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FAQs

• What is Patient-Focused Drug Development?

  Patient-Focused Drug Development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs and priorities are captured and meaningfully incorporated into drug development and evaluation. Click here to learn more about Patient-Focused Drug Development.

• What is an Externally-Led Patient-Focused Drug Development meeting?

  Usually referred to by its acronym, EL-PFDD, is a special meeting type defined by the US Food and Drug Administration (FDA) to ensure that drug developers at pharmaceutical companies and universities, in addition to FDA staff, hear directly from people living with a disease and those who care for them. Click here to learn more about EL-PFDD meetings.

• What are the topics?

  An EL-PFDD usually focuses on two primary topics having to do with drug development:

  • The patient (and caregiver) lived experience, with a focus on how the disease impacts your day-to-day life.
  • Patient (and caregiver) thoughts about current treatment options and their hopes/fears related to the treatment horizon.
• Who will host the meeting?

  The EL-PFDD will be planned and hosted by LBDA, in consultation with the patient and caregiver community.

• Who will speak during the meeting?

  An EL-PFDD is solely focused on the patient's voice. With the exception of two doctors, who will provide general overviews of the condition and the treatment landscape, all speakers will be DLB patients and caregivers.

  In general, patients should speak for themselves. Caregivers may also provide input, but it should be focused on the impact of the disease on the patient, rather than on the caregiver. We realize that the caregiver voice is incredibly important, but drug developers and the FDA need to understand the impact on the patient, specifically, because that is who drugs are developed for.

• Will the focus be on LBD, DLB, or PDD?

  This particular EL-PFDD will focus on DLB. However, anyone from the public is strongly encouraged to attend.

• Will I have an opportunity to speak or otherwise provide input?

  Yes! The entire point of the meeting is for your voice to be heard, documented, and shared with drug developers and the FDA. During the virtual meeting, there will be a toll-free number to call and share your experiences.

  In addition, written comments will be welcome during the meeting and for 30 days after the meeting via the EL-PFDD webpage on lbda.org.

• What happens after the meeting?

  The meeting will result in several durable outcomes:

  • The recording of the meeting will be hosted lbda.org and our YouTube channel, LBDAtv, and accessible to anyone, free of charge.
  • A written report of the meeting will be generated. This "Voice of the Patient" report will also be hosted by LBDA on the web.
  • The report and the link to the recording will be shared by LBDA with drug development researchers and the FDA.

  Click here for additional information and FAQs, provided by the U.S. Food & Drug Administration.