80/20 Update and Next Steps

This is the recording and slides of the session presented live at the 2022 AcCELLerate Forum: Creating a Sustainable Ecosystem of Cell and Gene Therapy. The event aired live on Thursday, November 17, 2022. 

Topics include:

• Background and Update on 80/20
• FDA Programs: The Purpose and Current Processes for REMS, EAPs, BLA 
• EAPs in CART Therapy: Site Challenges and Opportunities for Improvement 
• REMS &Education in CART Therapy: Site Challenges and Opportunities for Improvement 
• BLA and Audits: Site Challenges and Opportunities for Improvement 

Session Chairs:

• Noelle Frey (University of Pennsylvania)
• Partow Kebriaei (MD Anderson Cancer Center) 

Speakers: 

• Fred Locke (Moffitt Cancer Center)
• Peter Marks (FDA)
• Matthew Frigault (MGH)
• Sarah Nikiforow (Dana Farber Cancer Institute)
• Rebecca Gardner (Seattle Children’s Hospital) 

Panelists:

• Robb Richards (University of Pennsylvania)
• Madan Jagasia (Iovance)