Opportunity Information: Apply for RFA CA 08 021
Apply for RFA CA 08 021
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "SBIR Phase II Bridge Awards to Accelerate the Development of New Cancer Therapies and Cancer Imaging Technologies Toward Commercialization (SBIR R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research.
- This funding opportunity was created on May 14, 2008 and posted on May 14, 2008.
- Applicants must submit their applications by Feb 27, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $10,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
This funding opportunity, titled "SBIR Phase II Bridge Awards to Accelerate the Development of New Cancer Therapies and Cancer Imaging Technologies Toward Commercialization (SBIR R44)" (Funding Opportunity Number RFA-CA-08-021), was a pilot initiative run by the National Cancer Institute (NCI) within the National Institutes of Health (NIH). Its central aim was to provide additional SBIR support to small business concerns that had already completed an NIH SBIR Phase II project and needed targeted funding to move the technology from the end of Phase II into the commercialization-ready stage. The program was built specifically to tackle the well-known "Valley of Death," the period where promising biomedical innovations often stall because the technical, regulatory, manufacturing, and market-readiness work required to reach commercial investment or product launch is expensive and risky, and traditional research funding is typically no longer available.
A defining feature of this Bridge Award program was that it was not meant to operate in isolation; it was designed to actively pull private capital and strategic collaboration into the development pathway. Applicants were required to submit a detailed and credible commercialization plan that explained how the product would move toward the market and, critically, documented third-party financial support that was either already secured or strongly anticipated. The expectation was that independent third-party investor funding (for example, from venture capital, angel investors, corporate partners, or other non-federal sources) would match or exceed the amount of NCI funding requested over the Bridge Award project period. In practice, this structure signaled that the NCI funds were intended to de-risk and accelerate late-stage development while ensuring the project had real market pull and external validation from investors or partners who had performed their own diligence.
In terms of scope, the FOA was tightly focused on cancer-relevant technologies that were close enough to commercialization to benefit from a bridge mechanism. Only projects aimed at advancing new cancer therapies (including anticancer drugs, biologics, and oncologic therapeutic devices) or cancer imaging devices and imaging technologies were considered responsive. Projects could address either preclinical or clinical stages of development, recognizing that some innovations would need additional animal studies, formulation work, toxicology, device engineering, or manufacturing scale-up, while others might be ready to enter or expand human testing. Clinical trials were allowed when needed to reach a commercialization milestone, but a trial was not mandatory; the emphasis was on the work required to reach a product-development inflection point that would enable regulatory progress, investment readiness, and eventual market entry.
Administratively, this was a discretionary grant opportunity using the SBIR R44 mechanism and was only open to eligible small businesses. It was associated with CFDA program areas 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research). The opportunity did not require cost sharing as a formal matching requirement, but the program’s design effectively required substantial third-party investment as part of the commercialization plan. The total estimated funding associated with the announcement was about $10,000,000. The FOA was posted on May 14, 2008, and the final application deadline was February 27, 2009, with an archive date of March 30, 2009.
Overall, the Bridge Award concept reflected a practical commercialization strategy: the NCI would help promising SBIR-funded cancer technologies cross the late-development gap by pairing federal support with investor or strategic-partner capital, with the intended outcome of getting new cancer therapeutics and imaging solutions to patients faster and with a clearer path to real-world adoption.
FAQs: SBIR Phase II Bridge Awards to Accelerate the Development of New Cancer Therapies and Cancer Imaging Technologies Toward Commercialization (SBIR R44)
What is the official title of this funding opportunity?
The opportunity is titled "SBIR Phase II Bridge Awards to Accelerate the Development of New Cancer Therapies and Cancer Imaging Technologies Toward Commercialization (SBIR R44)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-CA-08-021.
Which agency ran this program?
This was a pilot initiative run by the National Cancer Institute (NCI) within the National Institutes of Health (NIH).
What was the main purpose of the Bridge Award?
The central aim was to provide additional SBIR support to small business concerns that had already completed an NIH SBIR Phase II project and needed targeted funding to move the technology from the end of Phase II into a commercialization-ready stage.
What problem was the program designed to address (the "Valley of Death")?
The program was built to tackle the "Valley of Death," where promising biomedical innovations often stall because the work needed to reach commercial investment or product launch (technical, regulatory, manufacturing, and market-readiness steps) is expensive and risky, and traditional research funding is typically no longer available.
What grant mechanism did this opportunity use?
It used the SBIR R44 mechanism.
Who was eligible to apply?
It was only open to eligible small businesses, and it was intended for small business concerns that had already completed an NIH SBIR Phase II project.
Was this a standard ongoing NIH program or something else?
It was described as a pilot initiative.
What kinds of projects were considered responsive to the FOA?
The FOA was tightly focused on cancer-relevant technologies that were close enough to commercialization to benefit from a bridge mechanism. Only projects aimed at advancing new cancer therapies or cancer imaging devices and imaging technologies were considered responsive.
What types of cancer therapies were within scope?
The scope included new cancer therapies such as anticancer drugs, biologics, and oncologic therapeutic devices.
What types of imaging projects were within scope?
The scope included cancer imaging devices and cancer imaging technologies.
Did projects have to be preclinical or clinical?
Projects could address either preclinical or clinical stages of development, depending on what was needed to reach an appropriate commercialization milestone.
Were clinical trials allowed under this opportunity?
Yes. Clinical trials were allowed when needed to reach a commercialization milestone.
Were clinical trials required?
No. A clinical trial was not mandatory; the emphasis was on the work required to reach a product-development inflection point that supports regulatory progress, investment readiness, and eventual market entry.
What kinds of development activities did the FOA anticipate funding?
The description indicates the Bridge Award could support late-stage development needs such as additional animal studies, formulation work, toxicology, device engineering, manufacturing scale-up, and activities needed to enter or expand human testing when appropriate.
How did the program connect federal funding to private capital?
A defining feature was that it was designed to actively pull private capital and strategic collaboration into the development pathway, rather than operate in isolation.
Was a commercialization plan required?
Yes. Applicants were required to submit a detailed and credible commercialization plan explaining how the product would move toward the market.
What did the commercialization plan need to demonstrate about outside support?
It needed to document third-party financial support that was either already secured or strongly anticipated.
What level of third-party funding was expected relative to the NCI request?
The expectation was that independent third-party investor funding (for example, venture capital, angel investors, corporate partners, or other non-federal sources) would match or exceed the amount of NCI funding requested over the Bridge Award project period.
Is third-party investment described as a formal cost-sharing requirement?
No. The opportunity did not require cost sharing as a formal matching requirement, but the program's design effectively required substantial third-party investment as part of the commercialization plan.
What kinds of third-party supporters were mentioned as examples?
Examples included venture capital, angel investors, corporate partners, and other non-federal sources.
What was the intended role of NCI funding in the overall financing strategy?
NCI funds were intended to de-risk and accelerate late-stage development while ensuring the project had market pull and external validation from investors or partners who had performed their own diligence.
What were the relevant CFDA program areas?
The opportunity was associated with CFDA 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research).
What was the estimated total funding associated with the announcement?
The total estimated funding associated with the announcement was about $10,000,000.
When was the FOA posted?
The FOA was posted on May 14, 2008.
What was the final application deadline?
The final application deadline was February 27, 2009.
When was the archive date?
The archive date was March 30, 2009.
What was the intended outcome of the Bridge Award concept?
The intended outcome was to help promising SBIR-funded cancer technologies cross the late-development gap by pairing federal support with investor or strategic-partner capital, with the goal of getting new cancer therapeutics and imaging solutions to patients faster and with a clearer path to real-world adoption.
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