Wanna Talk to the FDA? (Episode 146)

Guests: Ian Burkhart

Today, we are discussing Patient Focused Drug Development (PFDD) for SCI with Ian Burkhart. The PFDD is an authoritative process initiated and recognized by the Food and Drug Administration for identifying the treatment priorities of the people who live with certain diseases or conditions. This process is incredibly important and has been referred to as a “once in a generation” opportunity. Ian Burkhart is an influential, lived-experience advocate in the SCI community. He is the past President of the North American Spinal Cord Injury Association (NASCIC) and is one of the principal organizers of the PFDD.

What should you know up front before we unpack all the details of the PFDD? Its main feature is a virtual community meeting where the SCI community can address the FDA about what is important to us! Which is why we need you to be present. Whether you live with an SCI, are a caregiver, researcher, clinician, funder, whatever. We are shooting for 1000 people to be present and hope to surpass that number. The meeting is September 29th and you can register to attend at www.scipfdd.org.

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Bumper music: Dig a Hole by Freaque

Guest Bio

Ian Burkhart is a C5 tetraplegic and brain-computer interface pioneer whose work is reshaping how neurotechnology is developed and deployed. After a 2010 diving accident left him paralyzed from the chest down, Ian became the first person in the world to restore movement to a paralyzed hand using an implanted BCI, helping researchers demonstrate both motor and sensory restoration through neurotechnology.

He is the founder and president of the BCI Pioneers Coalition, a global community led by implantable BCI research participants that brings together lived-experience experts, researchers, companies, and regulators to guide ethical, patient-centered innovation in neurotechnology. Ian also leads the Ian Burkhart Foundation, serves as past president of the North American Spinal Cord Injury Consortium, and sits on the FDA’s Patient Engagement Advisory Committee, where he advocates for integrating patient perspectives into medical device development and policy.

Ian was also a key member of U2FP's Ohio Cure Advocacy Network (CAN), which passed a $3M SCI Research Grant bill in that state in 2018. Ian has served on the Advisory Board since the bill's inception, helping to determine which research proposals are funded.

Through his consulting, speaking, and advocacy, Ian works with medical device companies, research teams, and nonprofits to ensure that BCIs and other assistive technologies close the gap between lab breakthroughs and real-world access, improving independence and quality of life for people with spinal cord injuries worldwide.

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