009: CMC Considerations For In-Human Studies with Drs. Edith Perez & Nathan Ihle
Business Of Biotech
00:00
The Importance of Close Coordination With Health Authorities
You need to be very careful as you go up and scale, especially with biological processes. And so every time you do this kind of a change, every change needs to be assessed. There's no clear bright line that defines how much changes too much. If you change the molecular entity, that's obviously a change that is going to have to start from scratch.
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