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Publication Topic: Breakthrough Therapy

Public Comment | Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

Peer Review | Breakthrough Therapy Designation Criteria Identify Drugs that Improve Clinical Outcomes for Patients: A Case for More Streamlined Coverage of Promising Therapies

The breakthrough therapy designation (BTD) process was created to expedite clinical development timelines for drugs intended to treat serious conditions and preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies. This analysis demonstrates that BTD is a valuable tool for expediting approval of promising therapies in oncology. By comparing drugs indicated…

White Paper | Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation

White Paper | Blueprint for Breakthrough: Exploring the Utility of Real World Evidence (RWE) – Pre-Meeting Draft White Paper

White Paper | Conference on Clinical Cancer Research 2012 – Panel 2 | Developing Standards for Breakthrough Therapy Designation

White Paper | Friends/Alexandria Forum 2013 – A Blueprint for Drug/Diagnostic Co-development: Breakthrough Therapies

Peer Review | Developing standards for breakthrough therapy designation in oncology.

Peer Review | Regulatory watch: Impact of breakthrough therapy designation on cancer drug development

White Paper | Examining Manufacturing Readiness for Breakthrough Drug Development