Time to put the innovation into manufacturing

Recent drug discoveries and subsequent development failures have led some--investors and drugmakers among them--to question pharma's ability to innovate within the constraints of the current business environment. The discussion of innovation limitations is often restricted to discovery and development, as if the whole industry teeters as it attempts to right its development shortcomings.

But pharma has always been about more than the blockbuster in the spotlight. Manufacturing has a large, important role, as does the supply chain. Yet another, perhaps more in vogue now, is companion diagnostics--genetic tests to determine whether the patient's condition is likely to be helped by the companion drug in question.

These operations and diagnostics functions all have their origins at the drug development stage. Manufacturing marks its process paces from lab quantities to clinical supply, to commercial scale-up. The supply chain grows and evolves with product volumes that escalate through clinical trials, and the logistics of quantity and distribution form along the way.

Automation tools help. But manufacturing execution systems, enterprise resource planning software and warehouse management systems are a far cry from the Cray- and cloud-level horsepower being applied to discovery and development. Manufacturing and supply chain issues are somehow tied to the physical realm, a mismatch with the perceived uber strength of high-performance computing.

Maybe that's the problem: The perception that the mundane processes of pharma manufacturing are beyond any improvement except tweaking. Better to outsource it where labor is cheap and get the best deal possible.

That's a temporary solution at best, when you take the oft-forgotten long view, and we'll need to keep adjusting the supply chain as manufacturing migrates to India, China, Africa and then the next low-wage up-and-comer. We'll turn over pharma manufacturing, developed over centuries in the Western World, to those ambitious low-wagers in developing nations, until they become expert at what we no longer are.

That might be okay, if we get really good at discovery and development. But I think GlaxoSmithKline ($GSK) CEO Andrew Witty (photo)--and the European and American manufacturers and CMOs committed to maintaining their domestic presence--has it right. We can develop cost-effective manufacturing technologies (perhaps even the "departure from the traditional chemical manufacturing process widely used today" Witty alludes to) that integrate with increasingly sophisticated supply chains; we can manage manufacturing beginning at the development stage and simultaneously create companion diagnostics.

But we're going to have to maintain our manufacturing expertise to do it. - George Miller


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.