Kathe Stauber, Ph.D.

Provided high quality DMPK support to ongoing discovery, development and clinical programs. Identified and led the DMPK team in the design of mechanistic studies to address specific absorption, distribution, metabolism and excretion-related issues. Managed high throughput screening assays, pivotal PK / in vitro studies, and provided expertise to inform compound optimization leading to selection of 7 compounds for clinical development, representing a diverse array of pharmacological CNS targets. Conducted toxicology programs to support clinical study progression including study designs and study monitoring, preparing regulatory submissions, and interpretation to management and clinical colleagues. Provided input and recommendations to regulatory correspondences. Medical writing functions included authorship of a wide variety of reports and preclinical contributions to electronic regulatory submissions (IND - Module 2, IMPD, IB, protocols, CSR, DSUR). As functional area Director, provided an active role on all discovery and development project teams. Guided/mentored junior DMPK project team representatives.

Led the nonclinical DMPK team to provide early metabolism, pharmacokinetic, and toxicology characterization of discovery and early development compounds. Represented preclinical development on all discovery and development project teams. Provided a key role in the management and conduct of preclinical activities supporting FIH up to Phase 2 clinical plans. Successfully initiated and managed 5 preclinical development programs from lead optimization thorough to IND submission. • Provided oversight for in vitro studies including permeability, solubility, metabolic stability, biotransformation, transporter interaction, cytotoxicity, pharmacokinetics, and cytochrome P-450 inhibition studies. Designed mechanistic studies when feasible. • Designed DMPK and toxicology development strategy to support clinical development and led the plan execution by interacting with CROs and internal colleagues. • Provided early human dose projections and simulations using allometric scaling or simulation programs such as GastroPlusTM. • Managed all the preclinical toxicology programs. • Collaborated with clinical development colleagues by providing DMPK expertise with regards to drug-interaction potential and clinical pharmacokinetics. • Edited reports. Authored DMPK/toxicology sections for regulatory documents. Prepare presentations for a variety of audiences ranging from scientific overviews for alliance partners to those of educational value for junior staff/team members.