7:55 am Chair’s Opening Remarks
Evaluating Surrogate Endpoints to Accelerate Clinical Trials & Drive Innovation
8:00 am Panel Discussion: How can we Modernize Surrogate Endpoint Development? Moving Beyond Hard Endpoints
Synopsis
- Evaluating novel surrogate endpoints in addition to emerging standard of care
- Non-invasive imaging, patient-reported outcomes, UACR, and more: what is an acceptable endpoint?
- Considering payers perspectives’ on moving beyond hard endpoints and ESRD
8:30 am Regulatory Updates From the FDA: Advancing Endpoints & Innovative Trial Design for Chronic Kidney Disease Drug Development
Synopsis
- Evolving surrogate endpoints and assessing accelerated approval programs
- Identifying opportunities to implement real-world evidence in trial design
- Progressing patient focused drug development and decentralized trials
9:00 am Examining the Validity & Practical Implications of eGFR Change & Albuminuria as Surrogate Endpoints of Kidney Failure
Synopsis
- Exploring changes in GFR and albuminuria as surrogate outcomes for kidney failure in clinical trials
- Integrating Albuminuira and eGFR to more accurately establish efficacy
- Transforming innovative trial design to improve clinical outcome
9:30 am Structured Networking
Synopsis
This session is the ideal opportunity to connect with your peers during a face-to-face networking time, and understand who is also prioritizing and overcoming challenges within chronic kidney disease drug development
10:15 am Morning Break & Networking
Harnessing Novel Biomarkers to Evaluate Therapeutic Target Engagement
11:00 am Establishing Biomarker Panels to Improve Clinical Trial Design & Optimize Patient Safety
Synopsis
- Learn about translational biomarker panel development and proactive communication with regulatory agencies
- Explore the “Pre-clinical to Clinical Learn-and-Confirm” Paradigm: Prior success to accelerate novel biomarker panel development and implementation
- Discover the biomarker data repository: sharing anonymized data to benefit patient care globally
- Examine longitudinal biomarker data sharing and biomarker dynamics in subgroups with and without CKD
11:30 am Developing & Validating Early Biomarkers of Disease Progression & Therapeutic Effect
Synopsis
- Distinguishing prognostic and predictive biomarkers to advance trial design
- Predicting fast versus slow progressors of kidney injury
- Translating biomarkers of kidney function/health to the clinic
12:00 pm Urine Biomarkers of Activity & Chronicity in Lupus Nephritis: Can We Follow the Tissue Without a Biopsy?
Synopsis
- Overview of biomarkers for lupus nephritis
- Explore the development of an activity biomarker
- Analyze the development of a chronicity biomarker
One-Size Does Not Fit All: Implementing Precision Medicine Approaches to Targeted Therapeutics
11:00 am Executing Reclassification of Heterogeneous Diseases into Clinically Useful Subtypes
Synopsis
- Employing molecular phenotyping to enable deep characterization of disease etiology, and identify potential responders to targeted therapies
- Recategorizing histopathological diagnosis to capture biological nuances with proteomics and transcriptomics
- Applying reclassification of disease etiology to clinical research
11:30 am Unbiased Patient Stratification Approaches to Turn the Tide on Precision Medicine
Synopsis
- Capturing biological heterogeneity of disease through individual patient-level molecular profile analysis
- Uncovering novel patient subgroups with specific molecular profiles through unbiased stratification approaches
- Analyzing molecular data patterns in large cohorts of patients to enable molecular reclassification of CKD towards precision medicine
12:00 pm Leveraging a Precision Medicine Approach to Inform Future Directions of Drug Development in CKD
Synopsis
- Reflecting on recent progress: what has been achieved so far?
- Applying lessons in biomarkers and clinical trial innovation to CKD drug development
- Looking to the future: paving the way for pipeline progression and new therapies
12:30 pm Networking Lunch
Mapping Genetic Architecture of Cell types in the Kidney to Identify Avenues for Regenerative & Preventative Medicine
1:30 pm Keeping Kidneys Calm & Carrying on Working
Synopsis
- Uncovering the kidney as a site of action to reverse disease progression
- Preventing kidney inflammatory signals from the outside in
- Restoring cytoskeletal architecture to preserve function from the inside out
2:00 pm Leveraging Advances in Stem Cell Technology for Kidney Regenerative Therapy
Synopsis
- Translating in vitro kidney organoids
- Developing stem cell platforms to regenerate kidney tissue
- Employing pluripotent stem cell-derived renal cells to boost kidney function
One Size Does Not Fit All: Implementing Precision Medicine Approaches to Targeted Medicine
1:30 pm Dissecting the Genetic & Molecular Heterogeneity of Kidney Diseases into Clinically Actionable Subtypes
Synopsis
- Employing biobank scale exome and genome sequencing in human populations to elucidate mechanisms underlying kidney disease in the general population
- Developing and applying custom high-throughput metabolomic profiling to enable prediction of subjects with rapid progression of renal disease
- Advancing patient segmentation through the integration of multi-omics and outcomes in clinically relevant segments
2:00 pm Integrating Genomic & Clinical Data to Increase the Probability of Successful Drug Discovery & Development for CKD Therapeutics
Synopsis
- Applying integrated genomic biomarker strategies to support precision medicine
- Generating relevant human insights into the pathogenesis of CKD
- Leveraging the Kidney Genome Atlas to engage diverse patient populations in research
2:30 pm Afternoon Break & Networking
Patients, Trials & Endpoints: Pivoting to Rare Kidney Diseases to Meet Significant Unmet Medical Need
3:30 pm Panel Discussion: Challenges & Opportunities in Drug Development for Rare Kidney Diseases
Synopsis
- Incorporating clinical outcome assessments in trials
- Benefits of orphan drug designation and potential accelerated approval pathways in rare renal diseases
- Partnering with patient advocacy groups and registries in recruiting rare kidney disease patient populations
4:00 pm Clarifying Opportunities for Indication Expansion into Rare Kidney Diseases to Demonstrate Proof of Concept
Synopsis
- Where are there similarities in drug development in rare kidney diseases?
- Examining available endpoints in rare renal diseases to progress drug candidate development
- Attaining orphan drug designation and assessing prospects for cross-disease indication expansion
4:30 pm An Overview of the “Visionary” Study: A Phase 3 Trial of Sibeprenlimab for IgA Nephropathy
Synopsis
- Explore the current approach to IgAN treatment
- Understand the need for new therapies for IgAN
- Examine the role of the APRIL pathway in the pathogenesis of IgAN
5:00 pm Establishing Novel Imaging Biomarkers of ADPKD to Identify Rapidly Progressive Patients
Synopsis
- Optimizing total kidney volume (TKV) to accurately predict eGFR decline
- Uncovering opportunities to identify treatable patients with ADPKD earlier in disease progression
- Negotiating challenges in TKV from the payer to the regulator
5:30 pm Chair’s Closing Remarks
5:31 pm Scientific Poster Session
Synopsis
After the formal presentations have finished, the learning and networking carry on. The Poster Session allows you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships.
During this session, scientific posters will be presented on the very latest advancements in next-generation therapies for chronic kidney diseases with a focus on better understanding and overcoming translational challenges to inform the direction of future drug development efforts.