Fireside Chat: Interpreting Regulatory & Political Signals to Strengthen GC Engagement Amid FDA Volatility

  • Enable Boards to make better decisions and anticipate events by translating  apparently inconsistent FDA signals, shifting policies, and congressional initiatives,  e.g. user fee timelines, into clear strategic scenarios
  • Avoid unnecessary development disruptions by filtering regulatory shifts into those  which genuinely threaten timelines versus political noise
  • Strengthen enterprise resilience by building a forward-looking view of regulatory risk that spans political and litigation cycles, and enables long development horizons
  • Incorporate the global context, and reflect on how US activities do or don’t change  market access and commercial value elsewhere