Your Role at ICON:
I joined ICON in May 2010 to head up the Clinical Operations in China and lead the group of clinical-trial professionals based in Shanghai, Beijing, and Hong Kong. I am responsible for ensuring the optimal management of resourcing to meet the best interests of our clients. In addition to supervising daily operational activities, I am also involved in a wide range of business development initiatives and provide strategic inputs to support planning in terms of long-term business expansion.
I started my career in Taiwan and later moved to Seoul, South Korea to take charge of the country's operations for a global CRO. During my 12-year experience in the industry, I have gradually developed my expertise, ranging from global project management to providing strategic input to optimize study deliverables. From 2008–2010 I worked in Japan, providing guidance on the implementation of global clinical trials involving Asia Pacific and Japan, focusing in particular on the harmonization of operational processes. I hold a bachelor's degree in public health, a master's degree in genetics, and I am also a Certified International Project Manager (CIPM), awarded by the American Academy of Project Management (AAPM) in 2005.
To date, the main highlight has been my work with ICON. We have accomplished some remarkable achievements through coordinated teamwork. The team has constantly exceeded milestones by proactive planning and timely identification of resource needs, which has helped to secure the global last-patient-in (LPI) timeline and triple the initial target of country enrollment despite late participation in the trial. A recent case study, in which we achieved the first patient screen (FPS) within 8 weeks of receipt of State Food and Drug Administration (SFDA) approval, illustrates our successful proactive study management. We are also excited about the prospects for further expansion. In November, we moved into a new larger facility in Beijing and opened an office in Shanghai to help meet the growing client demand in China.
What are the most challenging factors in your role?
One of our biggest challenges has been hiring and retaining competent and experienced staff. The rapid growth of the Chinese pharmaceutical market, which was the fifth largest in the world in 2009 and is expected to become the third largest, has created great competition for the local talent pool. We work with a local recruitment agency on a strategic level and we put a lot of emphasis on training and developing our local team. In addition, it's of the utmost importance that we build core competency around firm teamwork, which is the strong foundation of the organization's culture and market branding. This enables employees to have a clear concept of their potential career path and also the opportunities for individual long-term development along with company growth.
What are some of the key factors attracting sponsors to your region?
Probably the most important is cost efficiency. Involving China at an early stage of a global drug-development plan can shorten by 2–3 years the lead time to launch a drug in China. China provides good access to large populations of treatment-naïve patients, which can help to secure the global LPI target, and there is a widespread network of clinical trial sites operating to GCP standards, with 384 SFDA-accredited sites across the country. The regulatory framework is being improved to reduce review and approval times and to harmonize regulations with those of the EMA in Europe and the FDA in the USA. An example is the SFDA special review procedures, which were introduced in January 2009. Finally, the improvements being made to intellectual property protection mean that companies are more willing to establish operations in China.
What advice would you give to a client considering China for a clinical trial?
Firstly, I would recommend that contingency plans are developed to cover all the clinical trial processes from regulatory challenges to study delivery. A proactive feasibility study should be performed to develop a site selection strategy and identify appropriate investigational sites. This will help to ensure future site performance. Training requirements will need to be tailored to the city tier. Approximately 60% of trials are conducted in first-tier cities, such as Beijing, Shanghai, and Guangzhou, which account for 25% of SFDA-accredited sites. Investigators at sites in second- (e.g. Chengdu, Tianjin, and Nanjing) and third-tier cities are eager to participate in global clinical trials but are less experienced than those in first-tier cities. Active support for site management will be important for those trial sites that are less experienced in global clinical trials. In summary, I would say that the key to success is to look for a partner with an experienced team that is able to leverage local knowledge to provide the necessary resources for effective trial management.
What incentives is the government introducing to improve the R&D landscape in China?
The Chinese government has a number of initiatives to promote local biotechnology and medical research and to improve infrastructure. It is calling for an investment of US$125 billion to enhance the healthcare system from 2009–2011 and has further increased the life-science budget to US$147 billion in the 5-year project. The investment will focus in particular on R&D development in 10 key diseases, including oncology (the number one disease nationally) and cardiovascular, to leverage efforts with multinational pharmaceutical companies, which are increasingly establishing R&D facilities in China.
With government commitments to continuously enhance the regulatory framework and promote biotechnology, ICON is looking at a promising expansion in the Asia Pacific market, in particular, an optimistic double-digit growth in China over the next 5 years.