Keith Lamb reveals why readiness to begin GMP manufacturing is a decision point that requires careful consideration and what those important considerations should include and why.

The article explains why the first patient treated with any new drug is a significant milestone, and achievement for every project team. It is also a measure of progress in a journey which, sometimes leads to “failure.” Those failures, he writes, provide the platforms for continued progression and the many successes we see in new drug approvals. In a landscape of such growth and impact of innovative technologies and new modalities, the decisions made along the way for these important steps represent the foundation being laid.

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