Srini Srinivas
Senior Medical Director Novartis
Seminars
This workshop is designed for business development professionals, biotech leaders, market access teams, and clinical development strategists working to strengthen the commercial foundations of rare kidney disease therapies. While scientific innovation in nephrology is accelerating, many programs struggle to translate clinical success into sustainable reimbursement and investment due to misalignment between development strategies, payer expectations, and pricing models.
This session will explore how clinical evidence, value demonstration, and pricing strategy can be aligned earlier in development to support stronger market access and investment readiness, helping teams integrate commercial thinking across the development lifecycle.
Dive into:
- Understanding payer and HTA expectations and how these should inform evidence generation, endpoint selection, and clinical trial design
- Developing pricing and value frameworks for rare kidney disease therapies, including how to articulate clinical and economic value to payers
- Building the strategic skills to evaluate commercial viability early, helping teams align clinical development decisions with reimbursement and investment considerations
- 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?
