Excellent read! Boiling it down to big companies being inherently structured for throughput, not efficiency really stuck with me.
The idea of a two-week NDA process not being seen as critical because these teams still still work on other drugs in the pipeline, and it's only when you have a single drug that you pay attention to every blocker, collaborate and bring processes in-house, and end up changing a hundred small things that all add up to a dramatically faster release.
Excellent read! Boiling it down to big companies being inherently structured for throughput, not efficiency really stuck with me.
The idea of a two-week NDA process not being seen as critical because these teams still still work on other drugs in the pipeline, and it's only when you have a single drug that you pay attention to every blocker, collaborate and bring processes in-house, and end up changing a hundred small things that all add up to a dramatically faster release.
This is great! I'm dying of recurrent / metastatic squamous cell carcinoma, originally of the tongue, and the FDA's pokey slowness is baffling and infuriating: https://jakeseliger.com/2024/01/29/the-dead-and-dying-at-the-gates-of-oncology-clinical-trials