A Tale of Two Timelines
Once upon a time, Far Far Away Therapeutics was hosting a kick-off meeting for the most important regulatory submission in its history. The gala affair culminated with the unveiling of the magnificent project timeline. All admired its milestones! The delicate weave of its tasks! The shimmering critical path! These elements made for a Most Beautiful Timeline. But what caused the most merriment that day was the promise of a swift completion.
The projected submission date did seem a tad ambitious, but the planning was perfect, and the work would surely take care of itself (wouldn’t it?).
If truth be told, the Most Beautiful Timeline was folly, its dates greatly adjusted to please the Court, not to reflect any sort of doable plan. The team forged ahead, however, and dissent in any form was silenced. The feasts, fairs, and tournaments that marked the early phases were jolly good fun, but soon it became clear that too much time and resources were being allocated to celebrate the launch of trivial tasks, while submission deliverables were hastily sacrificed in the name of speed.
By midwinter, milestones were missed and the backlog became unfathomable. The team was disheartened and chagrinned. But one afternoon, help arrived. An unassuming project manager agreed to offer assistance by creating something called, simply, The True Timeline. This new document was based on realistic goals and a smart evaluation of resources, facts, and assumptions. With little fanfare and much coordination, the team set to work. Soon, the project was back on track and the submission was sent in on time. When approval was granted, Far Far Away Therapeutics rejoiced, tipping their goblets to The True Timeline and their team’s success.
In the Lessons Learned meeting held at Court the next day, some attributed the project’s dramatic turnaround to magic. Other, more pragmatic witnesses were inclined to believe that the correct fulfillment of two fundamental needs were to thank: experienced writers and a well-informed plan. But we will never know for sure.
But we do know this: an experienced medical writer can distinguish fairy tale from reality. Strong program and submission managers working closely with drug developers can engineer a solid and realistic plan to execute their submissions. From data science, through medical writing, to editing and publishing, the whole team needs to be aligned to successfully see the project through to the end – Happily Ever After.
