Expedited Regulatory Pathways for Biologics

Join the discussion on how expedited regulatory pathways are compressing review timelines and incentivizing domestic manufacturing, accelerating patient access to new biotherapies while maintaining rigorous safety standards.

Register Free: https://www.biopharminternational.com/bp_w/pathways

Event Overview:

This episode of the BioPharm Drug Digest will examine strategic triggers that have thus far won expedited regulatory review for biologics in development. The episode will also address differences behind expedited regulatory pathways (e.g., RMAT, fast track, priority review, and breakthrough therapy) while exploring how these designations, alongside the new National Priority Voucher pilot program, aim to dramatically compress review timelines and incentivize domestic manufacturing for complex biologics and advanced therapies. We will also discuss whether these mechanisms are effectively keeping pace with the high volume of newer modalities, like cell and gene therapies, in the pipeline while maintaining safety standards.

Key Learning Objectives:

• Comparing expedited regulatory pathway designations
• Identifying strategic triggers for accelerated review
• Leveraging National Priority Vouchers for manufacturing
• Balancing pipeline speed and safety standards

Who Should Attend:

• Regulatory affairs and compliance professionals
• Biomanufacturing and operations leaders
• Clinical development and strategic planning officers
• Supply chain and global logistics managers
  

Speaker:

TBA

Register Free: https://www.biopharminternational.com/bp_w/pathways