FDA officials, patient representatives and industry stakeholders said the hiring provisions included in the drug user fee commitment letter are critical to the other goals outlined for the sixth iteration of the program, with an industry representative saying FDA’s ability to recruit scientists is crucial to the agency keeping pace with scientific advancement. But as…
The dismal accrual rates in cancer clinical trials are well known: Just 3% to 5% of adults with cancer enroll in clinical trials.1 The reasons patients are reluctant to participate in clinical trials are equally well known: fear of reduced quality of life, concern about receiving a placebo, and inconvenience. Patient surveys1 and the…
The young surgeon was mystified. A fist-size tumor had been removed from the stomach of his patient 12 years earlier, but his doctors had not been able to cut out many smaller growths in his liver. The cancer should have killed him, yet here he lay on the table for a routine gallbladder operation. …
In an effort to bring new drugs to cancer patients faster, the Friends of Cancer Research (FOCR) and Alexandria Summit collaborated in a meeting in Washington, D.C., to consider how real-world evidence can be used along with data collected from traditional randomized, controlled clinical trials in the approval of new drugs. The organizations presented a…
The White House’s cancer “moonshot” initiative will benefit research across disease groups as changes implemented address systemic issues that hamper research progress, a White House aide said July 19. “Cancer is a great place to start with the culture change because we’ll be able to see the benefit much more quickly than we can…
FDA tapped the director of the Office of Hematology and Oncology Products, Richard Pazdur, to head the agency’s new Oncology Center of Excellence that will focus on uniting cancer product regulatory review and leverage clinical expertise across FDA as part of the vice president’s Cancer Moonshot Initiative. As part of this scheme, the agency is…
Vice President Joseph Biden on Wednesday named the US Food and Drug Administration’s (FDA) top oncologist, Dr. Richard Pazdur, to head the newly formed Oncology Center of Excellence (OCE). The OCE is intended to accelerate the development of new oncology products, as part of Biden’s $1 billion dollar cancer “Moonshot” initiative, by working with FDA’s…
Oncology drug tsar Dr. Richard Pazdur–who earlier this month despaired at biopharma’s “me-too” approach to cancer development–has been named as the interim leader of a new Oncology Center of Excellence that will be run out of the FDA. The new Center aims to coordinate the reviews coming from the Agency’s work on cancer treatments. The…
The U.S. Food and Drug Administration’s high-profile cancer drug director, Dr. Richard Pazdur, has been named head of a newly created Oncology Center of Excellence that will coordinate the review of all the agency’s cancer therapeutics. The announcement was made on Wednesday by Vice President Joseph Biden during a summit to discuss the latest developments…
A corporate-government partnership to improve U.S. veterans’ access to personalized cancer treatments will highlight a nationwide series of gatherings and events Wednesday detailing of Vice President Joe Biden’s “Cancer Moonshot” program. IBM Corp. will donate access to its “Watson” supercomputer — best known for beating human champions on the television game show “Jeopardy!” — to…
