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» 23/07/2009 [Company watch]
China Aoxing Pharmaceutical Corp. Receives Renewal of GMP Certification for Capsule Dosage Form of Pharmaceutical Products
» 15/03/2010 [Industry news]
Recordati S.p.A And Lee Pharmaceutical Announce Partnership For Zanidip(R) In China
» 26/10/2009 [Finance]
China Growth to Remain Fast in Fourth Quarter, Official Says
» 17/08/2009 [Industry news]
Chindex Posts Profit on Product Sales, Health Services
» 07/05/2010 [Industry news]
Hong Kong: Recall of all products manufactured by Quality Pharmaceutical Lab Ltd
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»24/09/2009 [Independent reports]
Clinical development trends in APAC in recessionary environment

With ‘green shoots’ (recovery from the economic downturn) appearing in the global economy, it is a good time to consider what is happening in the Asia Pacific (APAC) biopharma scene. Dr Ross Horsburgh

With ‘green shoots’ (recovery from the economic downturn) appearing in the global economy, it is a good time to consider what is happening in the Asia Pacific (APAC) biopharma scene. Four trends stand out: continued rapid growth; increased focus on innovation; differentiation of opportunities; and India’s increased importance. Like bamboo, Asia’s green shoots grow faster than those in the West. IMS Health predicts low single-digit pharma growth for EU and the US, but double-digit growth rates for APAC over the next five years. With much of their incremental growth revenues coming from APAC, over the next decade, biopharma companies are shifting R&D spend into the region. This is not just to leverage the well-publicized lower costs and faster recruitment benefits, but is also about market access—as placing global trials in APAC speeds up product launches and product penetration. For us in the CRO space, this is of course very good news. Business for CROs is predicted to grow even faster than sponsor company growth. Why? Because in addition to the shift of R&D spend to APAC, many sponsor companies simply do not have large organizations in the region. Engaging a CRO means sponsors can go straight to a more agile, and flexible outsourcing model without complications of managing legacy and headcount issues. Growth remains the key word for APAC. Global biopharma and CRO companies are increasingly observing their success in APAC as a surrogate measure of their global success. The companies now realize that they cannot succeed globally without being successful in APAC. Innovation is becoming a buzz word for APAC. Some of this is traditional biopharma innovation generated in the labs—and the world will see more novel compounds appear from companies such as S-Bio in Singapore. The next decade will also see APAC biopharma companies replicating the process and enabling technology innovation, which is seen in the IT and electronic industries. This innovation will act synergistically with Asian advantages for drug development. A great example is the drug development enabling website, This site (incidentally set up by a Korean entrepreneur Jae Chung) will enable Next Generation virtual drug development companies to more easily tap into the burgeoning talent in APAC. Imagine the formation of an Asia-enabled drug development machine, which leverages Asia’s lower costs and faster project cycle times, to get products much faster and cheaper than in the West. This has the potential to change the global biopharma operating model in the same way that Japanese car manufacturers transformed the auto industry. For global CROs, there’s tremendous opportunity to facilitate innovation in APAC by providing a bridge between East and the West. As the region matures, greater differentiation is becoming apparent. I have always referred to the APAC region as a portfolio of countries, each with different opportunities. For example, the fast, efficient and predictable regulatory environment in Singapore allowing early site initiation, massive population in India and China providing rapid enrolment and Taiwan’s pedigree in oncology studies. Now, there is more clarity about what these differences are, and experienced CROs are better able to allocate development projects across different locations to optimize the mix of benefits and minimize downsides. Expect this trend to continue. Singapore provides a good example. Recognizing the limitations of its relatively small population, it is becoming a regional center-of-excellence in early-phase studies, that require small subject numbers but a fast and predictable regulatory environment. Another ‘small’ populated country, which is building on an already strong reputation in the early-phase space is Australia. Expect Australia to increase its focus on Health Economics and Outcomes Research (HEOR) work as there is a tremendous experience base, thanks to the strict requirements of their regulatory and reimbursement environment. CROs will also become more differentiated. People in APAC still have difficulty in explaining the differences between various CROs. However, the industry’s rapid growth in the region will provide real opportunities to build differentiated CROs in the region. CROs will be differentiated on the basis of service offering and leveraging across centers-of-excellence in different locations in APAC. For example, biometrics capability in India and China, regulatory and HEOR consulting in Australia and market access insight in China and Korea. Differentiation also will occur with certain product related opportunities. APAC has become the center-of-excellence for oncology studies as highlighted in a recent research article. Biosimilars are an area of real opportunity for APAC with companies such as Celltrion in Korea making global impact in this growing sector. The final trend that is increasingly prominent is India’s emergence as the hot growth area in drug development. Volumes have been written and many conference-hours spent discussing India’s clinical research capabilities, yet the story is still unfolding. India continues to offer new, unanticipated and interesting opportunities. The original drivers of low cost and access to patients continue to be attractive. India is making its regulatory system more robust, stringent and effective, which will further increase the country’s appeal. Those traditional benefits will ensure India to grow rapidly in its drug development industry for many years. India is also the real source of innovation, particularly in how things can be done better and more efficiently. One such idea is reversing the usual talent deployment approach for successful delivery of international projects. Traditional deployment of talent involved placing project leaders in more mature clinical research markets, while India/APAC’s participation remained limited to lower level functions in the value chain (e.g., monitoring and data entry). However, working towards maturing local talent to higher level functions in a systematic way offers several advantages including enhanced efficiency, 24/7 leadership coverage for projects and a ‘can do’ mindset that really resonates well with sponsors. For example, local employees at Kendle India love the career opportunities this provides, with the result, we enjoy as one of the lowest turnover rates of the employees in the industry. Macro level trends for India includes: (a) relatively stable economy and buoyant local biopharma companies and (b) well rounded progress of clinical development functions marked by addition of newer services, and as reflected in recent strategic deals initiated between top 10 multinational companies with Indian giants. Of course nothing is perfect. A wish-list for what can make India an even better destination includes: synchronization of Indian regulatory processes with other leading regulatory authorities (eg; FDA, EMEA, ASEAN), mass-awareness and education for media to avoid sensationalizing occasional bumps along the way and taking clinical development deeper into India’s massive population. In summary, it’s hard not to feel lucky to be working in APAC during this global recession. Even if growth rates have dropped, there’s a sense of optimism in the region about APAC’s increasing role in the global clinical development. People here are too busy building for future to spend much time looking for green shoots. © BioSpectrum Bureau

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