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    The innovation & entrepreneurship component of my GCS experience has enhanced my understanding of my research, and prepared me to work in the biotech industry. Unfortunately, the ability to engineer better medicines is affected both by scientific advancements, and by the demands and limitations of the biotechnology industry, patents and the FDA. The success of a novel medicine, therefore, is dictated not only by its therapeutic benefit, but also by its ease of production, cost to manufacture, safety, and similarity to other drugs on the market. Throughout my GCS experience, I have had the gained insight into the biotech industry through my two semester design class, Biotechnology Design with Dr. Mike Lynch, and by speaking with Dr. Kelli Luginbuhl, the founder of Isolere Bio, one of the several biotech companies that started at Duke.

    The skills and knowledge that I have gained from Biotechnology Design have helped me to understand the process of engineering better medicines, my goal as a GC fellow. The class’ lectures were focused on the topics such as fermentation, discounted cash flow analysis, copyright and patents, and FDA regulation. This knowledge allowed me to reflect on GCS project, to develop a biomaterial-based cancer vaccine, in the classroom. I gained insight about the R&D processes that would be necessary to develop such a therapy in industry, and the downstream process of implementing such a therapy into the clinic. My biotechnology design class also had a lab component, in which I enhanced my knowledge of protein engineering. Throughout the class, I solidified my knowledge of the techniques I use to develop my vaccine in the lab (such as His tag purification) by practicing new protocols and working with new proteins. I also learned new skills such as fast protein liquid chromatography (FPLC), which I can use to purify my protein, and is a common technique in industry. Throughout this course, I learned the knowledge and skills that will enable me to take a concept from design to a therapy, such as a cancer vaccine, that can be translated into the clinic.

    As a student in biotechnology design, I had the opportunity to pitch and complete a design project in the class. For my project, I proposed to develop a broadly neutralizing antibody against Hepatitis C (HCV) for a HCV therapeutic. I completed a needs-finding to justify the proposal, a discounted cash-flow analysis, and developed a plan complete with protocols to synthesize the antibody, and verify its therapeutic potential with binding and in vitro assays. Although we were not able to complete the remainder of the project due to Duke’s transition to remote learning, this process pushed me to think more broadly about the merit of a project, to be independent, and to learn about new techniques that may be relevant to me later in my career. It allowed me gain experience the innovation and entrepreneurship aspect of developing a novel therapeutic. It encouraged me to think about my GC project, and to appreciate the freedom I have to work on it in academia.

    In addition to this experience, I have had the opportunity to speak with Dr. Kelli Luginbuhl, the founder (and tour the facilities) of Isolere Bio. In doing so, I learned about the steps, from the design of the therapy to the market of the product, required to bring a novel medicine to market. These steps, though not necessarily engineering themselves, are equally important in ensuring that the therapy will be able to treat individuals. Additionally, I was able to learn about the challenges and rewards of starting a company, and get a glimpse of daily life at a startup. This enabled me to visualize what my GCS project might look like if it were successful in the laboratory, and moved onto the next stages of validation, before hopefully being translated into the clinic.