Keith Wonnacott

Company: Lexeo Therapeutics

Job title: Vice President, Regulatory Affairs

Seminars:

Fireside Chat: Analyzing the Most Recent FDA Draft Guidance on Potency Assays to Navigate Differences & Obstacles 11:45 am

Comparing the newly released draft guidance with previous versions Removing uncertainties stemming from the draft guidance to determine clear next steps Discussing strategies for updating and aligning potency assay techniques with the new guidanceRead more

day: Conference Day Two

Panel Discussion: Discussing Comparability Guidance & Gaining Insights on Negotiating with Regulatory Bodies 9:30 am

Understanding regulatory expectations for comparability protocols to ensure alignment with criteria Providing examples of negotiating comparability strategies with regulatory bodies to apply these approaches in real-world scenariosRead more

day: Conference Day Two

Enlightening the Regulatory Community on Accelerated Approvals to Break Down Criteria & Expectations 10:00 am

Evaluating the starting point for achieving accelerated approvals to guide companies pursuing this pathway Exploring scenarios where accelerated approvals are suitable and unsuitable to define who this would be relevant to Outlining how the timeline works for accelerated approvals to aid future planning effortsRead more

day: Conference Day One