On his way out the door, outgoing FDA Commissioner Scott Gottlieb writes a memo issuing a challenge to pharma: be more innovative. More specifically, he calls out the subsystem of CROs and other vendors to design new business models that are compatible with disruptive thinking.
Efforts to streamline medical product development based on advancing science can be frustrated by legacy business models that discourage collaboration and data sharing, and the adoption of disruptive technologies that make clinical research more effective. Without a more agile clinical research enterprise capable of testing more therapies or combinations of therapies against an expanding array of targets more efficiently and at lower total cost, important therapeutic opportunities may be delayed or discarded because we can’t afford to run trials needed to validate them.
“Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches,” he noted. New forms of collaboration are part of this story.
New research paradigms are needed to break down barriers between real world data and clinical research, so that evidence can be shared rapidly to improve both domains across a learning health care system. In some cases, the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable.
Which only underscores the why for a whole new innovation agenda in healthcare, the kind of systemic vision for transformation framed most recently by Kevin Schulman, Professor of Medicine at Stanford University, and Barak Richman, Professor at Duke Law School, in the New England Journal of Medicine earlier this year: “Toward an Effective Innovation Agenda.”
If you have government asking for disruption from industry, then you know we really have entered a whole new era.
Quoting Hunter S. Thompson: “When the going gets weird, the weird turn pro.”