#5SmartReads - December 2, 2020

On Georgia, the Royal Family, and the war for Christmas (movies)

Scoop: FDA chief called to West Wing (Axios)

I want to share one of my first days working in pharma.

I spent my first 3 months onsite at one of our partner companies, and on my first day I helped put together and package an FDA follow-up submission for one of our jointly developed products.

And I mean that literally.

Probably a hundred thousand pages were printed, hole punched, placed in binders, checked and checked and checked again, and placed into boxes. I was in the office with the rest of the team until 1 am, packing each of the binder in the correct box.

And this was a follow-up submission.

An FDA submission is reviewed by teams of experts in clinical and nonclinical development, formulation and chemistry, and manufacturing. It takes a lot of time to review every detail to ensure a therapeutic is safe and effective, especially when it’s a vaccine for a deadly virus that’s killed millions across the world and infected over 63 million.

I hope you consider this context as you read this ar…