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Precision Medicine In Trump Era? California Presses Own Modest Program

Xconomy San Francisco — 

[Updated, 11/22/16, 5:42 p.m. See below.] Among the many questions swirling around the incoming Trump administration is the fate of ambitious biomedical science projects that require federal funding. What will a Trump presidency and Republican control of Congress mean for the Precision Medicine Initiative and the Cancer Moonshot program, both championed by the Obama administration?

While that question hangs in the air, the state of California’s own precision medicine plan is moving ahead. It’s quite different than the $215 million federal effort. It has a much smaller year-to-year budget—$3 million for the first year, $10 million for the second. Its focus is funding projects that might provide near-term medical results, while the federal initiative is centered on a long-term study of up to 1 million volunteers.

While most eyes were on the national stage, the California Initiative to Advance Precision Medicine (CIAPM) announced six “demonstration” projects last week, each to receive $1.2 million, bringing the total to eight funded projects so far. Among them are studies to help make better treatment decisions for prostate cancer patients; to make more fine-grained diagnoses of patients with emergency head trauma; and to better predict heart attacks by collecting health data from people with wearable sensors.

“We want to get to something that can be demonstrated at the end of 18 months or two years, where a little bit of money can make a big difference and impact patients quickly,” says Atul Butte (pictured), principal investigator of CIAPM and director of UCSF’s Institute of Computational Health Sciences. (Butte also oversees a massive project to pool the medical records of 14 million patients across the University of California’s five medical centers—an effort that is separate from CIAPM.)

Whether CIAPM, with headquarters at the University of California, San Francisco, receives funding for a third year and beyond will be up to Democrats, who are in control of state government. The next budget should become clear in late spring or early summer 2017.

That said, California is one of the rare states to provide significant funding for biomedical research. A far larger allotment for stem-cell related research, controlled by the California Institute for Regenerative Medicine, began in 2004 when voters approved a $6 billion plan to fund work that was, under the George W. Bush presidency, heavily restricted from NIH funding.

But CIRM has come under fire for conflicts of interest and governance problems. Two years after the national Institute of Medicine recommended changes, CIRM’s former president Alan Trounson raised eyebrows anew by taking a board seat at a company that had received millions of taxpayer dollars through CIRM.

Under new leadership, CIRM now aims to help potential medicines move through clinical trials before funding runs out at the end of this decade.

Is CIAPM’s structure and modest budget a reflection of lessons learned from CIRM? If Trump and the GOP scuttle the federal Precision Medicine Initiative’s plan to recruit 1 million Americans within four years for a “big data” healthcare research program, can California serve as another option? (One of CIAPM’s promises is to “connect health data statewide.”)

To ask about CIAPM’s progress, some of the first projects, and the fallout from the election, Xconomy spoke with Butte last week. The following interview has been edited and condensed.

Xconomy: How did CIAPM choose these six new projects? Why are you still calling them demonstration projects?

Atul Butte: We want to get to something that can be demonstrated at end of 18 months or two years, what people have called “shovel ready,” where a little bit of money can make a big difference and impact patients quickly. I see the value of basic science, but this isn’t basic science.

The criteria point by point were determined by the governor’s office staff, public input, the legislature… The idea was to get patients engaged, the projects had to be feasible and innovative, and [the project leaders] also had to think about how the entire system of medicine could benefit economically.

None of the members of the CIAPM selection committee [are] connected to California. They [don’t] live here, work here, or work at an institution here. That made it even harder to get the team, and what an amazing team it was. [This answer was changed to clarify that there is no rule against committee members having a connection to California.]

X: The committee members [aren’t] associated with California? That brings to mind the tribulations CIRM has been through with conflicts of interest and oversight. What have you learned from CIRM?

AB: We learned enormously from that process. I’m used to dealing with NIH rules and governance; the state has similar rules and different ones. There are laws in place that govern the minutes you take, the community input before public meetings start. We followed every single one of those rules.

X: Only having evaluators who aren’t associated with California—will that hamstring you if you eventually ramp up?

AB: I don’t know, I’ve heard they have some good scientists in Texas, in Seattle, in the Boston and Washington areas. [Laughs] There are good scientists all over the country. It’s impressive how they stepped up to help us. They’re not getting paid. They also want to see how a state can really do this, perhaps inspire other states, perhaps even their own.

X: How have your considerations of the federal PMI changed since the election?

AB: They haven’t really changed. Our approach is complementary to the federal effort, [a big part of which] is the 1 million volunteer cohort, a longitudinal study with many technologies and measurements of behaviors. It’s very different from our approach, which is to fund key projects that are just a bit short of making a difference for patients.

X: If funding for the federal PMI goes away next year, does that take away anything you hoped to lean on? Were you hoping to tap into the cohort?

AB: I tend to be an optimist, perhaps overly optimistic sometimes. I see in the 300- to 400-word missive from the Trump healthcare team a line about advancing healthcare research and development. If there’s bipartisan support for the NIH, perhaps these projects could continue. There’s no reason right now to guess or count on things getting killed, it’s kind of meaningless to do that.

One benefit being in California, though: Remember in previous years when federal rules changed and stem cell research was much harder to do, California created CIRM. We have incredible resources that can be brought to bear. As a data scientist, of course, I can’t wait to use data … Next Page »

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