Explore the Agenda
7:00 am Check In, Coffee & Light Breakfast
7:55 am Chair’s Opening Remarks
Redefining Unmet Need & Advancing Precision Nephrology In Modern CKD
8:00 am Panel Discussion: Challenging the Definition of Unmet Need in Modern CKD to Reveal Where the Next Generation of Therapies Can Still Transform Outcomes
- Debating whether current standards of care are approaching diminishing returns for broad CKD populations
- Identifying residual biological and clinical risk that remains despite SGLT2, MRA, incretin and other therapies
- Prioritizing where new mechanisms can deliver clinically meaningful rather than incremental benefit and going beyond laboratory measures for quality-of-life considerations
9:00 am Session Reserved for Natera
9:30 am Panel Discussion: Moving from Broad CKD to Precision Nephrology to Match the Right Mechanism to the Right Patient at the Right Time
- Segmenting heterogeneous CKD populations according to biology, genetics, progression and therapeutic response
- Determining how far patient populations can be narrowed before development becomes operationally impractical
- Connecting patient stratification with mechanism selection, trial design and eventual treatment decisions
10:00 am Speed Networking
A prime chance to make the most of in-person networking and forge new connections with an expanding landscape of companies entering, or expanding their presence within, the CKD drug development space. Designed to maximize your introduction to numerous new individuals and serve as a catalyst for ongoing discussions during the summit, connect with peers across discovery, preclinical, translational, clinical, regulatory and commercial common, rare and genetic kidney disease research.
10:45 am Morning Break & Refreshments
Discovery & Preclinical
Designed for CSOs, preclinical researchers, discovery scientists, directors of biology and research, novel modality scientists, in vivo/in vitro modelling experts and many more fueling the next generation of CKD therapeutics
From Disease Biology To Actionable Targets For Precision CKD Drug Discovery
11:00 am Mapping Disease-Causing Kidney Cell States to Identify Actionable Pathways & Generate More Precise Therapeutic Targets
- Characterizing the cell populations driving initiation and progression across CKD stages
- Linking dysregulated cell states with molecular pathways and disease phenotype
- Selecting targets according to both biological relevance and therapeutic tractability
11:30 am Session Reserved for FibroFind
12:00 pm Selecting the Right Modality for the Right Kidney Target to Convert Novel Biology into Developable Medicines
- Comparing small molecules, antibodies, RNA, gene editing and gene therapy against specific target classes
- Evaluating durability, reversibility, safety and delivery requirements during modality selection
- Determining when biological novelty justifies the additional development complexity of advanced modalities
12:30 pm Session Reserved for Inotiv
12:40 pm Turning our Trials into Discovery Instruments: Closing the Innovation Loop with Multiscalar Data Integration from Research Kidney Biopsy Trials
- Integrating transcriptomic, genomic, proteomic and metabolomic datasets to define disease mechanisms
- Validating associations strongly enough to overcome investor and development scepticism
- Translating molecular phenotypes into targets with realistic therapeutic potential
Clinical & Regulatory
Tailor-made for medical directors, CMOs, clinical program leads, regulatory affairs professionals, access, reimbursement & HEOR colleagues, BD experts, clinicians and more; share expertise from diverse clinical challenges and innovation in CKD
Optimizing Endpoints & Patient Selection To Build Faster, More Efficient CKD Trials
11:00 am The Silent Kidney: When CKD Strikes Before it Progresses
- What proteinuria and eGFR dont tell us
- Non-Proteinuric CKD: Validating disease-appropriate endpoints
- CKD-associated metabolic acidosis and sarcopenia
- Enabling Phase II proof-of-concept without forcing every program into a proteinuria-based framework
11:30 am Session Reserved for Perspectum
12:00 pm Panel Discussion: Applying GFR Slope & Hierarchical Composite Endpoints to Capture More Patient Data & Increase Trial Efficiency, & Exploring Kidney Health Markers Beyond
- Determining where GFR slope is sufficiently robust to act as a primary endpoint
- Incorporating cardiovascular events, quality of life and additional components into hierarchical composites
- Evaluating whether these approaches can reduce sample size or required follow-up without weakening evidence
- The potential of the kidney HCE in specific kidney diseases: examples from FSGS and ADPKD
12:30 pm Targeting Pathogenic IgA Biology in IgAN to Test a First-in-Class Mechanism & Build Confidence for Late- Stage Development
- Evaluating ARGX-121 in the Phase II VERDANT study as a first-in-class IgA-targeting therapy to intervene directly in disease-driving immune biology, testing whether a more upstream mechanism can deliver differentiated benefit in an increasingly competitive IgAN landscape
- Using a randomized, placebo-controlled design in approximately 120 adults with primary IgAN, with change in proteinuria at Week 24 as the primary outcome to generate an early efficacy signal, supporting faster go/no-go decisions before committing to larger registrational studies
- Following patients through up to 52 weeks of ARGX-121 treatment while assessing renal function, pharmacokinetics and immune response to connect short-term proteinuria effects with broader biological and clinical readouts, strengthening confidence in mechanism, durability and Phase III development strategy
1:00 pm Lunch & Networking Break
Linking Mechanism To Translation To Select The Right Targets & De-Risk Clinical Development
2:00 pm Dissecting Immune & Complement Pathways to Select the Right Intervention Point & Increase Mechanistic Precision
- Comparing intervention points across inflammatory and complement cascades
- Matching pathway biology with patient populations most likely to respond
- Determining how immune-targeted mechanisms can complement broader CKD standard of care
2:30 pm Developing Rapid Translational Biomarkers to Confirm Target Engagement Early & De-Risk the Move into Phase II
- Identifying urine, plasma and PBMC markers capable of producing pharmacodynamic readouts within weeks
- Separating target engagement biomarkers from biomarkers expected to predict clinical benefit
- Building translational biomarker strategies into programs before first-in-human studies begin
De-Risking Development In Rare & Ultrarare Kidney Disease Through Novel Evidence, Regulatory & Funding Pathways
2:00 pm Panel Discussion: Integrating Natural History & Real- World Evidence to Strengthen Small-Population Trials & Reduce Dependence on Conventional Controls
- Defining when external or historical controls can provide regulatory-grade evidence
- Improving data quality, standardisation and comparability across real-world datasets
- Aligning industry and regulators on appropriate applications in rare and segmented CKD populations
2:30 pm Building New Regulatory & Funding Pathways for Ultra-Rare Kidney Therapies to Bring Bespoke Genetic Medicines into the Clinic
- Reframing development models for ultra-rare therapies where conventional commercial economics prevent promising programs from progressing
- Evaluating conditional, investigational and continuously monitored approval pathways that could reduce barriers between proof-of-concept and patient treatment
- Coordinating regulators, academia, funders, payers and industry to create sustainable routes for developing therapies for ultra-small genetic populations at scale
3:00 pm Afternoon Break & Scientific Poster Session
This is an informal session to help you connect with your peers in a relaxed atmosphere to continue forging new and beneficial relationships. With an audience of CKD experts eager to hear the latest discoveries in renal therapeutic research, you will have the opportunity to display a poster presenting your own work and innovations. Don’t miss out on the chance to connect, learn, and present.
Earlier & More Precise CKD Identification To Improve Patient Selection, Trial Access & Clinically Meaningful Outcomes
4:00 pm Diagnosing CKD Earlier & More Precisely to Expand Treatable Populations, Improve Trial Recruitment & Prevent Progression
- Identifying why CKD remains underdiagnosed despite relevant information already existing in patient records
- Driving differential diagnosis beyond broad CKD labels to uncover IgAN, FSGS, Alport and other underlying causes
- Connecting earlier diagnosis with appropriate therapy, clinical trial access and improved long-term outcomes
4:30 pm Session Reserved for MediBeacon
5:00 pm Panel Discussion: Integrating the Cardio-Kidney-Metabolic Continuum to Select Endpoints That Reflect What Matters Most to Patients
- Reconsidering whether kidney endpoints remain the most meaningful outcomes in CKD populations
- Assessing cardiovascular morbidity and mortality as increasingly relevant development endpoints
- Designing clinical programs capable of navigating overlapping renal, cardiovascular and metabolic disease