Panel: FDA Uncertainty and Balancing Innovation

Session details:

As regulatory landscapes shift and innovation accelerates, biotech companies face growing complexity in navigating FDA pathways. This panel will examine how evolving standards for priority review, the integration of AI and computational models, and the strategic use of Priority Review Voucher (PRV) programs are reshaping development timelines, investor interest, and regulatory strategy.

• How evolving FDA standards are shaping the approval landscape for novel therapies and platforms 
• Managing regulatory risk and review timelines in an increasingly unpredictable federal environmentThe evolving impact and valuation of PRVs in biotech financing and deal-making
• Priority review, and the value of voucher programs in biotech development