On May 23-24 the International Drug-induced Kidney Injury Biomarker Workshop will be held in a virtual format. Critical Path Institute, in collaboration with key opinion leaders from academic institutions, the pharmaceutical industry, health authorities and the patient community, is hosting this two-day public workshop for stakeholders to come together and align on a plan for developing improved tools to predict and detect drug-induced kidney injury (DIKI). A full playlist of all videos associated with the workshop is available, here.
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DIKI Biomarker Workshop: Day 1 May 23, 2022: 10:00 AM – 3:00 PM EST |
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| Session 1: Defining the Challenge and Unmet Need | |||
| Time | Topic | Summary | Speakers |
| 10:00 – 10:05 AM | Welcome | Nicholas King | |
| 10:05 – 10:30 AM | Stakeholder Perspectives | Perspectives on drug safety and data sharing | Rebecca Cheung Marla Levy Aliza Thompson Frank Dieterle Matthias Kretzler |
| 10:30 – 10:50 AM | Understanding Drug-Induced Kidney Injury (DIKI) | Need for improved tools to inform decision making, including workshop’s focus on DIKI biomarkers | Jonathan Himmelfarb Joe Bonventre |
| 10:50 – 11:20 AM | Defining the Challenge of DIKI | Defining the scope of the problem including the need for education, current inadequate tools/biomarkers, and need for data sharing | James Dear Vishal Vaidya |
| 11:20 – 11:35 AM | Current Landscape | Understanding current activities and opportunities and addressing ways to collaborate to make the highest impact | Gary Friedman |
| 11:35 – 12:35 PM | Leveraging DIKI Biomarkers to Inform Decision Making for Phase I – III Clinical Trials | Insights into biomarker strategy and outcomes, barriers, and challenges, preparing novel biomarkers for application in clinical trial decision making; how access to additional biomarker data would have improved study design and decision making before and after trials | Stefan Sultana Steve Piccoli Jeffrey Siegel |
| 12:35 – 12:45 PM | Break | ||
| 12:45 – 1:30 PM | Panel Discussion | All speakers in session | |
| Session 2: Addressing the Unmet Need Through Collaborations | |||
| 1:30 – 1:40 PM | Personal Perspectives | Drug safety and collaboration | Glenda Roberts |
| 1:40 – 2:10 PM | Addressing the Unmet Needs | Outline and discuss an action plan framework for implementing broad DIKI biomarker use | Gary Friedman Ameeta Parekh |
| 2:10 – 2:55 PM | Breakout Sessions/Q&A | Discuss what needs to be done to advance novel kidney injury biomarker application and implementation:
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Session Leaders:
Stefan Sultana / Gary Friedman / Aliza Thompson / |
| 2:55 | Closing Comments | Nicholas King | |
| 3:00 PM | END OF DAY 1 | ||
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DIKI Biomarker Workshop: Day 2 May 24, 2022: 9:00 AM – 2:00 PM EST |
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Session 3: Building Solutions and Innovative Drug Development Tools |
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| Time | Topic | Summary | Speakers |
| 9:00 – 9:10 AM | Welcome | Nicholas King | |
| 9:10 – 9:20 AM | Personal Perspective | Kevin Fowler Richard Knight |
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| 9:20 – 9:30 AM | Breakout Session Highlights | Summary of output from May 23 breakout sessions | Nicholas King |
| 9:30 – 10:35 AM | Success through Collaboration |
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Chirag Parikh Jiri Aubrecht Matthias Kretzler Nicholas King Yemi Adedeji |
| 10:35 – 11:05 AM | Panel Discussion | All speakers in session | |
| 11:05 – 11:35 AM | Breakout Sessions | Discuss implementation of an action plan to advance novel kidney injury biomarker application:
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Session Leaders:
Stefan Sultana / Gary Friedman / Aliza Thompson / |
| 11:35 – 11:45 AM | BREAK | ||
| 11:45 – 12:15 PM | Overcoming Barriers to Data Sharing: Why and How | Amanda Borens | |
| 12:15 – 12:35 PM | Data Sharing for Solutions |
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Christine Garnett Shashi Ramaiah |
| 12:35 – 1:30 PM | Panel Discussion | All speakers in session and Glenda Roberts, Rob Star, Mike Pacanowski, Ray Harris | |
| 1:30 – 1:50 PM | A Collaboration to Address the Action Plan | Present proposal for next steps as a consortium/collaboration | Nicholas King |
| 1:50 PM | END OF WORKSHOP | ||
