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Seamless fit for CRO
CHICAGO—The CRO Celsis International plc recently announced the addition of ADME-Tox studies and preclinical and clinical CMC development services to its research services portfolio. The new services are the result of Celsis' 2006 acquisition of In Vitro Technologies Inc., which has provided these services since 1990. To enhance these offerings, Celsis has also invested in instrumentation, upgraded its quality platform to GLP and GMP levels and formed a Development Services group, which is an extension of the company's Analytical Services division.
Celsis facilities in Baltimore, Edison, N.J. and St. Louis will all be expanded and head count will also grow incrementally.
"With the addition of these services, we fit more seamlessly into the CRO space from preclinical through filing an IND." says John Daniels, VP and GM of Celsis Analytical Services.
Daniels notes that the CRO world is tending to group itself into three segments. Big Pharma, he says, likes to partner with firms that can eventually help with human clinical trials. "Prior to that stage," he says, "they want someone to execute in a cost-conscious way." Smaller players, on the other hand, "are looking for partners who can help them understand what they need to do before they execute their program. This is where we tend to find ourselves a lot of the time."
The third segment Daniels sees as significant is offshore CROs in India and China, which are important for everything from early discovery and development through human clinical trials. "The FDA has become more open to receiving data from worldwide areas," he says, "and as markets become more and more global, data from Chinese subjects, for example, can help overcome concerns about population differences in drug response."
The ADME-Tox studies Celsis is adding to its offerings tend to stay more local, according to Daniels, as do the chemistry and manufacturing controls (CMC) services that are part of an NDA. "We want to show time and money savings, which the industry has come to expect, but also provide knowledge and a 'get it right the first time' service capability as part of the company's long-term strategy to offer comprehensive products and services to accelerate drug discovery and development."
According to Celsis, 30 percent of new drugs fail in the development pipeline due to toxicity profiles and side effects. By evaluating a pharmaceutical molecule's ADME properties and potential toxicity, ADME-Tox screening assays help to optimize the number of drug candidates for further development. The ADME-Tox services focus on in vitro drug metabolism, drug-drug interactions, permeability, absorption, organ toxicity, and plasma protein binding. In addition, Celsis Development Services will offer CMC drug development services to serve clients from discovery through all clinical phases of drug development. CMC services will include preformulation and formulation development for insight into the physicochemical properties of a drug molecule and its product formulations. Development Services, located at the Celsis IVT facility in Baltimore, will also provide a full spectrum of analytical and bioanalytical methods development services to aid in product characterization.