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Every Failed Program Looked Promising Once
Drug discovery has always involved making high-stakes decisions before all the answers are available. The challenge for R&D leadership is determining which uncertainties are acceptable, and which are systemic liabilities capable of derailing an entire program at the clinical threshold.
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Every Failed Program Looked Promising Once
Drug discovery has always involved making high-stakes decisions before all the answers are available. The challenge for R&D leadership is determining which uncertainties are acceptable, and which are systemic liabilities capable of derailing an entire program at the clinical threshold.
evadanielson55
2 days ago4 min read
The One-Shot Gamble: Why Most IND-Enabling Programs Enter GLP-TCR With Too Little Data — and How to Change That
Offspring Biosciences | Tissue Insights™ | Preclinical Safety There is a decision point in almost every therapeutic antibody program that receives far less strategic attention than it deserves. It sits just before the formal GLP Tissue Cross-Reactivity (TCR) study - the FDA and EMA-mandated IHC screen of the drug candidate across a defined panel of normal human organ tissues, without which an IND cannot be filed. Most program teams treat this as a fixed milestone: select a
evadanielson55
May 124 min read
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