Biotechnology Enterprise

This course provides an extensive overview of a process for the development of a pharmaceutical by a biotechnology company or pharmaceutical company. The course emphasizes the importance of intellectual property, the basic sciences underpinning the development of a product, and the importance of the interaction between a company and the Food and Drug Administration. Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes that govern the development, manufacturing, and eventual sale of biotechnological products. Hands-on solving of practical problems and guest lecturers who are experts in the field familiarize students with the intricacies of the process. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology I or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs. SCI

Students in this course analyze and discuss traditional philosophical theories regarding the nature of the moral good. They then apply these theories to critical issues and selected cases involving experiments with human subjects, organ transplantation, in vitro fertilization, the use of animals in research, the collection and publication of research data, peer review, conflicts of interest, and other topics of current concern.

This course provides students with knowledge of the fundamental principles of the molecular and cellular biology of cancer cells. The course explores the role of growth factors and signal transduction mechanisms, oncogenes, tumor suppressor genes, tumor viruses, and angiogenesis in tumorigenesis and metastasis. Special topics include cancer prevention and the array of cancer therapies, which include surgery, chemotherapy, radiation therapy, hormonal therapy, stem cell transplant, and immunotherapies. Prerequisites: 410.601 Biochemistry or equivalent, 410.602 Molecular Biology or equivalent, 410.603 Advanced Cell Biology or equivalent, 410.604 Cellular Signal Transduction. SCI

The roles of managers and leaders within biotechnology companies undergo constant change. Biotechnology managers and leaders must engage in new and innovative problem-solving strategies, lead a diverse and global workforce, develop partnerships with other businesses, customers, and competitors, manage horizontally and across teams, and utilize technology to a competitive advantage. The student is able to address and cure challenges in his/her own organization and learn methods of implementing change, such as negotiation techniques and motivation. The course includes in-depth discussions of leadership skills, communication, conflict resolution, and goal integration. Students research a biotechnology organization, analyze what is working and not working within its management systems, and suggest alternatives.

This course introduces students to the strategic and tactical approaches used in the marketing of biotechnological produce and services. Students gain a thorough understanding of the research and planning necessary to develop a marketing plan, the relationship between the marketing and sales functions, the difference between marketing a scientific product and a scientific service, pricing strategies, distribution alternatives, communications, promotion, and the importance of perception. Knowledge of marketing terminology and techniques proves helpful to anyone in the industry.

This course introduces statistical concepts and analytical methods as applied to data encountered in biotechnology and biomedical sciences. It emphasizes the basic concepts of experimental design, quantitative analysis of data, and statistical inferences. Topics include probability theory and distributions; population parameters and their sample estimates; descriptive statistics for central tendency and dispersion; hypothesis testing and confidence intervals for means, variances, and proportions; categorical data analysis; linear correlation and regression model; logistic regression; analysis of variance; and nonparametric methods. The course provides students a foundation with which to evaluate information critically to support research objectives and product claims and a better understanding of statistical design of experimental trials for biological products/devices. Prerequisites: Basic mathematics (algebra). SCI

This course provides a foundation to start or help guide a young biotechnology company from inception through early growth. Topics include market assessment of innovative technology, patents and licensing, corporate law, preparing a business plan, raising money from angels and venture capitalists, government grants, strategic alliances, sales and marketing, real estate, human resources, and regulatory affairs. The course provides a survey and overview of the key tasks and challenges typically faced by biotech entrepreneurs, their management team, and directors. Students will prepare a business plan for a biotech startup and present the plan to a panel of industry experts and financiers. Leaders from our local bioscience community will be guest lecturers for many of the classes.

This course covers the basic ethical issues associated with the responsible conduct of biomedical research using animals and human subjects. Students explore ethical dilemmas and decisions central to these issues, such as the appropriate use of animals in research, misconduct in science, informed consent for human subjects, the role of institutional review boards (IRBs), authorship, data integrity, peer review, intellectual property, and biosecurity.

Regulatory affairs are comprised of the rules and regulations that govern product development and post-approval marketing. In the U.S., the FDA establishes and oversees the applicable regulations under several statutes, many regulations, and partnerships with legislators, patients, and customers. Biotechnology products may be classified as drugs, biologics, or medical devices. Each type is regulated by a different center within the FDA. This course provides an overview of RA and its effect on product development. Topics include RA history, regulatory agencies, how to access regulatory information, drug submissions, biologics submissions, medical device submissions, GLP, GCP, GMP, and FDA inspections.

This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently. Students gain a thorough appreciation of FDA and International Council for Harmonisation regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a “backward” approach, discussing the final analysis and report before developing protocols. Topics also include an overview of preclinical investigations, NDA/BLA format and content, clinical development plans, product and assay development, the IND, and trial design, implementation, and management. Prerequisites: 410.303 Foundations of Bioscience OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admission to the MS in Regulatory Science Program OR Master of Biotechnology Enterprise and Entrepreneurship programs. SCI

Researchers must communicate effectively so their discoveries can be shared with others. In this course, students learn how to communicate their ideas to other researchers, their scientific peers, and investment communities. Students master both written and verbal communication skills, hone their expertise at making both formal and informal oral presentations, prepare poster presentations, and develop their own public speaking strategies. The course also presents personal strategies for improving daily communications, cross-cultural communications, and nonverbal skills. Students improve their written communication, editing, and informal writing skills. Participants also learn effective email strategies for getting their message across and learn how effective writing can improve their chances of getting grant applications approved. Class assignments include preparation of scientific papers, general science writing, oral presentations, PowerPoint presentations, and scientific posters.

Students will build an understanding of the basics of contemporary global monetary systems and the essentials of financial management. This course will include the means to develop a working knowledge of the critical financial factors for decision-makers from the perspectives of key stakeholders. The syllabus is designed to provide students with limited or no background in finance an opportunity to establish an understanding of financial basics and communicate clearly in financial terms when conducting business. This course is uniquely designed to meet the current needs of those leading the global life science industry. SCI

This course is an introduction to the multidisciplinary aspect involved in the process of translating innovations in technology into commercial use, particularly research discoveries emanating from universities and other nonprofit organizations.

Biotechnology impacts the world and our social, political, and physical environment in ways that many both inside and outside the industry may not fully understand or appreciate. It is critical to ensure that advances in biotechnology be accompanied by important public, political, and social considerations and discussions. This course will cover issues including domestic and global public perception of biotechnology, its benefits and risks, advances in bio-agriculture and genetically modified food, the impact of recombinant therapeutics on the pharmaceutic and health care industry, ways in which advances in biotechnology have and will continue to change our views of what life is, and how the political climate impacts advances in biotechnology discoveries. This highly interactive course will include thought-provoking debate and discussion with industry leaders, both proponents and opponents of biotechnology.

This course provides an overview of the important ethical, legal, and regulatory issues that are critical to the biotechnology industry. The course shares current trends and essential elements of ethics, legal issues, and regulations in a way that allows for an appreciation of how each influences the others. Students will examine core ethical values that guide the practice of science in the biotechnology industry. The course will provide an overview of legal issues, such as protecting inventions, intellectual property, licensing, and the range of regulatory oversight mechanisms with which the biotech industry must comply. This course will review the implications of strategic ethical, legal, and regulatory choices that add value to the biotechnology firm, customers, and society.

Today, many organizations use the approach called project management to handle activities that have a limited life span as opposed to routine, ongoing operations. This course will answer the question, “What do I do to be successful?” The units will provide guidance for project management success by considering each phase in the life of a typical project, from concept to closeout. We will discuss the nature of project management, the structure of projects, working with teams of technical experts, and all the other activities that make project management different from any other discipline. The course will rely heavily on group discussions. Topics will include deciding making decisions, developing a project plan, risk management, team leadership, monitoring and controlling during the project, scope change control, and traditional and modern approaches to project closeout. Concepts presented will be consistent with the Project Management Institute’s “Guide to the Project Management Body of Knowledge,” the U.S. standard for project management.

As bioscience companies grow and mature, leadership needs to evolve. Students will learn how to identify their company’s position in the “Leadership Life Cycle” and learn how to select the right leadership capabilities based on their current organizational needs. Research shows that the right leaders at the right time dramatically improve organizational success. Discussions will address the leadership needs of organizations from early-stage, research-based companies through fully integrated biopharmaceuticals. General leadership practices and strategies, moving ideas from the research bench to the consumer, and strategies to prevent failure will all be discussed.

This course will explore how biotechnology innovators are solving social issues, including developing medical diagnostics, discovering effective and safer medicine, producing cleaner energy, remediating environmental contamination, and improving crop yields. Students will think broadly in terms of the roles required to tackle these social, economic, health, and environmental issues and how these roles can add value to society.

This course will cover social entrepreneurship principles and practices in a range of sectors, including corporate social responsibility and public value missions in emerging markets. Students will have the opportunity to define their role in advancing biotechnology as it relates to the top global challenges.

Whether tackling business challenges in a clinic or creating global initiatives, being a healthcare provider, scientist, engineer, or entrepreneur means being a problem solver. This course focuses on helping students develop the problem-solving strategies and innovation development models necessary to more effectively tackle challenges in medical, industrial, and environmental areas of biotechnology. Students will develop a working knowledge of design thinking principles, lean startup, storytelling, and human-centered techniques, as well as an understanding of how they can be utilized to create positive change in any context. While evaluating real-world problems, students will consider how these techniques can be utilized to turn an innovative idea into an effective solution. Students will work individually and collaboratively on real-world projects, turn their ideas into practical action, and demonstrate their ability to leverage science, health care, technology, and social innovation to bring change through community-based and global initiatives.

In order to provide the best care possible, health care professionals are working together more now than ever before. As a result, strong leadership and teamwork skills are becoming necessities in joining the health care field. This course will provide hands-on activities to help students develop problem-solving skills, learn basic negotiation and mediation strategies, and understand their own tendencies as leaders and team members. Using real-world examples, students will explore how strong leadership and teamwork can drive innovative solutions to public health issues.

In this course, we study the nuts and bolts of putting together a new company and explore financial markets and the economics of life science companies. The course includes weekly discussions based upon textbook and outside reading materials; the latter are often topical and speak to the issues of the day and how they may affect investor’s confidence and funding. Video presentations on the part of all students are required. We will examine the roles of corporate officers and the venture community. The students will learn what makes the startup process both attractive and difficult, and will work through that process in a realistic manner.

This course is designed to help students working for life sciences companies understand the fundamentals of obtaining government funding for product/technology research and development. While the emphasis will be on grant funding from the National Institutes of Health, other Federal and state funding mechanisms will also be covered. Students will learn how to search for funding opportunities and receive an overview of the NIH funding mechanisms as well as explore the background and history of the Small Business Innovation Research (SBIR) program. The course will provide insights on preparing an SBIR proposal and submission procedure. Fundamentals of government contracting law will also be covered.

This course is open only to students in the MBEE or the MS in Biotechnology with a concentration in Enterprise and may be taken only after the student has completed five courses and has compiled a strong academic record. Prior to proposing a project, interested students must have identified a study topic and a mentor who is familiar with their prospective inquiry and who is willing to provide guidance and oversee the project. The study project must be independent of current work-related responsibilities as determined by the project mentor. The mentor may be a faculty member, a supervisor from the student's place of work, or any expert with appropriate credentials. The goal of the study project should be a "publishable" article. Students are required to submit a formal proposal for review and approval by the enterprise/regulatory program committee. The proposal must be received by the Advanced Academic Programs office no later than one month prior to the beginning of the term in which the student wants to enroll in the course. Students must interact with a member of the program committee periodically for discussion of the project's progress, and a written document must be completed and approved by the program committee and project mentor for the student to receive graduate credit. Additional guidelines can be obtained from the AAP administrative office.