John,

Join this event featuring a closer look at a new Health Affairs research article, “FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Times,” published in the July 2024 issue of the journal.

This event is exclusive to our Health Affairs Insiders.

Join us Tuesday, July 23, for a Health Affairs Journal Club event discussing the US Food and Drug Administration’s breakthrough therapy designation (BTD) program, one of several programs designed to expedite the development and approval of critical new drugs.

In “FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Times,” Kathleen L. Miller and colleagues analyze drug approval data and estimate that “the BTD program lowers late-stage clinical development time by 30 percent.”

The authors assert that the findings will “inform future regulatory and innovation policies aimed at driving efficiency in medical product development to ensure timely patient access to the most clinically meaningful therapies.”

On July 23, Miller, the deputy director in the Division of Science and Public Health Policy in the HHS Office of Science and Data Policy, will discuss the paper’s findings, data and methods with Health Affairs Deputy Editor Jessica Bylander.

Date: Tuesday, July 23, 2024
Time: 3:00 p.m. – 4:00 p.m. Eastern
Place: Online details will be shared with registrants 24 hours in advance of the event

If you have accessibility or support requirements in order to participate fully in this event, please contact [email protected] to ensure that we can arrange reasonable accommodations.

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