Wednesday, January 13, 2010

Funds to Jumpstart Commercialization

On January 5, 2010, NIH’s National Cancer Institute issued Funding Opportunity Announcement (FOA) RFA-CA-10-009 to help support the next stage for projects previously funded by SBIR Phase II Bridge Awards. The plan is to use the additional funding to help small business concerns transition their SBIR Phase II projects to the commercialization stage.

Areas of R&D supported by NCI often require substantial levels of additional financing beyond the SBIR Phase I and Phase II stages. Also, a number of emerging products in these areas are becoming increasingly complex due to the technological advance in multidisciplinary fields. For example, new products may involve measurement of both physical and molecular signatures, combine devices and molecular probes, or perform dual functions of diagnosis and therapy.

These products are referred to as combined technologies by FDA and examples in oncology include those related to genomics, proteomics, certain approaches to imaging, image-guided diagnosis and therapy, and other therapeutics. In addition, the developers of these technologies often face additional challenges during the regulatory approval process requiring even more time and effort to commercialize these technologies.

The development of medical biotechnology products is often impeded by a significant funding gap, known as the “Valley of Death” that occurs between the end of the SBIR Phase II award and the commercialization stage.

Large pharmaceutical and biotechnology companies as well as venture capital firms have traditionally provided the resources to fully develop and commercialize biomedical products and technologies initiated with NIH SBIR funding.

Recently, many investors in life science technologies have shown a bias toward financing the continued development of relatively mature technologies at established companies, rather than the higher-risk emerging technologies under development at many small businesses.

Therefore, the intent of this FOA is to help commercialize SBIR II Projects applicable to specific areas such as cancer therapeutics, cancer imaging technologies, interventional devices and in vivo diagnostics or in vitro and ex vivo cancer diagnostics and prognostics. Projects may address preclinical and/or clinical stages of technology development and clinical trials may be proposed but are not required.

The estimated amount of funds is $10,000,000 for fiscal year 2010 and will be available for up to ten projects with future amounts dependent on appropriations.

It is hoped that this FOA will promote partnerships between NIH awardees and third-party investors and/or strategic partners to accelerate the capital intensive steps that are required to commercialize new products and technologies. Applicants will need to provide a commercialization plan that includes information on any independent third-party investor funding that has already been secured or is anticipated.

The opening date to submit an application to is February 1, 2010 with applications due on March 1, 2010.

For more information, go to http://grants.nih.gove/grants/guide/rfa-files/RFA-CA.10-009.html.