Appendix B
Workshop Agenda
EXPLORING THE ADOPTION OF IMPLANTABLE BRAIN STIMULATION INTO STANDARD OF CARE FOR CENTRAL NERVOUS SYSTEM DISORDERS
The Keck Center, 500 Fifth Street, NW
Washington, DC 20001
OCTOBER 31, 2023
ROOM 100
| 9:00–9:05 | Welcome Frances Jensen, University of Pennsylvania; Co-chair, Forum on Neuroscience and Nervous System Disorders John Krystal, Yale University; Co-chair, Forum on Neuroscience and Nervous System Disorders |
SESSION 1—CROSSING THE CHASM: LESSONS LEARNED ACROSS TECHNOLOGIES
- Review the current state of knowledge regarding the clinical utilization of implantable brain stimulation across various CNS disorders and consider the future potential to improve quality of life for patients.
- Discuss the lessons learned from other technologies that have or have not “crossed the chasm” to be adopted into clinical care.
- Consider how these lessons learned might be applied to implantable brain stimulation.
| 9:05–9:15 | Workshop Overview Tim Denison, University of Oxford; Workshop Co-chair Helen Mayberg, Icahn School of Medicine at Mount Sinai; Workshop Co-chair |
- Share the scope of the workshop and what will not be covered.
- Introduce technology adoption theory as the theme for this workshop.
- Highlight that scalability, technology, comorbidities considerations, and opportunities to overcome these barriers will be implicit throughout the workshop.
| 9:15–9:20 | Setting the Stage: Where Do We Want to Be Brian Litt, University of Pennsylvania |
- What does it mean to be a part of the standard of care?
- Provide a brief history about cardiac pacemakers and defibrillators.
- What would be required for implantable brain stimulation to be adopted into the standard of care?
| 9:20–9:45 | Lessons Learned Across Therapeutic Areas |
- Provide an overview of the therapy and the patient need that was being addressed.
- Share insights into why the therapy has been or not been adopted into clinical care.
- What are some of the lessons learned that should be considered for any new implantable brain stimulation therapy?
| Overview of Approved Neuromodulation Therapies Vivek Pinto, U.S. Food and Drug Administration |
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| Cochlear Implants and Retinal Implants Carla Mann Woods, Adventus Ventures |
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| Responsive Neurostimulation for Epilepsy Mindy Ganguly, University of Pennsylvania |
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| Deep Brain Stimulation for Obsessive-Compulsive Disorder (OCD) Benjamin Greenberg, Brown University |
| 9:45–10:00 | Moderated Discussion Moderator: Brian Litt, University of Pennsylvania |
SESSION 2—BENEFITS AND CHALLENGES EXPERIENCED BY INDIVIDUALS WITH LIVED EXPERIENCE
- Explore what patients need from implantable brain stimulation to define it as a successful treatment.
- Discuss how adoption of this technology can impact patients and their quality of life.
- Consider what challenges and barriers prevent patients from selecting this treatment or causes patients to perceive the treatment as a failure.
| 10:00–10:05 | Session Overview Laura Lubbers, CURE Epilepsy |
| 10:05–10:25 | Speaker Remarks Steve Austin, CURE Epilepsy Jim McNasby, Michael J. Fox Foundation for Parkinson’s Research Jon Nelson, Jon Nelson Advisors, LLC Claudia Garrido-Revilla, Michael J. Fox Foundation for Parkinson’s Research |
| 10:25–10:55 | Moderated Discussion |
| 10:55–11:05 | Break |
SESSION 3—PRACTICAL BARRIERS I: PATIENT SELECTION AND ENGAGEMENT
- Review the challenges associated with patient selection and engagement and with managing expectations of patients and their families.
- Consider the ethics of ensuring equitable access to all patients and demographics.
- Explore the potential opportunities or collaborations that are needed to develop informed patient selection practices and equitable access to the technology.
- Review the concerns of patients regarding the possible complications and side effects of implantable brain stimulation and potential educational campaigns to increase patient awareness of and comfort with the technology.
| 11:05–11:10 | Session Overview Sarah Perides, Evelina London’s Children Hospital |
| 11:10–12:10 | Moderated Panel and Audience Q&A Joseph Candelario-Mckeown, National Hospital for Neurology and Neurosurgery Rachel Davis, University of Colorado Anschutz School of Medicine Nita Farahany, Duke University (Zoom) Doris Wang, University of California, San Francisco (Zoom) Alik Widge, University of Minnesota |
| 12:10–12:55 | Lunch |
SESSION 4—PRACTICAL BARRIERS II: HEALTH PROFESSIONAL BARRIERS AND ADOPTION
- Discuss the current barriers to increase training and engagement among health professionals on implantable brain stimulation and barriers of current practices.
- Explore what relationships might need to be developed across different specialties and clinical practices to facilitate referrals and continuance of care.
| 12:55–1:00 | Session Overview David McMullen, Food and Drug Administration |
| 1:00–2:00 | Moderated Panel and Audience Q&A Lauren Hammer, University of California, San Francisco (Zoom) Joan Miravite, Icahn School of Medicine at Mount Sinai Martha Morrell, NeuroPace, Inc. Michael Okun, University of Florida Yagna Pathak, Abbott Neuromodulation |
| 2:00–2:10 | Break |
SESSION 5—PRACTICAL BARRIERS III: REIMBURSEMENT AND OTHER ECONOMIC CONSIDERATIONS
- Consider the current economic barriers and technological limitations that prevent implantable brain stimulation from becoming scalable.
- Discuss what ongoing or future approaches need to be taken to improve the benefit-cost ratio and allow brain stimulation to be scalable for wider application in CNS disorders.
- Review the current status of reimbursement for implantable brain stimulation and discuss opportunities to increase reimbursement.
| 2:10–2:15 | Session Overview Yagna Pathak, Abbott Neuromodulation |
| 2:15–3:15 | Moderated Panel and Audience Q&A Julie Brown, Spark Biomedical (Zoom) Kevin Mahoney, University of Pennsylvania Health System Susan Miller, Centers for Medicare & Medicaid Services (Zoom) Peter Silburn, Queensland Brain Institute (Zoom) |
| 3:15–3:25 | Break |
SESSION 6—SYNTHESIS OF WORKSHOP THEMES
- Review the core themes and takeaways shared across the previous sessions.
- Based on previous discussions, explore creative approaches or collaborations needed to move the field forwards toward the end goal of adoption of implantable brain stimulation into the standard of care.
- Discuss the implications of comorbidities and opportunities to develop technologies and treatments to holistically treat patients.
| 3:25–3:30 | Session Overview Tim Denison, University of Oxford; Workshop Co-chair Helen Mayberg, Icahn School of Medicine at Mount Sinai; Workshop Co-chair |
| 3:30–4:25 | Moderated Panel and Audience Q&A Brandy Ellis, Neuromodulation Patient Advocate Lauren Hammer, University of California, San Francisco (Zoom) Doug Kelly, Food and Drug Administration Sarah Hollingsworth Lisanby, National Institute of Mental Health Kevin Mahoney, University of Pennsylvania Health System Chris Pulliam, Case Western University |
| 4:25–4:30 | Synthesis and Concluding Remarks Tim Denison, University of Oxford; Workshop Co-chair Helen Mayberg, Icahn School of Medicine at Mount Sinai; Workshop Co-chair |