Words from a Winner: Exocell, Inc.

Company name: Exocell, Inc.
Number of SBIR I Grants Awarded: 6
Number of employees: 20
Awarded by: Department of Health and Human Services

Exocell, Inc. is a biopharmaceutical company that specializes in the treatment of complications of diabetes. The company recently has spent time focusing on the microvascular elements of the disease, including the eyes and kidneys. Typically these are the areas of the body where complications progress most quickly. Exocell has discovered one mechanism that leads to kidney failure and consequently developed a compound that is currently in Phase III clinical trials for the prevention and treatment of kidney disease.

Phase III is considered by some to be the elusive final step in the SBIR process. Dr. Chip Shearman, Development Vice President and Regulatory Affairs at Exocell, concurs that the commercialization involved with Phase III is difficult to be sure and believes there is a "significant bottleneck in the program." Many small companies, particularly those with chemically-oriented programs, often struggle to find alternative funding for the costly clinical trials needed in order to truly commercialize their product. Dr. Shearman says Exocell has been no different, having to "limp through" the process as a small company. However, he remains optimistic that persistence will pay off.

While Exocell has succeeded numerous times in obtaining SBIR funding, they have, like most applicants, been denied proposals in the past. Dr. Shearman says that in those instances, he was satisfied with the debriefing process. The awarding agency supplied them with information about ways in which the company could improve its application and shared how close they came to receiving funding.

For those new to the process of applying for an SBIR grant, Dr. Shearman recommends presenting a clear idea of what exactly it is that you want to do and how you plan to accomplish it. He also stresses the importance of discussing preliminary data in your proposal. He says documenting previously conducted studies clarifies for reviewers the direction your project is headed and how it may lead to success.

Determining whether a project is compatible with what government agencies are looking for in their submission topics can sometimes be challenging. Dr. Shearman has found that with so many health institutes seeking such a variety of health-related technologies, Exocell has been able to basically work "from the inside out." They have written up drafts of their application and then sought out agencies in need of that particular technology. He says that health-related companies may have an advantage in this regard because the demand for their technology is so great.

This article is reprinted from its initial appearance in Innovation Philadelphia's Federal Funding Bulletin on December 2, 2002.