Michael T.

-Drafted sections for two phase I clinical publications -QC-ed data from supporting publications used in NDA documents

Managed the bioanalytical aspects of three clinical drug development programs (9 clinical studies).

Bioanalytical CRO oversight and management. Thorough understanding of GLP/GMP/GCP regulation and documentation (FDA, EMA, ICH). Act as the scientific and technical liaison between Arena and CROs for outsourced bioanalytical activities such as bioanalytical method development, validation, nonclinical/clinical sample analysis.

Authored, edited, and QC reviewed nonclinical regulatory documents (INDs, IBs, briefing books, and annual reports) as well as supporting preclinical reports. Authored, edited, and QC reviewed nonclinical protocols and study reports (bioanalytical, PK, toxicokinetics (TK), pharmacology, and dose formulation analysis) covering 4 development projects.

Coordinated with senior director on analyzing bioanalytical data to calculate pharmacokinetic (PK)/TK parameters, authoring, review, and finalization of nonclinical PK/TK reports. Department lead for software validations (WinNonlin), updating department SOPs, and the QC of bioanalytical data.

As a past employee, was hired as a consultant and was able to step in quickly and author 12 GLP and GLP-enabling toxicokinetic reports to meet aggressive timelines while updating department report templates. Initiated and maintained tracking of report review / finalization workflow through report study tracker and frequent communication with principal investigators, scientific reviewers, and quality systems.

Hired under contract to author bioanalytical reports (25) and method validation reports (6) to support preclinical GLP-toxicity and clinical studies by compiling bioanalytical data and source documents into formal reports. Coordinated with scientific staff, management, quality systems to have draft reports reviewed, comments provided, addressed, and finalized to meeting corporate timelines over 90% of the time.

The point of contact between bioanalytical Contract Research Organizations (CRO) and Arena's in-house departments to support GLP toxicology and clinical studies for preclinical development programs. Managed bioanalytical reference standards (API, metabolites and internal standards), then authored bioanalytical reference standard qualification reports to support GLP-regulated bioanalysis. Authored toxicokinetic reports. Member of Arena audit team for evaluation of contract labs, participating in 9 audits over ~4 years.

Instructed 8th grade students in Introductory to Physical Science using an interactive program (CIPS) to one class of English language learners and four regular track classes.

Developed assays using HPLC-UV, LC-MS, and LC-MS/MS instrumentation to quantify novel compounds to support preclinical development projects. Orchestrated rodent oral bioavailability studies (IV/PO) using validated methods of analysis. Routinely performed in-vitro metabolism studies using P450 liver microsomes.

- Member of the Product Feasibility Team and Technical Core Product Development Team to evaluate outside technologies for a strategic fit to the goals of the company -Developed optimal formulation and radio-labeling conditions for antibodies, fragments, peptides and small molecules using Y90, In111 and Tc99 -Operation, maintenance and design of HPLC techniques as a tool for the analysis

- Developed and implemented radio-immuno therapy studies in murine models containing human xenografts -Maintained existing tumor lines in mice and developed new tumor models -Radio-labeled antibodies and haptens to support biodistribution studies in rodent species -Implemented biodistribution studies in murine models

-Responsibilities included maintaining sterile surgical techniques during intrauterine catheterization of near-term fetuses of pregnant ewes (>95% survival rate) -Duties also included managing the post-operative care of the ewes during recovery periods and experimentation. This included collection of fetal and maternal blood, urine and amniotic fluid -Facilitated the operation and general maintenance of blood/gas, electrolyte, osmometer instruments, hematocrit determination, blood separation, data entry and analysis -Supervised student helpers and purchased supplies for laboratory vivarium and surgical suites

(Animal Technician III) -Duties included animal husbandry for medical research projects, routine examination of animals with suspect complications, filing daily animal health reports, and keeping the facility in a manner prescribed by University and AALAC Protocols and SOPs (Staff Research Associate I) -Managed the ordering of animals, obtaining blood and tissue samples, performing surgical techniques and radio-labeling lipoproteins for in-vivo catabolic turnover studies -Completed biochemical analysis of lipoprotein fractions including enzymatic assays, SDS polyacrylamide, and agarose gel electrophoresis

BS in BIology