To bring the patient perspective to the forefront of the drug development process, the GBS|CIDP Foundation International has hosted 2 Externally-Led Patient Focused Drug Development (EL PFDD) Meetings.
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.
FDA’s Role in Medical Product Development and Evaluation
One of FDA’s missions is to protect and promote public health by evaluating the safety and effectiveness of new drugs, biologics, and devices. FDA does not develop drugs nor conduct clinical trials. FDA does, however, play a constructive role in guiding, helping, or evaluating at some stages of the pre-clinical, translational, and clinical development work.
Learn more about EL PFDD Meetings
EL PFDD Meeting on Anti-MAG, GBS, and MMN
Thursday, May 16, 2024
The GBS|CIDP Foundation International hosted an EL PFDD Meeting on May 16th, 2024 to elevate the patient voice of those with Anti-MAG, GBS, and MMN. With an audience consisting of regulators and researchers who are involved in the drug development process, this meeting highlighted the needs and preferences of the Anti-MAG, GBS, and MMN patient communities.
Access the 2024 Voice of the Patient Report Here
Meet the Panelists
Anti-MAG Panelists
GBS Panelists
MMN Panelists
Thank You to Our Sponsors!
EL PFDD Meeting on CIDP
Friday, March 25, 2022
The GBS|CIDP Foundation International hosted our first EL PFDD Meeting on CIDP on Friday, March 25th, 2022. With the hope of better understanding CIDP patients’ preferences about treatments and their side effects we elevated the patient voice in this virtual meeting.
Access the 2022 Voice of the Patient Report Here
Stay Tuned for a Recording of this Meeting
Meet the Panelists
Diagnosis and Current Treatment Panelists
Everyday Burden Panelists
Patient Centered Trial Design Panelists
Potential Future of CIDP Treatment Panelists
Thank You to Our Sponsors!
Patient Listening Sessions
Patient Listening Sessions can either be FDA-requested (where FDA has a specific set of questions to ask) or patient-led (when a patient community wants to share their perspectives with the FDA). These sessions are a small and informal opportunity for patients to relay their experiences, perspectives, and needs related to their health or disease. These sessions are focused on helping the FDA better understand a condition, its affect on different communities, and treatments that impact the patient experience.
Patient Listening Session on CIDP
June 5, 2024
On June 5th, 2024, the GBS|CIDP Foundation International organized a patient-led listening session on Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). With attendance from the National Institute of Health (NIH) and 23 FDA offices, panelists were at the heart of the meeting to express various aspects of life with CIDP, including:
- Immunoglobulin Therapy and Side Effects
- Symptoms and Residuals of CIDP
- Relapses and their Causes
- The Physical and Emotional Toll of the Diagnostic Process
Patient Listening Session on GBS
September 29, 2020
On September 29th, 2020, the GBS|CIDP Foundation International organized a patient-led listening session on Guillain-Barre Syndrome (GBS). More than 30 members of various branches within the FDA logged onto the virtual meeting to hear about patients’ experiences with GBS. The FDA’s role was to listen and learn about what life is like during and after a GBS diagnosis. The 6 speakers captured various aspects of life with GBS, including:
- Variant Perspective
- Treatment & Diagnosis When the System Works
- Treatment & Diagnosis When the System Does Not Work
- The Emotional Burden on the Family
- Rehab, Recovery, and Residuals
