Honors College | Scholars Week Theses Presentations

Title

CAR T-cell Immunotherapy: An examination of approval rates and market pressures on current drug research and development

Presenter Information

Kristen CecilFollow

Academic Level at Time of Presentation

Senior

Major

Biology

Minor

Chemistry

List all Project Mentors & Advisor(s)

Dr. Ricky Cox; Dr. Warren Edminster

Presentation Format

Oral Presentation

Abstract/Description

Excitement from the recent discovery of a novel cancer treatment therapy, CAR T-cell immunotherapy, has large pharmaceutical companies like Novartis, Kite, and Juno racing for a promising drug. Patients diagnosed with acute lymphoblastic leukemia (ALL) can now receive treatments in clinical trials that specifically engineer and modify their T-cells to express chimeric antigen receptors (CARs) that recognize and attack cancerous cells.The Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) is responsible for the review and approval process of all new drugs like CAR T-cell immunotherapy. In order to expedite the approval process, the FDA can grant priority review status and designations to New Drug Applications (NDAs) with specific indications. As CAR T-cell immunotherapy approaches NDA submission, many cytotoxic side effects and deaths have occurred across numerous clinical phase trials. The rapid research and development of CAR T-cell immunotherapy and other novel drugs have raised many concerns on whether expedited approval rates are too quick and could possibly compromise patient safety. Approval rates from New Molecular Entity (NME) and non New Molecular Entity (non-NME) drugs approved from 2011-2016 by the FDA were investigated through a two-part analysis. First, the application cycle, drug indication, and drug sponsor of 505 drugs, NME and non-NME, were collected and analyzed. Second, the approval rate of NME drugs was analyzed based on review status and designations granted by the FDA. The purpose of the research and two-part analysis was to investigate the current FDA review and approval process to gain a better understanding of shorter timelines and drug’s efficacy and safety to patients especially to ALL patients.

Affiliations

Honors Thesis

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CAR T-cell Immunotherapy: An examination of approval rates and market pressures on current drug research and development

Excitement from the recent discovery of a novel cancer treatment therapy, CAR T-cell immunotherapy, has large pharmaceutical companies like Novartis, Kite, and Juno racing for a promising drug. Patients diagnosed with acute lymphoblastic leukemia (ALL) can now receive treatments in clinical trials that specifically engineer and modify their T-cells to express chimeric antigen receptors (CARs) that recognize and attack cancerous cells.The Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) is responsible for the review and approval process of all new drugs like CAR T-cell immunotherapy. In order to expedite the approval process, the FDA can grant priority review status and designations to New Drug Applications (NDAs) with specific indications. As CAR T-cell immunotherapy approaches NDA submission, many cytotoxic side effects and deaths have occurred across numerous clinical phase trials. The rapid research and development of CAR T-cell immunotherapy and other novel drugs have raised many concerns on whether expedited approval rates are too quick and could possibly compromise patient safety. Approval rates from New Molecular Entity (NME) and non New Molecular Entity (non-NME) drugs approved from 2011-2016 by the FDA were investigated through a two-part analysis. First, the application cycle, drug indication, and drug sponsor of 505 drugs, NME and non-NME, were collected and analyzed. Second, the approval rate of NME drugs was analyzed based on review status and designations granted by the FDA. The purpose of the research and two-part analysis was to investigate the current FDA review and approval process to gain a better understanding of shorter timelines and drug’s efficacy and safety to patients especially to ALL patients.