The Missing Data That Can Send A Program Back To The Bench

This segment of the Outsourced Pharma Live event, “Charting A Direct Pathway From Academia To CDMOs,” examines the red flags that can prevent a promising academic program from moving into external development. Michael highlights research models that may support publication but are not suitable for an investigational new drug package, while Leonardo identifies missing potency assays and preliminary stability data as common gaps that can undermine product release, formulation decisions, and confidence in the asset. Featuring Michael Salgaller, Ph.D., Supervisor, Technology Analysis and Marketing Unit, Technology Transfer Center at NCI, NIH, and Leonardo Sibilio, Ph.D., CEO, Nexantia Biotherapeutics.