In response to escalating costs of clinical development in North America and Europe, a new approach may be needed for de-risking therapeutic drugs. The panel will explore whether offshore clinical development is a viable strategy for exploring therapeutic utility at reduced cost without compromise in patient safety. The discussion will cover real vs. perceived differences in the economics of offshore clinical development, associated operational and regulatory implications, clinical indication impact on feasibility as well as regional differences. The hurdles to FDA or EMEA acceptance of offshore data as well as the cost/operational risk trade-offs involved in pursuing such a strategy will be addressed.

• Describe the differences between regulatory and operational requirements of clinical development in Asia — specifi cally China and India, and the US and Europe
• Outline what a realistic offshore clinical development strategy might look like for an emerging biotech
• Describe the specific challenges that would have to be addressed to implement such a strategy