Keith Wonnacott

Company: Lexeo Therapeutics

Job title: Vice President - Regulatory Affairs

Seminars:

Panel Discussion: A 101 in Expedited Programs for Gene Therapy 2:00 pm

Outlining the practicalities of gaining FDA expedited designations Criteria for designation and best practices with regulatory touchpoints Considerations for successful interactions with CBER reviewers  Common reasons for denial of RMAT applicationsRead more

day: Regulatory - PM

Expectations and Considerations for Using the Accelerated Approval Pathway 1:30 pm

Providing an overview of the program and current regulatory attitudes towards its role in the gene therapy field Learnings in terms of regulatory strategy from success with accelerated approval How to make a compelling case that your gene therapy will be reasonably likely to have a clinical benefitRead more

day: Regulatory - PM