This opening session will explore how the interplay between policy and economics – as well as the disconnect between science and the law – are affecting the novel therapeutics landscape. Panelists will detail how the latest regulatory and legislative developments are affecting biopharma R&D and commercial strategies and what the ramifications of these developments mean for novel therapeutics.

This session will also offer a pulse-check on the industry’s health, highlighting pivotal drug approvals, performance metrics and other biopharma market factors. Topics of discussion will include:

• Examining how recent legislative actions and regulatory shifts are impacting the research, development, and commercialization of novel therapeutics and regenerative medicines
  • Considering the impact of regulation on the structuring and negotiation of biopharma deals and alliances
• Understanding how recent policy changes are reshaping R&D priorities
• Analyzing of the biopharma market’s vigor post-March 2023, focusing on significant drug approvals and their technological underpinnings
• Examining therapeutics which have underperformed
  • Addressing the underperformance of COVID boosters and the implications for future therapeutic funding
• Best practices for biopharma companies to navigate market downturns, including diversification of therapeutic portfolios and reassessment of market strategies
• Exploring the regulations of laboratory developed tests (LDTs)
  • Utilizing companion diagnostics via smart tech