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October 7, 2016
A conversation with The Cancer Letter and the experts listed below.
Jeff Abrams, NCI acting director for clinical research and associate director of the NCI Cancer Therapy Evaluation Program. Abrams wrote his responses with Elad Sharon.
Jeff Allen, president and CEO of Friends of Cancer Research, an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments to patients.
September 28, 2016
Executive Summary
In an interview, Margolis Center for Health Policy's Mark McClellan and Gregory Daniel talk about their recent move from Brookings to Duke, the breadth and impact of their work with FDA on drug development issues, and opportunities for potential future collaborations under PDUFA VI.
September 25, 2016
Friends of Cancer Research (Friends) has announced that its Executive Director, Jeff Allen, PhD, will assume the role of President and CEO of the organization. Friends’ founder, Ellen Sigal, PhD, will continue with the organization as Board Chair. Dr. Allen will become the day-to-day lead of Friends’ scientific and policy programs and organizational operations, in addition to directing strategic legislative initiatives.
September 23, 2016
David R. Gandara, MD, director, Thoracic Oncology Program, professor, senior advisor to director, UC Davis Comprehensive Cancer Center, treasurer, International Association for the Study of Lung Cancer (IASLC), discusses the Lung Master Protocol (Lung-MAP) Trial and how it is an example of a rational clinical design that will impact patient care. Gandara shared this insight during an interview at the 2016 IASLC Multidisciplinary Symposium on Thoracic Oncology.
September 23, 2016
The National Cancer Moonshot Initiative is not slated to receive funding in fiscal 2017—neither the House nor Senate appropriations bill includes the $680 million the White House proposed for Vice President Joe Biden’s project.
Despite great bipartisan breast-beating in support of boosting the NCI and NIH budgets, Congress has not dedicated funding for the moonshot, a broad scientific and public health effort focused on improving clinical trials, data sharing, and streamlining regulatory processes for oncology products at FDA.
September 20, 2016
Clinical laboratories could face significant costs if the FDA moves forward with plans for lab-developed tests, the chairman of a Senate committee said Sept. 20.
Vanderbilt University’s lab in Nashville, Tenn., for example, could spend $30 million to $75 million to get Food and Drug Administration approval for a single high-risk laboratory-developed test (LDT) under the agency’s plan to regulate the tests, Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.) said during a hearing.
September 20, 2016
Senate health committee Chairman Lamar Alexander (R-TN) floated creating a new regulatory agency to oversee lab-developed tests, which he told lawmakers would be preferable to the current duplicative regulation by CMS, FDA and state regulators. He also told reporters he hoped FDA would not release a final version of its controversial draft guidance bringing LDTs under the medical device regulatory scheme, given Senate and House efforts to address the issue.
September 10, 2016
Executive Summary
Blue ribbon panel has plenty of industry-friendly recommendations on ways to accelerate oncology science, but with the clock ticking down on the Obama Administration, the question is whether the recommendations have any political traction.
Recommendations from Vice President Joe Biden’s Cancer “Moonshot” Blue Ribbon Panel have a specific emphasis on patient-focused research, new areas for oncology R&D and the establishment of a national clinical trial data network for “one-stop, free access” to patient data from studies across the country.
September 9, 2016
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 decline. Limited therapies meant little hope. In too many cases, a cancer diagnosis was a death sentence.
Gale, a lifelong New Yorker, died on March 13, 1986. She was 40. Her daughter, Jillian, was 4 years old.
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