NDA/BLA Submission Tips
Preparing an NDA/BLA submission is a big deal. It takes a lot of people working in unison to pull together lots of information and data into the proper format. Efficient submissions are achieved by highly organized teams that do the necessary prework to make the final push as smooth as possible. These tips might seem simple, but sometimes the simplest solution is the best.
Review Team Composition. BLAs and NDAs are a high profile enterprise. While there is pressure to add names to the review teams, keeping review teams as lean and focused as possible will make a huge difference in terms of efficiency and speed.
Table, Listing, and Figure Output Review. Make sure that the team knows what is coming for clinical data-driven aspects of the submission. Ensure that your analysis plans are final and include a full list of outputs (TLF shells).
Document Shell Review. Creating document shells can be a great way to prepare the team for what is coming. Use draft data or mock table shells as placeholders to give the reader a feel for how the document will shape up.
Team Engagement. All the preparation is just busy work if the team is not critically engaged. If the team doesn’t sharpen their focus until the last couple of months (or weeks!), then you are not going to have a smooth finalization period.
Adapt. The final data will drive the messages. Prepare for success, but leave flexibility in your documents to pivot and create stronger and more accurate conclusions.
Don’t Go Overboard. Review fatigue is real; overwhelm the team too early and they will burn out. Try to keep a realistic perspective on when the prework becomes a waste of time and resources.
Michael Claffey, VP, Acumen
