Developing EGFR-Targeted Nanoliposomal Therapeutics in Head and Neck Squamous Cell Carcinoma; The Impact of Biosimilars on the Provision of Value-Based Healthcare

Karkar, Abhishek, School of Engineering and Applied Science, University of Virginia
Seabrook, Bryn, EN-Engineering and Society, University of Virginia
Kester, Mark, MD-PHAR Pharmacology, University of Virginia

The technical report found in this portfolio covers an investigation of developing a nanoliposomal drug delivery mechanism for FDA-approved biopharmaceutical drugs that have been shown promising in clinical trials against HNSCC. The three drugs involved in the study were EGFR inhibitors named Erlotinib, Gefitinib, and Cetuximab. Erlotinib and Gefitinib are water soluble compounds that were shown to be promising against Non-Small-Cell Lung Carcinoma (NSCLC) and cancers in other isolated tissues while Cetuximab is a monoclonal antibody currently being tested in FDA-approved Phase-2 clinical trials with the use of the Ceramide Nanoliposome (CNL). The CNL is a liposomal delivery vehicle developed by the Kester Lab that contains its own unique lipid compound formulation and, along with ghost liposome formulations, comprises the group of delivery vehicles used in the study. The objective of the technical research project was to investigate various combinations of a single dissolved or bioconjugated drug with either a ghost liposome or a CNL and the effect these developed therapies had in vivo on human HNSCC cells and in vivo in a rodent model. The goals of the study were to identify which of these developed therapies proved to be most efficacious in treating HNSCC in laboratory and clinical settings as well as to model the stability of the therapies under in vitro conditions mimicking the human physiological environment. Ultimately, the idea is to use translational medicine for utilizing clinical trials results in perfecting a human-administered HNSCC drug delivery therapy.
The STS research investigates the relationship between the biopharmaceuticals industry and the healthcare market. More specifically, this paper analyzes how biosimilar products can influence the provision of healthcare in terms of quality and affordability of care. The paper aims to answer the question: How can the use of biosimilars increase the affordability of healthcare and consequently shift the current healthcare provision model towards one that is value-based? Value-based healthcare is assessed against the more widely-practiced volume-based care model and is connected to the biopharmaceuticals market using literature review to collect research and evidence. The paper shapes this evidence into an argument by establishing the relationship between these value-based care and biosimilar products in healthcare. Actor-network theory (ANT) is utilized to assess how connections exist between biosimilars and the value-based care model and how key components and roles in both aspects allow physicians to practice using this model as opposed to the volume-based model. Scientific, political, and commercial aspects of these relationships and the network connecting the healthcare model and the drug markets are evaluated in this paper. The arguments made in this paper aim to establish that the introduction and use of biosimilars in the U.S. healthcare market, provide an economic advantage to both physicians and patients that allows the value-based model of healthcare to become the most efficient and predominantly utilized model of care provision. Through this research, a healthcare policy that results in more affordable and accessible healthcare in the United States can be investigated and developed.

BS (Bachelor of Science)
Cancer Therapeutics, Head and Neck Squamous Cell Carcinoma, Biosimilars, Value-Based Healthcare, Actor-Network Theory

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Technical Advisor: Mark Kester
STS Advisor: Bryn Seabrook
Technical Team Members: Patrick Beck, Sally Greenberg, An Smith

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