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American Reinvestment and Recovery Act

Recovery Act Investment in Small Business Programs Helping to Drive Innovation

For small businesses, it's often a long, difficult path from conception of a research idea to commercialization of an innovative technology or drug that promises to improve cancer prevention, detection and treatment. This is even more challenging in today's economic climate where sources of funding to develop these promising ideas can be hard to come by. For some small businesses, the funding gap can mean innovative ideas never reach the patient. With the help of government-funded programs, such as the National Cancer Institute's Small Business Innovation Research and Small Business Technology Transfer (NCI SBIR & STTR) programs, emerging companies can get the necessary funding to move their ideas to market and into the hands of the doctors that treat cancer patients.

NCI's SBIR & STTR programs are among the largest sources of early-stage funding in the country, and are an important driving force in stimulating technological innovation and collaboration among small businesses. SBIR & STTR are government set-aside programs for domestic small businesses to engage in research and development of products that have the potential for commercialization and public benefit. In addition to SBIR & STTR funding, in 2009, grantees were also eligible for supplementary funding through NCI's American Recovery and Reinvestment Act (Recovery Act) program. The combined funding assistance by both of these programs is enabling the advancement of potentially life-saving products during hard economic times.

Driving Innovation in Diagnostic Technologies

Metastasis, the spread of cancer from one part of the body to another, is largely responsible for the majority of deaths related to cancer. Scientists believe one cause of metastasis may be the presence of circulating tumor cells (CTCs) that slough off from tumors and circulate in the bloodstream. The level of CTCs in a patient's blood may provide important information for early detection and diagnosis of metastasis, and serve as a good indicator for prognosis. Although different techniques have been used to separate CTCs from blood cells, there is still a need within the diagnostic and prognostic market for a simpler, more effective way to observe CTCs.

Columbus NanoWorks, a small business based in Columbus, Ohio, is an STTR grantee that was awarded a supplementary Recovery Act grant. The company is developing magnetic nanoparticle reagents – tiny magnets that are added to a system to make cells magnetic – for the detection of cancer cells from various sources, such as bone marrow and peripheral blood.

"I think that conducting tests for circulating tumor cells is just beginning to become clinically relevant, so there's a need for rapid methods that are reliable and affordable," said Dr. Arfaan Rampersaud, president and owner of Columbus NanoWorks.

The company has developed magnetic nanoparticles smaller and stronger than those currently available, which are designed for a magnetic separation device known as a Quadrupole Magnetic Sorter (QMS). The QMS system was developed by researchers at The Ohio State University and the Cleveland Clinic, and removes magnetic nanoparticles from the blood. Magnetic nanoparticles are designed to bind to cancer cells, then, mixed with blood and separated on the QMS instrument, allow cancer cells to be analyzed for abnormalities. Dr. Rampersaud and his team are hoping their research will lead to the development of a simple blood test that could improve early detection and perhaps early prognosis of metastatic cancer, and would be available to patients through any physician's office.

The STTR and supplementary Recovery Act funds have proven very important for the company's momentum, and enabled the company to retain its staff and hire a new technician to resolve technical roadblocks. Dr. Rampersaud felt the grants came at a good time. For instance, utilizing the Recovery Act funds, Columbus NanoWorks was able to develop a business relationship with a biotechnology company that led to modifications of the magnetic particle to minimize non-specific binding. It also allowed them to think of different ways to apply magnetic nanoparticle technology for research in stem cells, drug delivery and other areas.

"Through the funding mechanisms, we were able to prove that our technology worked, develop new applications and collaborations, and out of all of that, develop a business that can help patients," said Dr. Rampersaud.

Accelerating Translational Research and Advancing Personalized Medicine

Labmatrix in use

BioFortis' award-winning technology platform, LabmatrixTM, is used by researchers in multiple industry sectors to manage clinical, specimen and molecular assay data.

A major challenge in the translational research space is the sheer amount of information available. This glut of information prevents scientists from making meaningful discoveries or collaborating seamlessly with each other. The data exploration bottleneck is partly fueled by the lack of tools available to allow researchers to efficiently evaluate large amounts of complex data in sophisticated ways.

"I like to quote Star Trek, 'to go where no man has gone before.' Explore new worlds—that's what I want the scientists to be able to do," said Dr. Jian Wang, president and CEO of BioFortis, a software company based in Columbia, Md. BioFortis has developed data management software solutions to help improve research productivity and collaboration. The company's technology platform, LabmatrixTM, helps reduce the data mining process timeframe from months to a matter of minutes. It provides scientists with a system to enter data and integrate existing information, allowing them to manage the data operations of running a translational and clinical research program.

"Today's translational research is tomorrow's personalized medicine. You've got to be able to translate the insights back and forth between the molecular understanding of a physiological or pathological process and the clinical manifestations of that," said Dr. Wang. "So what we're doing today is focused on supporting translational research, which will gradually lead to the maturing of personalized medicine as a way of healthcare. And our technology will evolve into that arena."

BioFortis is continuously updating its technology, with new software version releases multiple times a year. The latest update, partially funded by the Recovery Act grant, involves the addition of a visualization component to LabmatrixTM, which helps researchers narrow down datasets to more manageable, relevant subsets. The Recovery Act grant was a natural extension of BioFortis' existing STTR grant.

"The SBIR & STTR programs' balance of scientific, technological rigor and business has been very helpful," said Dr. Wang. The Recovery Act grant enabled BioFortis to hire a software engineer to move the technology forward, accelerating BioFortis' ability to bring the next iteration of LabmatrixTM to the market by a year. It was released in September 2010. This latest 4.2 version will help drive new business opportunities and generate new revenue, allowing the company to retain the new position they created and likely hire more staff.

LabmatrixTM has won multiple industry awards and has been adopted by researchers in the biopharmaceutical industry, academia and within government research institutions. Early adopters of the technology include the NCI and the National Human Genome Research Institute. In the past couple of years, pharmaceutical companies have also begun working with BioFortis. Although there may be subtle differences in terms of how research is conducted, the fundamental challenges of data exploration and translational research cut across all sectors.

"Small companies don't lack ambition or imagination. Often times, we lack resources to realize those ambitions and ingenuity. As a small business, there are different sources of funding that allow us to innovate and to realize the vision we're dedicated to," said Dr. Wang. "I always say that it's easy to have a vision but it's very difficult to realize that vision. The SBIR & STTR programs and Recovery Act have been extremely helpful for small companies."