Bridge the Gap
Connect what matters to patients with what regulators evaluate.
Registration open • Free virtual events
The North American Spinal Cord Injury Consortium (NASCIC), alongside a coalition of national spinal cord injury organizations, is organizing the first Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting for spinal cord injury (SCI), taking place September 29, 2026, co-hosted by Ian Burkhart.
A recorded session on what to expect from the September 29 meeting.
Watch the recordingShare your experience directly with the FDA and treatment developers.
Register for the meetingAbout the meeting
Patient-Focused Drug Development (PFDD) ensures the voices of those living with spinal cord injury (SCI) help shape the future of treatment development.
Connect what matters to patients with what regulators evaluate.
Influence which symptoms and outcomes clinical trials should measure.
Ensure diverse SCI experiences are heard by decision-makers.
At the meeting, people living with SCI and their care partners share their experiences while U.S. Food and Drug Administration (FDA) staff and drug developers listen. The discussion is captured in a Voice of the Patient report shared with the FDA, where it can shape how clinical trials are designed and which outcomes are weighed when SCI therapies are evaluated for approval.
Meeting co-host
Ian Burkhart is a C5 tetraplegic, advocate, and neurotechnology innovator. He is the past President of the North American Spinal Cord Injury Consortium, where he championed research, technology, and policies that center on lived experience and drive meaningful improvements in health, independence, and quality of life for people with spinal cord injuries.
Proven impact
See how PFDD meetings have changed treatment landscapes for other conditions.
Before PFDD: One repurposed cancer drug for decades, and 30% of trials failed enrollment.
After PFDD: Three FDA-approved SCD-specific agents within five years, with new outcome measures accepted.
Impact: shifted focus beyond pain to red blood cell function.
Before PFDD: One treatment (Spinraza) approved just six months prior to the meeting.
After PFDD: Two new treatments, including the first FDA-approved gene therapy (Luxturna) and Zolgensma.
Impact: patient risk tolerance informed approval decisions.
Learn more
A guide to understanding how PFDD meetings shape FDA decisions and accelerate meaningful treatments for the SCI community.
Guiding our approach
Essential insights from successful PFDD meetings.
Include complete injury levels, ages, backgrounds, and experiences to capture the full spectrum of SCI impact.
Combine personal stories with quantitative data through polling and surveys.
Engage treatment developers early as listeners to understand patient priorities.
Align meeting timing with FDA review cycles and emerging treatment pipelines.
Industry partners
Over the past two years, NASCIC and a coalition of national SCI organizations have built the foundation for this SCI EL-PFDD meeting: an SCI PFDD white paper published and disseminated, findings presented to national audiences, sustained community outreach, FDA acceptance of our letter of intent in September 2025, the launch of an FDA-reviewed SCI PFDD website, and an SCI PFDD Steering Committee guiding planning for the September 29, 2026 meeting.
Remaining funding supports meeting production, medical writing for the Voice of the Patient report, and the development and dissemination of the Patient Experience Dossier. By supporting this initiative, sponsors help ensure the SCI community's voice reaches regulators and treatment developers, contributing to better-designed clinical trials and more patient-centered therapies.
This initiative is made possible in part by financial support from industry sponsors and partner, which helps fund activities such as meeting production, medical writing, and patient and caregiver honoraria. Sponsors do not control or influence the meeting agenda, discussion or polling questions, selection of patient panelists, the conduct of the meeting, or the resulting Voice of the Patient report; these remain independent and patient-led. Financial support does not constitute NASCIC's endorsement of any sponsor's products or services. The FDA does not organize Externally-Led PFDD meetings, and its acceptance of this meeting does not constitute FDA endorsement. NASCIC discloses sponsor relationships consistent with its conflict-of-interest and sponsorship policies.
To learn more about the sponsorship levels and their full benefits, request our sponsorship prospectus or reach us through the Contact Us page.
Request the sponsorship prospectusGet involved before September 29
Watch the recording of the free community webinar about the September 29 SCI EL-PFDD meeting. Learn what to expect, how the meeting will be conducted, and how taking part can help shape spinal cord injury treatment development.
Your voice counts
Here is how you can contribute to this initiative.
Share your lived experience directly with FDA representatives.
Contribute data that strengthens our collective voice.
Help us reach every corner of the SCI community.
Add your experience to an official record the FDA and treatment developers can use to help shape future therapies.
Part of the SCI Patient-Focused Drug Development initiative. Full meeting details are at scipfdd.org.