Tag: CMC
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From Pivotal Data to Approval: The Regulatory Review Strategy
This is Part 6 of The Drug Development Playbook. This article explains how to turn that data and your manufacturing story into an approval.
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Hit Discovery and Lead Optimization – how teams turn a validated target into an actual drug candidate
This is Part 3 of The Drug Development Playbook. We answer the next question: how do you find molecules that not only hit that biology but can become safe, manufacturable medicines?
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From Idea to Patient: How Drug Development Actually Works
This is the first article in The Drug Development Playbook, an eight-part series on bringing a medicine from idea to patient use. Part 1 outlines the full journey, key stages, and where most programs fail, setting up practical deep dives into each phase that follow in the rest of the series.
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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 