial opportunity
estimated and revenues/P&L modeled? Were
uncertainties of these estimates provided?
Was a “go to market” strategy provided?
Was additional capital required, estimates and
potential sources identified? Were barriers to
capital access identified (within/beyond the
project timeframe)?
Were product distribution channels and access
uncertainties/risks identified?
Was a manufacturing/scale up plan proposed?
Technology Development Program
Request for Applications – August 2014
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