The Importance of International Collaboration in First in Human Studies

It's really important as you design your first in human studies to make a conscious decision about what countries you want to work in because each country may have some different expectations and different regulations that you need to be aware of. There's been a strong global effort to try and harmonize much of the CMC expectations and not just CMC but the whole, the whole drug development process. The expectations for running a first in human study in Australia are somewhat different from South Korea or the US. You just need to work with your clinical colleagues, work with your regulatory colleagues to define where you intend to run your F.I.H. program. And then also looking ahead after that F.I