FDA Law Blog: Latest FDLI Update Magazine Features Interview Conducted by HP&M’s James Valentine on Patient Engagement in Drug Development

FDA Law Blog: Latest FDLI Update Magazine Features Interview Conducted by HP&M’s James Valentine on Patient Engagement in Drug Development

Latest FDLI Update Magazine Features Interview Conducted by HP&M’s James Valentine on Patient Engagement in Drug Development

Posted: 03 May 2017 02:18 PM PDT

The latest issue of FDLI’s Update Magazine features an interview conducted by Hyman, Phelps & McNamara, P.C.’s James E. Valentine. In the interview, James Valentine talks with rare disease patient advocate Christine McSherry about patient engagement in the drug development and approval process, focusing on the Jett Foundation’s involvement in the approval of Exondys 51 (eteplirsen) for Duchenne muscular dystrophy and opportunities under the patient provisions of the recently enacted 21st Century Cures Act (see our previous webinar on the drug and biologics provisions of the 21st Century Cures Act here). Among other things, the interview discusses the Jett Foundation’s presentation of “Patient and Caregiver-Reported Outcomes of Patient in Clinical Trials of Eteplirsen for Treatment of Duchenne” at the April 25, 2016 FDA Peripheral and Central Nervous System Advisory Committee meeting – this first known presentation by a patient advocate during the core presentation at an FDA advisory committee meeting (recording and report available here).

The article is available for download here and a full audio recording of the interview is available here.

Interested in this topic and attending the FDLI Annual Conference on Friday, May 5th?

James Valentine will be facilitating a Table Topic Discussion on patient engagement in regulatory decision-making on May 5th at 12:30pm. More information about the FDLI Annual Conference can be found here.