On March 13, PAREXEL announced a partnership with CHA Medical Group (CHA) to enhance its early phase clinical development capabilities in South Korea. A growing hub for drug development, South Korea is ranked sixth in the world for the number of clinical trials conducted in the country . To learn more about South Korea’s drug development environment and why it’s become an attractive location for early phase clinical trials, we sat down with Stanford Jhee, PharmD, Corporate Vice President, Early Phase Scientific Affairs.
PAREXEL recently announced a partnership with CHA to provide biopharmaceutical companies with clinical research and regulatory expertise for conducting early phase studies in South Korea. What factors make South Korea such an attractive location for clinical research in general and early phase studies in particular?
Stanford Jhee: South Korea has become an attractive location for early phase trials due to many factors, including support from the government, strong research infrastructure, easy and rapid access to patients, low costs, and a favorable regulatory environment. According to our analysis of clinical trials registered with the U.S. National Institutes of Health, South Korea conducted more industry-sponsored trials between 2012 and 2016 than any other country in Asia.
Can you expand on these factors and what benefits they bring to biopharmaceutical companies?
Stanford Jhee: Due to the support of the South Korean government and its investment in the industry, drug development programs move rapidly in this market. This level of government support is incredibly beneficial to sponsors. For example, the country’s Institutional Review Board (IRB) and Investigational New Drug (IND) process run in parallel, resulting in faster study initiations. Global programs are a priority and have resulted in a rich pipeline in South Korea. In addition, the regulatory environment follows a Western-style IND system, modeled after the U.S. Food and Drug Administration. This enables sponsors to use the data they collect from their early phase studies conducted in South Korea for global development.
South Korea’s strong research infrastructure also delivers key benefits to sponsors. With English-speaking research staff, an advanced IT infrastructure, and western-trained clinical pharmacologists and translational scientists, sponsors have access to a quality research foundation they would expect in a western location.
One of the more significant challenges sponsors face with running clinical trials is recruiting patients for enrollment. Access to patients is another significant benefit of conducting early phase trials in South Korea. With a population density more than 15 times the average population density in the U.S., high education rates, as well as longer life expectancy , a readily-accessible patient pool is a major advantage for sponsors conducting their studies in this location.
Where and how can data collected in South Korean early phase studies be used?
Stanford Jhee: Studies should be conducted at investigative sites with extensive expertise and experience in conducting clinical pharmacology and early phase studies. By applying ICH Good Clinical Practice, data may be used throughout the world, including submission to major regulatory agencies such as the FDA, EMA, PMDA and CFDA.
It’s clear there are many benefits to conducting early phase studies in Korea. What are some of the challenges sponsors face?
Stanford Jhee: All clinical studies present challenges. However, specific challenges sponsors may face when running early phase studies in South Korea include potential language barriers if a site is chosen without careful review, as well as potential ethnic differences in reporting data to western agencies. Scientists must carefully review the potential ethnic differences and include counter measures, if appropriate. For example, sponsors may want to consider tools like pharmacogenomics and ethnobridging (comparative ethnic sensitivity studies) to explain possible differences.
What specific benefits does the PAREXEL-CHA collaboration deliver to biopharmaceutical companies?
Stanford Jhee: The partnership between PAREXEL and CHA delivers unique benefits to sponsors because it combines PAREXEL’s global clinical research and regulatory expertise with CHA’s experience conducting early phase studies in South Korea.
By working together, we can help biopharmaceutical companies looking to conduct their early phase studies in South Korea from start to finish. We can help sponsors gain access to patients and quickly enroll their studies, generate the data needed for the global development of their drugs, and ultimately bring them to market so patients can access them sooner.
 Business Korea, “Due to High-quality Medical Services Seoul Ranks First in the World in Number of Clinical Trials per City.”
 KoNECT, “The Right Place for Clinical Trials in Asia: Start with Korea,” http://kcc.konect.or.kr/jsp/popup/file/Start%20with%20Korea_20160609.pdf.
CHA Medical Group
Global Drug Development
Regulatory and Market Access