Critical Role of CMC Project Management
Critical Role of CMC Project Management
Critical Role of CMC Project Management
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Mean Duration in Months<br />
Number <strong>of</strong> INDs<br />
Time Lines From Lead Candidate Identification to IND Filing<br />
25<br />
20<br />
15<br />
23<br />
17<br />
15<br />
6 Plus 6 Initiative<br />
Small Molecules<br />
12<br />
12.4<br />
12.6<br />
10<br />
5<br />
12<br />
9<br />
8<br />
12<br />
12<br />
8<br />
0<br />
2003 2004 2005 2006 2007 2008<br />
Year<br />
Coordination <strong>of</strong> all <strong>CMC</strong> activities toward initial IND submissions allows<br />
consistent completion <strong>of</strong> Pre-Dev to FIH activities in ~12 months
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