Endpoints: How Do We Get a Drug to Market?

9:00 am Drug Development Considerations for Kidney Diseases: A Regulatory Update

  • Aliza Thompson Clinical Team Leader, Division of Cardiovascular & Renal Products, FDA

9:30 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

10:00 am Selective ETA receptor antagonist ATRASENTAN for the Treatment of Primary Glomerular Diseases

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

10:30 am Morning Break & Networking

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

Translational Drug Development Track

Clinical Drug Development Track

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

 

12.00 Using twoXAR’s AI-platform for the Discovery & Preclinical Val

Anjali Pandey, Senior Vice President of Nonclinical R&D &
Chemistry, twoXAR Pharmaceuticals

Engaging with Patients & 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 FSGS: Finding the Patients

Josh Tarnoff, Chief Executive Officer, NephCure Kidney
International

 

12.00 Panel Discussion: Navigating Enrollment of Minority Patients

Kevin Fowler, President, The Voice of the Patient

Dorothee Oberdhan, Associate Director, Health Outcomes, Otsuka Pharmaceuticals

Josh Tarnoff, Chief Executive Officer, NephCure Kidney International

 

12:30 pm Lunch Break & Speed Networking Session Two

Beyond the Results: Dissecting Lessons Learned From Clinical Trial Success

1:30 pm Panel Discussion: Understanding Renal Fibrosis as a Hallmark of CKD & Debating if Targeting TGF is Best to Reverse it

  • Matt Breyer Distinguished Scientist, Janssen
  • Ravi Kumar Senior Vice President & Chief Scientific Officer, Acceleron Pharma
  • Hitesh Soni Renal Fibrosis Gene Therapy Lead , Renascent Biosciences
  • Scott MacDonnell Associate Director, Cardiovascular & Fibrosis Research, Regeneron Pharmaceuticals

2:00 pm Rationale & Results of Subgroup Analyses of the CREDENCE Study

  • Yshai Yavin Director, Cardiovascular & Metabolism Development , Janssen Pharmaceuticals

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

2:30 pm A Blueprint for Success: Janssen’s CREDENCE Clinical Trial

3:00 pm Afternoon Break & Networking

3:30 pm Talk Details to be Revealed

  • Colin Meyer Chief Research & Development Officer, Reata Pharmaceuticals

4:00 pm Talk Details to be Revealed

  • Borut Cizman Senior Director & Lead Nephrologist, ASCEND Program, Specialty Pharma, R&D , GSK

4:30 pm Chair’s Closing Remarks & End of Summit