CONFERENCE DAY ONE
MONDAY, MAY 6 2019

7.50 

Chair's Opening Remarks

Matt Breyer
Distinguish Scientist
Janssen Research &
Development

Patient Engagement Facilitates Drug Development: Starting & Ending with the Patient in Mind

8.00

Patient Centricity: From Concept to Reality

• Outlining a patient centered approach in trial design and execution
• Sharing real world examples from the Kidney Health Initiative and beyond
• Inviting the patients perspective from the KHI Patient Family Partnership Council

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Barbara Gillespie
Adjunct Professor,
Division of
Nephrology &
Hypertension
University of North
Carolina

Melissa West
Adjunct Professor,
Project Director,
Kidney Health
Initiative
American Society of
Nephrology

8.45

One Patient's Impact on CKD Trials

• Fireside chat with a patient actively involved with the Kidney Health Initiative Patient Family Partnership Council to understand how she (and other patients) have impacted the protocols and study design for CKD clinical trials.

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Melissa West
Adjunct Professor,
Project Director,
Kidney Health
Initiative
American Society of
Nephrology

Nichole Jefferson
KHI Patient Family Partnership Council 

Evaluation of Endpoints: Clinical Endpoints Predictive of Treatment Effect in Earlier Stage Kidney Disease

9.15

Use of Surrogate Endpoints to Optimize Drug Development

• Changes in albuminuria
• GFR slope
• Combination of albuminuria and GFR slope

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Lesley Inker
Director, Kidney & Blood Pressure Center
Director, Kidney Function & Evaluation Center
Director, Quality Improvement
Associate Professor
Tufts University School of Medicine

 

9.45

Speed Networking

Our organized networking session means you meet one-on-one with every
attendee and speaker at CKD3, allowing you to establish meaningful connections
and relationships with other leaders in the field to follow up with for the rest of the
conference.

10.30

Morning Break

 

11.00

Regulatory Update on Efficacy Readouts for Approval 

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Aliza Thompson
Division of Cardiovascular & Renal Products, CDER
FDA

 

Lessons Learned From Genetically Defined & Rare Glomerular Diseases

11.30

Modelling Crosstalk Between Inflammation & Fibrosis with Human Kidney Organoids

• Outlining mechanistic understanding of rare, genetically defined kidney diseases
• Developing novel, precision medicine therapeutics
• Targeting autosomal dominant kidney disease

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Anna Greka
Director of the Broad
Kidney Disease
Initiative
Broad Institute of
MIT & Harvard

A Translational Journey: De-Risking Drug Discovery to Improve Drug Development Through to the Clinic

12.00

Future Target Identification & Validation in CKD

• Addressing why most CKD clinical trials fail due to lack of efficacy
• Outlining the changes in target identification and validation required
• Demonstrating use of humaized translatable models and big data patient data set for CKD target identification and validation

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Pernille B.
Laerkegaard
Hansen
Senior Director, Head
of Bioscience, CKD,
CVRM, IMED
AstraZeneca

12.30

Integrating Genomics & Functional Modeling to Yield Validated Targets
& Translatable Pharmacology

• Applying human genetics at the Regeneron Genetics Center for target discovery, molecular profiling of human and model disease tissue
• Establishing pathology relevance and functional modeling to develop translatable preclinical in vivo tools

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Lori Gowen Morton
Vice President
Research
Regeneron
Pharmaceuticals

13.00

Lunch & Networking

 

14.00

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
Therapeutics

14.30

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

The Cardiorenal Conundrum: Are Renal & Cardiovascular Endpoints Related?

15.00

Empagliflozin in Kidney Disease: Past, Present & Future

• Detailing Empagliflozin as the first SGLT2 inhibitor to receive FDA approval for the prevention of cardiovascular death in patients with type 2 diabetes
• Initially the focus was on concerns surrounding SGLT-2 inhibitors and kidney safety
• Evidence from EMPA-REG OUTCOME and other trials show potential benefit of SGLT2 for kidney disease
• Multiple trials including the EMPA-KIDNEY now evaluate benefits its beyond type 2 diabetes

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Jyothis George
Head of Clinical
Development,
Therapeutic Area,
CardioMetabolism
Boehringer
Ingelheim

15.30

Afternoon Break & Networking

 

16.30

Dissecting Renal Outcome Studies – Do Cardiovascular Outcomes Drive Renal Endpoints?

• Reviewing prespecified renal endpoints in CV trials
• Discussing the timing and risk of FDA approved renal outcomes in CV trials
• Understanding the role of maximal CV risk reduction affecting renal outcomes

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George Bakris
Director,
Comprehensive
Hypertensive Center
University of
Chicago

17.00

Considerations in Choosing Composite Endpoints for CKD Drug Development

• What are the considerations in choosing endpoints for trials in kidney disease?
• What should the components be, and how should they be defined
• Should they include CV components?
• When could proteinuria/albuminuria and eGFR change be used?

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Vlado Perkovic
Executive Director
The George Institute Australia

17.30

Panel Discussion: Debating CREDENCE & SONAR

• Contextualizing with an overview of CREDENCE and SONAR to date
• Can you have a reasonable number of endpoints in a renal population if cardiovascular endpoints are excluded?
• What is the regulatory perspective on the safety of these drugs?

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Moderated by:

John Brennan
Pharmaceutical
Industry Consultant

Panellists:

George Bakris
University of
Chicago

Jyothis George
Boehringer
Ingelheim

18.00

Chair's Closing Remarks

Matt Breyer
Distinguish Scientist
Janssen Research &
Development

18.10

Poster Session & Drinks Reception

 
After the formal presentations have finished, the learning and networking carries
on. The Poster Session is an informal part of the conference agenda, allowing you
to connect with your peers in a relaxed atmosphere and continue to forge new and
existing relationships.