Biden outlines 'Moonshot' initiatives to fight cancer

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[June 30, 2016]  By Toni Clarke

WASHINGTON (Reuters) - U.S. Vice President Joseph Biden on Wednesday announced plans as part of the administration's "Cancer Moonshot" initiative, aimed at speeding development of treatments by cutting bureaucracy and easing collaboration between scientists, industry, patients and government.

Speaking at a cancer summit at Howard University in Washington, Biden made an impassioned plea for increased urgency in the fight against cancer. The event was part of a national day of action involving hundreds of researchers, patient advocates and data experts across the country.

Biden's son Beau died last year at age 46 from brain cancer, something Biden said helps inform his passion for the project.

"I believe we can do in the next five years what would normally take 10 years," he said. "Time matters, days matter, minutes matter."

Among proposals intended to bypass inefficiency at the federal level, he announced the formation of an Oncology Center of Excellence at the Food and Drug Administration, which will coordinate and review all of FDA cancer treatments.

It comes as scientific advances in diagnostics allow for greater tailoring of drugs to an individual's genetic profile. It is the first of four potential centers proposed under a bill moving through Congress.

Under the existing review system, companies submit products to different divisions of the agency depending on whether it is a drug, device or biologic, a drug made from living cells. A treatment that combines a drug and a diagnostic device could get reviewed on different timelines.

"We are moving into a very complicated area in oncology where drugs and devices and biologics are going to be used in combination or sequentially," Dr. Richard Pazdur, the FDA's cancer drug director, said in an interview.

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Pazdur will oversee the establishment of the center and act as its director for the next 120 days, with the potential for the position to be renewed. He will report directly to FDA Commissioner Robert Califf.

The "Cancer Moonshot" initiative was announced by President Barack Obama at his State of the Union address in January.

Biden outlined a slew of other collaborations and initiatives, including making it easier for patients to find and enter clinical trials through the creation of a cancer trials website and making it easier for scientists to focus on research and less on raising money.

"We have to change the culture that turns scientists into grant writers," he said. "We have to reward teamwork."

(Reporting by Toni Clarke in Washington and Bill Berkrot in New York; Editing by Bernard Orr and Jonathan Oatis)

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