It’s been a busy spring for drug development. We’ve had leadership changes at FDA, legislative pushes in Congress, and a host of conferences and meetings to present and advance ideas from the cutting edge of science and policy. It’s a lot of keep up with. Here are the biggest stories from the last few months.
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Changing Leadership at FDA
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February 5
FDA Commissioner Margaret Hamburg steps down
After almost six years, Commissioner Hamburg announced she would be leaving FDA at the end of March.
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May 18
A Conversation with Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco
Friends of Cancer Research hosted a forum with incoming FDA leadership to discuss enhancing patient input and regulatory innovation.
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On Capitol Hill: 21st Century Cures
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On April 28th, the House Energy and Commerce Committee (E&C) released the second discussion draft of the 21st Century Cures bill. On April 30th, the committee held a hearing to discuss new provisions in the legislation, including an increase in NIH appropriations. Two weeks later, a new version of the bill was released, in which additional updates were made. The next day, on May 14th, the E&C Subcommittee on Health advanced the legislation to the full committee by a voice vote. Finally, on May 21st, the full Energy and Commerce Committee unanimously approved the 21st Century Cures Act, H.R. 6.
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The Senate HELP Committee has embarked on a parallel initiative to 21st Century Cures, called “Continuing America’s Leadership.” The committee has convened three hearings to date, on precision medicine , biomarkers and translational research , and on the role of FDA and NIH in fostering biomedical innovation.
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AACR Annual Meeting Highlights
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Value-Based Drug Development
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Clinical Trial Enrichment Strategies: Designing a Prospectively Defined Retrospective Analysis Study
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Incorporating Next-Generation Sequencing into Oncology Diagnostics, Therapeutics, and Treatment
Regulatory Strategies to Expedite Oncology Drug Development
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ASCO Annual Meeting Highlights
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ASCO Wrapup: Immunotherapy Shines, Hope For Brain Tumors, & The Great Cancer Drug Price Debate
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ASCO Roundup: Checkpoints, Pushback Against Prices, CAR-T & More
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