Asia-Pacific region

The Asia-Pacific region is becoming increasingly attractive for global clinical development activities.  There are numerous factors driving this trend, including a shortage of trial volunteers in Europe and North America, the sophisticated healthcare systems in many Asian countries, and the availability of highly trained medical professionals in the region.  Equally important, Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing.  Japan is the second largest biopharmaceutical market in the world, and China is expected to become the fifth largest within the next few years.

The environment surrounding the regulation of pharmaceutical products has shown steady improvement, with significant changes over the last five years.  These changes have brought greater transparency and professionalism to the regulatory arena, and increased the opportunities for the biopharmaceutical industry to conduct clinical trials and introduce novel therapies. Health officials throughout the region have made it clear that they want to play a greater role in the global drug development process and offer their citizens the latest therapies at the same time they are available in Europe and North America.

PAREXEL’s strong presence in the Asia/Pacific region includes offices in China, Japan, Australia, Indonesia, Malaysia, the Philippines, Singapore, South Korea, Taiwan, and Thailand. Our wide geographic coverage and extensive local knowledge give us the resources to successfully support any aspect of clinical development and market expansion throughout the region.  Equally important, our regulatory experts work closely with government officials in each country, giving us a thorough understanding of steadily improving regulatory environment for clinical development and product marketing.

China

China’s growing economic strength and population of more than a billion people hold tremendous potential for global pharmaceutical companies – both as a location for clinical trials and a market for novel therapies.  Biopharmaceutical sales in China are expected to reach $27 billion by 2013.  China is attractive for a wide range of clinical development activities because of its large patient population, expanding medical infrastructure, and trial costs that average about one-half of those in the US or Western Europe.  Although the regulatory environment is challenging, the requirements covering clinical trials and the sale of new therapies have been steadily improving – providing greater opportunities for biopharmaceutical companies to include China in their development and market registration plans.  PAREXEL is committed to helping sponsors reduce their development costs, accelerate patient recruitment, and decrease time to market by incorporating China in global development planning, which would bring important new treatments to patients in China, and around the world, sooner.

Japan

Both the biopharmaceutical industry and the Japanese government have a vital interest in speeding up and expanding the marketing of novel therapies in Japan.  The regulatory environment in Japan has improved substantially in the last decade as the result of public health concerns about the “drug-lag” challenge facing Japan, where new biopharmaceutical products typically enter the market more than four years after their approval in the US or Europe.

With the improving regulatory situation, more companies are including Japan in their global development plans.  Japan also offers development advantages, including advanced technologies and skills that are comparable to Western standards, excellent quality of data, and a large pool of talented clinical trial staff.  Through its long experience in Japan, PAREXEL understands the key success factors for faster product development in Japan, such as:

• Incorporating Japanese and other Asian populations at the earliest stages of development to support efficient global registration and marketing
• Establishing a broad ethnic base of patient data, coupled with studies designed to bridge the data between countries and regions
• Performing PK, PD, and other Phase I testing with multiple populations as early as possible to reduce the chances of ethnicity-based safety issues
• Working with Japanese regulators to ensure that study designs, protocols, analytical methods, and bridging strategies will meet their requirements

Click here for a list of PAREXEL’s offices in the Asia/Pacific region.