009: CMC Considerations For In-Human Studies with Drs. Edith Perez & Nathan Ihle
Business Of Biotech
00:00
The Importance of Accurate Manufacturing in Preclinical Models
In the I and D, we have essentially three main components. We are touching on the manufacturing aspect. The other two components are the preclinical data that really justify our interest or confidence that this is an agent that is appropriate to go into into human studies. So having this accurate manufacturing is extremely important. You know, it's actually our ethical obligation to do so. And we want the same agent that we tested in preclinical models to be evaluated in patients.
Play episode from 09:07
Transcript
