In this white paper, we explore the challenges of the lengthy and expensive preclinical development pipeline for cell therapies. We discuss how characterizing cell avidity can improve decision-making in selecting lead candidates, accelerating Investigational New Drug (IND) filings. This approach offers up to 50% greater predictive power for in vivo outcomes compared to traditional in vitro assays, like cytokine secretion and cytotoxicity.
Learning objectives:
- Preclinical cell therapy drug development is a costly and time-consuming process, with a high failure rate in clinical trials.
- Traditional in vitro assays often yield inconclusive results, leading to limited predictive power for in vivo efficacy and a high probability of not identyfing the optimal candidate for clinical trials.
- Cell Avidity has emerged as a superior predictor of in vivo efficacy, offering an accelerated pathway towards a successful IND filing.