Clinical research news in brief
pharmafile | March 2, 2010 | News story | Research and Development | Community Research, Evotec, FDA, INC Research, Kendle, Parexel
A round-up of recent developments in the clinical research arena includes proposals from the FDA on reporting falsified trials, Kendle’s fourth-quarter results and news from Parexel, Evotec, INC Research and Community Research.
Clinical trial sponsors who suspect that their clinical trial data or its analysis may have been falsified must report the information to the US Food and Drug Administration (FDA) within 45 days, under a new rule proposed by the agency. The proposed rule is “intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorisation of certain labelling claims and to protect research subjects”, said the FDA. Comments are due by May 20.
Contract research organisation Parexel International has opened a new early phase clinical unit in Port Elizabeth, South Africa with around 40 beds. The move expands the CRO’s global early phase capacity to more than 580 beds. In addition to conducting a variety of studies in healthy volunteers, the Port Elizabeth unit will focus on early phase studies in patients, from first-in-man to proof-of-concept studies.
US CRO Kendle reported revenues of $97 million in the fourth quarter of 2009, down 11%, while operating income came in at $4.9 million, down from $10.9 million a year ago. The CRO has initiated a staff-cutting programme to “balance … levels with customer demand and sales,” it said in a statement, which indicated it expects to save $16-$18 million in 2010 as a result. The firm is not publishing 2010 earnings guidance “given the continued volatility in the CRO market, particularly with regard to late stage project cancellations and delays”.
US anti-infective specialist Cubist Pharmaceuticals has extended a contract with Evotec of Germany for fragment-based drug discovery until the end of 2010. The collaboration is trying to identify novel compounds against a series of antibacterial targets selected by Cubist. Cubist and Evotec have been working on the project since mid-2009. Financial terms have not been disclosed.
Community Research – an early-stage clinical research specialist based in the US – has opened a new 15,000 sq. ft. hospital-based clinical research facility in Cincinnati, Ohio. The unit is based at the Mercy Anderson Hospital and has a capacity of 44 beds for first-in-man and phase I testing. The plan is to expand the unit to 56 beds in future, said the firm.
Tim Dietlin has joined INC Research as vice president of alliance development, with the brief of pursuing strategic-level alliances with pharmaceutical and biotechnology customers, rather than service level agreements. Commenting on the appointment, Alistair Macdonald, executive vice president, strategic development, said: “drug developers are starting to realise that the traditional role of a preferred CRO provider is not producing the financial, efficiency and quality benefits they had hoped for.”
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