Voices from the DLB Community
Sharing lived experiences with the FDA
In October 2024, LBDA in collaboration with the Alzheimer's Association hosted the first-ever Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting on dementia with Lewy bodies (DLB). The EL-PFDD is a unique opportunity for the FDA, drug developers and other key stakeholders to hear directly from people living with a disease and their care partners.
Watch the EL-PFDD meeting on DLB
The EL-PFDD Meeting on DLB focused on insights from people living with DLB and current or former care partners in two sessions: DLB Symptoms & Daily Impacts and Current & Future DLB Treatments. Watch it on-demand, and share with your family, care partners and health care providers.
Coming Soon: The Voice of the Patient Report
As an outcome of the EL-PFDD meeting, LBDA will publish the Voice of the Patient Report. This landmark report will include all the perspectives and shared experiences from the DLB community captured before, during and after the meeting, as well as a detailed summary and analysis of the data and insights. This report will be shared with the FDA, clinical researchers, drug developers and other key stakeholders as an important tool to guide and inform the development of better treatment options for those living with DLB. It will be free for you to read, and share with your family, care partners and health care providers.
To receive updates on the Voice of the Patient Report sign up for Lewy Digest.
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, it is a special meeting type defined by the US Food and Drug Administration (FDA) so that drug developers and 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 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.
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 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 on 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.
Thank You to Our Partner and Sponsors
Collaborative Partner
Diamond Sponsors
Gold Sponsors
ACADIA Pharmaceuticals
Eisai Inc
Novartis
Silver Sponsors
Amprion
Cognition Therapeutics, Inc.
Learn about LBD
Educational resources to assist individuals with LBD, their families and healthcare providers.
