Contract research news in brief
pharmafile | March 5, 2012 | News story | Research and Development |Â Â CPR, Celeron/Ricerca, Certara, PRA, QuintilesÂ
CPR opens first bioanalytical lab in Singapore, PRA wins an MS vaccine trial contract, plus M&A and alliance news from Celeron/Ricerca, Certara and Quintiles.
Australian contract research organisation (CRO) CPR Pharma Services says it plans to open what it claims will be the first bio-analytical laboratory in Singapore to support the country’s fast-growing clinical trials market, which is estimated to be worth $166 million by 2015. The lab is expected to employ 15 technicians over the next three years and “bring in millions of dollars into the Singapore economy,” according to CPR chief executive Jason Valentine. The unit has been constructed by CPR’s strategic partner Maccine Pte, a Singaporean pre-clinical CRO, which will also be the first customer for the lab.
Pharmaceutical Research Associates (PRA) has won a contract from Opexa Therapeutics to manage a Phase IIb clinical trial of Tovaxin, Opexa’s therapeutic T-cell vaccine for multiple sclerosis. PRA will support a study in patients with the secondary progressive form of MS. Tovaxin is a therapy based on attenuated autoreactive T cells, which are taken from the patient, rendered non-replicating but viable in vitro and re-injected subcutaneously to stimulate an immune response.
US CROs Celerion and Ricerca Biosciences have set up a collaborative venture – called the Biosimilars Alliance – devoted to providing pre-clinical and early clinical studies of biologics manufactured by a new supplier. The alliance aims to tap into a growing market for biosimilars, which is tipped to expand dramatically from $2.4 billion in 2012 to $44 billion by 2020, helped by the creation of a regulatory route to market for these products in the US. By joining together the two CROs will be able to provide in vitro and in vivo pharmacological assessments of activity, toxicological and immunotoxicological studies, bioanalytical assay development, pharmacokinetic (PK) and pharmacodynamic (PD) modelling and immunogenicity screening during clinical studies.
UK-based Simcyp has been acquired by Certara, a US provider of drug discovery and development software and consulting services. Simcyp has developed a modelling and simulation platform for predicting the fate of drugs in virtual patient populations, including children. Certara chief executive Jim Hopkins said combining the two companies provides “broader capabilities to predict drug disposition as a function of molecular structure, and the ability to utilise a single unified suite of tools to facilitate pre-clinical and clinical PBPK and PKPD modelling and analysis”.
Quintiles says it has forged an alliance with Russian investment company RVC Biofund to support expansion of clinical development services within the Russian Federation, a country which is “under-represented in terms of clinical development activity and over-represented in term of unmet medical needs,” according to Ben Cons, Quintiles’ global vice president, corporate development. The two organisations are expecting to announce plans for specific joint ventures in the near future.
Phil Taylor
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