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Zaina Qureshi

Zaina Qureshi

University of South Carolina, USA

Title: Rituximab and biosimilars Equivalence and reciprocity

Biography

Assistant Professor, Arnold School of Public Health, University of South Carolina, Columbia, SC. (Aug. 2012 – present) +Taught HSPM 775 “Managerial Epidemiology and Statistics for Healthcare” during the fall semester. +Served on an ad-hoc school committee where I worked on curriculum development with Dr. Addy and others within the school of public health. +Advised MHA, MPH and doctoral students. +Applied for internal and federally funded grant programs. Post-Doc Research Assistant, College of Pharmacy, University of South Carolina, Columbia, SC. (Jul. 2010 – present) +Contributed to the analysis, data interpretation, data presentation and manuscript preparation for projects. +Assisted in putting together local and national grants including SBIR, NIH R01, R13, R18, R21, SCTR, U01, U19 among others. +Conducted secondary data analysis and published manuscripts on Medicare and Pharmaceutical fraud. +Collected data using RADAR/SONAR methodology (from FDA sources including MedWatch) and published manuscripts on serious adverse events associated with cancer drug use. Post-Doc Research Associate in Outcomes Research and Health Economics (Sep. 2009 – May. 2010) Rutgers University, College of Pharmacy, New Brunswick, NJ + Lectured and managed 230 undergraduates in a course titled, “Pharmacy Marketing Management.” + Conducted secondary data analysis using Medical Expenditure Panel Survey to investigate the trends in healthcare expenditure among elderly patients with concomitant diabetes and obesity. Page 8 of 9 Zaina Qureshi Teaching Assistant, College of Pharmacy, the Ohio State University, Columbus, OH. (Aug. 2007 – Aug. 2009) + Assisted in teaching 5 different courses at the graduate and undergraduate level. Ohio Department of Job and Family Services, Ohio Health Plans, Bureau of Clinical Management (Jun. 2008 – Sep. 2008) + Contributed to the design and testing of protocol to improve worker efficiency in analyzing insurance claims and support appropriate use and quality improvement + Gained experiences in proposal writing, IRB submission, study design and analysis plan development, data analysis using SAS, and project management within a government organization + Conceptualized, developed and implemented a burden of illness study for the Medicaid Breast and Cervical Cancer Project to ensure the main drivers of cost were cancer-related cost. College of Public Health, The Ohio State University & Universal Health Care Action Network of Ohio, Columbus, Ohio. (Feb. 2008 – Dec. 2008) + Assisted in implementing “Consumer Voice for Affordable Health Care” project funded by the Columbus Medical Association Foundation, Columbus, Ohio. + Managed data collection, established the protocol for data management, analyzed data and assisted in the preparation of the final report for the initiative. Research Assistant, College of Public Health and Centers for Health Outcomes, Policy and Evaluation Studies, The Ohio State University, Columbus, OH. (Jun. 2006 - Jul. 2007) + Assisted in conducting literature review, writing and editing a research grant to Ohio Medicaid. + Evaluate the medical cost attributable to obesity among Ohio Medicaid population as part of the grant proposal. Graduate Research Assistant, College of Pharmacy, the Ohio State University, Columbus, OH. (Jun. 2006 – Aug. 2007) + Created an Excel database to examine Food and Drug Administration guidelines on labeling of pharmaceuticals for pregnant women. +Model comparing drug utilization and medication adherence in a retiree population. Graduate Teaching/Research Assistant, College of Pharmacy, the University of Toledo, Toledo, OH. (Aug. 2004 - May 2006) + Coordinated surveys, designed, implemented and managed projects surrounding issues like obesity, depression, emergency contraception and medication therapy management. + Assisted in teaching 7 different courses at the graduate and undergraduate level.

Abstract

Cancer is a debilitating disease affecting millions of people daily. Over the years cancer treatment has advanced in leaps and bounds. Antibodies are important breakthrough therapeutic agents for cancer. These agents, proteins produced by B lymphocytes of the immune system in response to antigens, bind to receptors on cell surfaces so that the antigen-antibody complexes can be recognized and destroyed by phagocytes. While each B cell synthesizes only one kind of antibody, an entire population of different types of B cells and their respective antibodies are produced in response to various antigens to which the organism had been exposed. However to be useful clinically, substantial amounts of a single antibody must be generated from a single ancestral B cell. These populations of antibodies produced by a specific population of B cells are the monoclonal antibodies that have become the cornerstone of treatment for cancer and many immunologic illnesses. The purpose of this report is to provide an overview of the clinical development of biosimilars in clinical oncology focusing on rituximab and like biosimilars.

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