Tag: Translational Science
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Preclinical Development and IND/CTA Readiness: making the candidate safe enough to test in people
This is Part 4 of The Drug Development Playbook. We talk about building nonclinical and CMC evidence that lets regulators say yes to first-in-human trials.
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Why Scalability Matters More Than Breakthrough Biology
The importance of scalability in drug development is emphasized, revealing that many scientific breakthroughs fail due to overlooked manufacturing complexities and costs. Teams should assess scalability early using four key axes: manufacturing, supply chain, cost-of-goods, and regulatory expectations. Practical changes, like embedding manufacturing expertise in early projects, can enhance readiness for commercial success.
Aryan Kenia 