High-throughput in vitro profiling assays: lessons learnt from experiences at Novartis

Area of Science:

• Pharmacology
• Drug Discovery
• Toxicology

Background:

• Early drug discovery relies on predictive assays to assess compound safety and exposure.
• Implementing robust in vitro assays is crucial for efficient decision-making in pharmaceutical research.
• Novartis has experience with various in vitro assays in real-world drug discovery projects.

Purpose of the Study:

• To review the application of in vitro assays for exposure and safety assessment in early drug discovery.
• To share practical experiences and insights from Novartis' drug discovery programs.
• To provide guidelines for organizing assays, extracting value from data, and contributing knowledge.

Main Methods:

• Review of in vitro assay implementation at Novartis.
• Analysis of data from a large number of drug discovery compounds.
• Discussion of strategies for assay organization and data utilization.

Main Results:

• Identification of successful strategies and areas needing improvement in in vitro assay use.
• Demonstration of how to best leverage assay data for informed decision-making.
• Insights into organizing assays for maximum value extraction and knowledge contribution.

Conclusions:

• Effective use of in vitro assays is vital for successful early drug discovery.
• Strategic organization and data analysis enhance the value of safety and exposure assessments.
• Guidelines are provided to optimize assay performance and knowledge generation in drug development.