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Executive Track

Executive Track: Guiding Good Science to Patients Through Evolving Markets and an Uncertain Regulatory Environment

Wednesday, May 13, 2026
8:00 AM - 9:30 AM PT
Location: Coral 1-2

Sponsored By 
As biopharma finds its new normal following the boom-and-bust cycle initiated by the COVID-19 pandemic, biotech C-suites have a lot to balance. Funding remains tight, with VCs and Big Pharma alike valuing later-stage pipelines. Meanwhile, global regulatory expectations are evolving, including in the United States, where the FDA is undergoing a radical shift with implications for global commercialization plans.

As organoids, AI-based models, and other technologies start their journey to eventually supplanting animal studies for preclinical research, the clinical space is also transforming. Combined with the market pressures to deliver in-human data, investigator-initiated trials are becoming more common. These trends stand to change the face of drug development for the better, but a lack of global data sharing, cooperation and trust could stand in the way.

Learning Objectives:

  • Understand how the investment model has shifted and learn about new funding models driving financing.
  • Dive into how global regulatory agencies are responding to technological innovations, such as AI-based modeling and organoids, as the push for non-animal models grows.
  • Examine the increasing localization of regulatory pathways as new markets for product development emerge and the impact on data sharing.