My Profile

Karen M Shaver

Contact Details

United States

Bio

Experience: Clinical and Regulatory Management at Interleukin Genetics: clinical trials on genetically stratified populations for more effective outcomes - - and regulatory filings for approvals Manager of Clinical Development at Schering AG: Pharmaceutical development of new cardiac agents Quality / Regulatory Affairs at Johnson Matthey / PharmEco laboratories: bulk pharmaceutical CMC, over 50 different chemical drug compounds developed Enzytech (MIT - Bob Langer spin-off company) / Alkermes: development of prototype controlled release formulations for biologics - FDA experience, IND writing and entry into clinic for first-in-man studies of new formulations Organic Chemist at Dupont: Synthesis of heterocyclic ring compounds for pharmaceuticals
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Education

The University of Texas at Austin

Job History

Clinical / Regulatory Management
December 2007 - present