Panel Discussion: A 101 in Expedited Programs for Gene Therapy

Time: 2:00 pm
day: Regulatory - PM

Details:

• 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 applications

Speakers:

Jim Wang Senior regulatory professional with more than 20 years of global experience managing full spectrum drug development, marketing applications, and regulatory approvals, including the approval of Read more

Keith Wonnacott

Mantej (Nimi) Chhina

Aron Stein Aron is the Sr VP of Global Regulatory Affairs at Intellia Therapeutics. He has over 35 years of product development experience in pharmaceutical and biotechnology Read more