Michael Hart, Ph.D. Email & Phone Number

Louisville, Ky, Us

Louisville, Ky, Us

Bethesda, Md, Us

-Reviewed clinical study concepts for scientific accuracy and research plan consistency.-Prepared meeting summaries, reports, and requests for medical officers for cancer clinical trials in the United States and internationally.-Conducted literature reviews to identify safety concerns with investigational agents and to prepare reports on agent background information.-Performed QC review of regulatory and medical writing documents.-Authored protocols, informed consent documents, Central Institutional Review Board (CIRB) documents and associated protocol documents in coordination with study teams for oncology studies.-Developed and maintained the Development Safety Update Reports (DSURs), clinical study reports (CSRs), Comprehensive Adverse Events and Potential Risks Lists (CAEPRs), and study protocols to support clinical trials for more than 200 INDs.

Dublin, Ie

-Led review committee meetings and collected feedback from review committee subject matter experts on submitted concepts and research protocols.-Experience in collecting data for study management tools (SMTs), and supported in the updating of the Tableau IST SMT Dashboard to monitor clinical and preclinical study progress.-Experience in supporting Jazz contracting team in agreement negotiations with external institutions sponsoring Jazz-approved trials.-Led all operations for Oxybate studies and JZP150 Expanded Access Program (EAP) requests and supported IST operations for Sativex and US-approved Epidiolex studies.-Skilled in conducting quality control of all submitted concepts and protocols in VisionTracker and iEnvision to ensure alignment with strategic research objectives in conjunction with the larger development team.-Coordinated deadlines with and collected study files from principal investigators and medical science liaisons for approved and ongoing ISTs.-Expertise in conducting fair-market value (FMV) analyses of submitted IST budgets and processing invoices for completed study milestones in coordination with Accounts Payable.-Aided in reviewing and updating standard operating procedures (SOPs) within IST and EAP operations.

Pa, Us

-Synthesized and developed targeted and activatable fluorophores for detection of non-small cell lung cancer.-Designed protocols for evaluating fluorescence imaging of human, canine, and murine lung tumor tissues.-Compared lung tumor fluorescence resulting from prototype fluorophore administration to fluorescenceresulting from application of FDA-approved fluorophores.-Coordinated with clinical and veterinary teams to obtain patients samples for fluorophore validation.-Mentored high school, undergraduate, and graduate students in molecular imaging techniques.-Aided in NIH grant writing and editing for optical imaging projects.-Prepared abstracts, poster presentations, slide decks, and manuscripts detailing the results of the thesisproject.

Danville, Ky, Us

-Designed a research project analyzing the effects of antibodies on amyloid-beta aggregation (one of the primary causes of Alzheimer's disease progression) and testing the efficacy of a widespread assay technique. Applied and interviewed for the program (one of seven students taken for the 2016-17 academic year). Funded by Centre College.-Conduct experiments improving skills in assay development and SDS-polyacrylamide gel electrophoresis.-Will give a presentation and write a report in April summarizing the results of my research.

Danville, Ky, Us

-Aid the Director of Greek Life in organizing Greek events and informing the Department of Public Safety of all Greek activities.-Organize information for the Greek chapters on campus for the Director of Greek Life, including member rosters and the preparation of policy forms.-Manage the scanner entry and exit system utilized to track attendance at Greek-sponsored events.

Danville, Ky, Us

-Conducted organic chemistry research screening the potential of peptide-linked metal chelators to inhibit amyloid-beta aggregation (one of the primary causes of Alzheimer's disease).-Gained experience using UV spectroscopy, assay development, nuclear magnetic resonance spectroscopy, high performance chromatography, SDS-polyacrylamide gel electrophoresis, solid-phase polypeptide synthesis, and organic synthesis.-Presented research at the 252nd National Meeting of the American Chemical Society in Philadelphia.

Danville, Ky, Us

-Assisted in instruction and laboratory management in an introductory course to biochemistry and molecular biology.-Proctored quizzes and maintained the laboratory in the absence of the professor.

Doctor Of Philosophy - Phd, Pharmacology

Bachelor Of Science (B.S.), Biochemistry And Molecular Biology