Day 1

Day 2

8:15 am Chair’s Opening Remarks

Endpoints: How Do We Get a Drug to Market?

8:20 am Navigating Trial Endpoints in a Therapeutic Area without Regulatory Precedent

8:50 am Renal Function Surrogates for Trial Endpoints & Clinical Decision Support: Are We Reshuffling an Old Deck or Adding New Cards to the Table?

  • Joseph Stavas Senior Vice President, Clinical Development, inRegen

9:20 am Phase 2a Results, Phase 2b Study Design, & Investigations into the Mechanism of Action of Verinurad, a URAT1 Inhibitor, in Development for CKD & Heart Failure

9:50 am Selective ETA receptor antagonist ATRASENTAN for the Treatment of Primary Glomerular Diseases

  • Andrew King Head of Renal Discovery & Translational Medicine, Chinook Therapeutics

10:20 am Morning Break & Networking

Forward Thinking Questions to Shape the Next Generation of Drug Development Decisions

Translational Drug Development Track

Chaired By: Jeremy Duffield, Global Head of Human Biology, Vertex Pharmaceuticals

Later Stage Clinical& Commercial Drug Development Track

Chaired By: Annadoir Staveley, Associate Director of Clinical Disclosure& Data Sharing, Ethics& Compliance, Otsuka Pharmaceuticals

Harnessing the AI to Maximize Data Interrogation & Debating the Importance of Renal Fibrosis 

11.00 Use of Artificial Intelligence in CKD Drug Discovery & Disease Understanding 

Pernille Hansen, Senior Director & Head of Bioscience, AstraZeneca

 

11.30  Use of Human Genetics, Biomarkers & AI to Drive Target Discovery & Validation

Maria Chiara Magnone, Vice President Kidney Diseases & Boston Site Head, Janssen

Considering Costs of CKD as a Significant Public Health & Orphan Indications 

11.00 The 3 “R”s of Orphan Kidney Disease Research: Risk, Resources & Reimbursement

Frank Czerwiec, Chief Medical Officer, Goldfinch Bio  

 

11.30 Implementing Evidence for CKD Care : Program Development & Early findings at CVS Kidney Care

Bruce Culleton, Vice President & Chief Medical Officer, Kidney Care, CVS Health

 

11:30 am Use of Human Genetics, Biomarkers & AI to Drive Target Discovery & Validation

Synopsis

  • AI approach to target discovery and validation using human genetics and clinical data
  • Using high content omics data for targets and biomarkers discovery
  • Using proprietary biobank and clinical data for biomarkers identification

12:00 pm Lunch & Networking

Understanding the Patients’ Perspective & Dramatically Changing the Patient Experience

1:00 pm A Blueprint for Success: Janssen’s CREDENCE Clinical Trial

1:30 pm Impact & Relevance of Guidelines to Clinical Decision Making & Clinical Research

1:45 pm FSGS: Finding the Patients

2:15 pm Panel Discussion: Navigating Enrolment of Minority Patients

2:45 pm Afternoon Break & Networking

Clinical Updates on Innovative Compounds

3:30 pm Latest Advancements in the Development of Sparsentan, an Investigational Selective Antagonist of both Endothelin type A (ETA) Receptor & Angiotensin II Type 1 (AT1) Receptor, for Rare Glomerular Diseases

4:00 pm Research Update in Polycystic Kidney Disease

  • Ron Perrone Scientific Director, Clinical & Translational Research Center; Professor, Tufts University School of Medicine

4:30 pm CKD DM199 Research Update

5:00 pm Chair’s Closing Remarks & End of Summit

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