Asian countries can offer great value as locations for clinical study sites. This is the second of a four-part series on getting the best out of your Southeast Asia clinical trial strategy. This article will focus on South Korea, the biggest country in the so-called "Tier 2" Asian countries, which also includeTaiwan, Singapore and Hong-Kong. The latter three countries will be discussed in PartIIb of this series.
As a group, the four Tier-2 Asian countries have a strong potential to be knocking on the door of the lone Tier-1 giant, Japan. The one common factor that has brought these countries this far is a strong government commitment and 360-degree vision to be competitive with the West. This aspiration to be on a par with Western standards of quality and good clinical practices has resulted in exponential improvements in facilities, infrastructure, human resources and streamlining of regulations.
From the perspective of both timelines and costs, biotech companies in the US and Europe would do well to consider an Asia-first clinical development strategy. In particular, for four therapeutic areas - Cancer, Heart disease, Diabetes, and Infectious Diseases - South Korea is an attractive place to start.
So what do we mean by "Asia-first?" Picking up where we left off in the introductory article, let's go back to our US-based biotech company with a preclinical lead candidate. The conventional approach would be to follow a "US-first" development strategy. That is, yourdevelopment plan would be to obtain US FDA approval and launch first in the US, and then proceed to the EU and Asia. An IND-enabling data package would be focused on obtaining approval for conducting clinical trials in the US. This would put you in line to seek an out-licensing deal with a big pharma company following successful completion of Phase I / II.
In the "Asia-first" approach, the IND-enabling data package should be such that it would pass muster in both the US and an Asian country, say Korea. The idea would be to carry out early- and late-stage clinical studies in Korea with express purpose of first launching the product there, and then expand to US/EU. This approach would also be consistent with the current vogue of "virtual company" start-ups, where much of the development work is outsourced to CROs. Today, conditions in Korea are ideally suited to pursue this approachand make it a viable proposition. These factors are:
- High market potential for newly discovered pharmaceuticals
- Strong government commitment and programs to promote new drug R&D for both domestic and global markets
- Over 15 years of experience and steady improvement in training, building and enforcing compliance with international Good Clinical Practice (GCP) guidelines
- Relatively large and accessible patient pools, guaranteeing decent accrual rates in the four therapeutic areas mentioned above
- Increasing ability to conduct early-stage (Phase I) clinical trials
- The presence of a robust CRO industry for clinical trials outsourcing
With a population of over 51 million, South Korea is the third largest pharmaceutical market in Asia behind Japan and China and the tenth largest worldwide. Revenues clocked $18 billion in 2015 and are projected to surpass $20 billion in 2020, according to a GlobalData report released in April 2016. The Korean pharmaceutical industry comprises domestic giants, such as Donga and Hanmi as well all the global pharmaceutical companies, such as Pfizer and GSK. Korean pharma companies have been investing in R&D, with R&D as a percent of sales steadily rising from 5 percent in 2009 to almost 8 percent in 2013 (compared to US pharma R&D spending of nearly 20 percent of sales in 2015). The strong domestic R&D climate has provided the impetus to produce a highly trained and motivated cadre of experienced scientists and clinical investigators supported by professional nurses, clinical research associates, etc.
Since year 2000, the Korean government has embarked on an aggressive program to beef up and streamline the country's clinical trial capacity and capability. In 2013, Korea ranked number ten in the number of clinical trials conducted. The clinical trial approval processing time has come down dramatically from 120 days in 2000 to 28 days in 2014. According to data from the Ministry of Food and Drug Safety (MFDS), the number of Investigational New Drug (IND) approvals for sponsor-initiated multinational clinical trials grew from five in 2000 to 291 by the end of 2014, and domestic trials rose from 28 to 361 during the same period. In 2014, 49 drugs were approved by the MFDS of which 27 were new drugs.
Over 98 percent of the population in South Korea is enrolled in the mandatory universal health insurance system. This serves as a centralized resource to identify and access good patient pools for clinical trials.
Another significant consequence of the abundant expertise acquired from domestic R&D is the fact that more and more early phase clinical trials are being conducted in South Korea. The number of Phase 1 clinical trials of Korean pharmaceutical companies has doubled from 75 studies in 2010 to 152 studies in 2014. Multinational Phase I clinical trials increased from 23 in 2010 to 40 in 2014.
With domestic and global R&D feeding off each other, supported by a large pharmaceutical market, world class facilities, infrastructure and human resources, and positive government intervention, South Korea is poised for exponential growth in new drug development.
*Ramani A. Aiyer, PhD, MBA is the Principal at Shasta BioVentures, San Jose, California, USA. To post comments to the author, Ramani can be reached at: [email protected]