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Session 3 - APAC-Initiated Global CT: Go Global Clinical Development Strategy
Session Chair(s)
Vicky Hsu
Senior Vice President, Head of Project Leadership and Biotech Operations Asia
Parexel International, Singapore
Sannie S Foong Chong, PhD
Senior Director, Global Regulatory Policy
MSD International, Singapore
Historically, global clinical trials have been launched from the U.S. or EU, while clinical trials in APAC tend to be done in a single country or a few countries within the region. In this session, we explore the steps needed for making the leap to APAC-initiated multi-regional/global clinical trials. Strategies such as acceptance of foreign data, regulatory harmonization and reliance and streamlined utilization of existing services can get us there. Join us to gain expert insights for how to bridge the gaps to going global from the APAC region.
- Consideration for development, different therapeutic targets, strategize development approaches for going global/ MRCT.
- Stepping out from single country approach.
- Acceptability of foreign clinical data by major NRAs, utilising existing services.
- Feasibility of CTA regulatory reliance approach .
- Bridging the gaps to be global – into ASEAN townhall discussion.
Speaker(s)
Challenges and Opportunities of Developing Drugs in Asia
Damian O'Connell
Experimental Drug Development Centre (EDDC), Singapore
Chief Executive Officer
Innovative Trial Design with Regulation Considerations
Hueybee Pey
Parexel, Singapore
Senior Director, Project Leadership
Moving Forward Together in APAC Clinical Trials
Joyce Lim
AbbVie , Singapore
Associate Director, Clinical Development Organization
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