An ad hoc committee will plan and conduct a 1.5-day public workshop to explore multimodal therapeutic approaches for nervous system disorders (i.e., combinations of interventions aimed at different aspects of a disease). This could include, for example, a drug prescribed along with a device, psychosocial intervention, lifestyle adjustment, or dietary intervention. The workshop will bring together key stakeholders to examine scientific, clinical, regulatory, and reimbursement issues related to multimodal approaches and identify potential opportunities to enhance clinical outcomes for individuals with nervous system disorders.

Invited presentations and discussions will be designed to:

• Explore recent advances in the development of multimodal therapeutic approaches for nervous system disorders and approaches to using these therapies (e.g., earlier versus later in disease progression), and discuss future research needs to further advance understanding of these approaches.
• Highlight disease areas in which a multimodal approach could be particularly useful (e.g., areas in which the pathophysiology is well understood).
• Discuss methodologies for establishing efficacy for multimodal therapies compared to monotherapies, including clinical and statistical considerations.
• Consider regulatory issues for multimodal therapies, including for approaches in which only one component is regulated (e.g., drug plus psychosocial intervention), and discuss potential opportunities for addressing challenges.
• Consider reimbursement issues for multimodal therapies for nervous system disorders, and discuss potential opportunities for addressing challenges.
• Incorporate lessons learned from other therapeutic areas in which multimodal approaches are more frequently used (e.g., diabetes, HIV, cancer).

The committee will develop the agenda for the workshop, select and invite speakers and discussants, and moderate the discussions. A summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.