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

  • Jerome Rossert Vice President, Head of Clinical Renal, AstraZeneca
  • Richard Nkulikiyinka Vice President, Head of Therapeutic Area Cardiology & Nephrology, Bayer
  • Hiddo Heerspink Professor, University of Groningen
  • Aliza Thompson Deputy Director of the Division of Cardiology & Nephrology, FDA
  • Sven Moosmang Therapeutic Area Head Translational Medicine & Clinical Pharmacology Cardiometabolism, Boehringer Ingelheim
  • Agnès Bénardeau Senior Director, Head of Cardio-Renal Biology, Novo Nordisk
  • Gary Friedman Director, Inflammation & Immunology, Pfizer

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

  • Aliza Thompson Deputy Director of the Division of Cardiology & Nephrology, FDA

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?

  • Brad Rovin Director, Division of Nephrology, Ohio State University

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

  • Matthias Kretzler Professor of Internal Medicine & Bioinformatics, University of Michigan

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

  • Anna Reznichenko Senior Director, Team Lead Experimental Medicine, AstraZeneca

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

  • Alex Duncan Chief Scientific Officer, Walden Biosciences

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

  • Dermot Reilly Director, Genetics & Translational Biology, Johnson & Johnson

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

  • Julie Lin Global Project Head, Clinical Development, Rare Diseases & Rare Blood Disorders, Sanofi Genzyme
  • Andrew King Chief Scientific Officer, Chinook Therapeutics
  • Nader Najafian Executive Director, Clinical Development Sciences, Alexion
  • Anthony Johnson President & Chief Executive Officer, Goldfinch Bio

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

  • Seemi Khan Senior Vice President, Chief Medical Officer, Reata Pharmaceuticals

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

  • Alan Yu Professor & Kidney Institute Director, University of Kansas Medical Center

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.