Business Of Biotech

009: CMC Considerations For In-Human Studies with Drs. Edith Perez & Nathan Ihle

Sep 21, 2020
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1
Introduction
00:00 • 4min
2
The Importance of an IND for Research
03:38 • 5min
3
The Importance of Accurate Manufacturing in Preclinical Models
09:07 • 4min
4
The Importance of Collaboration in the CMC Section of the IND
12:44 • 3min
5
The Importance of International Collaboration in First in Human Studies
16:14 • 3min
6
The Role of Patient Centricity in First in Human Studies
19:19 • 2min
7
The Patient Centricity Conversation
20:53 • 3min
8
The Importance of Listening to Patients
23:50 • 1min
9
The Evolution of the CMC Package at Bolt Bio
25:05 • 5min
10
How to Manage and Document Changes to CMC
29:52 • 5min
11
Scalping Scalp: Common Pitfalls and Problems
35:04 • 2min
12
The Importance of Close Coordination With Health Authorities
36:58 • 5min
13
The Importance of CMC in a Successful ID
41:53 • 3min