Notice Number: NOT-HL-11-157
Key Dates
Release Date: November 21, 2011
Issued by
National Heart, Lung, and Blood Institute (NHLBI)
Purpose
The National Heart, Lung, and Blood Institute (NHLBI) intends to publish a Funding Opportunity Announcement (FOA) to establish Centers for Accelerated Innovations (CAI) that will address the problems that hinder the critical, early steps necessary to translate novel scientific advances and discoveries into commercially viable diagnostics, devices, therapeutics, and tools that improve patient care and advance public health. The CAI Program will not conduct hypothesis-driven research. Rather, the Centers will nurture the development of high priority early-stage technologies within the NHLBI’s mission in a manner consistent with business case development and regulatory requirements by (1) providing funding for product definition studies (feasibility, prototype development, or proof of concept), (2) providing unified and coordinated access to expertise in areas required for early technology development, including scientific, regulatory, business, legal, and project management, (3) leveraging existing NIH resources, such as Science Moving Rapidly Towards Translation (SMARTT) and the Clinical and Translational Science Awards (CTSAs), (4) establishing novel partnerships and strengthening existing alliances between stakeholders, including public, private, non-profit, and academic sectors, (5) providing investigators with training and hands-on experience in entrepreneurship, and (6) creating cultural and systemic changes by providing the necessary resources to proactively and more rapidly move from breakthrough innovations to products that will have health, economic, and societal impact.
This Notice is provided to allow prospective applicants time to consider the CAI Program and develop essential collaborations and plans prior to submitting an application in response to the published FOA.
The FOA is expected to be published in the NIH Guide for Grants and Contracts in Spring 2012 with an expected receipt date in Fall 2012.
The FOA will utilize the U54 funding mechanism, which is a cooperative agreement that requires significant interaction between the awardees and the NHLBI staff.
Anticipated Research Initiative Details
1. Each Center should systematically solicit and select the best discoveries that address NHLBI priorities that (a) address an unmet medical need, or present a great scientific opportunity, and have commercial potential or (b) do not have an apparent broad commercial market, but compelling reasons exist for continued development (e.g., targets a rare disease).
2. Each Center should provide (a) funds for conducting feasibility studies or prototype development and (b) resources for project development, management, continuous assessment of project milestones and mentoring that include a cadre of mentors with alliances and expertise in:
- appropriate technology areas
- business development
- entrepreneurship
- project management
- regulatory submission, evaluation, and review
- technology and product development
- market and commercial evaluation
- IP protection and evaluation
- pre-clinical and clinical studies
3. A Center would facilitate technology development to a point suitable to attract independent financing or appropriately exit the Center (e.g., via licensing to a for-profit or not-for-profit entity, starting a small business). It is anticipated that the federal government will be unable to provide sufficient funds for projects to reach a suitable exit. Hence, a Center is encouraged to raise additional funds from non-federal sources (e.g., recipient institutions, foundations, for-profit investors, other state resources) that equal or exceed the federal investment.
4. Each Center would use project management processes that enable continuous assessment of the progress of the feasibility studies relative to established milestones in order to make strategic decisions regarding each project [e.g., discontinue a failing project early (quick kill), direct it to another interested party (e.g., disease advocacy organization), or develop it further].
5. A Center would train and mentor innovators about medically needed technologies in order to allow them to better assess the commercial potential of their research within that context by bringing together experienced entrepreneurs and scientists and by providing connections between the businesses, industries, and research performing institutions. Furthermore, a Center would provide focused entrepreneur support and "hands-on learning" targeted at the needs of the innovator, so that scientists have the opportunity to engage in entrepreneurial activities.
In summary, the CAI program will provide funds for early stage development of the technology through exit from the Center, and for access to resources and expertise for project management, market research, business plan development, IP protection, regulatory submission, and evaluation and review processes. The CAI program offers the potential to benefit public health by identifying, accelerating, and increasing the number of highly innovative scientific discoveries within the NHLBI mission that are translated into marketable products designed to extend healthy life and to reduce the burdens of illness and disability. The program is structured to create public-private partnerships with an integrated environment of resources (funding, knowledge, expertise) and the culture needed for sustained technology development.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Inquiries
Please direct all inquiries to:
Jodi B. Black, PhD; MMSc
Deputy Director
Division of Extramural Research Activities
National Heart, Lung and Blood Institute
(301) 496-5861 (Direct)
(301) 435-0260 (Main)
(301) 480-1124 (Fax)
Email: [email protected]
Kathleen Rousche, PhD
Scientific Program Manager and Technical Writer
Office of Translational Alliances and Coordination
Division of Extramural Research Activities
National Heart, Lung and Blood Institute
6701 Rockledge Drive, MSC 7924, Room 7104A
Bethesda, MD 20892
Phone: 301-594-5507
Email: [email protected]
and Human Services (HHS)
