Robert Califf, former commissioner of the Food and Drug Administration, urged wider data collection and data sharing in order to make drug development faster and cheaper.
Califf, speaking at the NewYorkBIO conference on Wednesday, lamented the high costs of drug development. He said drugmakers can and should use the tools from the “Fourth Industrial Revolution” to make the process better.
“The idea is that physical, biological, and information sciences are converging into a single discipline,” Califf said. “I think all of us can see this happening, but we’re just on the front edge of it. We can take the power generated by the revolution in digital technology [and] use it for good things–for people’s health–instead of bad things.”
Califf is working on a project in his advisor role at Verily’s Project Baseline that is collecting health data to share for trials. So far, the project has gathered data from about 1,000 people, he said. Verily is the life sciences arm of Alphabet.
Verily’s project mirrors a similar project from the National Institutes of Health, “All of Us,” announced at the beginning of May. “All of Us” seeks to collect DNA and health habits information from one million people to improve prevention and treatment.
Another way to make data sharing easier, Califf said, is the consolidation and sharing between hospital systems, a trend already on the rise.
“The question is: If you organize patients in specific disease areas, [and] had them allied with health systems, could you create a system that generated the kind of evidence I’ve talked about at a much faster rate at much lower costs?” he asked. “In an initial trial, the answer is you can, but there’s still a lot of work to do. We can amass a massive amount of data now if we can just get everybody organized to conduct studies at a lower cost.”
In general, Califf said he hopes the entire healthcare system can shift from a “passive system, where every study is done one-off at a very high expense to an active system that is constantly collecting data.” Though, as a former clinical study lead himself while at Duke Health, he understands that making that change would be taking a risk.
Part of that risk is lumping more expectations on already-overworked doctors. In Califf’s experience, people are fine with their health data being collected, while doctors–and industry–are resisting it.
“Everything I’ve seen says Americans would like their data used if they had confidence it was being used in the right way,” Califf said. “I don’t think it’s a lack of people wanting to do it, it’s just the way things evolved. Our system got out of kilter and it’s so hard for an industry like the medical product industry where there’s so much at stake, it’s so hard to take a risk on changing it.”