A new UK-based contract research organisation, QCTR, says it hopes to make its mark on a competitive marketplace by specialising in clinical trials in the psychiatry and neurology field, particularly in the use of essential fatty acids.
“We feel that specialising in a single therapeutic area is the best way to deliver the optimum service to a pharmaceutical company working in this area. Dedicating ourselves to one area means we can realistically keep up with the latest scientific research and get to know the investigators and pharmaceutical companies well,” explained managing director, Susan McGoldrick. And it is already in discussions with several pharmaceutical players, with a tie-up expected to be announced within the next three months.
The four founders of QCTR – McGoldrick, Fiona Duffy, Crispin Bennett and Amanda Harrison – have worked together for 10 years.
“Prior to setting up QCTR we worked for a 'virtual' pharma company specialising in central nervous system disorders,” McGoldrick noted. This virtual company contracted out the majority of its services to CROs – with the exception of investigator selection and project management – as well as the overall CRO management. “We had, therefore, extensive experience in using various CROs, as well as a deep knowledge of various CNS disorders and a relationship with a lot of investigators. Against this background we developed a strong idea of the service and support we would have found helpful from a CRO.”
But is there much demand for clinical trials using EFAs in psychiatry? “There is a growing awareness and interest in the whole field of EFAs and its importance in brain development and also in the areas of psychiatry and neurodegeneration as medicines,” McGoldrick adds.
“This ranges from attention-deficit hyperactivity disorder, depression and various depressive disorders and schizophrenia through to neurodegenerative diseases such as Huntington's disease, Parkinson's disease and dementia. There are a significant number of academic institutions that are very interested in this area, including the National Institute of Mental Health in the US, as well as a growing number of pharmaceutical companies. And, as there are more manufacturers of pure lipids to pharmaceutical standards, then this area has potential for substantial growth.”
“In fact,” she noted, “there are already a number of lipid pharmaceutical products approved for cardiovascular use, such as Epadel in Japan for hyperlipidaemia and Omacor, which is approved in the US for triglyceride lowering. The whole area of lipids in CNS disorders is a relatively new, but rapidly growing, area. For example, Amarin Corporation, a speciality neurology company, is currently in Phase III clinical trials of a pure lipid compound in Huntington's disease.”
One of the principal challenges facing CROs today is how to demonstrate added value for pharmaceutical clients, explains McGoldrick, but she believes the prospects for the industry are rosy. “Pharma is still outsourcing. There has been a lot of consolidation in the CRO industry and some big names have disappeared as companies pursue growth through acquisitions, for example, Inveresk's purchase by Charles River. In terms of the market, however, the global clinical research market was estimated at $10 billion in 2005 and continues to grow by 12% per annum” (source: biospectrumindia.com.
And she stresses her belief that there will be little impact for CROs in the wake of the Northwick Park incident, in which six volunteers were hospitalised with multiple organ damage after being exposed to a developmental antibody drug.
“The events at Northwick Park were unprecedented in the area of Phase I clinical testing. I think there will be an understandable reaction by the regulators to add some more regulation to this area, in particular to the class of drug that was being tested. But I don't think the CROs will really feel an impact. At the end of the day, there is still a huge need for new treatments for diseases and these treatments need to be carefully tested.”