009: CMC Considerations For In-Human Studies with Drs. Edith Perez & Nathan Ihle
Business Of Biotech
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The Role of Patient Centricity in First in Human Studies
There are strictly regulated guideposts around first in human studies. But within those guideposts, there are corporate or cultural approaches that vary a little bit from one company to the next. What do you consider the central tenets of patient centricity as you enter a first in human study? We need to be very cautious to be sure that we thoroughly understand they're not only their interest or what the regulatory environment that they practice on.
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