CBI and Partners Start Phase I Clinical Research Services Company; Organization Will Address the High Demand Phase I Clinical Research Market.

ROANOKE, Va. -- The Carilion Biomedical Institute (CBI) is pleased to announce that it has partnered to form Roanoke Clinical Research, Inc. (RCR), a new Phase I clinical research clinic that will provide clinical research services to the pharmaceutical and biotech industries. "CBI is thrilled to partner in the start-up of a new company that will supply needed Phase I clinical research services to an industry that faces aggressive drug development timelines and is currently facing capacity shortages for Phase I trials. We have a very experienced team on board and I can't think of a better place than Roanoke to run this type of operation. RCR will further strengthen the growing biomedical bedrock that has been created in this region," states Daniel Barchi, President and Chief Executive, Carilion Biomedical Institute.

The core RCR team has worked together in the pharmaceutical industry over the last 17 years, collectively possesses more than 50 years of industry experience and has started and built companies in the pharmaceutical services sector. "I am very excited to be a part of this venture states RCR Chief Executive Patricia Povtak. She further states, "I am pleased to be putting my years of experience in clinical research to work here in Roanoke and I look forward to executing on our plan." The pharmaceutical industry typically out-sources the conduct of clinical research to contract research organizations (CROs) including placing Phase I studies at sites such as RCR. The CRO industry at-large is one that generates between six and ten billion dollars each year in revenues (up from approximately $1 billion just a decade ago). An estimated 25% of this revenue is generated from early stage clinical work (Phase I/IIa studies), clinical laboratory and bioanalytical laboratory services. The CRO services market historically posts high operating margins averaging at about 15%-20% and the market remains strong and is expected to continue to post impressive growth.

According to industry sources, in 2004, there were 32 percent more compounds in Phase I testing than in 2000. This increase and the demand for early development services is being driven by efforts to improve the efficiency of research and development operations by quickly moving more candidates through the drug development pipeline and also by the improved funding environment for early-stage companies. According to an article in the Associated Press on May 8, 2006, the number of drugs that entered clinical testing surged 52 percent in the three years ended in 2005. These factors are driving demand for early stage clinical testing causing backlogs in study scheduling of up to six months.

In the United States the drug approval process is regulated by the Food and Drug Administration (FDA). Prior to entering Phase I clinical trials, new drug candidates spend as many as six years being studied and analyzed first in a laboratory setting and then in pre-clinical testing. The vast majority of Phase I trials require healthy volunteers (subjects) or actual patients with a certain medical condition to be confined in a controlled, hospital-like environment, the Phase I clinic, while the studies are being run.

Roanoke Clinical Research could potentially begin enrolling subjects in six to nine months. The company is currently securing additional funding and seeking appropriate real estate to locate the business.