This workshop will address optimization, refinement, and establishment of acceptability criteria for technologies, assays, and clinical outcomes used in regulatory packages to advance interventions. Speakers will discuss the necessary data required to accelerate clinical development and evaluation of novel therapeutics which treat a broad array of unmet, rare lung diseases and sleep disorders. The workshop will bring together experts in the field of lung/sleep research, pulmonary critical care, and sleep medicine to discuss gaps and opportunities for the current state of physiologically relevant and fit-for-purpose technologies, tools, assays, model systems, and clinical endpoints across the spectrum of acute/chronic lung diseases and sleep disorders. These discussions are intended to facilitate advancing therapeutic leads in IND-enabling studies for IND (Investigational New Drug) application submission to the U.S. Food and Drug Administration (FDA). Discussants will also make recommendations for gaps in technologies, tools, assays, and models which need further development for utilization and adoption in regulatory submissions for pulmonary and sleep interventions. Invited speakers also include relevant federal, industry, and venture capital stakeholders to this workshop to discuss how partnerships between research and technology development companies can be made. Importantly, knowledge will be shared from clinical trialists who have successfully navigated this process to deliver meaningful therapies to their patients. Attention will be made to understand the patient journey through working with patient engagement and advocacy groups to understand the unmet needs for the lung and sleep community. The goal will be to bring in drug developers, advocacy groups, and regulators to discuss the important partnerships needed to advance novel therapies.

Registration Close Date:
Closes: December 13, 2024 at 5 PM ET