FIRST QUARTER 2016
actually global standards, and in 2016, they will be required for clinical trial submissions by not only the FDA, but also the Japan Pharmaceutical and Medical Devices Agency. These standards have been developed in collaboration with the National Cancer Institute and are recognized by the International Organization for Standardization. They also are supported by the Innovative Medicines Initiative — funded by the European Commission — as well as patient and research advocacy groups such as the Critical Path Institute, One Mind, the Bill and Melinda Gates Foundation and many others.
On a panel discussing his Moonshot initiative, Biden said, “When you go home and talk to your friends about a cure for cancer […] I’ll bet you lunch that none of them say ‘data standardization.’” He also mentioned that we need to “speak plainly” about this issue, and “eliminate silos.” Without question, Biden is correct. And, those that know what it will take to land his Moonshot are working to do just that. The cure for cancer won’t ever be found by doing research in silos. We need to shout from the rooftops that there are clinical research data standards that break down barriers, that by using these accepted, universal data standards, data can speak in a way we all understand, allowing us to learn from it and giving ourselves the chance to collaborate with that data — all in the effort to act, saving billions of dollars and, more importantly, millions of lives.
To see original article, Statesman website here. As Seen in Roll Call —
Confirmation of FDA Commissioner Likely Next Week Andrew Siddons, CQ Roll Call
18 February 2016 — In the five months since he was nominated to lead the Food and Drug Administration, Robert Califf has come under fire for his ties to the pharmaceutical industry and taken heat for FDA issues that long predate him, such as painkiller abuse, genetically modified salmon and the agency’s role in drug prices.
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But after defending the agency’s policies and meeting with lawmakers to address their concerns, it’s likely that next week the Senate will confirm Califf to become the FDA commissioner.
On Monday, the Senate will have a cloture vote on his nomination, an attempt by Majority Leader Mitch McConnell, R-Ky., to prevent a promised filibuster from Sen. Joe Manchin
III, the West Virginia
Democrat who opposes Califf ’s nomination over the FDA’s history of approving opioid painkillers such as OxyContin. If the Senate can clear the 60-vote threshold for cloture, it is expected to hold the vote on Califf ’s nomination later in the week, overcoming objections
from other lawmakers including Sen.
Edward J. Markey, D-Mass., Sen. Bernard Sanders, I- Vt., and Kelly Ayotte, R-N.H.
In the 11 months he can count on having the job, Califf will likely attempt to make meaningful changes at the FDA in areas that he’s spent his career working on, such as improving how the agency utilizes patient perspectives and real-world evidence in regulatory decision making.
“A year is in many ways a short time but it’s enough to set some policies forward,” said Mark McClellan, who ran the FDA from 2002 to 2004 and now leads the Duke-Margolis Center for Health Policy. “The good news for him is there’s a strong foundation to build on thanks to legislation and FDA programs enacted in recent years.”
Califf's Priorities Califf joined the FDA last February as the deputy commissioner for medical products and tobacco. For 30 years before that, as a Duke University cardiologist, he also ran a major clinical research institute where he worked closely with major drug companies.
While his public footprint at the agency so far has been light, his priorities were evident in various forums, including speeches to medical professionals and blog posts published on the FDA’s website.
One of his big-picture interests is how the FDA can better utilize the massive influx of new data and evidence
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