FAQs

The 6th Rare & Genetic Kidney Disease Drug Development Summit is a focused, industry-led meeting dedicated to advancing therapies for rare and inherited renal diseases. This year, the summit brings together leaders from pharma, biotech, academia, regulators, and patient advocacy to address the key scientific, clinical, and regulatory challenges impacting kidney disease drug development.

The agenda spans multiple rare and genetic kidney disease indications, including IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), autosomal dominant polycystic kidney disease (ADPKD), Alport syndrome, and C3 glomerulopathy (C3G). Sessions are designed to reflect both indication-specific challenges and cross-cutting development themes.

The summit is designed for professionals across the end-to-end rare kidney disease drug development continuum, including clinical development leaders, translational scientists, biomarker and imaging experts, regulatory teams, and commercial decision-makers from pharma, biotech, academia, not-for-profit organizations, and specialist service providers supporting renal drug development.

The agenda covers end-to-end rare kidney disease drug development, from target discovery and translational strategies through clinical trial design and regulatory alignment. Core topics include surrogate endpoint validation, biomarker development, imaging and monitoring technologies, patient recruitment in small populations, adaptive trial designs, and patient stratification using genetic and real-world data.

Surrogate endpoint validation is a central focus of the meeting. Sessions explore the use of proteinuria, imaging measures, tissue profiling, and emerging biomarkers to support earlier proof-of-concept, regulatory acceptance, and accelerated development timelines across rare kidney disease programs, with insights from organizations including University of Michigan, Bayer, and Calliditas Therapeutics.

Speakers share practical strategies to improve trial feasibility in small and heterogeneous patient populations. This includes the use of external control arms, natural history data, real-world evidence, and patient-centric trial design approaches aimed at reducing burden and improving enrollment and retention, with KidneyFuture, Boehringer Ingelheim and Vera Therapeutics.

The speaker faculty includes senior leaders from global pharma and biotech companies, academic experts, regulators, and patient advocacy organizations. Confirmed speakers represent organizations such as Novartis, Calliditas Therapeutics, Travere Therapeutics, and Vertex Pharmaceuticals, actively advancing rare and genetic kidney disease pipelines and contributing real-world experience across discovery, clinical development, and commercialization.

See the full speaker faculty.

Yes. The summit includes pre-conference workshops focused on improving translational predictability, advancing clinical endpoint and biomarker strategies, and strengthening commercial and market access planning. These sessions are designed to provide deeper technical discussion and practical takeaways beyond the main conference agenda. 

Learn more about the workshop day here. 

Solution and service providers can engage through tailored partnership opportunities designed to connect them with decision-makers actively advancing renal pipelines. Key areas of interest include clinical CRO services, preclinical and translational models, biomarker and imaging platforms, genetic testing, and end-to-end development support. 

Get in touch with the team to discuss this further at: sponsor@hansonwade.com 

The 6th Rare & Genetic Kidney Disease Drug Development Summit will take place in August 2026 in Boston, Massachusetts. The meeting combines pre-conference workshops with two main conference days of in-person content and networking.