Endpoints: How Do We Get a Drug to Market?

Plenary Moderator: Joe Stavas, Senior Vice President of Clinical Development, ProKidney

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

  • Shira Perl Global Clinical Program Lead , AstraZeneca

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

Track Moderator: Julie Williams, Director/Science Lead Bioscience Rena, AstraZeneca

Harnessing AI to Maximize Data Interrogation for Drug Discovery & Validation

11:00 am Use of Artificial Intelligence in CKD Drug Discovery & Disease Understanding

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

12:00 pm Using twoXAR’s AI-platform for the Discovery & Preclinical Validation of Therapeutic Leads with Novel MOAs for CKD

  • Anjali Pandey SVP of Nonclinical R&D & Chemistry, twoXAR Pharmaceuticals

Clinical Drug Development Track

Track Moderator: Kevin Fowler, President, The Voice of the Patient

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

11:00 am The 3 “R”s of Orphan Kidney Disease Research: Risk, Resources & Reimbursement

11:30 am FSGS: Finding the Patients

  • Josh Tarnoff Chief Executive Officer, NephCure Kidney International

12:00 pm Panel Discussion: Supporting Enrolment of Minority Patients

12:30 pm Lunch Break & Speed Networking Session Two

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

Beyond the Results: Dissecting Lessons Learned From Clinical Trial Success

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

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

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

  • Seemi Khan Senior Vice President, Chief Medical Officer , Reata Pharmaceuticals

4:00 pm Clinical Development of Sparsentan: A Novel, Dual-acting Endothelin Type A & Angiotensin II AT1 Receptor Antagonist for the Treatment of FSGS & IgAN

  • Radko Komers Senior Medical Director, Nephrology , Travere Therapeutics

4:30 pm Challenges of Clinical Research During the COVID-19 Pandemic

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

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