Lynne Yao
Director - Division of Pediatrics & Maternal Health US Food & Drug Administration (FDA)
Seminars
Wednesday 18th March 2026
Strategies for the Development & Evaluation of Treatments for Children with Renal Diseases
9:30 am
- Review ethical and legal obligations in studying drugs in childrenÂ
- Discuss unique considerations for designing paediatric drug development programs
- Present innovative tools and strategies to increase the feasibility and success of pediatric drug development programsÂ
Wednesday 18th March 2026
Panel Discussion: Who Are the High-Risk CKD Patients Now? Redefining Risk Beyond Proteinuria
4:30 pm
- Understanding what is the unmet need on top of standard of care and treatment landscape Combinations & Polypharmacy?
- Are traditional definitions of high risk (low eGFR, proteinuria) still sufficient in the era of multi-omics and cardiometabolic overlap?
- What biomarkers and surrogate endpoints are emerging to identify and serve non-proteinuric CKD patients?
- How can we define clinical endophenotypes, such as patients with reduced ejection fraction, diabetes, or obesity—that may signal higher risk or non-response?
- What data are missing from current longitudinal cohorts (e.g., cardiovascular outcomes, repeat biopsies), and how do we fill these gaps to better guide drug development?
Tuesday 17th March 2026
Making CKD Clinical Trials More Accessible, Feasible & Patient-Centered: Bridging Research Goals with Real-World Realities
5:30 pm
- Understanding the broader patient experience from both patient, caregiver and clinician perspective
- Exploring the decision to participate in a clinical trial, and factors that may limit patient involvement
- Examining strategies to make trials more accessible to patients including geographical, financial and logistical barriers, while fostering open communication between researchers and participants
- Reducing burden for patients to participate in a clinical trial through innovative strategies
