Drug Development 101: How to Build a Good Review Team, Tip #4

We at Acumen write a lot of documents and work with many cross-functional teams. We get a front row seat to see what works (and what doesn’t) when it comes to document development. Before building a document, you need to build a review team which basically boils down to the following:

• Keep it lean

• Stay in your lane

• Know your roles and responsibilities

• Set realistic expectations

Realistic Expectations

Timelines, while the bane of our existence, are critical for meeting goals. However, they only work if they are realistic. Documents are often written with a specific completion date in mind and often start out being very aggressive. One “realistic” thing universal to all timelines is that they almost always change. All review team members need to prepare for this from the start and look ahead to personal calendars for competing or conflicting activities or out-of-office time and identify back-ups. The consideration of potentially immovable factors, such as data availability, external report finalization, holidays, or company closures, and competing resource expenditure of your reviewers, as part of initial timeline development can mitigate the need for substantial delays (and uncomfortable conversations with senior management!) down the road.  

Advice: Save time and trouble by starting with a realistic timeline and have the courage to speak truth to senior management if their expectations conflict with reality.

(Not so) Funny Anecdote: We once worked with some senior executives who had the idea that an NDA could be written in 2 weeks from final data. Answer, it’s more like 4 months.

-Justin McLaughlin

CEO, Acumen Medical Communications