Critical Path Institute’s Predictive Safety Testing Consortium hosted a public workshop on September 28-29, 2023 in Bethesda, Maryland with stakeholders from the U.S. Food and Drug Administration, academia, model developers, and the pharmaceutical industry to improve complex in vitro model (CIVM) development. Attendees discussed model standards and features that will enable the qualification of liver CIVMs for regulatory assessment. Sessions included Developing Contexts of Use, Analytical Considerations for establishing CIVM and system performance, and Biological Performance Considerations for CIVM with appropriate test compounds and biomarker endpoints. The final agenda, including links to presentation slides, is posted below.
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Complex In Vitro Model (CIVM) Qualification Framework Public Workshop: Day 1 September 28, 2023: 9:00 AM – 5:00 PM EST |
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| Topic | Summary |
Speakers |
Links |
| Welcome | Opening Remarks and Introductions |
Nicholas King |
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| Keynote Address | Perspective on Translating New Drug Development Tools into Regulatory Use |
David Strauss |
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| Overview of Qualification and Application to CIVM |
Jeffrey Siegel |
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| DILI and CIVM | Complex In Vitro Models for DILI – Challenges & Opportunities: A Clinical Hepatology Perspective |
Mark Avigan |
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| Industry Clinical Perspective on DILI and CIVM Application |
Eric Cohen |
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| Break | |||
| Session 1: Developing Contexts of Use | |||
| Developing Contexts of Use | Developing Contexts of Use Introduction |
Klaus Romero |
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| CDER/PharmTox (PTOX) Perspective on Potential Contexts of Use (COU) |
Nakissa Sadrieh |
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| Model Developer Perspective on Contexts of Use and Their Addressability |
Daniel Levner |
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| Panel Discussion |
Klaus Romero Daniel Levner Nakissa Sadrieh David Strauss Eric Cohen |
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| Lunch Break | |||
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Session 2: Analytical Considerations – Model Characterization and Validation of Performance |
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| Analytical Considerations | Session 2 Introduction |
Graham Marsh |
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| Identifying Appropriate CIVM for a COU | Deidre Dalmas | Slides | |
| Validating Appropriate CIVM for COU: Regulatory Challenges |
Kevin Ford |
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| Panel Discussion |
Graham Marsh Deidre Dalmas Stephen Hahn Kevin Ford Tomasz Kostrzewski |
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| Break | |||
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Session 3: Biological Considerations – Necessary Study Performance Attributes as Related to the Specified Context of Use |
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| Biological Considerations | Session 3 Introduction |
Nicholas King |
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| Pharma Perspective on the Development of Context of Use (CoU) for Liver Complex In Vitro Models (CIVM) |
Ravi Kodihalli |
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| Biomarkers and Meaningful Endpoints: Perspective from an FDA Research Lab |
Qiang Shi |
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| Panel Discussion |
Nicholas King Qiang Shi Donna Mendrick Ravi Kodihalli Jonathan Jackson |
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| Closing Comments | Day 1 Summary |
Graham Marsh |
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| END OF DAY 1 | |||
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Complex In Vitro Model (CIVM) Qualification Framework Public Workshop: Day 2 September 29, 2023: 9:00 AM – 3:00 PM EST |
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| Topic | Summary |
Speakers |
Links |
| Welcome | Opening Remarks |
Nicholas King |
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| Keynote Address | Lessons Learned from Developing Credibility Assessment Framework and Contexts of Use for Computational Models |
Tina Morrison |
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| A Clinical Reviewer’s Perspective on CIVM for Drug Development |
Paul Skip Hayashi |
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Session 4: Breakout Sessions to Draft a Qualification Outline |
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| Breakout Session | Drafting a Qualification Outline Utilizing Sessions 1, 2 and 3 |
4 Groups led by: Klaus Romero, Graham Marsh, Nicholas King, Katrina Peron |
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| Lunch Break | |||
| Breakout Session Summary | Summary of Breakout Sessions |
Klaus Romero, Graham Marsh, Nicholas King, Katrina Peron |
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| Panel Discussion | Reflecting on Refined Contexts of Use |
Klaus Romero Daniel Levner Nakissa Sadrieh David Strauss Eric Cohen |
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| Closing Comments | Closing Remarks and Next Steps |
Nicholas King |
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| END OF WORKSHOP | |||
