Manatt Health Partner Rachel Sher will moderate a panel titled “Current Issues in Drug Development for Rare and Neurodegenerative Diseases” at the upcoming Food and Drug Law Institute (FDLI)’s Annual Conference in Washington, D.C. from 2:20—3:20pm EST on May 16, 2024.  

Historically, emerging therapies for heterogenous diseases with low patient populations have presented practical development difficulties for drug manufacturers, including limited clinical data, lack of established clinical trial endpoints, and quality inconsistency. Now, with the rise of tools to personalize therapies—advanced therapeutic modalities products and AI-based treatments—there are additional challenges to navigate. This session will explore FDA’s approach to reviewing these novel drug development tools to better serve rare and neurodegenerative disease patients, and best practices to proactively engage with regulators to identify expectations and potential hurdles.

Rachel Sher has nearly two decades of experience in the health policy space. She is a prominent Food and Drug Administration (FDA) regulatory leader with sophisticated experience in policy and legislative strategy who helps support life sciences companies as they navigate the broader FDA regulatory process across all stages of a product’s life cycle. 

To learn more and register, click here.