August 19, 2024 at 2:16 pm
I agree with Aaron about the concerns with shipping unlabeled material to a site. This might be possible in the US but significant controls will need to be put into place. Outside the US I do not see that as a way to speed up the timeline given the regulations. If the trial is going to be in the US labeling requirements are minimal. Could you create a very generic simple label under a faster timeline?
Is your drug solid oral? I spent a number of years working on a dedicated early phase team that created a rapid PI program using drug-in-capsule and a standardized packaging/labeling scheme. We were able to transition from a drum of drug substance to the clinic as quickly as clin ops could write and prepare the protocol. It was an extremely efficient system if your drug is in that category. The concept could be applied to sterile liquids although we did not have the opportunity to push that while I was on that team.