Thirty years ago, I watched my sister Gale die of breast cancer. In those days, that meant seeing a strong and beautiful woman lose an excruciating battle against a disease that we had barely begun to understand. What few drugs we had were toxic; at best, they offered a poisonous pause in a patient’s painful…
The Obama administration’s “cancer moonshot” took a major step forward Wednesday when a committee of top cancer researchers and patient advocates recommended an ambitious set of scientific goals designed to sharply accelerate progress against the disease. The 10 ideas, which were developed by a blue-ribbon panel, dealt with an array of topics, including research,…
Executive Summary Success of enhanced communications in particular made one stakeholder wonder whether FDA could use it with non-breakthrough applications. The success of the breakthrough therapies program has stakeholders wondering whether some of its tenets could be applied more broadly. It is a question that likely will come down to FDA’s ability to…
The cancer “moonshot” initiative led by Vice President Joe Biden would continue under a Clinton administration, the Democratic presidential nominee confirmed Aug. 15. Hillary Clinton’s campaign released a statement ahead of a rally with Biden in Scranton, Pa., in which she called for restoring robust funding to the National Institutes of Health, along with…
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…
