NIH’s National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Advancing Translational Sciences (NCATS) seek applicants for the Funding Opportunity Announcement (FOA) titled “Small Market Awards: SBIR Phase IIB Competing Renewals for Heart, Lung, Blood and Sleep Technologies with Small Commercial Markets” (RFA-HL-14-012).
The awards are to help Phase II SBIR awardees develop technologies needed by NHLBI that can address small commercial markets, as in the case of rare diseases or technologies needed by the young pediatric population ages 0-12 years.
With the FOA release, NHLBI intends to commit $2,000,000 to fund later stage R&D (referred to as Phase IIB) for SBIR projects that show promise that were previously funded. The goal is to help applicants continue to develop technologies with private funding after NHLBI support ends. However, applicants will need to submit a Commercialization Plan that includes details on any independent third-party funding.
Today, developing therapeutics, medical devices, and combined technologies often requires a number of years and substantial capital investments because of the costs associated with conducting clinical trials and other steps mandated in the federal regulatory approval process.
This is particularly difficult for companies developing products that have small potential revenue streams or target small patient populations. These companies face additional barriers to entering markets. This fact makes these companies less attractive to investors and strategic partners. In addition, many of these technologies require complex clinical trial designs because of small and geographically diverse patient populations.
Eligible applicants need to be small business concerns and located in the U.S. The letter of intent is due May 19, 2013 and in May 2014, and May 2015. Applications are due June 19, 2013, 2014, and 2015. The earliest start date is April 2014.
Applicants may also want to look for other available financial resources besides NHLBI funding. Companies should investigate opportunities such as FDA incentives to increase and accelerate small market product development. Additional programs that can be researched include the Orphan Drug Designation, Humanitarian Device Exemption, and the Pediatric Exclusivity Provision programs.
In addition, applicants should investigate if they are eligible to participate in the NIH Therapeutics for Rare and Neglected Diseases (TRND) and the Bridging Interventional Development Gaps (BrIDGs) programs. Projects selected for either of these programs will get in-kind funding and resources to support drug development projects that aim to bring novel therapies to treat rare diseases.
Go to http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-14-012.html to view the FOA.