I lead a group of highly skilled scientists who design and implement nonclinical safety, efficacy and pharmaceutical studies supporting a portfolio of novel agents. I collaborate closely with other functional area leads to identify program needs and deliver key information supporting product development. I lead the Pharmacology and Toxicology program, contribute to the robust biomarker program led by Acerta's Translational Scientists, and oversee Pharmaceutical Sciences. My team works closely with Clinical Pharmacology, Clinical Science and Regulatory Affairs to build appropriate data and prepare regulatory submissions supporting our clinical development goals. We recently received accelerated approval from the FDA for our lead product, acalabrutinib.

I feel strongly that trainees should be made aware of opportunities for scientific careers in drug development. With colleagues from the Toxicology and Pharmaceutics programs, I proposed, developed and co-taught a graduate-level course on bio-pharmaceutical product development; this curriculum is now a permanent offering at UW. I also give lectures on drug development, sensory organ toxicology and CE courses for the Dept. of Environmental and Occupational Health Sciences.

I co-chaired a joint Translational Medicine team for a newly launched oncology drug, working with a corporate partner to address scientific questions raised by the product development team. The TM team supported biomarker and target expression-response analysis in design of new clinical studies, and provided scientific input to plans for indication expansion, combination studies and patient selection. I developed biomarker plans for Phase 1 studies of novel antibody-drug conjugates, collaborating with Research, Preclinical, Clinical Pharmacology and study teams to identify appropriate markers and sampling schedules. I worked closely with Clinical Operations to implement these plans. Some biomarkers required development of new fit-for-purpose assays. I selected and worked with vendors to develop custom assays, including flow cytometry for target expression and receptor occupancy, and I provided due diligence on established labs/assays for biomarker analysis in serum and tissues. I worked with Statistical Programming to analyze and report results, and collaborated with functional area experts to interpret findings and update study teams.To provide a resource for future biomarker research, I established a Biospecimen Repository program for clinical samples. I worked with study teams to review consents, address ethics board queries, and operationalize the transfer of specimens into this repository. For the MSL team, I served as the primary liaison for preclinical academic research collaborations, working with Research and Translational Medicine teams to evaluate proposals and develop study plans, establish MTA's, and monitor research progress. I provided regular reports to management on the status and results of these collaborations, and facilitated the review of proposed publications.

Consultant for biotech product development, focusing on translational studies: mechanism of action, biomarker design and proof-of-concept, and target-oriented pharmacogenetic strategies.

Preclinical team leader in oncology and autoimmune programs developing cytokine and antibody therapeutics for early clinical testing. I designed research and safety assessments to support regulatory filings, directed research activities to identify clinical development strategy, and represented two mAb and one cytokine therapeutic as preclinical lead on the core team. I authored regulatory documents and reported original research (from my lab and others) for regulatory submissions and nonclinical updates. I also designed and implemented a pharmacogenomics program to support Phase 2 clinical studies in oncology, autoimmunity and chronic hepatitis C.

I directed a computational toxicology program for the BioPrint project, a proprietary pharmaco-informatics database and tool set. As project manager for two major clients, I coordinated the activities of a diverse multinational team: led database design and implementation, developed multivariate data-mining tools, participated in model validation and built adverse drug reactions database. I also led smaller external collaborations, including design of a custom safety pharmacology database, development of mechanism-based in vitro hepatic toxicity screening assays, and the predictive modeling of G-protein receptors for target identification.

Studied biochemical mechanisms of control of the antioxidant enzyme glutamate-cysteine ligase. Collaborated with several investigators to study the role of glutamate-cysteine ligase in lymphocyte activation, mercury toxicity, chemotherapy resistance, and Parkinson's disease.

As part of my dissertation research, studied effects of oxidative stress on lymphocyte activation and anergy, and investigated the mechanism of action of vanadium-based phosphotyrosine phospatase inhibitors.

Advised students and managed multi-year research programs for the Environmental Studies Program and Marine Biology Laboratory, including studies of nutrient flux through local watershed into Maquoit Bay, a valuable shellfish resource; and bottom enhancements to optimize settlement of oyster larvae. Conducted studies on mechanisms of oil injury to marsh grasses and mussels, and developed tools for assessing oil damage to intertidal organisms.

Conducted studies of allograft rejection, involving MHC I and II molecules as pre-transplant tolerizing regimens.