- Responsibilities: Overall planning and management of multiple phase 1 and phase 2 studies expanded to include additional and/or larger studies in multiple countries and participation on Clinical Strategy Team. Supported CTA preparations and submissions. Completed CAPs in response to site audits by Abbott/AbbVie QA. Direct reports were transitioned to director-level in 2009 due to reorganization but later transitioned back to manager-level in 2013.- Highlights: Managed multiple phase 1 studies including FIHs, collection of CSF, PK in kidney disease patients, PK in schizophrenia patients and PET in schizophrenia patients. Managed multiple phase 2a studies in CIAS in US (a new and unchartered indication for Abbott and industry) followed by multiple phase 2b studies in CIAS in multiple countries. Collaborated with medical director to identify and pilot a novel compliance methodology to improve study drug adherence by clinical trial subjects (results pending study completion). Contributed to process improvement initiative for standard requirements for interactive response technology (IRT). Served as study team lead on piloting risk-based monitoring (RBM) in collaboration with AbbVie RBM core team and contributed to training materials and improving process/tools/templates for future implementation across the development operations organization.

- Responsibilities: Overall planning and management of multiple phase 1 and phase 2 studies with scientific and operational complexities, including estimates of timelines and costs, with addition of matrix management of functional areas and management of up to 3 CRAs as direct reports, including mentoring and delegation of activities. - Highlights: Collaborated on design and planning of abuse liability studies. Planned and executed an exploratory PET imaging study requiring coordination between a phase 1 specialty CRO and an academic center. Managed a second PET study at a different academic center. Managed first seamless phase 1 FIH study design (SD, MD, FE) at Abbott phase 1 unit from start-up to completion. Operationalized Abbott’s first adaptive randomization study for a phase 2a POC in Alzheimer’s disease, requiring coordination of new technologies and systems where there was no precedent, and received Life Cycle Management Award for Innovation. Successfully transitioned an ongoing phase 2a study from a CRO to Abbott’s newly formed Clinical Field Operations group for site monitoring.

- Responsibilities: Assisted with coordination and management of start-up activities, conduct and close-out of studies in phase 1, phase 2 (ADHD) and phase 3 (migraine). CRA responsibilities expanded to include assistance with recruitment and investigator meeting activities, vendor and CRO management, preparation and delivery of training to CRO monitors and investigators, trip report review, study budget planning and tracking. Supported management of investigator-initiated studies with Depakote.- Highlights: Collaborated with internal team members, consultants and investigators on study design and protocol development for a phase 2a POC pediatric ADHD study. In support of Depakote pediatric written request from FDA, surpassed enrollment goal and retention goal for long-term safety was achieved ahead of schedule for migraine studies. Created and maintained a drug supply forecasting spreadsheet that ensured drug supply needs were met for IIS sites.

- Responsibilities: For phase 1 studies in healthy volunteers, assisted with coordination of start-up activities to include site and vendor selection, preparation of protocols, investigator brochures, informed consents, development of CRFs, site and study budgets, site and vendor contracts. On-site monitoring responsibilities included pre-study, initiation, routine and close-out visits. Coordinated clinical supplies and activities across sites and Abbott functional departments. Assisted in preparation and review of clinical study reports. Reviewed site and vendor invoices.- Highlights: Applied scientific background and training to design and implementation of phase 1 studies. Prepared first edition of IB for ABT-089 to support FIH study and prepared updates to support continued development through phase 1 investigations. Initiated the former Knoll phase 1 unit on the ABT-089 FIH protocol for the first Abbott study conducted at the unit following the Knoll acquisition. Collaborated with Abbott QT Working Group to assemble the first Covance agreement for central ECG reading services for an Abbott study. Contributed to preparation of ABT-089 IND submission documents and multiple IBs.

Contributed to development of an obstructed pig model for evaluation of compounds to treat bladder overactivity and a pig urethral pressure profilometry model. Developed a novel, non-invasive conscious dog urethral pressure model. Established rat penile erection model to investigate drug-induced erectogenic effects. Set up an in vivo rat model to measure intracavernosal pressure, with pharmacological validation using literature standards and evaluated Abbott compounds for pro-erectile effects.

- Established and characterized in vivo models of neurodegeneration, biochemically and behaviorally, to evaluate Abbott compounds for neuroprotective potential. Developed animal models of vertigo to support exploratory project. Established i.c.v. injection procedure in mice to evaluate in vivo CNS activity of Abbott compounds for anti-convulsive activity. Screened and characterized Abbott compounds for therapeutic potential to treat stress urinary incontinence using in vivo techniques in dogs. Collaborated on development of a rat cystometry model to investigate mechanism and potential efficacy of Abbott compounds on urge urinary incontinence.

Assisted with providing basic research in evaluation of reference and Abbott compounds in behavioral in vivo models for cognitive, anxiolytic, analgesic and drug discrimination properties. Performed stereotaxic surgery in rats and used histological techniques to examine lesions.