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Critical Role of CMC Project Management

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<strong>Critical</strong> <strong>Role</strong> <strong>of</strong> <strong>CMC</strong> <strong>Project</strong> <strong>Management</strong><br />

The Wyeth Model <strong>of</strong> Small Molecule Development<br />

Wyeth Model: The Way it Was<br />

Applies to small molecules development Similar systems<br />

exists for Biotech, Vaccine & Consumer Products divisions<br />

3 Tiered approach to <strong>CMC</strong> <strong>Project</strong> <strong>Management</strong><br />

<br />

<br />

<br />

Early Development Teams (<strong>CMC</strong> <strong>Project</strong> Leader-TAL)<br />

Global Technology Team (Operational Team Leader-<br />

NPL)<br />

Supply Chain Team (Supply Chain Team Leader-SPL))<br />

2

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