What a Real Submission Timeline Looks Like

All submissions (INDs, NDAs, BLAs) are built on a series of interconnected timelines that stitch together how scores of documents will be written, reviewed, QCd, published, and ultimately submitted. Timelines that do not take into consideration the specifics of each task they describe are almost as bad as having no timelines at all. It might go without saying, but a team tasked with doing the impossible might feel a tad discouraged.

For your next submission, make sure that your PM (the owner of the timelines) appreciates and has accounted for the full complexity of what is being described, which allows them to know what tasks can be shortened and which ones can’t. One way around this is to engage Fernando Venegas and his team of project managers at Acumen. They have spent time in the submission trenches working with cross-functional teams, and know the important nuances of planning, like how to account for late-arriving GLP toxicity data in an IND without compromising the timelines.

Justin McLaughlin, CEO