What Is A Data Science Mindset — And Does Pharma R&D Really Need One?

Pharma, I am constantly told by colleagues in Silicon Valley, needs to acquire a “data science mindset.” Yet the entire business of drug discovery and development is deeply rooted in data, in science, and in evidence. 

Robust documentation is required by strict regulators at every step along the path, from the composition of the therapeutic molecule to exactly how it’s manufactured to exactly how it behaves in model systems to exactly how it behaves in people – its absorption, metabolism, distribution, and of course, critically, its safety and efficacy in patients with a particular condition, as demonstrated, generally, in multiple prospective, randomized controlled trials (RCTs). I’ve heard stories of companies shipping off reams of documentation to the FDA in trucks, prior to the days of electronic submissions.

Author: David Shaywitz

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