Seamless fit for CRO

CHICAGO—The CROCelsis International plc recently announced the addition of ADME-Tox studiesand preclinical and clinical CMC development services to its research servicesportfolio. The new services are the result of Celsis' 2006 acquisition of InVitro Technologies Inc., which has provided these services since 1990. Toenhance these offerings, Celsis has also invested in instrumentation, upgradedits quality platform to GLP and GMP levels and formed a Development Servicesgroup, which is an extension of the company's Analytical Services division.

Celsis facilities in Baltimore,Edison, N.J.and St. Louis will all be expandedand head count will also grow incrementally.

"With the addition of these services, we fit more seamlesslyinto 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 itselfinto three segments. Big Pharma, he says, likes to partner with firms that caneventually help with human clinical trials. "Prior to that stage," he says,"they want someone to execute in a cost-conscious way." Smaller players, on theother hand, "are looking for partners who can help them understand what theyneed to do before they execute their program. This is where we tend to findourselves a lot of the time."

The third segment Daniels sees as significant is offshoreCROs in Indiaand China,which are important for everything from early discovery and development throughhuman clinical trials. "The FDA has become more open to receiving data fromworldwide areas," he says, "and as markets become more and more global, datafrom Chinese subjects, for example, can help overcome concerns about populationdifferences in drug response."

The ADME-Tox studies Celsis is adding to its offerings tendto stay more local, according to Daniels, as do the chemistry and manufacturingcontrols (CMC) services that are part of an NDA. "We want to show time andmoney savings, which the industry has come to expect, but also provideknowledge and a 'get it right the first time' service capability as part of thecompany's long-term strategy to offer comprehensive products and services toaccelerate drug discovery and development."

According to Celsis, 30 percent of new drugs fail in thedevelopment pipeline due to toxicity profiles and side effects. By evaluating apharmaceutical molecule's ADME properties and potential toxicity, ADME-Toxscreening assays help to optimize the number of drug candidates for furtherdevelopment. The ADME-Tox services focus on in vitro drug metabolism, drug-druginteractions, permeability, absorption, organ toxicity, and plasma proteinbinding. In addition, Celsis Development Services will offer CMC drugdevelopment services to serve clients from discovery through all clinicalphases of drug development. CMC services will include preformulation andformulation development for insight into the physicochemical properties of adrug molecule and its product formulations. Development Services, located atthe Celsis IVT facility in Baltimore,will also provide a full spectrum of analytical and bioanalytical methodsdevelopment services to aid in product characterization.