CONFERENCE DAY TWO
TUESDAY, MAY 7 2019

7.50 

Chair's Opening Remarks

Matt Breyer
Distinguish Scientist
Janssen Research &
Development

Optimizing Drug Development via Progressive Disease Enrichment of Clinical Trial Populations

8.00 

Using Machine Learning to Combine Biomarker plus EHR-based Data to Enrich for Clinical Trial Enrolment

• Exploring why machine learning is needed to create risk scores from EHR datasets
• Comparing discriminatory and positive predictive performance for standard risk models versus machine learning
• Examining how industry can leverage existing biobanks linked to EHR for more efficient clinical trial design

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Steven Coca
Associate Professor,
Medicine,
Nephrology
Mount Sinai

8.30 

Stratifying Fast vs Slow Progressing, Responding vs Non-
Responding CKD Populations

• Do we have any better predictor(s) than albuminuria?
• What do large CKD databases tell us?
• Can we predict who will respond to treatment?

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Bergur Stefansson
Senior Research
Physician, Medical
Lead in Chronic
Kidney Disease
AstraZeneca

9.00 

Precision Medicine 2019: The Right Trial for the Right Patient in
Glomerular Disease

• Demonstrating how comprehensive molecular characterization has become possible for glomerular disease
• Showcasing how matching the profiles with pathway targeted in early phase trials in public private partnerships offers the opportunity to test the precision medicine concept for glomerular diseases and pave the way for application across CKD

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Matthias Kretzler
Professor of Medicine
Nephology/
Internal Medicine &
Bioinformatics
University of
Michigan

9.30 

Morning Break & Networking

 

10.00 

Utilizing Genetic Variations in CKD to Move Towards Precision Medicine

• Targeting genetically-defined patient populations living with CKD
• Utilizing genetic variations to deliver precision medicine
• An update of Ziltivekimab in phase 2

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Rahul Kakkar
Chief Medical Officer & Chief Strategy Officer
Corvidia Theapeutics 

Harnessing Human Pluripotent Stem Cells: Regenerative Medicine & Disease Modeling

10.30 

Modelling Crosstalk Between Inflammation & Fibrosis with Human Kidney Organoids

• Delineating mechanisms of fibrosis driven by inflammatory cytokines in CKD and maladaptive kidney repair
• Dissecting the impact of discrete inflammatory cytokines using human kidney organoids
• Demonstrating how to study fibrosis in human kidney organoids

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Dario Lemos
Medicine at
Harvard Medical
School, & Associate
Bioengineer
Brigham & Women’s
Hospital

Analyzing Renal Fibrosis as an Emerging Area of Phase 2 Development

11.00 

Translating the Novel Anti-Inflammatory Profile of Bardoxolone to Multiple Types of CKD:

• Sharing preclinical and clinical rationale
• Design and status of the CARDINAL trial, a Phase 2/3 study of Bardoxolone in Alport syndrome
• Reviewing data from the PHOENIX trial, a Phase 2 study of Bardoxolone in ADPKD, IgAN, T1D CKD, and FSGS
• Detailing future plans

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Colin Meyer
Chief Medical Officer
& Executive Vice
President, Product
Development
Reata
Pharmaceuticals

11.30 

Development of Sparsentan, a Dual Angiotensin & Endothelin Receptor Antagonist, in Glomerular Diseases

• Detailing rationale for dual angiotensin/endothelin inhibition in renal diseases
• Outlining mechanism of action for Sparsentan
• Sharing past and ongoing clinical studies

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Radko Komers
Director, Nephrology
Retrophin

12.00 

Lunch & Networking

 

13.00 

Targeting Pathological Fibrosis to Provide Organ Protection in CKD

• Certa’s approach to advance small molecule candidates against novel therapeutic targets for fibrosis
• Analysis of FT011 efficacy in diabetic nephropathy and FSGS
• Outlining phase 2 to date

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Darren Kelly
Chief Executive
Officer & Managing
Director
Certa Therapeutics

13.30 

CKD New Therapeutic Development: DM-199 for Chronic Kidney Disease

• Addressing CKD and KLK1 levels
• Demonstrating KLK1 approved use in Japan and China
• Discussing KLK1 synthetic form as the first of its kind in the US

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Harry Alcorn
Chief Medical Director
Diamedica

Challenges & Efficacy Targeting CKD Complications

14.00 

Current & New Treatments for Hyperkalemia as a Complication of CKD

• Incidence and clinical importance of hyperkalaemia
• Current and new therapeutic options for recurrent hyperkalemia
• Evidence generation to support new therapeutic candidates

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Carol Moreno Quinn
Senior Global
Medical Affairs Lead
AstraZeneca

14.30 

Afternoon Break & Networking

 

15.00 

Rationale for Raising Current Clinical Practice Guideline Target for Serum 25-Hydroxyvitamin D in Chronic Kidney Disease

• Reviewing the widely recognized clinical threshold for serum 25 OH vitamin D sufficiency in general population
• Discussing data in support of higher levels of 25 OH Vitamin D levels requirements to suppress iPTH in patients with chronic kidney disease
• Understanding the role of extended release calcifediol in management of non dialysis in CKD

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Akhtar Ashfaq
Senior Vice President of Clinical Research & Development & Medical Affairs
Opko Pharmaceuticals

15.30 

Dilemmas in Cardiorenal Patients

• Understanding the Catch-22 of hyperkalemia versus RAASi therapy
• Assessing intravenous iron treatment in cardiorenal patients
• Reviewing other treatment options for iron deficiency and anemia in cardiorenal patients

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Claudio Mori
Medical Strategy & Portfolio Lead Corporate Strategy Director
Vifor Pharma

16.00 

Approach to Innovation in CKD

• Tackling anemia with multiple mechanisms
• Approaches to building a renal pipeline and incorporating outcomes that matter to various stakeholders

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Gigi Shafai
Director of Medical
Affairs
Akebia Therapeutics

16.30

Chair's Closing Remarks

Matt Breyer
Distinguish Scientist
Janssen Research &
Development