• How emerging legal frameworks like Montana’s Right To Try expansion could impact patient access to unapproved personalized vaccines – and what that means for regulatory strategy

• Balancing IP protection vs. platform flexibility in an era where proprietary algorithms, tumor-specific libraries, and bioinformatic tools are central to value creation

• The role of patent exclusivity, trade secrets, and data protection in enabling commercial viability for PCVs – especially when facing fragmented regulatory landscapes