Parexel places new focus on CNS

Explaining the decision, Michelle Middle, corporate vice president and worldwide head of Clinical Pharmacology at the contract research organisation (CRO) said that CNS diseases, which include neurodegenerative diseases such as Alzheimer's and conditions characterised by chronic pain, are reported to account for one third of the world's disease burden. As such, it is one of the key disease areas tipped for growth in drug discovery and development in the coming years. In augmenting its CNS services, the company said it is adding pain modelling capabilities and "combining traditional pharmacodynamic methods with relevant biomarkers​" in order to "to help clients make earlier and more effective decisions regarding CNS treatments​". A biomarker is a measurable characteristic, for example a DNA or RNA signature, that is an indicator of normal biologic, pathogenic processes, or a response to therapeutic or other interventions. The pharmaceutical industry is seeing a continued evolution of clinical drug development towards increased reliance on biomarkers to guide development and improve the safety and efficacy of novel drugs. "Parexel's dedicated clinical pharmacology services directed at alleviation of pain and related symptoms use neuroscience biomarkers to enhance exploration of safety and efficacy and pharmacokinetic analysis. This expanded approach for a broad range of psychiatry, neuropsychopharmacology, neuroimaging, and neurophysiology clinical studies provides greater information about CNS treatments in early phase development​," the firm said. Parexel prides itself on its dominance in the early-phase arena and has built this part of its business up to the point where it now has a total of more than 550 beds, "which is among the largest capacities worldwide​". The CRO recently bolstered its clinical pharmacology capacity with the completion of Phase I expansions at clinical pharmacology research units located in three global locations - Baltimore, Maryland in the US; London, UK; and Berlin, Germany. In Baltimore, the unit has been expanding capabilities and capacity for client programs since its inception in 2001. Following the most recent expansion, it now has 90 beds. This facility focuses on areas such as vaccine and immunology research, pulmonary, and oncology studies, and provides leading offerings such as advanced neuroimaging and radiochemistry capabilities using positron emission tomography (PET). At the same time Parexel's site in London has been expanded to a 64-bed capacity. The unit has expertise in conducting cardiology and respiratory studies, with a dedicated respiratory laboratory and cardiac telemetry and electrocardiogram (ECG) monitoring capabilities. In addition, the CRO's two research units in Berlin now have 160 total beds. The twin facilities have sleep research capabilities and a sleep laboratory, as well as a specialisation in cardiovascular, central nervous system, respiratory, dermatology, metabolism and endocrine, and infectious disease studies. In addition to the abovementioned units, the company also has clinical pharmacology research units in San Diego and Los Angeles in the US, and in Bloemfontein and George, South Africa, and also delivers early clinical development programs through a joint venture arrangement with Synchron Research based in India. Meanwhile, Parexel is not the only large CRO displaying an increased interest in the lucrative CNS arena of late. Rival firm Kendle recently announced the purchase of Canadian early-phase CRO, DecisionLine, which gives it new scientific expertise with psychopharmacology high-end exploratory/translational medicine capabilities, and in particular, specialises in the conduct of Phase I studies involving the measurement of pharmacodynamic effects of CNS drugs.