A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize and conduct a 1.5-day public workshop that brings together experts and key stakeholders from academia, industry, government, philanthropic foundations, and disease-focused non-profit organizations to examine the potential to develop multimodal biomarkers for central nervous system (CNS) disorders through integration of different biomarkers. The workshop will explore steps toward this goal, such as data collection for biomarker discovery, development, validation, and assessment of clinical utility; standardization; and regulatory considerations.
Invited presentations and discussions may:

• Review current state of knowledge regarding biomarkers for CNS disorders (e.g., blood-based, imaging, molecular, proteomic, genetic) and ongoing efforts to generate multimodal biomarkers.
• Examine current practices for data collection, cohort development, and measurement standards for discovery of biomarkers that are representative of the CNS disease phenotype.
• Explore the process of replicating biomarker research findings and validating single and multimodal biomarkers.
• Discuss opportunities to standardize the methodologies, terminology, and metadata for biomarker discovery, validation and use in order to increase applicability across diverse populations/cohorts and enable accessible data sharing.
• Review the current regulatory guidance for decision making regarding multimodal biomarkers for CNS disorders, current barriers, and implications for clinical utility.
• Discuss innovative and new methodologies for biomarker integration in CNS disorders, including consideration of lessons learned from other therapeutic areas.

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