Kelly Hanna

Provided management of all aspects of outsourced nonclinical study conduct. Served as the single point of contact with the Contract Research Organization (CRO), facilitated contracting and protocol development under the direction of the project scientist in collaboration with the Study Director. Operational responsibilities included tracking budgets, purchase orders and invoices, maintaining study database to track study and project milestones, archiving study documents, participating in project teams and departmental meetings, performing review of draft study reports and coordinating revisions and finalization of nonclinical reports.

Conducted pre-clinical muscle biology and cancer efficacy studies. Responsible for Rigel's TGFb mouse PK/PD studies and this program was partnered with BMS for an upfront payment of $30 million. Coordinated all aspects of study planning, conduct and completion. Many methods of dosing were performed including continuous infusions using tether systems and various pumps. Experience with complex technology and equipment such as MRI, IVIS imager, LabChart ECG, treadmills, Noldus tracking software, dorsi-flexion, and metabolism cages.

Conducted pre-clinical oncology and metabolism efficacy and PK studies in mice. Planned and carried out elaborate metabolism efficacy studies in a diabetes induced obesity mouse model. Performed cell culture for xenograft implantation studies. Determined appropriate formulations and serial dilutions of new compounds for testing. Acted as the study lead and supported other department members as needed in their studies by performing dosing, blood collection, tissue harvests or necropsies in mice and rats.

Responsible for the overall conduct of GMP/GLP biocompatibility, pharmacokinetic, and toxicology studies.  Areas of focus included canine PK studies, bioassays, biocompatibility testing, and large animal special studies. Scheduled testing for the company's largest client involving nine staff members each day. Wrote protocols, departmental SOPs, and reports. Dosed animals, performed clinical observations and bench work in support of testing.