Pre-Conference Workshop Day

Tuesday 19th March 2024

7:00am Check-In & Coffee + Light Breakfast

8.00 – 10.30am Workshop A

8:00 am Validating the Relevance of Proteinuria & eGFR Decline in Diverse CKD Populations to be Optimized as Regulatory Accepted Endpoints


Over the past year alone, tremendous efforts have been made to advance research on proteinuria and GFR slope, pushing the boundaries beyond their current scope and expanding into other populations to draw the link more tightly to long term endpoints. Engage in learning, collaboration, and discussions with nephrologists at the forefront of this research to:

  • Examine recent progress to understand how GFR slope may strengthen implications of clinical benefit, including insights from a meta-analysis across diverse CKD populations
  • Extending these surrogates into different populations, with considerations for their relevance in FSGS, Lupus Nephritis, PKD and more

11.00am – 2.30pm *with 1 hour break for lunch
Workshop B

11:00 am Repositioning AKI at the Forefront of R&D: Targeting Complex Pathophysiology, Overcoming Heterogeneity & Enhancing Return on Investment

  • Tobias Agervald Chief Executive Officer, Guard Therapeutics
  • Amit Sharma Vice President & Head Of Clinical Development & Global Therapeutic Area Nephrology & Hematology, Alexion Pharmaceuticals
  • Bhupinder Singh Chief Medical Officer, Renibus Therapeutics
  • Giorgia Jurisic Snijder Head of Cellular Pharmacology & Imaging Zurich, CSL R&D


The heterogeneity across phenotypic subtypes has made AKI significantly difficult to study, therefore making progress of new specific treatments and disease management rather stagnant in recent years. From balancing the need for AKI resolution while minimizing long-term kidney damage, to addressing AKI subtypes with medical interventions that target specific underlying causes, tackle key questions with industry peers to spearhead investment in the AKI landscape:

  • How can resolution of AKI be achieved in a way that minimizes scarring in the kidney that leads to CKD?
  • How can we advance knowledge of heterogeneity across pre-renal, intrinsic renal and post-renal AKI to develop more specific treatments?
  • What must be done to place a greater focus on the underlying causes of AKI rather than targeting the kidney directly?
  • Given the great unmet need, what will it take to grow investment into AKI research to strive for a solution?

3.00 – 5.30pm Workshop C

3:00 pm Making Pediatric Trials a Feasible Reality: Extrapolating Data from Adult CKD Studies to Fulfil Considerable Unmet Needs in Pediatric Populations

  • Kirtida Mistry Senior Physician & Clinical Reviewer, Division of Cardiology & Nephrology, FDA
  • Lynne Yao Director - Division of Pediatrics and Maternal Health, FDA
  • Ogo Egbuna Vice President - Clinical Development, Vertex Pharmaceuticals
  • Lauren Eva Executive Vice President, Professional Relations, NephCure
  • Thomas Hiemstra Fellow and Senior Director, Clinical Development, GSK
  • Dominik Steubl Senior Clinical Program Lead, Boehringer Ingelheim


With significant prevalence of CKD in children, it is vital for drug developers to address this unmet medical need by conducting studies to gain regulatory approval in pediatric populations. Collaborate with regulators, pediatric nephrologists and industry sponsors to deliberate how to streamline feasibility of CKD trials in children, and discuss key considerations:

  • How do drug developers make their CKD programs more available for the pediatric community?
  • What must be demonstrated to meet regulatory requirements for potential approval of the drug in children with CKD? Extrapolation?
  • How do we navigate considerations of ethical approval, informed consent, recruitment, and dosing when enrolling pediatrics into CKD trials?
  • Exploring and contrasting traditional vs more innovative trial designs in the pediatric population