Design of a Colon Cancer Master Protocol (ASSIGN)
Design of a Colon Cancer Master Protocol (ASSIGN), March 7, 2014, Washington DC
Immuno-Oncology Working Group Meeting
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…
Examining Manufacturing Readiness for Breakthrough Drug Development
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…
A Blueprint for Drug/Diagnostic Co-development: Next-Generation Sequencing (NGS)
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…
A Blueprint for Drug/Diagnostic Co-development: Breakthrough Therapies
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…
