The Role of the Asia-Pacific Region in Global Drug Development Strategy
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The Role of the Asia-Pacific Region in Global Drug Development Strategy
5. Edmrnd Tsrei, PhD Regional Head, Pharma Development Operations. Asia-Pacific-Africa. Roche Products Pty Limited, Australia
Key Words Asia-Pacific; Commercial potential; Drug development potential: Capacify; Capability Correspondence Address Dr. S . Edmund Tsuei. Roche Products Pty Limited. 4 - 10 lnman Road, Dee Why, NSW 2099, Australia (email: [email protected]).
The views expressed in this article are entirely those of the author and d o not reflect fhe views of Roche Products Pty Limited.
Asia-Pacificis a region of high economic growth with largeforeign currency reserves. IMS Health reported that the Asian pharmaceutical market was the fastest growing region in 2 W , with more than double theglobalgrowth rate. From a commercial perspective, it is a region that will drive growth in the future. From a drug development perspective, the large population with an increasingly Westernized lifesqle and disease patterns, together with a large pod of health care professionals and a favorable competitive environment, will allow fast recruitment ofpatients, resulting in shortened drug development time and allowing early access to innovation by patients as well as cost savings to the pharmaceutical industry. The lack ofclinical trial experience is compensated for by the return of highly skilled Asians from overseas. Many governments have made significant investment in both infi-
INTRODUCTION One ofthe major challenges facing the pharmaceutical industry is low research and development (R&D)productivity. Despite significant increases in R&D investment, R&D output, in terms of number of new molecular entities (NMEs) approved by regulatory agencies, has been declining. In 2007, the US Food and Drug Administration (FDA) approved only 18 truly new medicines-16 drug NMEs and 2 biologic NMEs (1). The need to reduce costs and shorten drug development timelines has led to the restructuring of R&D activities in the pharmaceutical industry. Reducing development time will not only allow earlier access to new pharmaceutical products by patients, it will also reduce development costs. Dimasi showed that a 50% reduction in development time will result in a 29% reduction in development costs (2). The International Conference on Harmonization (ICH) released its Guidelines for Good Clinical Practice (GCP) in 1996, setting global minimum Ihq I~ifi~rr~intiori .ka~niul,Vd. 43. pp. 35-40.2009 0092-8615,2009
structure and training to ensurequality.National GCI! based on ICH GCE has been launched in all major countn'es within the region, and GCP is law in many counkes. Results of FDA clinical inspections published on its website showed quality similar to North America and Western Europe. Regulatory agencies have made significant improvements in terms ofefficiencu, and the timeline for clinical trial approvals is now competitive on a global basis in most countn'es. The formation ofFERC4P in 2000 and its tmining and recognition programs have made signijkant contr
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