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Monday, June 9, 2008 |
| 7:00 - 8:00 a.m. |
Registration and Continental Breakfast |
| 8:00 – 8:15 a.m. |
Welcome and NIDDK Perspective on the Need for Improved Methods To Assess Kidney Function and Damage
Robert Star, NIDDK, NIH |
| 8:15 – 8:30 a.m. |
Welcome and Purpose of the Workshop and Deliverables
Robert Toto, University of Texas Southwestern Medical Center |
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Theme 1: Perspectives on Biomarkers |
| 8:30 – 9:00 a.m. |
Biomarkers of Cardiovascular Disease with an Example of a Useful Biomarker and of Multiple Biomarkers
Vasan Ramachandran, Boston University School of Medicine |
| 9:00 – 9:30 a.m. |
What Biomarkers Are Needed To Advance Our Understanding of Chronic Kidney Disease?
Catherine Stehman-Breen, Amgen |
| 9:30 – 10:00 a.m. |
What Are the Characteristics of Biomarkers Needed To Advance Diagnosis and Prognosis of Acute Kidney Injury?
Chi-yuan Hsu, University of California, San Francisco |
| 10:00 – 10:30 a.m. |
Break |
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Theme 2: State-Of-The-Art: Biomarkers of Kidney Function |
| 10:30 – 11:00 a.m. |
Cystatin C
Michael Shlipak, University of California, San Francisco |
| 11:00 – 11:30 a.m. |
Serum Creatinine-Based Estimating Equations: Application in Adults
Lesley Stevens, Tufts University |
| 11:30 – 12:00 p.m. |
Measurement of Kidney Function in Children
George Schwartz, University of Rochester |
| 12:00 – 1:00 p.m. |
Lunch (on your own) |
| 1:00 – 1:30 p.m. |
Imaging the Kidney: Conventional Methods
Andrew Taylor, Emory University |
| 1:30 – 2:00 p.m. |
Imaging of the Kidney: Non-Conventional Methods Applicable to Humans
Pottumarthi Prasad, Evanston Northwestern Healthcare |
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Theme 3: Biomarkers and Surrogate Markers of Injury and Kidney Disease Progression |
| 2:00 – 2:30 p.m. |
Urine Protein Excretion
David Warnock, University of Alabama at Birmingham |
| 2:30 – 3:00 p.m. |
Diagnosis and Monitoring of Acute Kidney Injury
Joseph Bonventre, Harvard Medical School |
| 3:00 – 3:30 p.m. |
Break |
| 3:30 – 4:00 p.m. |
Assessing Risk for Progression of CKD
Harold Feldman, University of Pennsylvania |
| 4:00 – 4:30 p.m. |
Diagnosis and Monitoring CKD Progression
Tom Hostetter, Yeshiva University, Albert Einstein College of Medicine |
| 4:30 – 5:00 p.m. |
Frailty as a Surrogate Marker for CKD Outcomes
Kirsten Johansen, University of California, San Francisco |
| 5:00 - 5:15 p.m. |
Brief Summary and Instructions for Breakout Sessions and Plans for Day 2
Robert Toto, University of Texas Southwestern Medical Center |
| 5:15 – 7:15 p.m. |
Concurrent Breakout Sessions* |
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| Breakout Session #1: |
Acute Kidney Injury (Wisdom Room)
Prasad Devarajan, Cincinnati Children's Hospital Medical Center |
| Breakout Session #2: |
Identifying and Predicting CKD Progression (Balance Room)
Andrew Levey, Tufts Medical Center |
| Breakout Session #3: |
Imaging for Injury and Disease Progression (Insight Room)
Bruce Molitoris, Indiana University School of Medicine |
| Breakout Session #4: |
Designing Clinical Trials with Surrogate Markers (Juniper Room)
Glenn Chertow, Stanford University School of Medicine |
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| 5:15 – 7:15 p.m. |
Poster Session (posters available, but authors are not required to be present) |
| Posters to include descriptions of available datasets, ongoing clinical trials, and resources available through the NIDDK Data and Bio-Sample Repositories. |
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| Tuesday, June 10, 2008 |
Theme 4: Outcome Measures and Drug Development |
| 7:00 – 8:00 a.m. |
Continental Breakfast and Poster Session Continued |
| 8:00 – 8:30 a.m. |
Biomarkers and New Drug Indications: The FDA Viewpoint
Federico Goodsaid, U.S. Food and Drug Administration |
| 8:30 – 9:00 a.m. |
Surrogate Markers in Trials of CKD: The FDA Viewpoint
Melanie Blank, U.S. Food and Drug Administration |
| 9:00 – 9:30 a.m. |
Deploying Translational Biomarkers to Resolve Kidney Safety Concerns During Drug Development: An Industry Perspective
Frank Sistare, Merck and Company, Inc. |
| 9:30 – 10:00 a.m. |
What You Need to Start a Drug Development Program in CKD
Tom Daniel, Celgene Corporation |
| 10:00 – 10:15 a.m. |
Charge to Breakout Sessions
Robert Toto, University of Texas Southwestern Medical Center |
| 10:15 – 10:30 a.m. |
Break |
| 10:30 – 11:30 a.m. |
Concurrent Breakout Sessions* |
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| Breakout Session #1: |
Acute Kidney Injury (Wisdom Room)
Prasad Devarajan, Cincinnati Children's Hospital Medical Center |
| Breakout Session #2: |
Identifying and Predicting CKD Progression (Balance Room)
Andrew Levey, Tufts Medical Center |
| Breakout Session #3: |
Imaging for Injury and Disease Progression (Insight Room)
Bruce Molitoris, Indiana University School of Medicine |
| Breakout Session #4: |
Designing Clinical Trials with Surrogate Markers (Juniper Room)
Glenn Chertow, Stanford University School of Medicine |
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| 11:30 – 12:30 p.m. |
Reports and Discussion from Breakout Sessions |
| 12:30 – 1:30 p.m. |
Working Lunch: Continue Reports/Discussion from Breakout Sessions |
| 1:30 – 2:30 p.m. |
Continue Reports from Breakout Sessions
Session Leaders |
| 2:30 – 2:45 p.m. |
Closing Comments
Robert Toto and Robert Star |
| 2:45 p.m. |
Meeting Adjourns |
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*Goal of Breakout Sessions:
- Identify gaps in our knowledge and describe future areas of research.
- Discuss information on what resources are available in which biomarkers could be validated, including cataloging of ongoing studies.
- Discuss the best way to validate biomarkers in terms of sensitivity, specificity and predictability.
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