SCD Voices Shaping Change

  • Home
  • SCD Voices Shaping Change

The Sickle Cell Voices Alliance, a partnership among the Sickle Cell Disease Association of America, Inc., Sickle Cell Disease Association of Canada and Sickle Cell Society (UK), is hosting an externally led patient-focused drug development (EL-PFDD) meeting.

This virtual forum brings together national and global sickle cell patient and caregiver voices to ensure early involvement in drug development and encourage the U.S. Food and Drug Administration (FDA) and key stakeholders, including other regulatory authorities, to consider a broader range of clinically meaningful endpoints when evaluating therapies for SCD. Participants will have the opportunity to contribute through live testimony, panel discussions, audience polling and written comments. The perspectives collected during the meeting will be summarized in a Voice of the Patient Report, which will be submitted to the FDA and other regulatory agencies to support future regulatory review, clinical trial design and therapeutic innovation.

What Are Externally Led Patient-Focused Drug Development (EL-PFDD) Meetings?

Externally led patient-focused drug development meetings give the U.S. Food and Drug Administration (FDA) and other key stakeholders, including medical product developers, health care providers and federal partners, an important opportunity to hear directly from patients, their families, caregivers and patient advocates about the symptoms that matter most to them, the impact the disease has on patients’ daily lives, and patients’ experiences with currently available treatments. This input can inform the FDA’s decisions and oversight both during drug development and during review of a marketing application.

Meeting Agenda

The agenda will feature key opinion leaders in the sickle cell space, including warriors, caregivers and other SCD experts and stakeholders. Check here often as the agenda is confirmed.

Questions: ELPFDD2027@sicklecelldisease.org

Hosted by the Sickle Cell Voices Alliance, a partnership among the Sickle Cell Disease Association of America, Inc., Sickle Cell Disease Association of Canada and Sickle Cell Society (UK).