009: CMC Considerations For In-Human Studies with Drs. Edith Perez & Nathan Ihle
Business Of Biotech
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The Importance of Collaboration in the CMC Section of the IND
The CMC section of the IND requires a lot of collaboration organizationally within a company like Bolt Bio. Manufacturing preclinical, clinical, quality and regulatory are all different personas within the company who kind of amalgamate at that point in time. So FDA obviously puts a lot of emphasis on CMC and ultimately that's to benefit patient safety. Are there any other maybe less obvious reasons that FDA emphasizes the CMC portion of the IND so much?
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