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Angie Drakulich was editorial director of Pharmaceutical Technology.
Contract research organizations such as Covance are heading further east through Europe.
Contract research organizations (CROs) such as Covance (Princeton, NJ) are heading further east through Europe. The company opened new clinical development offices in February 2009, in Kiev, Ukraine, and Bratislava, Slovakia (a third office opened in Tel Aviv, Israel) (1). Covance has provided clinical support services in Central and Eastern European (CEE) countries and the Commonwealth of Independent States (CIS) since 1994, with offices in Poland, Hungary, the Czech Republic, Bulgaria, Romania, and Russia, but these new offices, which will support staff in Ukraine and Slovakia, demonstrate a firm commitment to the developing region. "A comprehensive global presence combined with a balanced approach to leveraging emerging markets is critical...to be able to meet clients' demand in multinational trials, in terms of quality, time, and budget," explains Dr. Yuri Shakhov, executive director of clinical development services in CEE for Covance. "Working with investigative sites in Central and Eastern Europe enables a winning trifecta: The sites are known to be fast enrollers due to patient availability, while at the same time providing high quality data—all at costs that offer a clear competitive advantage over established markets."
CEE countries, in particular, have additional benefits for CROs that are managing clinical trials. For starters, most countries in the region have a highly centralized medicine system capable of screening a high number of patients per day. There are also large cohorts of patients throughout CEE, including patients with rare indications, which are of increasing interest to pharmaceutical companies looking toward personalized medicine, adds Shakhov. "This is important in these post-Vioxx times considering the increasing demand by regulatory agencies, particularly the FDA, to test drug safety in large patient cohorts," he says.
CEE countries also tend to have fast enrollment times and lower costs for conducting clinical trials, says Shakhov. And it doesn't hurt that 10 countries in the region are part of the European Union [Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia] and follow well-established EU regulations. Being part of the EU enables them "to offer predictable processes and good quality clinical study conduct," explains Shakhov. "From a regulatory perspective, approval and start-up timelines in Central and Eastern Europe are similar to Western Europe and India, but significantly shorter than in China. This means the countries of Central and Eastern Europe can take their place among the first countries to be active in a clinical trial instead of coming online only once the trial is far progressed."
But as with any market, challenges exist within CEE and CIS markets, including regional tension and conflicts. Variations in the regulatory requirements of non-EU countries, such as the need to separately import clinical trial materials into each non-EU country, can pose problems as well, notes Shakhov.
Another example is provided by, Albany Molecular Research (AMRI, Albany, NY). The company experienced some trouble with restrictions on air travel caused by strikes, natural gas shortages precipitated by Russia, and a host of other issues that could not be anticipated when doing business in Hungary, according to Michael Trova, senior vice-president of chemistry at AMRI.
Yet Trova points out that its operations in Hungary have provided the opportunity to "to establish relationships with the large number of biotechnology companies located throughout Europe." AMRI acquired an existing company in Hungary in 2006 because it "provided an immediate presence in Europe in an EU member state with a significantly lower cost structure than Western European countries," says Trova. It also allowed the CMO to recruit employees from the US and UK. More recently, AMRI completed construction of a new 32,000-ft2 research and development facility in Budapest with capacity that will allow the company to double its synthetic chemistry services over the next five years. The facility also includes a scale-up laboratory for non-GMP synthesis for batch sizes up to 25 L, says Trova.
Another CRO, PPD (Wilmington, NC), acquired AbCRO, a CRO operating in CEE that focuses on Phase II-IV clinical services, in April of this year, to strengthen its presence in "a highgrowth, emerging region for clinical research," according to a company release. With the acquisition, PPD gained access to Romania, Bulgaria, Serbia, and Croatia. The CRO already had operations in Poland, Russia, and Ukraine.
According to ClinicalTrials.gov, a registry of federally and privately supported clinical trials around the world, Poland had 516 open studies as of Sept. 1, 2009. The Czech Republic had 345, Hungary had 281, and Russia had 394. Looking at overall studies, including open and concluded or terminated studies, the CEE countries had a total of 6943 as of Sept. 1, 2009. Compare this with the total studies reported as of Sept. 1, throughout Western European countries (11,536), the CIS (1333), China (1269), and India (1062) (2).
1. Covance Press Release, Feb. 3, 2009.