7:30am Check-In & Coffee + Light Breakfast

8:25 am Chair’s Opening Remarks

  • Jerome Rossert Vice President, Head of Clinical Renal, Late CVRM, AstraZeneca

Combining Patient Insight & Fostering Diversity in Renal Trials

8:30 am Minimizing Patient Burden & Expanding Recruitment Efforts to Promote Diversity in CKD Trials

  • Amit Sharma Vice President & Head Of Clinical Development & Global Therapeutic Area Nephrology & Hematology, Alexion Pharmaceuticals


  • Gaining a deeper comprehension of the factors contributing to the underrepresentation of minorities in CKD studies
  • Exploring what can be done, from leveraging social media to collaborating with advocacy groups, to revolutionize recruitment strategies
  • Evaluating what is being done on a site, study and global level to reduce patient burden and encourage participation

9:00 am Panel Discussion | Enhancing Global Inclusion of Underserved Communities in CKD Trials for Greater Representation in Clinical Samples


Opening up trials to more countries to address underserved populations

Exploring case studies of conducting CKD trials in different countries

Highlighting the benefits of expanding the reach into more countries

Emerging Therapies in Acute Kidney Injury (AKI)

9:30 am The Selective Cytopheretic Device: A Novel Cell-directed Extracorporeal Therapy Targeting the Host-Response


  • Despite improvements in critical care medicine, acute kidney injury continues to cause high mortality rates in critically ill patients.
  • AKI promotes a systemic inflammatory response resulting in microvascular damage and can lead to multi-organ dysfunction.
  • This session will describe the processes of a dysregulated immune response, the mechanism of action of the novel selective cytopheretic device, FDA approval in pediatric AKI due to sepsis, and the study design of the pivotal NEUTRALIZE-AKI trial in adult AKI

10:00am Morning Break & Refreshments

Leveraging the Availability of Advancing Technologies to Identify New Targets

  • Maarten Hoek Senior Vice President, Head of Research, Maze Therapeutics

10:30 am REMODEL: Understanding the Kidney-Specific Mode of Action Using Novel Technologies

  • Thomas Idorn International Medical Vice President, Novo Nordisk


  • Mechanistic, exploratory trials in clinical drug development
  • Combining novel methodologies for a holistic understanding of the MoA
  • The concept of kidney biopsies for research purpose • Applying Single-Cell RNA-Seq to Correlate Particular Genes to Certain Mechanistic Pathways

11:00 am Utilizing GWAS as a Tool to Define Pathogenic Signalling Pathways Associated with Glomerular Sclerosis & Prioritize New Drug Targets


  • Performing large-scale and accurate genome-wide association studies to dissect the etiology of FSGS and its subphenotypes
  • Applying this approach to identify novel and specific pathways that are amenable to drug targeting and intervention

11:30 am Harnessing Whole Exome Sequencing for Discovery of Chronic Kidney Disease Therapeutic Targets

  • Mary Haas Senior Manager - Cardiovascular Metabolic & Skeletal Disease Genetics, Regeneron Genetics Centre


  • Use of whole exome sequencing at scale for discovering potential targets in chronic kidney disease
  • Analytical challenges in genome-wide genetic analyses of CKD

Clinical Progress in Regenerative Medicine: Striving Towards a One-Dose Cure for CKD

  • Amit Sharma Vice President & Head Of Clinical Development & Global Therapeutic Area Nephrology & Hematology, Alexion Pharmaceuticals

10:30 am Systemic Cell Therapy in Early Phase Trials for Diabetic Kidney Disease


  • Showcasing successful demonstration of feasibility, safety and preliminary efficacy of allogeneic cell therapy for Progressive CKD in a phase 1/2 trial setting
  • Setting the scene for Phase 3 trials in US, Japan & EU
  • Evaluating how close this is to widespread commercial/ clinical reality

11:00 am Harnessing Podocyte Gene Therapy to Provide LongTerm Remedies for Kidney Disease


  • Reviewing gene therapy opportunities in both genetic and nongenetic glomerular disease
  • Feasibility of AAV-based gene therapy for kidney disease
  • Future perspectives on podocyte gene therapy

11:30 am Developing antifibrotic and anti-inflammatory therapeutics in clinical stage for common and rare renal diseases including CKD and Alport syndrome


  • Developing Vonafexor in the Proof-Of-Concept Phase 2 study “ALPESTRIA-1” in Alport syndrome
  • Validating efficacy of Vonafexor on kidney function and kidney remodeling in a severe preclinical mouse model for CKD as much as for Alport syndrome
  • Expanding Vonafexor analog development to larger kidney indications

Translating New CKD Therapies into Clinical Practice Guidelines in a Rapidly Changing Landscape

  • Jerome Rossert Vice President, Head of Clinical Renal, Late CVRM, AstraZeneca

10:30 am Evolving Clinical Practice Guidelines for CKD Management in Response to the Growing Availability of New Treatment Options

  • Jay Elliott Executive Director, Global Medical Strategy, Otsuka


  •  Reviewing where all the current therapies fit into the current standard of care management
  • Outlining how clinical practice guidelines are developed and evolved over time and delineating the criteria for assessing the inclusion of new drugs
  • Investigating how the diverse mechanisms of action among the numerous drugs in development could lead to complementary treatments in practical scenarios

11:00 am Panel Discussion | Bringing Drugs Evaluated in Trial Cohorts Selected Based on Proteinuria Enrichment into Practical Application in Real-World Scenarios

  • Jay Elliott Executive Director, Global Medical Strategy, Otsuka
  • Jonathan Barratt Professor of Renal Medicine, University of Leicester
  • Kerry Cooper Senior Vice President - Medical Affairs, Vera Therapeutics


  • Recognizing that the enrichment criteria employed in a trial do not necessarily limit a drug’s suitability exclusively to that specific population in real-world scenarios
  • Translating the evidence generated in trials into suitable recommendations for treating patients with varying UACRs
  • Discussing how clinical practice guidelines anticipate keeping pace with the rapidly evolving landscape of new CKD therapies

12:00pm Lunch & Networking Break

Innovating Translatable Model Systems to Assess Novel Drug Modalities & Specific CKD Targets

1:00 pm Nanoparticle Carriers: Translating into Clinical Practice to Minimize Systemic Side Effects & Enhance Therapeutic Accumulation in the Kidney

  • Edgar Jaimes Chief of Renal Service, Department of Medicine, Weill Cornell Medical College


  • Reviewing the emerging nanoparticle design strategies available to potentially clinically deliver CKD therapeutics
  • Optimizing targeting ligands to actively direct nanoparticles to specific kidney components
  • Reviewing challenges for the successful clinical translation of nanoparticle-based therapies

1:30 pm Panel Discussion | Sharing Learnings from Successful Model Systems Used to Demonstrate Efficacy of Treatment in CKD & Accelerate Progression to the Clinic


  • Ensuring confidence of in vivo or in vitro kidney tissue to behave like in the human condition
  • Assessing the suitability of different models for testing specific targets
  • Despite successes, outlining key aspects of preclinical model development in CKD that require further refinement to enhance translational capabilities

Exploring Current & Potential Immune Targets in Clinical Development for Kidney Disease

1:00 pm Translating Advancing Knowledge of Complement’s Role in Glomerular Disease Pathophysiology to Drive Clinical Development of Novel Targets


  • Deepening understanding of the precise mechanisms driving complement activation in different glomerular diseases
  • Exploring the interactions between complement and other inflammatory pathways to develop targeted agents that disrupt underlying pathophysiological processes
  • Analyzing opportunities for new trials to be instigated with therapeutic complement inhibitors

1:30 pm Exploring the Potentials of Complement Inhibition as a Therapeutic Strategy to Improve Kidney Transplant Outcomes


  • Role of complement dysregulation in kidney transplant recipients
  • Potential role for complement inhibition in improving kidney transplant outcomes

Optimizing Real-World Evidence to Supplement Clinical Studies & Maximizing Payer Support

1:00 pm Panel Discussion | Navigating Payers Perspectives & Moving Towards Surrogate Endpoints to Demonstrate Reimbursement for CKD Patient Populations


  • How important is having hard outcomes data vs a surrogate measure of CKD progression or improvement?
  • What will it take to pivot away from hard endpoints to demonstrate convincing evidence of improvements in renal function?
  • What are the clinical evidence requirements from payers and insurers to demonstrate reimbursement and offer effective therapies to CKD patients sooner?

1:30 pm Securing Payer Buy-In to Enhance Patient Access to Your CKD Treatment

  • Phil McEwan Chief Executive Officer, Health Economics and Outcomes Research Ltd


  • Strategically analyzing optimal avenues for reimbursement generation post-approval
  • Emphasizing the significance of educating payers on the burden of CKD and the unmet need of existing therapies
  • Establishing robust, evidence-based treatment guidelines, specific to CKD stage or patient subtype, to maximize support from payers and insurers

2:00 pm Benchmarking Real-World Evidence Data to Transform Efforts of Earlier Stage Diagnosis & Improve Patient Outcomes


  • Outlining insights on widespread underdiagnosis and importance of detecting CKD earlier obtained from RWE studies
  • Transforming patient care using RWE data to optimize CKD treatment guidelines 

2:30pm Afternoon Break & Refreshments

What’s Next for CKD Drug Development?

3:00 pm Optimizing the Potential of the Kidney Cell Atlas: A New Era in Target & Pathway Discovery

  • Matthias Kretzler Warner Lambert- Parke Davis Professor of Medicine and Bioinformatics, University of Michigan


  • Translating the data collected from the kidney cell atlas to identify new pathways and targets associated with CKD
  • Mapping out the target landscape in each kidney disease
  • Charting molecular signatures to ultimately predict which patients are at risk of progression to kidney failure 

3:30 pm Panel Discussion | From Slowing Progression to Halting Entirely: Debating the “What’s Next” for Diabetic, Hypertensive & Rare Kidney Diseases

  • Nikhil Agrawal Global Development Medical Director, AstraZeneca
  • Matthias Kretzler Warner Lambert- Parke Davis Professor of Medicine and Bioinformatics, University of Michigan
  • Jerome Rossert Vice President, Head of Clinical Renal, Late CVRM, AstraZeneca


  • From SGLT2s and ERAs, to GLP1s and anti-APRIL: where is the field heading next?
  • Evaluating the most exciting opportunities for new treatment options
  • Shifting the focus towards more pivotal therapies specific to underlying kidney pathophysiology, with an end goal of stopping, rather than slowing, CKD progression

4:00 pm Chair’s Closing Remarks & End of Conference

  • Jerome Rossert Vice President, Head of Clinical Renal, Late CVRM, AstraZeneca