November 2018

Strategy With A Mouse Click

hile attending a recent Roundtable on the growing potential of AI and machine learning applications in regulatory affairs, it occurred to me that we might soon be able to instruct a machine to generate a global regulatory strategy for a new drug, medical device, or cell/gene therapy in two minutes or less by clicking a mouse button. In fact, why not an entire product development and market access strategy?

Currently, this task requires dozens of experts in local regulations and harmonization, drug development, CMC, Pharm/Tox, Pharmacokinetics, Clinical, Market Intelligence, Pricing and Reimbursement, and much more. They labor for months to produce a document that can become obsolete in a disappointingly brief time due to ever-changing local circumstances and global dynamics.

A suitable machine, fed with all relevant information such as the local regulatory requirements of 200+ countries, the current and anticipated competitive landscape, corporate goals, all scientific evidence pertaining to the product being developed and its competitors, pricing decisions by payers and local authorities, and armed with suitable algorithms, could vastly shorten time-to-strategy and update the document in real time until we tell it to stop. The quality of the inputs will determine the quality of the output. Or will it?

Is it a good idea to have an up-to-the-minute product development and market access strategy? Will it be any good or even useful? That’s where thoughtful humans (ever fearful of losing their jobs to a machine) come in. Good judgment is still a human quality that a machine may or may not be able to apply and deliver in quite the same way as a sensible person with experience.

The “convergence” of humans and machines is upon us in many different ways that affect us every day – from the way we use technology to accomplish complex tasks to the way technology (for example, social media) uses us to shape our behaviors and influence our decisions.

Is there still room for pause and reflection, thoughtful analysis, discerning judgment? Definitely (in fact, especially so) in the Age of Warp Speed.

But we must be prepared to work and think differently, to let go of old habits, to accept and leverage the speed that technology gives us. For processing speed and massive data integration, the machine will always win. But we cannot abandon good judgment and “gut feelings;” because even the fastest and best-fed machine cannot predict the behavior of the stock market–or the fate of a product–with 100 percent accuracy.

Not yet.