Contract research news in brief
pharmafile | May 1, 2012 | News story | Research and Development |Â Â BML, Cetero Labs, Covance, Harlan and Chiltern, PRAÂ
A round-up of recent developments in the contract research sector, featuring updates from PRA, Cetero Labs, Covance/BML, Harlan Labs CRS and Chiltern International.
PRA has won a contract with Amgen to run a series of Phase III trials of biosimilar drugs currently in the US biotech firm’s development portfolio. Amgen forged an alliance with generic firm Watson Pharmaceuticals late last year to develop a range of oncological biosimilars outside of Amgen’s current branded drug portfolio. Under the terms of that deal, Watson will contribute up to $400 million in co-development costs to the project. PRA said the contact “represents a key milestone in PRA’s commitment to supporting our clients’ biosimilar development programmes”.
The FDA and contract research organisation Cetero Labs have reached an accord over charges of improper practices at its bioanalytical facility in Houston between 2005 and 2010. The FDA sent the CRO a warning letter last year claiming that the company’s staff faked and manipulated data, failed to maintain complete records and falsified documents, allegations which led to a crisis in customer confidence and drove Cetero to file for bankruptcy in March. The upshot is that the agency will accept some studies carried out during the period for submission without reanalysis, repeating or auditing, while others will be accepted if a third-party audit has been carried out. Others will require a complete reanalysis or repeat of the study. Cetero said it was ‘pleased’ with the outcome.
Covance and Japanese partner BML Inc. have announced plans to expand a jointly run laboratory in Kawagoe City, Saitama Prefecture, by around 50 per cent. The Covance-BML Clinical Trial Laboratory will also benefit from new analytical platforms, testing equipment and storage space that will allow it to tap into “the growing demand for in-country testing services” in Japan, said the two companies. The new services will be in the areas of immunoassays, flow cytometry, and protein chemistry.
Harlan Laboratories Contract Research Services has signed a three-year agreement with French pharma company Ipsen to develop a stable of early pre-clinical stage drug candidates for undisclosed therapeutic indications. Harlan Laboratories specialises in pharmacokinetics, in vitro and in vivo ADME (Absorption, Distribution, Metabolism and Excretion) studies and has facilities in Barcelona, Spain, and Switzerland.
UK-headquartered CRO Chiltern International says it has set up a unit in Taiwan to sit alongside its current offices in India, Singapore and Australia. The company’s executive director for Asia-Pacific and managiung director for India, Dr Umakanta Sahoo, said that in light of regional collaboration between Asian countries for mutual acceptance of Asian data: “Japan, US and European clients have shown increased interest in Taiwan to perform global clinical trials due to [its] supportive regulatory environment, excellent hospital infrastructure and healthcare system.”
Phil Taylor
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