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

Regulatory Update on Efficacy Readouts for Approval in the U.S.

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Aliza Thompson
Division of Cardiovascular & Renal Products, CDER
FDA

 

10.15

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.

11.00

Morning Break

 

11.30

Innovative Renal Diagnostic Solution for Precision Management of CKD 

• Overview the development of novel renal biomarkers at BPM
• BPM solution for risk assessment for renal function loss (eGFR decline) in T2DM and its potential application for enrichment strategy in the DKD-related trial
• BPM solution for early assessment and monitroing of patients with tubular injury, especially drug-induced kidney injury

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Lee-Ming Chuang
Professor, Division of Endocrinology & Metabolism
National Taiwan University Hospital

Lessons Learned From Genetically Defined & Rare Glomerular Diseases

12.00

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

12.30

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

13.00

 

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

13.30

Lunch & Networking

 

14.30

Speaker to be Confirmed 
IQVIA Biotech 

The Cardiorenal Conundrum: Are Renal & Cardiovascular Endpoints Related?

14.40

Update on the Trajectory of DKD: Where are we Now?

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George Bakris
Director,
Comprehensive
Hypertensive Center
University of
Chicago

15.10

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

15.40

Imaging - A Hollistic Way to Understand Cardiac & Renal Pathophysiology & Function 

• The need for improved biomarkers to aid drug development and therapy monitoring
• MRI Imaging - a holistic biomarker
• Results from the AM-01 study in CKD patients

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Paul Hockings 

Imaging Director

Antaros Medical 

16.10

Afternoon Break & Networking

 

16.45

Canagliflozin Effects on Renal & CV Outcomes in CKD & T2DM: Results of the Credence Trial 

• Overview of the burden and unmet need
• Review of the design and objectives of the CREDENCE clinical trial
• Presentation of the primary and secondary efficacy endpoints

• Presentation of the overall safety data

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Jack Lawrence
Head of Global
Development, CVM
Janssen R&D 

17.15

(Remote Presentation) Considerations in Choosing Composite Endpoints for CKD Drug Development (Remote Presentation)

• 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?

Please note, this is a remote presentation done with an AV link

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Vlado Perkovic
Executive Director
The George Institute Australia

17.45

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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Panellists:

George Bakris
University of
Chicago

Jyothis George
Boehringer
Ingelheim

Jack Lawrence 
Janssen R&D

18.15

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.