Stacey Tiamfook

Global regulatory strategic lead for multiple late-stage oncology assets

Led the first Project Orbis submission, leading to simultaneous approvals in US, Australia, and Canada.

Led the strategy and submission of company's first breakthrough therapy designation. Led the submission of the NDA, managed the review, and subsequent approval of lenvatinib as a second-line treatment for renall cell carcinoma.

Providing global regulatory input to scientific project teams to enrich development strategies and future study designs. FIling CTA/IND applications, requesting and conducting health authority meetings, preparation of briefing packages.

Running microbiological assays for the antibacterial unit of the Infectious Diseases dept. MIC, MBC, kill curves, growth curves, protein binding assays, API identification Tripled data output by developing a semi-automated MIC method Decreased the time, costs, and materials of the time-kill assay by developing a more efficient plating technique Prepare SOPs, research method reports, and study reports Project management Identification of bacterial strains Reorganized and re-mapped the infectious disease strain collection Created antibiotic profiling protocol for newly acquired bacterial strains In vivo experience with some mouse dosing models Trained associates in microbiological techniques and antibacterial testing

Placed as temp in August 2005. Hired as a fulltime employee in Feb 2007. Promoted to Scientific Associate II in Dec 2009.

Maintenance of Lab equipment (Making buffers, pouring plates, autoclaving, ordering supplies, refilling from stock room, keeping lab clean and organized) Transformation, PCR, gel electrophoresis Sterile growth techniques Isolation of Plasmid DNA (Mini and maxi prep) Literature searches

Worked with post-doc in ophthalmology, in electrophysiology lab Literature review Creating buffers, nutrient solutions, and experimental equipment Analysis of data using graphical software Presentations of findings