“In order to take advantage of today’s advancements in science, drug development, and patient treatment, the U.S. Food and Drug Administration’s (FDA’s) structure needs reorganization to focus its resources and ensure the best outcomes for patients. Friends of Cancer Research (Friends) proposes enhancing coordination at the FDA based on specific disease areas, rather than approving…
Executive Summary Products like Amgen’s viral therapy for melanoma could benefit under proposals to replace FDA’s modality-based organization with disease-specific centers. FDA’s biologics center proved itself capable of reviewing the oncologic, but the drugs center already had extensive recent experience with the fast-changing melanoma market. The FDA review of Amgen Inc.’s Imlygic could provide support…
Executive Summary Commissioner Califf says review staff reorganization based on disease will go ahead regardless of what other headway VP Biden’s initiative makes. Oncology product regulation at FDA will be reorganized no matter what happens with VP Joe Biden’s Cancer Moonshot. The White House initiative intended to boost efforts to find a cure for cancer…
Today is a new day for cancer research, with the introduction of transformational immune-based therapies that have the potential to change patients’ lives. Such potential means that everyone must innovatively collaborate on ways to speed the drug development and regulatory process so that potentially life-saving therapies reach patients with the greatest urgency, many of whom…
The FDA’s breakthrough therapy designation has led to shorter drug development times and shorter FDA review times, industry experts said April 12 during a Senate briefing. Enacted in July 2012 as part of the Food and Drug Administration Safety and Innovation Act (Pub. L. No. 112-144), the breakthrough therapy designation expedites the development and review…
THE POWER OF COLLABORATION Friends Annual Meeting We are proud to host our yearly Annual Meeting with support from the American Association for Cancer Research, American Society of Clinical Oncology, and Susan G. Komen to address critical issues in the development of new oncology drugs. As of 2016, the Conference on Clinical Cancer Research has become the Friends Annual…
Chair and founder of Friends of Cancer Research, Ellen Sigal, has been appointed to the National Cancer Institute’s Blue Ribbon Panel that will advise the National Cancer Advisory Board on Vice President Joe Biden’s moonshot cancer initiative. The panel will be comprised of scientific experts that will advise the advisory board on scientific opportunities to…
The Senate Health Committee has unveiled formal legislative language to direct FDA to test consolidated medical product reviews in at least one disease area. The legislation would direct FDA to create “Intercenter Institutes” focused on specific disease areas. Each Institute would “develop and implement processes for coordination of activities, as applicable to such major disease…
Greg Simon, a former pharmaceutical executive and congressional staffer who survived cancer, was named executive director of the Obama administration’s “moonshot” cancer initiative, the White House announced Friday. In recent years Simon has worked as a venture capitalist in the biotechnology and life sciences sector. From 2009 to 2012, he served as a vice president…
The FDA and NIH Workforce Authorities Modernization Act was introduced in the Senate by Republican and Democratic leaders of the health committee. The bill aims to help FDA and NIH “attract top talent during this exciting time in science.” The bill, introduced by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), looks to improve coordination…
