Biotechnology

BIOT 5100. Introduction to the Science in Biotechnology. (3 Credits)

This course covers the molecular foundations of biotechnology, receptor pharmacology, genomics, cell biology and signaling, immunology, molecular biology, virology, molecular microbiology, microarray analysis, proteomics, biosensing, and analytical methods in biotechnology.

BIOT 5200. The Biotechnology Enterprise. (3 Credits)

This course exposes students to the “business of biotech” from scientific discovery startup through its product launch and subsequent organizational and scientific pipeline growth. Topics include scientific discovery, biotech-related funding and organizational structures, an introduction to regulatory and clinical trial considerations, biotech alliances, patient access, ethics and compliance, and commercialization and growth to meet consumer needs in this highly regulated industry. Students will experience what it means to be a professional in this industry with all its complexities.

BIOT 5300. Law and Regulation in Biotechnology. (3 Credits)

This course introduces laws that govern the biotechnology industry and its processes. Students will receive an overview of early-stage research, the clinical trials process, good manufacturing practices, the FDA’s approval requirements, post-approval marketing and safety, and rules and testing requirements for generics and biosimilars. The course also surveys law related to the business and financing side of biotechnology, including intellectual property, funding for research, material transfer agreements and other contractual arrangements, and corporate structures.

BIOT 5400. Experimental Design, Biostatistics and Math for Data Science. (3 Credits)

This course explores the principles of experimental design and statistical analysis. The class emphasizes research in the molecular and biological sciences and biotechnology. Topics include probability theory, sampling, hypothesis formulation and testing, parametric and nonparametric statistical methods, discrete and continuous random variables, vector spaces, linear algebra, and graph theory.

BIOT 6900. Biotechnology Capstone 1. (0 Credits)

This course offers students an opportunity to integrate and apply the skills learned in earlier courses to an independent research project supervised by a faculty/industry mentor or an industry internship.

BIOT 5076. Strategy, Commercialization and Finance in Biotechnology. (3 Credits)

This course describes the working of an existing biotechnology firm, including its organizational structure, strategy, pipeline creation, building patent portfolios, strategic alliances and partnerships, and finance strategies. Emphasis is on late-stage startups and biotechnology divisions of big pharma. Students learn about commercialization of biotechnological innovations, business models, funding strategies, and market analysis.

BIOT 5080. Medicinal Chemistry. (3 Credits)

This one-semester course will cover the basics of drug development, the process of taking a concept for treating a disease state through to a marketed prescribed drug, and the role medicinal chemistry plays in this enterprise. Through various case studies, fundamental concepts of lead discovery and modification; structure-activity relationships (SAR); drug target interactions; and absorption, distribution, metabolism, and excretion (ADME) will be studied. Additionally, there will be a discussion of drug synthesis. Rational drug-design will be highlighted throughout the discussions, and such issues as patentability, market strategies, and competition from generic drugs will be highlighted.

BIOT 5203. Healthcare Compliance. (3 Credits)

The healthcare industry is governed by numerous statutes that are actively enforced by federal and state regulatory bodies. This Healthcare Regulations Compliance course focuses on the federal and state statutory and implementing regulatory provisions enacted to detect and deter healthcare fraud, waste, and abuse. Over the course of the semester, students will cover, among other compliance laws and regulations, the following fraud and abuse laws: (i) the Federal and State False Claims Act; (ii) the Physician Self-Referral (“Stark”) Law; (iii) the Anti-Kickback Statute; (iv) the Civil Monetary Penalty Law; and (iv) the Criminal Health Fraud Statute. Students will also learn the required elements of an effective compliance of ethics program and how to perform a risk assessment, including risk identification, scoring, and prioritization. In addition to the foregoing, the course will cover corporate governance, human subject research compliance, record management, as well as patient privacy and data security under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the data breach notification provisions under Heath Information Technology for Economic and Clinical Health Act (“HITECH”) provisions of the American Recovery and Reinvestment Act (“ARRA”) of 2009.

BIOT 5222. Advanced Biochemistry and Cancer Metabolism/Biochemistry 2. (3 Credits)

This course delves into the biochemical properties of eukaryotic cells with particular emphasis on cell-to-cell and cell-extracellular matrix interactions, biochemical changes causing epithelial-mesenchymal-transition, signal transduction pathways, over-expression of signaling, proteins, mutations, cell-cycle control, apoptosis, neoplastic transformation, tumor progression, and metastasis. Current chemotherapeutics and immunotherapeutic drug therapy and their mechanism of action will also be discussed.

BIOT 5290. Health Care Law. (3 Credits)

This course presents an in-depth overview of the U.S. health care system, focusing on landmark cases, statutes, and policies, as well as key stakeholders in the system. Comprising an estimated one fifth of the nation’s economy, the system impacts virtually every sector of contemporary society—from employers to government entities to insurers to biotechnology innovators, as well as patients, physicians, and hospitals—in the massive undertaking of providing for the health of the American people. The course introduces students to a comprehensive approach for understanding, analyzing, and resolving the myriad legal issues related to health care practice and administration. Initial sessions examine the evolution of U.S. health care and the historical forces that converged to bring about this unique system, as well as the challenges of access, price, quality, and equity that continue to plague the system. In addition, this semester we will spotlight the challenges of health care disparities and the controversy surrounding the recent Supreme Court Dobbs decision. The course next analyzes the major legislation and landmark cases that distinguish American health care, while highlighting the role of key stakeholders such as physicians, hospitals, and pharmaceutical companies in shaping the health care landscape. Specifically, we will evaluate the Affordable Care Act (“ACA”), explore “conscience clauses” through the Hobby Lobby case, and discuss HIPAA, HITECH, and GINA. Finally, imminent changes—hospital consolidation, physicians in 21st-century America, telehealth, the promise of genetic medicine and pharmaceutical breakthroughs, the impact of public health challenges such as COVID-19, and the role of private equity in health care services —will be analyzed. Upon successful completion of the coursework, students will have attained skills enabling them to successfully navigate the legal challenges associated with health care cases, to draft policies and legislative recommendations, and to devise effective strategies for addressing these complex issues. The class will be graded based on class participation and discussion, a presentation on a topical health care issue (35%), and a final paper providing a critical legal analysis of a topical health law issue (65%). Students may use the course to satisfy the writing requirement.

BIOT 5363. Law & Medicine. (3 Credits)

This course combines the presentation of legal and scientific theory with practical examples and discussions. The legal theory of medical malpractice is reviewed including such topics as physician’s standard of care, informed consent, current issues in physician malpractice, strategic approaches of plaintiffs, as well as defendants to malpractice actions, discovery techniques, effective use of medical experts, and key elements of a medical malpractice trial. The course also will deal with the preparation and presentation of medical proof in civil and criminal cases. Study is also given to legal, medical, social, and moral issues involved in the areas of right to treatment, human experimentation, organ transplants, allocation of scarce resources, euthanasia, and right to life.

BIOT 5532. Neuroscience. (3 Credits)

This course will cover the study of the anatomy, biochemistry, and physiology of neurons and neural pathways that comprise the peripheral and central nervous systems and their relationship to behavior.

BIOT 5621. Applications of Nanobiotechnology in Medicine and Diagnostics. (3 Credits)

In response to recent advances and investments in biomaterials with particular emphasis on developments in nanotechnology, this course delves into modern biotechnological approaches for therapeutics using nanotechnological approaches. With emphasis on tissue regeneration and remodeling, development of biocompatible scaffolds for 3D and 4D bioprinting, targeted tumor therapeutics, drug delivery devices, design of bio-organic polymers and peptoids. The development of biosensors and theranostics using SPIONS, quantum dots, and gold nanoparticles will also be discussed.

CISC 6500. Bioinformatics. (3 Credits)

This course studies the relation of (interaction between) molecular biology and information science and the impact and applications of combinatorics, computing, and informatics on the biomedical sciences and clinical processes. Topics include: DNA sequence and alignment, database searching and data analysis, phylogenetic analysis and evolution, genomic and proteomics, structure and function, gene regulatory networks and metabolic pathways, microarray technology, and gene expression algorithms.

Attributes: CSAT, CSDA, DATA.