CONCORD, Ohio—Ricerca Biosciences LLC in December completed a capacity expansion of its in vivo pre-clinical testing capability and was also in the process of a similar expansion in its medicinal chemistry and chemical development services. The additional capacity was needed to allow Ricerca to meet growing demand for its pharmacokinetics, infectious disease animal model testing and toxicology.
"We have been getting more and more recognized in the industry for delivering value in the pre-clinical space," says Thomas Bradshaw, Ricerca CEO. "In addition, the space for this kind of service is growing at a 15 to 20 percent rate a year."
Market research indicates that total expenditures on contract research organization services has grown from about $1 billion in the early 1990s to just shy of $10 billion dollars today and continues a robust annual growth rate in the high teens.
But Ricera's growth rate is outstripping the industry as a whole, in part, Bradshaw says, due to its integrated approach of providing testing and support services in chemical, biological and combined chemical-biological drug development, the last of which is growing at a faster pace than other services provided by the company.
"We see our growth as a result of two things," Bradshaw says. "On the biotech side there was a healthy financing cycle between late 1999 and 2001. Lots of money poured into the biology discovery process and those biotechs are now moving to pre-clinical development stage and they have to outsource.
"The second dynamic is that major pharma has developed a large number of early lead candidates and they also have a developmental need which is larger than they've had in the past. There has also been a lot of capacity added and major pharma is taking advantage of that outsourcing ability."
According to Bradshaw, a typical customer for Ricerca is a well-financed biotech company that has 50 to a couple hundred employees. But its client roster is also peppered with companies ranging from very small biotech start-ups to large pharmaceutical companies.
One such client is Philadelphia-based Glycadia, Inc. (formerly known as Exocell), a company that provides clinical diagnostics, clinical investigation, laboratory research, reagents and reference standards in the area of diabetes and diabetes complications. With a staff of only 18 people, the company simply didn't have the internal resources to conduct in-house testing of a compound for which it hopes to file an IND in 2005.
"Probably the biggest reason we chose Ricerca was because they have expertise in both the biological and chemical testing and we needed both," says Chip Shearman, Glycadia vice president of development. "We have done a lot of animal work here, but the type of animal work we needed to get an IND was beyond our area of expertise."
Glycadia also needed help to develop a "more robust method of synthesis" for its compound and Ricerca was able to provide that service, as well. "Because they were the GMP manufacturer, the material was there for the biology work, it was easy to shift the compounds from manufacturing to their analytic and biology branches," Shearman says.
Delivering this kind of integrated service to customers will remain the core focus of Ricerca. "Our model is to have a significant biotech base for our integrated services and we will fill in for the individual needs of big pharma," Bradshaw says.
