Personal Information
Organization / Workplace
San Francisco Bay Area United States
Occupation
Senior Director of Pharmaceutics, Plexxikon Inc. (Member of Daiichi-Sankyo Group)
Industry
Medical / Health Care / Pharmaceuticals
About
Pharmaceutics subject matter expert: >15 years experience in drug product development, preclinical (PK, pharmacology, efficacy, toxicology), polymorph/salt screen, QbD-based formulation development, process selection (direct compression, roller compaction, granulation, spray-dried dispersion, hot-melt extrusion) scale-up, validation, regulatory submissions, extensive experience in CMO selection and management, budgeting, staff hiring and development.
Projects delivered:
- Cotellic (Cobimetinib): QbD-based formulation development FIH-Phase III (Formulation Patent, NDA)
- Seroquel (Quetiapine): Developed new formulations, authored DP reports and CMC modules (NDA)
- Crestor (Rosuvastatin): A...
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