PPD, PRA International, SpineMark and Pacific Biometrics – Clinical contract news

Pharmaceutical Product Development (PPD)​ becomes the latest contract research organisation (CRO) to venture into new territory with the opening of an office in Istanbul, Turkey. The firm, which already has offices in Russia and the Ukraine said that the move is part of the planned growth of its Phase II-IV clinical development services in Eastern Europe - an emerging clinical trials hot spot. "Eastern Europe offers recruitment opportunities and quality investigators, and our Istanbul office is an important part of our strategic growth in this region​", said Fred Eshelman, CEO of PPD. Turkey in particular is one of seven emerging market countries, along with China, Brazil, Mexico, South Korea, India and Russia, that are tipped to contribute a quarter of the pharmaceutical industry's global growth within the next few years, with their market value expected to grow 12-13 per cent next year alone to be worth $85-90bn. "With a population of 74 million people, Turkey is becoming an attractive place to conduct clinical trials​," said Eshelman. From this new location the firm plans to conduct clinical monitoring services in key therapeutic areas. Meanwhile, PRA International​ has announced the relocation of its existing German operations in Berlin into a facility that triples the size of its existing site. The move was required to accommodate increased staff acquired in PRA's early phase services business following the purchase of Pharmacon late last year, in addition to the company's "increasing need for headcount" within Germany, specifically the Product Registration group. "The demand for Phase I patient studies is growing exceptionally fast​," said John Horkulak, vice president of Early Development Services, Central and Eastern Europe. "The expanded offices in Berlin, from where we coordinate our trials in Central Europe, are designed to support this fast growing business​." PRA's Central and Eastern European Early Development Services business is headquartered in Berlin and from this location, PRA provides project management, clinical monitoring, biometrics, pharmacovigilance and late-phase services. This business unit also has operational sites in Poland, Hungary and the Czech and Slovak Republics. Recently, spinal-focused CRO SpineMark​ has established an alliance with Wooridul Hospital​ of Korea to develop spine centres of excellence and facilitate clinical research on a more international scale. "Wooridul Hospital is renowned for its state of the art facilities and work in spine treatment research​," said Marcy Rogers, president and CEO of SpineMark. Through the joint venture, SpineMark and Wooridul said they plan to co-establish a CRO and set up spinal research organisations (SROs) in Korea, Shanghai, Singapore, Japan, India and Abu Dhabi. In addition, they plan to develop a medical education centre with a training facility in Singapore, similar to the Medical Conference Center that SpineMark already has in Texas, in order to train physicians on the latest clinical advancements in spine care. Under the agreement, medical device companies will be able to contract with SpineMark and Wooridul to gain access to their network of research sites. "Our goal is to create global medical destination centers that provide advanced treatment options to people who suffer from spinal disorders and diseases​," said Dr Jihoon Jeong, director of research and international business at Wooridul Hospital. "Ongoing research and education activities are at the heart of this goal. SpineMark's model of offering physicians and device companies the oversight and support needed to conduct clinical trials under one umbrella will allow us to further our R&D efforts on a global level​." In other news, Pacific Biometrics​ said it has been awarded a series of contracts with a top multinational pharmaceutical company to the value of $1.3m, to provide biomarker assay-development and testing services for 21 preclinical and clinical drug development programs. Specifically, the company will set up and validate custom assays and test clinical samples for novel biomarkers and for anti-drug antibodies. Testing has already commenced and is expected to continue into the fourth quarter of 2009. Ron Helm, chairman and CEO of PBI said that it is the company's objective is to become a "significant player" in the clinical biomarker services market, which it described as "rapidly growing and evolving​". "There is an increasing trend to outsource all components of the drug-development continuum, and that includes the provision of novel biomarker assay development and testing for clinical trials​," said Helm. "A recent analysis indicated that biomarker services for clinical trials is the fastest-growing segment of the biomarkers and outsourced-lab market and is expected to grow at a CAGR of 23.5 per cent over the next five years​".