Somewhere over the rainbow, there’s:
The funding round
The clinical trial interim results
The next stability time point
THE manufacturing slot at the CDMO
So many things in drug development take place in the future, that its easy to forget the present when waiting.
Did the team capture all the knowledge gained so far?
Go ahead and finalize that report.
Capture all the data in your knowledge system
Don’t have a system? Create one! It doesn't have to be fancy, but folders, files, and reports are NOT a system.
Update your company slide decks.
Draft the next version of Module 3 sections with what’s already known…
Think of all the dry work that nobody wants to do- and do it!
Not only does it not cost you anything beyond the team’s time- you might realize there are some gaps that are better attended now, at ease, and not when the investors/regulators or your CDMO comes knocking on the door.
Do you have a little budget left for some minor wet work and process improvements?
People think of process development as BIG efforts- scale-ups, new technologies, tech transfers and more.
But the reality is that some efforts are minor and oftentimes neglected.
That alternative source for an excipient, or optimizing the chromatography parameters- those could be within budget and generate invaluable data for when the time comes to actually change something in the GMP process.
And the added benefit is time! Because stability can’t always be sped up, and even exploratory data can get you some early hints before going all in with a change.
None of these things can be done quickly, so why not do them now?
Look for the low-hanging fruits while waiting for the big events.
Any stories of things you wish you had done when there was nothing else going on, and now when everything is blowing it's just too late?
Would love to hear about it in the comments!
Want to dive deeper into the CMC Development rabbit hole?