8:25 am Chair’s Opening Remarks

  • Ivan Formentini Scientific Vice President & Head of Translational Science , Novo Nordisk

What Is the Next Step After SGLT2 Inhibitors? Complementing the New Standard of Care

8:30 am Predicting Future Standard of Care with SGLT2 Inhibitors to Design Relevant Clinical Trials

Synopsis

  • What will the standard of care look like in drug development for CKD?
  • Designing trials that will allow for the inclusion of novel therapies alongside SGLT2 inhibitors
  • Considering the future standard of care: combining SGLT2 inhibitors with multiple therapies

9:00 am Challenges for Trials in the New SGLT2i Landscape

  • Meg Jardine Professor of Medicine, The University of Sydney

Synopsis

  • Generating evidence when standard of care might not be real world delivered care
  • Role of new endpoints and alternative designs in trial efficiency
  • Identifying fast progressors to streamline clinical trials

9:30 am Panel Discussion: Identifying & Validating a Novel Therapy to Complement SGLT2 Inhibitors

Synopsis

  • Defining the next wave of therapeutics discovery after SGLT2i to improve clinical outcomes
  • Measuring incremental benefit of novel therapeutics in addition to SGLT2 inhibitors
  • Optimizing a smart preclinical screening platform to monitor efficacy in addition to standard of care
  • Considering innovative trial design and untraditional endpoints to demonstrate efficacy and meet regulatory requirements

10:00 am Morning Break & Networking

Leveraging In Vivo & In Vitro Models to Predict Target Engagement & Understand Disease Mechanisms

  • Ivan Formentini Scientific Vice President & Head of Translational Science , Novo Nordisk

11:00 am Exploring Complex 3D Models to Illuminate Disease Mechanisms & Predict Therapeutic Efficacy

Synopsis

  • Evaluating next-generation models to understand translational potential for kidney disease
  • Expanding the use of reproducible and easily modulated 3D cultures to model interactions between different tissue types
  • Leveraging advances in organ-on-a-chip technologies and 3D bioprinting to mimic human physiology

11:30 am Interrogating Translatability of In Vitro to In Vivo Models to Select Appropriate Kidney Models & Predict Efficacy

Synopsis

  • Acute Kidney Injury (AKI): How does the multitude of AKI models relate to patient disease?
  • Which readouts matter the most?
  • Could cellular assays help to optimize the in vitro to in vivo models translatability?

12:00 pm Using Animal Models of Chronic Kidney Disease to Inform Drug Discovery & Mechanisms of Action

Synopsis

  • Evaluating differential drug responses in animal models of chronic kidney disease
  • Using genetically modified mouse models to enable mechanistic understanding of kidney disease
  • Employing omics platforms to characterize models that are most relevant to specific disease etiology

Innovating Clinical Trial Design to Engage Patients & Optimize Study Outcome

  • Martin Lefkowitz Vice President, Global Clinical Research & Development, Novartis

11:00 am Implementing Decentralized & Patient- Centric Approaches to Clinical Trials to Improve Patient Outcomes & Accelerate Clinical Development

  • Uli Broedl Senior Vice President, Head of Global Clinical Development & Operations, Boehringer Ingelheim

Synopsis

  • What have we learned from shifting to clinical trials during the pandemic?
  • Establishing a logistical framework for operationalizing decentralized clinical trials: where are the opportunities to innovate?
  • Adopting alternative clinical trial designs to evaluate multiple interventions

11:30 am Moving the Needle on Decentralized Trial Design & Real World Evidence

Synopsis

  • Integrating real-world evidence into clinical trial design to establish efficacy
  • Screening, recruitment, monitoring and follow up: implementing remote monitoring and visits in clinical trials
  • Regulatory considerations for decentralized trials and implementing real world evidence

12:00 pm AFFINITY: A Phase 2 Basket Trial to Study the Safety & Efficacy of Atrasentan in Multiple Proteinuric Glomerular Diseases

Synopsis

  • Evolving opportunities in developing basket trials to accelerate efforts to tailor effective therapies to different disease subgroup of patients most likely to respond
  • Optimizing clinical trial procedures and infrastructure
  • Assessing patient inclusion criteria to optimize data

12:30 pm Lunch & Networking

1:30 pm Examining the Interaction Between Mechanical Stress & Podocyte Defects in Chronic Kidney Disease

  • Di Feng Assistant Professor of Medicine, Harvard Medical School

Synopsis

  • Assess organs-on-chip technology to study chronic kidney disease, particularly the effects of mechanical stresses on podocytes
  • Looking to the future: personalizing organs-on-chips for precision medicine and drug screening

1:30 pm Toward More Patient-Centered Clinical Trial

  • Kerry Willis Chief Scientific Officer, National Kidney Foundation

Synopsis

  • Learnings from patient-focused drug development workshops on rare kidney diseases
  • An interactive, web-based CKD patient registry
  • Enhancing patient-centricity in clinical trial design to enhance patient participation

Confronting Patient Recruitment: How can we get the Right Patients into Trials?

2:00 pm Panel Discussion: Championing Enrolment of Underserved & Underrepresented Patient Populations

  • LaToya Coffey Senior Director, Global Development Team Leader, Otsuka
  • LaVarne Burton President & Chief Executive Officer, American Kidney Fund
  • Kerry Willis Chief Scientific Officer, National Kidney Foundation
  • Cibele Pinto Director, Global Medical Affairs, Otsuka

Synopsis

  • Exploring opportunities to tackle lack of trust in healthcare and clinical trials
  • Ensuring patient population is representative of the target population
  • Deepening our understanding and efforts toward patient-centricity in trial design for underrepresented patient populations

2:30 pm Addressing the Unknown Causes of Kidney Diseases: A Roadmap for Change

  • Michael Spigler Vice President, Patient Services & Kidney Disease Education, American Kidney Fund

Synopsis

  • Overview of the current data discussing the percentage of cases of kidney disease of unknown etiology
  • Review the impact of barriers to accurate, early diagnosis of kidney disease cause on patient outcomes, particularly patients of color
  • Highlight the need for increased awareness and testing for rare and genetic diseases that impact the kidneys
  • Discuss a consensus document for addressing barriers through development of data-driven solutions for policy, patient and professional-facing interventions

3:00 pm Afternoon Break & Networking

Dissecting Clinical Updates to Influence the Next Generation of Trials

3:30 pm Designing & Implementing a Robust Clinical Program For Anaemia in CKD & Update on Clinical Data

Synopsis

  • Study design considerations development of drugs for anaemia caused by chronic kidney disease
  • Explore the adaptations of study design and execution in the time of COVID – lessons learned for the future conduct of clinical studies
  • Get an update on clinical data for the phase 3 studies for Daprodustat

4:00 pm Neutralization of APRIL with BION-1301: A Targeted, Potentially Disease-Modifying Approach to IgA Nephropathy

  • Andrew King Chief Scientific Officer, Chinook Therapeutics

Synopsis

  • Learn how excess production of galactose-deficient IgA1 (Gd-IgA1) by IgA secreting plasma cells is considered the initiating pathogenic event (Hit 1) in IgAN
  • Hear about PRoliferation Inducing Ligand (APRIL), a TNF-family cytokine that drives IgA class-switching, survival of IgA-secreting plasma cells and stimulates Gd-IgA1 secretion
  • Explore how BION-1301, a novel humanized monoclonal antibody that binds and blocks APRIL, has demonstrated initial validation of this targeted mechanism in patients with IgAN in a Phase 1/2 clinical study

4:30 pm Discovery & Development of Tenapanor for the Treatment of Hyperphosphatemia in Patients with CKD on Dialysis: A Novel Blocker of Paracellular Phosphate Absorption

Synopsis

  • Physiology of phosphate homeostasis and the cardiovascular sequelae of hyperphosphatemia in patients with kidney disease
  • New mechanistic understandings of phosphate absorption and control
  • Clinical development of tenapanor as a novel blocker of paracellular phosphate absorption

5:00 pm Chair’s closing remarks

  • Ivan Formentini Scientific Vice President & Head of Translational Science , Novo Nordisk