Live Insights Lab: Navigating FDA & CBER Leadership Changes Impacting CGT Development

Time: 3:45 pm
day: Conference Day One

Details:

Join this interactive session to reflect on a year of FDA changes, explore their impact, and collaborate in small groups to craft key questions and discussion points, then watch them come to life in a dynamic panel conversation.

• Shifts in trial design expectations: from single-arm studies to randomized controlled trials and innovative alternatives
• Evolving CMC and analytical requirements: balancing regulatory rigor with manufacturing realities
• Changing agency interactions, global harmonization challenges, and the growing role of real-world evidence and patient engagement

Speakers:

Keith Wonnacott

Jad Adaimi Jad is an accomplished regulatory affairs leader that led regulatory efforts across multiple therapeutic areas, contributing to the advancement of breakthrough products from early development Read more