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April 19, 2022 PRINT PDF

Register Now | International 2022 Drug-induced Kidney Injury Biomarker Workshop

 

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). We encourage you to attend both days.

Register Now

DIKI Biomarker Workshop: Day 1

May 23, 2022: 10:00 AM – 3:00 PM EST
Session 1: Defining the Challenge and Unmet Need
Time Topic Summary
10:00 – 10:05 AM Welcome
10:05 – 10:30 AM Stakeholder Perspectives Perspectives on drug safety and data sharing
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
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
11:20 – 11:35 AM Current Landscape Understanding current activities and opportunities and addressing ways to collaborate to make the highest impact
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
12:35 – 12:45 PM Break
12:45 – 1:30 PM Panel Discussion
Session 2: Addressing the Unmet Need Through Collaborations
1:30 – 1:40 PM Personal Perspectives Perspectives from individuals living with kidney disease
1:40 – 2:10 PM Addressing the Unmet Needs Outline and discuss an action plan framework for implementing broad DIKI biomarker use
2:10 – 2:55 PM Breakout Sessions/Q&A Three breakout options to discuss what needs to be done to advance novel kidney injury biomarker development:

  1. How much data needs to be collected to support a given Context of Use?
  2. What is the best way to collect needed data?
  3. What type(s) of biomarker(s) are needed?
2:55 Closing Comments
3:00 PM END OF DAY 1

DIKI Biomarker Workshop: Day 2

May 24, 2022: 9:00 AM – 2:00 PM EST

Session 3: Building Solutions and Innovative Drug Development Tools
Time Topic Summary
9:00 – 9:10 AM Welcome
9:10 – 9:20 AM Personal Perspective Perspectives from individuals living with kidney disease
9:20 – 9:30 AM Breakout Session Highlights Overview of day one breakout session outcomes
9:30 – 10:35 AM Success through Collaboration
  1. Biomarkers of drug-induced acute interstitial nephritis (AIN)
  2. Glutamate dehydrogenase application to detect drug-induced liver injury
  3. Kidney Precision Medicine Project
  4. C-Path’s Predictive Safety Testing Consortium and Biomarker Data Repository
  5. Case study: Data sharing generating new insights into DIKI biomarker application
10:35 – 11:05 AM Panel Discussion
11:05 – 11:35 AM Breakout Sessions Three breakout options to discuss implementation of an action plan to advance novel kidney injury biomarker development:

  1. What and how much data needs to be collected to support a given Context of Use?
  2. What type of biomarker(s) are needed?
  3. What type(s) of assay and approval process are needed?
11:35 – 11:45 AM BREAK
11:45 – 12:15 PM Overcoming Barriers to Data Sharing: Why and How
12:15 – 12:40 PM Data Sharing for Solutions
  1. FDA perspective on data sharing
  2. Industry perspective on data sharing
12:40 – 1:30 PM Panel Discussion
1:30 – 1:50 PM Next Steps A collaboration to advance the action plan
1:50 PM END OF WORKSHOP

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