Uptal Patel
Head, Biogen west Coast Hub Biogen
Seminars
Wednesday 18th March 2026
Panel Discussion: Data Sources in Nephrology Drug Development: Choosing Wisely, Mitigating Bias, and Maximizing Impact
3:00 pm
- Sharing experience using different data sources (clinical trials, registries, EHRs, biobanks, biopsies) for drug development – from discovery through regulatory approval and post-market
- Comparative strengths and limitations of each data source: e.g. trial data offers control and randomization; registry/EHR data offers large-scale, real-world generalizability but more noise; biopsy samples offer deep mechanistic insight but are invasive and limited in availability
- Strategies to handle missing, incomplete, or biased data: statistical techniques, data linkage, standard operating procedures for sample collection, dealing with confounders, ensuring representative sampling
- How to align data sourcing strategy with regulatory and payer requirements: the evidentiary standards, reporting, validation, transparency, reproducibility
Wednesday 18th March 2026
Leveraging Public-Private Partnerships to Accelerate Kidney Disease Innovation
4:00 pm
- Establishing public-private partnerships to advance therapies for people with kidney diseases
- Promoting patient-centered approaches in designing and developing innovative therapies
- Facilitating the development and multisector adoption of tools, data standards, and endpoints that advance new therapies
- The role of the Kidney Health Initiative (KHI) in facilitating collaboration between stakeholders
Wednesday 18th March 2026
Endpoints in Kidney Transplantation: Integrating Biopsy, Biomarkers & Surrogate Tools in Trials
9:00 am
- Combining kidney graft biopsy histology, de novo donor-specific antibodies (dnDSA), eGFR and proteinuria in a single composite biomarker panel for earlier prediction of long-term graft loss
- Positioning iBox, a composite biomarker panel, as a “reasonably likely surrogate endpoint” under FDA’s accelerated approval for immunosuppressive therapies in transplant settings
- Addressing technical and clinical challenges: assay standardization (dnDSA MFI), biopsy variability (Banff classification), and timing of assessment (first year after transplant)
- Evaluating how iBox can accelerate trials of therapies for antibody-mediated rejection and other transplant complications
