The primary objective of this Track is to introduce life scientists to entrepreneurship and core business functions. Our Biotech Program has a long-standing track record for life science entrepreneurship. The founding Program Director is an academic entrepreneur who is the founder of Life Technologies, now a part of ThermoFisher and four additional biotechnology companies. Two of the companies became publicly traded companies. Likewise the teaching faculty has achieved remarkable private sector success.

As with all the offered biotechnology tracks, a four-year undergraduate degree is required. Students with full-time work experience, an M.S. or PhD. degree will be seriously considered. Well-established, vetted and successful strategies will be employed as the basis of the proposed program. Students in this track will undertake a yearlong internship in private life science sector companies. Topics covered will include establishing a biotechnology company, raising angel and venture capital funding, protecting scientific inventions with intellectual property, managing product development, skills required to recruit and manage various functions of a start up company. Students must have a minimum of one year full time work experience in the life sciences and an above 3.0 undergraduate GPA. Necessary verbal and written language skills required to be considered for this Track.

This 30-credit track is divided into 5 components: business core, science core, regulatory science core, capstone, and elective courses. Elective courses are divided into BioBusiness and BioScience courses.

Degree Requirements:

Business Core

15 Credits

BIOT-509: Introduction to the Biotechnology Industry

Credits: 3; Semester: Fall; 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.

BIOT-510: Entrepreneurial Biotechnology

Credits: 3; Semester: Spring; Prerequisites: BIOT-509, BIOT-520 & BIOT-523.

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.

BIOT-520: Financial Matrix for Biotechnology

Credits: 1; Semester: Fall; Prerequisites: BIOT-509 & BIOT 523 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.

BIOT-523: Intellectual Property

Credits: 2; Semester: Fall; 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.

BIOT-550 Management Strategies for Biotech Companies

Credits: 1; Semester: Spring; Prerequisites: BIOT-509, BIOT 520 &  BIOT 523 

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.

BIOT-551 Commercialization for the Biotechnology Industry

Credits: 1; Semester: Spring; Prerequisites: BIOT-509, BIOT 520 &  BIOT 523. BIOT-510 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.

BIOT-566 Drug Development to Post Approval

Credits: 1; Semester: Spring; Prerequisites: BIOT-509, BIOT-520, & BIOT-523. BIOT-510-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.

BIOT-602: Strategies for Startups

Credits: 1; Semester: Fall; Prerequisites: Instructor permission required

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.

BIOT-651 Advanced Strategies for Commercialization

Credits: 1; Semester: Spring; Prerequisites: none.

TBA

BIOT-801: Portfolio & Project Management

Credits: 1; Semester: Spring; 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.

Science Core

7 Credits

BCHB-713: Principles of Biochemistry

BCHB-713: Principles of Biochemistry

Credits: 3; Semester: Fall; Prerequisites: None

TBA

BCHB-514, 515: Introduction to Bioinformatics

Credits: 1; Semester: Fall or Spring; 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.

BIOT-516 Molecular Medicine

Credits: 2; Semester: Spring; 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.

BIOT-559 New Frontiers in Biotechnology

Credits: 1; Semester: Fall; 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.

Regulatory Science Core

2 Credit

BIOT-543 Current Good Manufacturing Practices for Biotechnology

Credits: 1; Semester: Spring

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.

BIOT-643 FDA Case Studies

Credits: 1; Semester: Spring; Prerequisites: BIOT-509 BIOT 543

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.

Capstone

4 Credits

BIOT-502: Biotechnology Capstone Internship

Credits: 4; Semester: Fall, Spring or Summer

This is the capstone course in which students will be working to pursue defined objectives in companies in the biotechnology industry and agencies and institutions in the Washington, DC Metropolitan area. Internships can be in basic research, business functions, industrial and biomedical sciences or intellectual property.

Required Non-credit Courses

1 Courses

BCHB-554 Research Ethics & Integrity

Credits: 0; Semester: Fall or Spring; 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.

Electives

2 Credit Minimum

BioBusiness

BIOT-552 Marketing Applications in Biotechnology

Credits: 1; Semester: Fall; 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.

BIOT-555: Government Science & Technology Management

Credits: 1; Semester: Spring; 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

BIOT-557: Strategic Leadership in Science & Tech

Credits: 1; Semester: Spring; Prerequisites: None

TBA

BIOT-568 Principles of Business Development 

Credits: 1; Semester: Spring; Prerequisites: None

This one credit course is specifically designed for Biotechnology M.S. degree students. This course is designed to be taken with BIOT-502 Biotechnology Internship. Students will be prepared to pursue internships in various aspects of business development. Permission of instructor required.

BIOT-570 Structuring a Drug License Deal

Credits: 1; Semester: Spring; Prerequisites: None

TBA

BioScience

BCHB-507, 508: Laboratory Applications of Biotechnology

Credits: 3; Semester: Fall, Spring; Prerequisites: None

This is a comprehensive hands-on, laboratory-based course that introduces students to core techniques such as electrophoretic analysis of nucleic acids and proteins, polymerase chain reaction (PCR), Southern and Western blotting, ELISA, protein purification, tissue culture, DNA cloning, cell culture and Bioinformatics.

BCHB-522: Drug Targets/Drug Design

Credits: 2; Semester: Spring; 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.

BCHB-531: DNA Damage, Repair & Human Therapy

Credits: 1; Semester: Fall; Prerequisites: None

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.

BCHB-507, 508: Laboratory Applications of Biotechnology

Credits: 3; Semester: Fall, Spring; Prerequisites: None

This is a comprehensive hands-on, laboratory-based course that introduces students to core techniques such as electrophoretic analysis of nucleic acids and proteins, polymerase chain reaction (PCR), Southern and Western blotting, ELISA, protein purification, tissue culture, DNA cloning, cell culture and Bioinformatics.