PARXEL - Albert Liou speaks about drug development trends in the Asia Pacific region
I do see three major trends that are happening in the Asia Pacific region. The number one is Japan, because the cost of clinical development is increasing every year and the PMDA regulatory requirement also is allowed to accept the foreign data as a part of the package. That trigger allowed pharmaceutical companies to start to initiate Japan initiatives. This includes the Asia studies and global studies. Because of this trend, there are many advantages. The overall cost is low. The study efficiency-the timeline is shortened and the time market is reduced dramatically. Because of these advantages, I see that Japanese initiatives are increasing. However, this strategy also has alot of challenges, including study conducting, regulatory challenges in different countries and to ensure the variant quality in hospitals in different regions are challenges to this strategy. PAREXEL has the perfect solution and track record for this strategy. PAREXEL started to conduct an Asia study more than ten years ago and we continue in leading this area because PAREXEL consultants have regulatory expertise in this region. They can navigate the regulatory environment for our client. Also, PAREXEL Informatics can provide drug development efficiency in clinical trials as well as consistency and efficiency in data collection and study executions. Since ten years ago, we have accumulated alot of professional experience in this arena. PAREXEL is unique in this area. The second trend I see is in China. The Chinese government made the regulatory environment more favorable to developing drugs from China. Because of this, alot of global pharmaceutical companies or regional pharmaceutical companies came to China to set up their R&D centers in the last five years. This triggered another trend for alot of local Chinese studies in China. This also has alot of challenges for the R&D centers because it complicates the regulatory environment with lengthy timelines and the variant quality and dynamic healthcare policy changes and regulatory requirement and reforms that take place many times. This adds difficulty to conducting a study in China. However, PAREXEL provides a channel solution of a 100% owned subsidiary in China. It is a perfect channel solution for all the global and local pharmas to conduct studies in China. We have expertise in terms of regulatory expertise and local expertise and we are helping clients to un-complicate the regulatory environment. We have medical expertise in this company to help decide protocol and to identify the right site and the right PI for conducting the study. We have global PAREXEL quality and training support to ensure that the staff is of quality and that there is clinical trial execution. PAREXEL is very unique in this trend. The overall trend in Asia is that generic drug companies also establish new drug development companies, emerging biotech companies, in the biosimilar area or new drug development. Those companies lack the man power or talent to do the global study or regional study or even local Phase I/Phase II study. PAREXEL has accumulated more than 30 years experience and a great amount of expertise in this area and is helping to make a drug development strategy and form drug development plans for global submission. The talent we have makes PAREXEL a unique company for these trends.