Updated on 13 April 2012
A fundamental goal of QuintilesAsia Strategic Drug Development Unit is to work with sponsors to map out a strategic plan that has the end game in mind not simply moving from phase to phase of the trial process but truly understanding the regulatory and market-entry barriers that need to be met once the end zone is reached. This type of strategic planning wraps a safety net around the clinical trial time-line, so that the sponsor can be assured that the time spent in each phase will not be wasted.
In the 1990s, clinical trials were performed in Asia merely because of access to patients. In the last decade, the commercial opportunities of entering Asia markets with global products were recognized. Currently, there is a trend for reverse innovation in which Asian disease trends and medical needs can guide global R&D planning. Asia, however, is different from North America and Europe; it has no unifying FDA or EMEA. The regulatory landscape in Asia is complex. China, Japan, East Asia and the ASEAN countries all have regulatory bodies that differ as widely as their languages, ethnic differences, disease trends and cultures. A strategic plan that works well for the US and Canada may be inappropriate for Taiwan, Korea and Japan. Without Asia-focused regulatory and clinical strategic expertise, physically located in the Asia Pacific region, it is unlikely that globalization of Asian healthcare solutions will occur as quickly as the partners aspire to.
Activities within Asian drug development over the next few years will be interesting to observe. One would predict that the CROs with Asian aspirations will adjust their hiring priorities. Rather than doers of operational tasks, they will focus on the thinkers with vision, Asian cultural sensitivity and ability to plan strategically.
Ten years ago, it was unthinkable that a CRO would have a department of strategic planning focusing solely on Asia. Today, it is a reality.
The author Dr Anthony Rebuck is senior medical consultant, Strategic Drug Development (SDD), Quintiles Asia, Singapore. He guides clinical and regulatory strategies for clients wanting to develop their medicines in Asia. He has also held senior leadership positions in GSK and Pfizer. He was formerly professor of medicine at the University of Toronto and a respiratory medicine specialist at the Toronto Lung Clinic.