Biotechnology Track

This course is first in a two-seminar sequence that introduces students to the science and business of the biotechnology industry. The course explores cutting-edge translational research that is shaping current commercialization and industry trends. Students  engage directly with primary research literature and learn from leading scientists and industry executives. Example topics include AI, gene editing/therapy, precision medicine, tissue engineering, biomanufacturing, and synthetic biology.

This course is second in a two-seminar sequence that introduces students to the science and business of the biotechnology industry. In addition to continued exploration of translational research, this course focuses on deeper scientific and commercialization topics specific to the industry, including operational and financial perspectives across all stages of organizational maturity. Students learn from industry leaders who are commercializing, analyzing, and investing in biotechnology.

This course focuses on how to successfully commercialize breakthrough technologies that have high potential to generate social and/or economic value. Issues related to identifying market needs and potential, developing commercialization plans, and understanding business models and entrepreneurial strategy are covered. As an introduction, this is not an appropriate course for students who minored in or have a strong foundation in entrepreneurship.

Business analytics leverages the vast data resources available today to identify trends and patterns that are critical to enhancing business performance. This course introduces students to contemporary business analytics methods, including predictive and descriptive analytics techniques, and demonstrates how to practically apply analytics to real-world business decisions.

This course Introduces students to the techniques needed for the evaluation of health outcomes from the perspectives of the patient, the physician, the healthcare provider, and society. It presents the measurement and evaluation of survival, functional status, quality-of-life, and health values, and evaluates the efficacy, effectiveness, and cost-effectiveness of devices, interventions, and processes of care. Prerequisite: PHS 7000 and 7001 or instructor permission.

This course covers the design and analysis of Phase I-III clinical trials. Topics include choice of study population and endpoints, choice of study design and sample size estimation, randomization and masking, patient recruitment, data collection and quality control, data monitoring committees, data analysis, and the interpretation and reporting of results. Cross-listed as STAT 5310. Prerequisite: Instructor permission; PHS 7000 or equivalent.

This course presents a project-based grounding in biomedical product design, with emphasis on clinical immersion and topics including design fundamentals, problem/needs identification, delineation of realistic constraints and product specifications, intellectual property, market analysis, entrepreneurship, specific advanced design topics, business plan development, venture funding, and medical product testing methods. Prerequisite: Instructor permission.

This course applies engineering science, design methods, and system analysis to developing areas and current problems in biomedical engineering. Topics vary by semester.

The course covers human genetics and genomics, including the human/mammalian genome variation; determination of genomic variation on phenotype and disease risk; mapping and characterizing genetic variants on phenotype; determining the putative impact of genetic variants on gene expression (transcriptomics, epigenomics); the promise and implications of genome science on precision medicine; and the ethical, legal and social implications. Prerequisite: BIOL 3010 or BIOL 4210 or instructor permission.

The course focuses on engineering’s role in commercialization of vaccines and biologics. Biologics are more complex than small molecule drug products and present unique challenges in commercialization. This course includes an overview of vaccines and biologics from historical context; product, proces,s and analytical technologies; immunology; clinical, regulatory, and ethical considerations; economics; risk mitigation; and impact on human health. Prerequisites: Fourth-year or higher, CHE or BME standing, or instructor permission.

This course provides and introduction to the properties, production, and use of biological molecules of importance to medicine and industry, such as proteins, enzymes, and antibiotics. Topics may include fermentation and cell culture processes; biological mass transfer; enzyme engineering; and implications of recent advances in molecular biology, genomics, and proteomics. Prerequisite: Instructor permission.