Novartis CEO Vas Narasimhan told attendees of PhRMA’s Innovation Day on Thursday that as biopharmaceutical companies embrace digital technologies to speed the discovery and development of new medicines, regulators will have to adapt more quickly.
“FDA has been, more than any other regulator in the world, interested in working with these technologies,” Narasimhan said. But he also opined that when the “rubber hits the road” and companies begin filing applications with these technologies, “will we hit brick walls? I think yes.”
For its part, FDA has been working with digital health and technology companies on a precertification program for software-based medical devices. And the agency also has released draft guidance on clinical decision support software, but industry has pushed back on parts of it.
And Narasimhan explained how Novartis uses new technologies, such as artificial intelligence (AI), to monitor the cost, quality and speed of every trial the company is engaged in.
But he noted some problems associated with the use of algorithms, explaining, “You need good training data and if we don’t understand what’s going on with many diseases, it’s hard for an algorithm to understand.” There are cases where these new technologies will open up disease areas, he added, but the bar “is only going to get higher as the standard of care creeps up.”
Former FDA Commissioner Scott Gottlieb also discussed digital health opportunities in clinical trial innovation, with master protocols, basket trials targeting different disease phenotypes and changes to how trials are structured.
“The regulatory process is adapting to that. Scientific change is driving a response from regulators,” Gottlieb said. Although in describing his interactions with other regulators, Gottlieb said while he was at FDA, he did not have a lot of dialogue on novel, cutting-edge technologies. “There was a sense that we were a little ahead of them, in all honesty,” he said.
Narasimhan also touched on the “explosion” of real-world evidence (RWE), although Nancy Dreyer, chief scientific officer at IQVIA, explained how RWE needs to have a complimentary role to the randomized, controlled trial. “What we’re starting to see is the unique role RWE for expediting approval of secondary indications,” she added. FDA recently highlighted some of those added indications thanks to RWE.
Dreyer added that in some ways, the European Medicines Agency is ahead of the US as it released a big data report with details on how to make RWE most useful. And last month, Chinese regulators came out with draft guidance on RWE, with examples of where they used medical records to extend certain indications.
Moving forward, Narasimhan said he thinks there will be “a lot more companies in the digital health space,” although he also cautioned, “We encounter a lot of hype. For the smaller companies, it’s better to promise what you can actually deliver.”
He also called on industry to encourage FDA to be more open to modernization. “I think we need to get to the next wave of productivity because change is happening whether we like it or not,” Narasimhan added.