The activity of local and international firms establishing preclinical testing services to good laboratory practice (GLP) standards in Asia continues to gain momentum.
Quest Pharmaceutical Services (QPS) has announced the formation of a partnership with Japanese firm Integra to bring its preclinical and clinical laboratory testing services to the country. The company is already operating these services from facilities in the US and Taiwan and said it chose the partnership with Integra to "to streamline the pharmaceutical development process for its clients and significantly improve the so called "drug lag" between countries in Asia, North America and Europe by facilitating simultaneous drug development and three-party studies."
It takes an average of 3.5 years longer for a drug to reach the market in Japan than in the US and Europe and a lot of this has to do with the fact that the country requires pharmacokinetics (PK) and pharmacodynamics (PD) study data (generated from at least single-dose safety and PK study) on its own population first before any other studies in the country can begin. According to QPS president and CEO Ben Chien, its new partner will assist QPS with ethnic comparative studies in Asia, in addition to Phase I to IV clinical studies, data management and medical writing in Japanese, and regulatory issues.
Integra is a clinical trials consulting firm with "extensive experience and coverage throughout Asia," said Chien. In neighbouring China, WuXi PharmaTech has now started building its new $40m (€28m) preclinical drug safety evaluation centre from which to provide global clients with a range of toxicology services.
The company has already started providing some toxicology services from a small temporary facility in Suzhou, near Shanghai, however, the new site, which will be situated in the same area, will allow the firm to greatly broaden its capacity and scope. After its expected completion in 2009, the firm boasted it believes it will "become the largest modern drug safety evaluation centre in China."
China is aggressively pursuing a foothold in the global preclinical outsourcing market, having identified this as a niche area in which it can attract international business due to its low cost base, speed and the favourable regulatory environment for such studies. Meanwhile, nearby Malaysia is also gearing itself up to grab a slice of the preclinical action. The country has recently established the Penang Science Park at Bukit Minyak, as a push by the government to develop the country's biotechnology sector.
The new science park's first tenant is a preclinical contract research organisation (CRO) - the first of its kind in Malaysia - and is part-funded by a UK venture capital fund. Called Progenix, the CRO is offering toxicology services to the global biopharma market and houses a range of mammalian species for the purpose, from mice through to primates. According to the firm, it has a particular area of expertise in inhalation toxicology.
In addition, the facility can conduct regulatory safety evaluation studies on experimental compounds, as well as non-regulatory toxicology research studies of existing chemicals.
The company's 230,000m site currently has over 200 staff operating in 76 laboratories.