25-26 May 2011, Singapore – Asia’s stakeholders in early stage trials gathered for a two-day discussion and forum with a common objective; Is Asia Ready to play a bigger role in Early Stage Trials?
Among the highlights:
Dr Yuko Tsukamoto (Janssen Pharmaceutical) discussed the “Drug Lag” in Japan, and the strategies MHLW & PMDA had put in place to overcome this. Dr Tsukamoto also presented Janssen’s innovative clinical development strategy to shorten timelines.
Dr Darshan Bhatt (Vanthys) discussed shared their strategies in ensuring a safe transition from First-In-Man studies to Phase 2 studies. The most common paradigm in Phase 1 trials has been the Dose Limiting Toxicity or the Maximum Tolerated Dose. While subject’s safety is paramount, efficacy signal is an added benefit which can be explored combined with emphasis on correlative studies. Quoting Dr Bhatt “Being a Phase 1 trials is not as simple – it requires courage”
Dr Zaiqi Wang (MSD) shared his opinion what will make Asia attractive for Early Clinical Studies. CROs must aim high and be on par with CROs from US/Europe. Transparent & predictable regulatory outcome is vital. Flexible and adaptive IRB/IEC. Greater focus on processes and human factors vs hardware. Adequately resourced investigative sites for procedural intensive studies. Speed & Cost.
Dr TC Lee (Info Kinetics) gave an insight to Malaysia, the emerging early stage clinical research. Malaysia has real potential to become a clinical research hub in the region, especially with a strong commitment of the government to the sector. Malaysia’s competitive edges in this sector include strong support from the government, stringent drug regulatory policies and diverse genetic pool of human subjects. Under the Malaysia My Second Home Program, Malaysia has a large pool of expatriate community that could contribute to the growth and development of clinical research.
At the end of the 2-day conference, we can all agree that more trials are now shifting to emerging regions, such as developing countries in Asia. The diverse genetic pool of human subjects and effective cost in Asia remains as the key drivers to shift early clinical studies to Asia.
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