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…
Vice President Biden will convene a day-long cancer summit in Washington on Wednesday that will be part pep rally, part Ted talk, part wonk-a-thon — all designed to garner support for the Obama administration’s year-long initiative to advance cancer research. The summit, expected to draw as many as 300 people from academia, industry and advocacy…
Executive Summary Industry, patient advocates seek to use data collected outside traditional clinical trials to confirm benefit or broaden labeling, but FDA officials say large drug effects would be needed to overcome ‘noise’ from more loosely structured studies. Breakthrough-type drugs for which effect sizes are expected to be large may provide a potential avenue…
Executive Summary Symptom control, overall survival and time to treatment failure may be more useful measures in a real-world setting than progression-free survival, FDA oncology director Pazdur says. If the biopharma industry wants to rely more on real-world data to support regulatory decision-making, it may need to look at endpoints different from those used…
Executive Summary Under the Information Exchange and Data Transformation initiative, existing clinical trial datasets will be standardized and integrated with real-world sources in a new data environment. FDA’s Office of Hematology and Oncology Products is trying to better leverage the clinical data already in-house while also integrating it with real-world data sources under a…
Executive Summary FDA is close to announcing a new “Oncology Center of Excellence” to consolidate drug, biologic and device review functions in cancer. In the run up to the announcement, CBER has been stressing the need to preserve its culture and experience with novel manufacturing techniques. FDA is moving forward with a “Center of…
CALIFF’S VIEWS: REAL-WORLD DATA IN DRUG APPROVALS — The FDA head said he sees openings for “real-world” evidence in drug development and approvals. Drug makers and some members of Congress have been pushing the topic, as the industry hopes to capitalize on all that data from electronic health records to speed up and reduce the…
