SAN FRANCISCO — Uncle Sam wants you to turn over your health records. And Dr. Robert Califf, the cardiologist who now runs the Food and Drug Administration, is determined to make that happen.
The Obama administration has set a goal of recruiting 1 million volunteers to hand over their genetic and health data, as part of the $215 million Precision Medicine Initiative.
Califf thinks that’s far too modest an ambition. “Let’s think in terms of 10, 20, or 100 million,” he said in an interview with STAT here at a global biotech convention.
And that’s not his only goal: Califf is also calling on life sciences companies to share information about the genetic data they collect and analyze in the quest to develop new treatments.
To accomplish that, Califf is touting a new tool: precisionFDA. It’s an online, cloud-based portal that was launched this past December, offering scientists from academia, industry, and the government a common space to work together. (It was first dreamed up about six years ago, before Califf joined the FDA, but he said he’d heard it had been greeted with derision: “At the time, people were like, ‘What is this guy doing, smoking pot?'”)
The Precision Medicine Initiative will ultimately generate a massive amount of genetic data (particularly if Califf gets his 100 million volunteers on board) — and that will be difficult to decipher. Dr. Francis Collins, director of the National Institutes of Health, often says that only 1 percent of the vast volume of DNA sequenced each year is actually understood.
The precisionFDA tool is aimed at encouraging diagnostics companies, in particular, to set aside their competitiveness and work together. Currently “hundreds” are working on the precisionFDA platform, Califf said.
The tool also allows for reality checks like a recent “consistency challenge,” which asked several rival diagnostic companies to try their hand at deciphering a portion of one genome. The FDA’s goal: To see how consistent they were in their interpretations, and how their results matched up against what was previously known about that particular DNA segment.
(The winners, announced last week: Sentieon of Mountain View, Calif., for “best performance and highest reproducibility,” and a scientist from Sanofi-Genzyme for “highest accuracy.”)
Califf’s call for more collaboration is echoed in the White House. Vice President Joe Biden on Monday urged the 30,000 oncologists at this week’s American Society of Clinical Oncology annual meeting to collaborate in the search for a cancer cure.
“I’ve been involved for a long time in medical informatics, and the amount of information that needs to come together in various times and places to get sequenced is profound,” Califf said.