A Friends of Cancer Research roundtable with: Dr. Robert Califf Deputy Commissioner for Medical Products and Tobacco U.S. Food and Drug Administration Tuesday May 19, 2015 – 9:00am – 12:00pm The West Health Policy Center – 1909 K St NW, Washington, DC A forum for leaders of disease and health advocacy organizations, industry, trade associations,…
Design of a Colon Cancer Master Protocol (ASSIGN), March 7, 2014, Washington DC
Summary: Immuno-oncology (I-O) has been fueled by numerous clinical trial successes in recent years and has already transformed traditional approaches to cancer treatment. As our understanding advances and I-O therapies are implemented into routine treatment of cancer, many challenges and complexities remain to be addressed. Broadly, outstanding challenges fall into two categories: scientific, related to…
With the passage of the Advancing Breakthrough Therapies for Patients Act in 2012, sponsors are able to expedite the development of promising treatments ensuring patients gain access to safe and highly efficacious drugs that demonstrate substantial improvement over existing therapies. With expedited clinical development timelines though, drug manufacturing and characterization timelines have been put under…
In this 3rd installment of the Blueprint for Drug/Diagnostic Co-development, Friends of Cancer Research and Alexandria Real Estate Equities, Inc. brought together researchers, sponsors, advocates, and regulators to discuss possible approaches to expedite development of Next Generation Sequencing (NGS) as a companion diagnostic. Leading up to the event, a large collaborative group put together a…
On September 6, 2013, Friends of Cancer Research and Alexandria Real Estate Equities, Inc. held their second forum on the co-development of drugs and companion diagnostics. This year’s forum brought together researchers, sponsors, advocates, and regulators to discuss possible approaches to the expedited development of a companion diagnostic device (co-Dx) that is intended for use…
