More products were approved in 2025 than in any year since 2021, expedited pathways are being used more creatively, and a growing wave of biologics submissions is testing frameworks built for small molecules. This session explores how the landscape is shifting and what that means for companies with assets in development.

• What a best-in-class pre-submission strategy looks like in the current environment
• The 2025 approval surge: what's driving it and whether it's sustainable
• Regulatory strategy for biologics, mAbs, stem cells, and gene therapies: what's different and what's still being figured out
• IP positioning, pathway choices, and how regulatory strategy shapes launch timing and competitive positioning
• Expedited pathways: where the real opportunities are and how to qualify for them