Fireside Discussion: Navigating Global Regulatory Expectations by Understanding Considerations for Trial Design, Surrogate Endpoints & Genotype-Driven Development to Support Efficient Global Approvals

• What should sponsors consider when designing rare kidney disease trials intended for global approval across different regulatory jurisdictions?
• How are regulators currently thinking about surrogate endpoints and emerging biomarkers as more therapies enter development for rare kidney diseases?
• What regulatory considerations arise when multiple trials compete for the same small patient populations or when therapies target genetically defined subgroups?

Speakers:

Kristin Van Goor

Executive Director & US Head, Global Regulatory Policy & Innovation

Takeda

Srini Srinivas

Senior Medical Director

Novartis