Entrepreneurship Track

3 credits | Fall Semester
Prerequisites: None

The course will cover in-depth various aspects of the Biotechnology Industry. Emphasis will focus on established Biotechnology and BioPharma companies. Topics covered will include intellectual property, products and their market shares, and career opportunities in Biotechnology. Contributions will be made from senior scientists from academia, business managers from the biotechnology industry and government agencies.

3 credits | Spring Semester
Prerequisites: BIOT 5009, BIOT 5200 & BIOT 5230

This course gives an introduction to problems and opportunities of start-up biotechnology companies and provides in-depth look at starting a biotechnology company to exit strategies for investors. Students will develop and report assigned case studies based on their ideas for start up biotechnology companies. Contributions will be made from venture capitalists, industrial scientists and business managers.

1 credit | Fall Semester
Prerequisites: BIOT 5009 & BIOT 5230 Concurrently

The course focuses on the importance of financials and how it directs various aspects of a biotechnology company. Emphasis will be on the basics of accounting and establishing a company budget.

2 credits | Fall Semester
Prerequisites: None

The course provides an opportunity for students to learn about intellectual property rights and their uses in biotechnology. Topics addressed include: rights conferred by different types of intellectual property; the uses of biotechnology patents; determining “patentability,” interpreting the rights conferred by a patent; the patent-granting system in the US and elsewhere, patent costs and values; and the post grant processes for enforcing and challenging US patents.

1 credit | Spring Semester
Prerequisites: BIOT 5009, BIOT 5200 & BIOT 5230

The complex, multi-disciplinary nature of the biotechnology industry requires that managers develop effective strategies for key aspects of their business. This course examines how biotechnology company executives approach strategic issues that are critical to their firm’s success: Developing pipeline assets, making portfolio investment decisions, creating a culture of high-performing individuals and cross-functional teams, and ensuring supply of clinical and commercial product while continually driving process innovation.

1 credit | Spring Semester
Prerequisites: BIOT 5009, BIOT 5200 & BIOT 5230. BIOT 5100 Concurrently

The course will provide an overview of the commercialization process for complex biologics. It will focus on the key tools, analytics, strategies and tactics that apply in healthcare sales and marketing. By the end of the course students will have a basic understanding of the following: The role of Commercial Operations in a biopharmaceutical company; The relationship between marketing, sales, commercial operations and managed markets; How commercial operations impact research and development as early as Candidate Drug nomination; The differences in promoting medicines versus consumer goods; How technology drives disease awareness and product choice by educating the provider and patient communities.

1 credit | Spring Semester
Prerequisites: BIOT 5009, BIOT 5200, & BIOT 5230. BIOT 5100 Concurrently

A one credit course delivered over two weekends and 14 hours of class time. 2 assignments covering two of the segments of development. No textbook. Assignments and research from a rich public domain. Instructor will guide students in research and provide relevant articles, cases and personal experience.

2 credit | Fall Semester
Prerequisite: Open only to MS Biotechnology Entrepreneurship Track students

Limitations: Minimum, 3 students; Maximum, 8 students

Successful entrepreneurship requires understanding and mastering basic tools that are essential to initiating and building a successful company. While the path for each company is unique, this course will concentrate on core principles that are ingredients for success. Many startup companies are known to fail for one or more reasons that can be avoided. Several guests who have successfully started biotechnology companies will present their individual paths to building their companies. Independent studies will include analysis of successes and failures of startups. Exposure to NIH SBIR and SBA funding and independently writing of a business plans will be included. Students will identify internships in startup small companies and with individuals who have started companies that have been able to succeed in bringing products to market.

The course offers a pragmatic, hands-on progression in the formation, development and financing of a biotechnology company.  Students assume the position of “founders” of the company and work together as a team to complete the foundation documents of i. Company Overview; ii. Business Plan; iii. Financial Plan; and iv. Investor Pitch.  These documents constitute the final deliverables for the course.

1 credit | Spring Semester
Prerequisites: None

Biopharmaceutical companies frequently face a strategic dilemma – too many potential projects and not enough resources to pursue them all. This course will provide students with an overview of the key analyses, processes and decisions companies take to optimize their portfolio of product development projects. It will draw from real-world examples and incorporate industry professionals as guest lecturers, and students will gain “hands on” experience from simulations and small group project teams.

3 credits | Fall Semester
Prerequisites: None
Restrictions: BioBusiness students, Instructor approval for others

This course will cover the fundamental knowledge on key players in biochemical reactions and the processes of the central dogma of molecular biology.  We will discuss structures and functions of different biomolecules, including nucleic acids and proteins.  DNA replication, transcription and translation processes in both prokaryotes and eukaryotes will be covered in details.  A variety of canonical signaling cascades in cells will be introduced to demonstrate the cross-talks between biomolecules and the physiological consequences.  This course is taught by several instructors based on their specialized areas.

1 credit | Fall & Spring Semester
Prerequisites: None

The sequencing of the human genome that was completed in 2001 and the explosion of ”omic data” has accelerated our understanding of basic genetics and how we think of biology. We are now in the “omic” era of molecular biology that has given birth to the new field of Bioinformatics. All this data can be used meaningfully for biological and clinical research only if we can extract the relevant functional information from them and convert biological data into knowledge of biological systems. Fortunately, by using bioinformatics we can make headway in understanding and extracting relevant biological information from these sequences. The aim of this course is to introduce the various tools and resources that are available as applicable to biomedical research. This course is highly experiential with both lectures and “hands-on” sessions.

2 credits | Spring Semester
Prerequisites: None

This course provides students with an overview of the entire Drug Development process, from inception of discovery to the final marketed product and review of the principles underlying preclinical and clinical development of new therapeutic drugs and procedures. Presentations will describe and evaluate specific examples, and discussions to include regulatory, financial and ethical regulations that apply to Drug Development.

1 credit | Fall Semester
Prerequisites: None

This course will examine new technologies and ways to license them from the Lawrence Livermore National Laboratory. A majority of the presentations will be teleconferenced.

1 credit | Spring Semester

This course is designed to familiarize students with Current Good Manufacturing Practices (cGMP), Current Good Laboratory Practices (cGLP), and the regulations that guide the manufacture of FDA-approved biopharmaceutical and biotechnology products.

1 credit | Spring Semester
Prerequisites: BIOT 5009, BIOT 5430

To work in the pharmaceutical industry, familiarity with the Federal Regulations that govern the field is required. Final drug product regulations from 21 CFR 211, otherwise known as the current Good Manufacturing Practices and other regulations, will be covered using real-life examples from the pharmaceutical industry. Current hot topics and FDA areas of concern will be highlighted.

0 credits | Fall & Spring Semester
Prerequisites: None

This course will review scientific ethics and integrity, plagiarism and how to submit documents to SafeAssign as well as other program specific ethical issues.

0 credits | Fall Semester
Prerequisites: None

This course will prepare and guide Biotechnology students for Internship (BIOT 7950) and inform them of the search process.

1 credit | Fall Semester
Prerequisites: None

Discovery drives the life science industry but how value is determined in the inventor’s laboratory can be different than in the marketplace. The role of marketing allows for the value of a product to be described in terms of the customer. The value of that product is key to projecting sales, obtaining investments, finding partners and launching the product. This course provides an introduction to the strategic and tactical considerations employed by marketing to create customer value. Students will be exposed to basic marketing and sales concepts with examples that draw from participants and situations in the life science industry. The course provides an approach for understanding the marketplace as a basis for developing, pricing, promoting and distributing products and services that satisfy customer needs.

1 credit | Spring Semester
Prerequisites: None

Our Federal Government has an important regulatory role regarding how biotechnology companies maintain their viability, as well as how taxpayer dollars are distributed such that humanity benefits from scientific research in tangible ways. The National Institutes of Health (NIH), for example, is responsible for the distribution of nearly $30 billion in financial support for research, clinical trials and many other health-related activities. Guest speakers from other agencies such as the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), the National Institute of Standards and Technology (NIST), and United States Patent and Trademark Office are also invited to share their perspectives. Our guest speakers will share information regarding career opportunities and tell us how they arrived at their current positions. *US Citizenship or Residency Required

1 credit | Spring Semester
Prerequisites: None

This course is designed to give an overview of strategic leadership in science and technology and prepare individuals to take on these roles. An understanding and appreciation of Strategic Leadership in Science and Technology will position students to make the most of their career opportunities starting at the MS level and in the future. Therefore, this course is aimed at Master-level students who aspire to leadership roles in research. The content is based on the 5R’s model (Dormer) of Scientific and Technology leadership and will include learning concepts of strategic thinking, organizational context, understanding your leadership style, team dynamics, decision-making, conflict management, change management and project and portfolio management.

1 credit | Spring Semester
Prerequisites: None

Provide students with a high-level understanding of selected strategic considerations for Gene and Cell Therapies that are distinct from traditional drug development modalities (antibodies, vaccines, small molecules, etc.)

2 credits | Spring Semester
Prerequisites: Program Director Approval

Selected readings concerning topical subjects in biotechnology.

1 credits | Spring Semester
Prerequisites: None

The Food Biotechnology course provides an introduction to the fascinating field of biotechnology and its role in the food industry. With broad-brush strokes, it covers many facets of the world of foods, which is very diverse yet very personal to all of us. The topics covered relate to food ingredients, fermentations, bioterrorism, FDA regulations, rapid detection techniques of foodborne pathogens, chemical senses, nutrigenomics and nutraceuticals.

This course has NO laboratory component.

2 credits | Spring Semester
Prerequisites: None

This course is designed to provide students with a comprehensive background in the history of pharmacology and therapeutics leading to the current theory and practice of drug design and basic pharmacology, biochemistry, molecular biology and bioinformatics concepts that drive it. An understanding of fundamental biological and biotechnological concepts required to assess current and future approaches to drug discovery along the “critical path” from basic biomedical research to identification of cellular and molecular mechanisms of disease, drug targets, and rational design and high throughput screening of drug candidates will be gained.

1 credit | Fall Semester
Prerequisites: Some background knowledge and/or familiarity with molecular biology and genetics through either formal coursework or tutorials will be helpful in understanding course material.

DNA repair and human therapy will focus on the innovative and rapidly expanding field of gene editing and genome engineering as molecular medicine for human therapeutics. Our focus will be on the historical development of the current tools being advanced toward clinical application and how these tools will be used to treat inherited disease, infectious disease and cancer. Through a series of weekly readings and websites that will augment lecture material, the concepts surrounding this form of gene therapy will be discussed.

1 credit | Fall Semester
Prerequisites: None

This course will introduce students to the foundational concepts of Pharmacology and Toxicology. Topics to be discussed will include classifications and drugs as they relate to organ systems or major pathophysiological effects such substances are likely to engender.

Toxic substances in food, water, and medicine will be discussed as well as in industrial chemical substances that can be encountered in the environment at work, home and at leisure.

This course has NO laboratory component.