Kathe Stauber

WORK HISTORY

EDUCATION

ABOUT KATHE STAUBER

Seasoned pharmaceutical scientist with broad experience in small molecule drug discovery and preclinical development fostered by leadership roles with strong technical skills and expertise in drug metabolism and pharmacokinetics. In-depth understanding of DMPK providing expertise to project teams influencing compound optimizations, lead candidate selection and preclinical / clinical development. Extensive experience in pharmacokinetics. Proven record in the design and execution of studies to understand drug disposition. Proven track record in regulatory writing including nonclinical / clinical study-related submission documents and life-cycle regulatory correspondences including study reports, CSRs, IB, IMPD, eCTD, IND, DSUR. Excellent editorial skills. Seasoned in the CRO selection, design, management and interpretation of non-GLP and GLP toxicology and DMPK studies in accordance with FDA and ICH guidelines. Proven track record in rapidly bringing compounds from lead identification to IND stage clinical development and proficient in the design and execution of DMPK / toxicology programs. Excellent collaborations with internal and external colleagues. SKILLS Calculation of nonclinical and clinical PK / TK parameters. Noncompartmental modeling and simulation using Phoenix WinNonlin and GastroPlus software, including first-in-human dose projections and associated PK profiles, drug-drug interactions. Building of “top-down” or “bottom-up” PBPK models GLP and non-GLP CRO study management: study design, interpretation, and monitoring of pharmacokinetic, toxicology, human and animal ADME, and in vitro studies. Assay development and validation Management and execution of early ADME profiling studies to support compound design