Asia-Pacific countries are becoming the new hub for clinical trials, luring biotech sponsors from Europe, and even America, to conduct research in the Far East. Since 2016, Asia’s clinical trial activity increases by 26% per year. A number of factors are involved including regulatory reform, improving intellectual property rights and a burgeoning principal investigator (PI) scene with over 43,000 PIs and key opinion leaders.
Improving Regulatory Landscape in Asia-Pacific
As reported in Labiotech, regulatory progress moves at a fast speed as national authorities in Asia seek modernization, health progress and strategic position in the global clinical trial landscape. Whether it be China’s modernization—decreasing by 16 months regulatory timelines since 2016 to its forthcoming proposed fast-track reviews for clinical priority indications and breakthrough technologies, a series of reforms are imposed to improve drug review processes, compressing IND and NDA timelines and boosting the development of innovative drugs within the world’s most populous country and second-largest economy.
Asia-Pacific may have attractive advantages to conduct clinical trials over Europe and North America as biotechs seek to commence ever more clinical trials. Challenges for European and North American biotech at home including:
· Trial density (national population divided by the number of recruiting sites)
·Less competition within Asia-Pacific
·Few patients that have been exposed to trials before (treatment naïve populations)
· European and North American biotechs have greater opportunities to bolster enrollment in certain therapeutic areas such as gastric cancers or liver diseases if they move more studies to Asia-Pacific (more prevalence in Asia)
·Access to a myriad of different ethnicities (Required for many drugs)
Asian CRO Novotech Reports
First clinical trials are not growing nearly as fast as in Asia-Pacific—10% in Europe over the last 12 months. Yooni Kim, Executive Director of Asia Operations at Novotech reports that European biotech apparently occurs at far greater levels later in the pipeline. The implication of this is clear: Europe’s biotechs will seek to expand their R&D programs to other locations where trial density is lower and where sponsors can find high-quality sites.” Asia offers the answer.
Novotech, based in Australia, of course, utilizes the rest of the article to position its strength to help European or U.S biotech companies enter into Asia-Pacific to conduct clinical trials.
Call to Action: We recommend if biotechs in Asia or Europe seek to explore Asia Novotech is a sizeable, reputable CRO and Yooni Kim is a knowledgeable executive to discuss the various options. With a Ph.D. in regenerative medicine, Ms. Kim has been involved with Asian clinical research on the CRO side for nearly two decades.