Conference Day One
7:00 am Check In & Morning Refreshments
7:55 am Chairs Opening Remarks
Adapting to the Changing Renal Landscape & Implications on Drug Discovery & Development
8:00 am Fireside Chat: Navigating the Multi-Drug Treatment Landscape in CKD: Understanding the Implications on Drug Discovery & Development to Inform Future Directions
Synopsis
As the chronic kidney disease treatment landscape evolves, marked by significant breakthroughs such as SGLT2i, GLP-1s, ACEi/ARBs, MRAs, the field is rapidly advancing toward more effective multi-drug therapies. However, these advancements present new challenges and considerations for drug discovery, development, and clinical trial design. This panel will explore the complexities of leveraging these successes to fuel future innovation while addressing critical hurdles related to endpoint selection, composite markers, and long-term therapeutic outcomes
- Evaluating how the success of SGLT2i, GLP-1s, ACEi/ARBs, MRAs reshapes the CKD treatment paradigm and the implications for discovering new therapeutic targets
- Examining the complexities of designing trials in a crowded therapeutic landscape—how do we integrate new treatments without compromising patient safety and trial validity?
- What are the next steps in CKD drug discovery, considering the saturation of existing treatment modalities? How do we ensure that innovation keeps pace with the changing standard of care while addressing unmet needs?
9:00 am Session Reserved for Natera
9:30 am Advancing CKD Drug Discovery to Develop Distinctive Therapies with Substantial Clinical Impact in a Dynamic Market Landscape
Synopsis
- Explore the limitations of current therapies and identify patient populations and disease mechanisms that remain underserved, paving the way for next-generation innovations
- Discover strategies to design and position novel treatments that offer clear advantages over existing options, including improved efficacy, safety, and patient outcomes
- Gain insights into drug design and trial planning in the context of emerging multi-drug regimens, evolving therapeutic benchmarks, and increasing regulatory expectations.
10:00 am Speed Networking
Synopsis
This informal session provides the perfect opportunity to connect with the industry frontrunners and key opinion leaders from across the nephrology field. Establish meaningful connections to build upon for the rest of the conference and gain exclusive first-hand insights into the latest research and developments driving progression in CKD.
10:45 am Morning Break
Track 1: Discovery, Preclinical & Translational
Improving Mechanistic Understanding of Disease Pathophysiology to Uncover Novel Targets & Novel Approaches to CKD Treatment
11:00 am Harnessing Genetic Insights for New Target Discovery in Kidney Disease
Synopsis
- Explore cutting-edge research into the genetic foundations of kidney diseases, focusing on the discovery of novel genes and pathways involved in podocyte function and glomerular cell biology, and their potential as therapeutic targets
- • Discuss how initiatives contribute to a deeper understanding of genetic variations in kidney diseases, accelerating the identification of targetable mechanisms across diverse patient populations
- Examine the potential of gene therapy targeting podocytes, led by programs like Purespring Therapeutics, to transform treatment paradigms in kidney diseases by addressing root genetic abnormalities with precision and durability
11:30 am Human Precision Cut Kidney Slices: An Unrivalled Preclinical Platform for biomarker identification, target discovery & drug efficacy evaluation
Synopsis
- Human precision cut kidney slices (PCKS) retain the cellular complexity and architecture of the native tissue in culture
- Utilizing dynamic models of toxicity, inflammation, lipid accumulation and fibrogenesis in PCKS
- Application of PCKS for drug testing, target engagement, assessment of efficacy and toxicity
12:00 pm Translational Strategies in CKD Drug Development: From Target Discovery to Clinical Application
Synopsis
- Exploring cutting-edge approaches to identify and validate novel CKD therapeutic targets, from preclinical models to early-stage trials
- Integrating biomarker-driven insights for patient stratification, enhancing trial outcomes, and refining CKD treatment strategies
- Utilizing back-translation to align preclinical findings with clinical realities, supporting more effective drug development and diagnostic innovation
12:30 pm A Blood-Based Protein Index for Earlier Assessment of Kidney Damage
Synopsis
- Exagen has developed a 4-protein index for detection of kidney damage from plasma
- It was guided by set of proprietary rules for protein selection, which accelerated development
- The index was shown to outperform serum creatine and eGFR in cohorts of kidney disease associated with Diabetic (N=100) or Lupus Nephropathy (N=31), yielding AUCs of 0.91 and 0.92 respectively
Track 2: Clinical Innovation, Regulatory & Outcomes Track
Optimizing CKD Trial Success: Integrating Endpoints, Biomarkers & Patient-Centered Outcomes to Ensure Efficient & Rigorous Evaluation of New Therapies
11:00 am Maximizing Success in CKD Trials: Overcoming Challenges in Endpoint Selection
Synopsis
- Discuss why traditional endpoints like albuminuria may fail to predict outcomes in non-diabetic CKD subtypes, such as IgA nephropathy and ADPKD, and the need for more reliable biomarkers
- Explore non-proteinuric markers, including GFR slope and emerging plasma and urinary biomarkers (e.g., urine NGAL, KIM-1), and their potential to predict disease progression across different CKD populations
- Review new surrogate endpoints, such as plasma cytokines and urine proteomics, that offer earlier, more accurate predictions of long-term outcomes, and discuss the progress made in validating these tools
11:30 am Session Reserved for EYNO
12:00 pm Clinical Development Strategies to Overcome Unique Challenges in End-Stage Renal Disease
Synopsis
- Designing patients that accommodate dialysis schedules, high comorbidity rates, and mobility limitations, using flexible, patient-centric trial designs to enhance ongoing participation
- Establishing dosing and safety monitoring frameworks that account for advanced renal impairment and high comorbidity in ESRD, balancing therapeutic efficacy with potential adverse events and ensuring robust, adaptable safety endpoints
- Choosing endpoints that capture meaningful clinical outcomes in ESRD, incorporating surrogate biomarkers, patient-reported outcomes, and progression markers to better reflect intervention efficacy and align with evolving regulatory standards.
12:30 pm Opportunity to Partner
12:40 pm Lunch Break
1:00 pm Pathophysiology of the Transition from AKI to CKD: Mechanisms of Injury & Repair in AKI and CKD Progression
Synopsis
- Examining the biological overlap between AKI and CKD, emphasizing the role of maladaptive repair, inflammation, and fibrosis in disease progression
- Investigating key drivers of injury, including tubular epithelial cell injury and endothelial dysfunction, and how repair mechanisms, if dysregulated, lead to chronic disease
- How understanding the transition from AKI to CKD can open up novel therapeutic targets for early CKD intervention
- Focus on therapeutic strategies aimed at modulating repair pathways, including the potential role of senescence and autophagy modulators, and anti-fibrotic agents.
Navigating the Evolving Landscape of Kidney Health: Insights into CKM, GLP-1 Mechanisms, & Treatment Combinations
1:30 pm Introducing Cardiac Kidney Metabolic Syndrome (CKM) – Pathophysiology & Impact on Drug Discovery
Synopsis
- Discuss the underlying metabolic disturbances that characterize CKM, including mitochondrial dysfunction, inflammation, and the dysregulation of glucose and lipid metabolism, explore how these processes drive CKD progression and impact kidney function
- Explore the added complexity of target ID and validation in CKM
- Investigate metabolic pathways in the pathogenesis of CKM, and how these pathways can facilitate the discovery of more precise molecular targets and guide drug design
- Discuss novel approaches to preclinical modeling of CKM and how better-defined disease models can improve the translation of experimental therapies into clinical settings
2:00 pm Diving into GLP-1 Receptor Agonists & Obesity in the Renal Space – Exploring Metabolic Mechanisms & Clinical Promise
Synopsis
- Review how GLP-1 receptor agonists improve insulin sensitivity, reduce inflammation, and influence mitochondrialfunction in kidney cells, focusing on their role in slowing CKD progression in patients with metabolic dysfunction
- Explore ongoing research into expanding GLP-1 receptor agonists beyond diabetic nephropathy to treat CKD across a broader range of metabolic phenotypes, including potential combination therapies with renoprotective agents and their future role in CKD treatment
2:30 pm Driving Progress in Kidney Disease Research Through Specialized Surgical Preclinical Models
Synopsis
- Overview the company and its mission
- Services and Expertise
- Study case
1:00 pm Examining Clinical Trial Design for Phase 2 CKD Studies to Provide Confidence in Endpoints, Sample Size & Outcome Predictions
Synopsis
- Explore strategies for designing Phase 2 trials that are more predictive of Phase 3 success, focusing on proper patient stratification and using surrogate markers effectively to gauge outcomes early on
- Review the challenges of selecting appropriate Phase 2 endpoints and sample sizes, ensuring that trial design is robust enough to provide meaningful data while balancing costs and timeline considerations
- Explore innovations in adaptive trial design that allow for flexible modifications based on interim results, improving the confidence in trial outcomes and lead to more informed decision-making for Phase 3
Innovative Approaches to CKD Trial Design: Bridging Confidence, Superiority, & Patient Perspectives
1:30 pm Designing Clinical Trials to Demonstrate Superiority Over Robust Standards of Care to Breakthrough the Plateau
Synopsis
- Explore alternative endpoints to reveal incremental benefits when standard clinical markers indicate limited room for progress, such as using patient-reported outcomes or advanced biomarkers to capture subtler treatment effects
- Evaluate novel trial designs like adaptive trials or crossover studies that allow flexibility in assessing superiority over the standard of care, potentially enhancing statistical power and improving study efficiency
- Discuss patient population stratification strategies to identify subgroups more likely to benefit from novel interventions, allowing for a targeted approach that highlights areas where standard treatments may not address specific needs fully
2:00 pm Leveraging the Utility of Master Protocols in Kidney Disease: Unveiling the World’s First Umbrella Clinical Trial in Nephrology
Synopsis
- Introducing an umbrella trial in nephrology and the potential for a transformative shift in nephrology research, explore using a single overarching master protocol to simultaneously evaluate multiple therapeutic interventions and disease subtypes
- Understand how this approach maximizes efficiency in clinical trials by allowing flexibility in patient populations and treatment arms, leading to faster identification of effective therapies in chronic kidney disease
2:30 pm Opportunity to Partner
3:30 pm Session Reserved for SeaStar Medical
Moving Beyond Precision Medicine to Stratified Medicine: Getting the Right Drug to the Right Patient at the Right Time to Improve Therapeutic Benefit
4:00 pm Understanding the Molecular Heterogeneity of CKD
Synopsis
- Explore how large-scale data integration from genomics, transcriptomics, proteomics, and metabolomics has enabled the identification of molecular drivers of CKD progression. Discuss the benefits of combining this with clinical phenotypes and digital histology to create more detailed patient profiles
- Uncover how systems biology helps stratify patients based on molecular and clinical phenotypes, and explore the role of genetic predisposition and environmental exposures in influencing CKD outcomes
4:30 pm Introduction:Translating Disease Heterogeneity into Precision Medicine
4:45 pm Panel Discussion: Translating Understanding to Implementation: What is the Path to the Nephrologists Office? Assessing the Implementation of Precision Medicine
Synopsis
- Discuss the systemic barriers that impede the integration of precision medicine approaches into CKD treatment guidelines
- Focus on how patient-reported outcomes, alongside molecular data, can guide the development of more individualized and effective treatments
- Highlight how collaboration between academia, industry, and regulatory bodies can accelerate the translation of precision medicine approaches from bench to bedside