Clinical Research: Phase I - Phase 4

Untapped Potential: Asia-Pacific’s Growing Role in Biotech Drug Research

Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2]

Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence of non-Hodgkin’s lymphoma, non-small cell lung cancer, and certain gene rearrangements are much greater than in the United States and Europe. Combine these incidence rates with the Asia-Pacific (APAC) region’s sheer size — it’s home to 60 percent of the world’s population — and you would expect sponsors to be rushing to take advantage of this setting for clinical trials in these indications.

Right?

Not exactly — at least not yet. For all its demographic promise, the APAC region has been slow to emerge as a center for US and EU biotech clinical drug research. The larger biotech and pharmaceutical companies have been selectively tapping into this part of the world to expedite their drug development plans for more than a decade, but the perception still persists that this region has a complex regulatory environment and is more costly compared to the United States and Europe. Others feel it’s difficult to find quality trial sites and that there’s no point looking at ROI for APAC as the timelines are too long, making it less than welcoming.

But patient access is a strong motivator for an industry eager to address these unmet needs and reduce time to market, and having access to the huge APAC population can mean enrolling a trial in months, not years. That’s motivating Western researchers to explore APAC countries more aggressively than ever — and here are some things we’ve observed:

The growth of innovative biotech. Specialty biotech and pharma companies excel at developing innovative new drugs but are least able to negotiate the often varying regulatory environments that govern clinical trials in APAC countries. They need help from CROs experienced in this environment, and historically only the largest contract researchers have had that kind of expertise. Mega-CROs and small biotechs generally aren’t the best mix, however, so we specialize in China, Taiwan, Hong Kong, South Korea, and Japan to give our clients expanded access to patients in these countries.

The region is very large and diverse. China is not Japan and Japan is not Korea, and you need to understand the cultural, political, and regulatory nuances specific to each country where you seek to do business. U.S. and European sponsors recognize the depth of our experience in the region and increasingly look to us for guidance on strategically designing trials there.

APAC pharma coming of age. The large unmet medical needs of people in APAC countries are not lost on local industry and drug regulators, and to address those needs, APAC pharma companies are making inroads in the traditional research strongholds of Europe and the United States. Local regulators are taking a broader view as well. The China Food and Drug Administration recently joined ICH, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, as it seeks to standardize practices in drug manufacturing and distribution. The agency also announced that it would begin accepting data from clinical trials performed outside the country as part of regulatory filings in China.

As a fast-developing country of 1.4 billion people, China presents enormous opportunity as a center for research and a market for new treatments and cures — as does the rest of this traditionally underserved part of the world. For more information, contact our team today.

[1] Custer B, Sullivan SD, Hazlet TK, Iloeje U, Veenstra DL, Kowdley KV (2004). “Global epidemiology of hepatitis B virus”. J. Clin. Gastroenterol38 (10 Suppl 3): S158–68. doi:10.1097/00004836-200411003-00008PMID 15602165.

[2] Liu, J.; Fan, D. (2007). “Hepatitis B in China”. The Lancet369 (9573): 1582–1583. doi:10.1016/S0140-6736(07)60723-5.

[3] Chen W, Shu W, Wang M, et al. Pulmonary tuberculosis incidence and risk factors in rural areas of China: a cohort study. PLoS One. 2013;8(3):e58171.