Biotechnology   

Business Principles of the Biotechnology Industry: is a comprehensive study of the commercial practices used to deliver life science based products to the market. Having emerged less than 40 years ago, the modern biotechnology industry has developed into a dynamic and very diverse commercial segment spanning healthcare, agriculture and industrial applications. In many respects, it is unique compared to other industries. Commercial development timelines are considerable longer than other technology areas, manufacturing involves the use of highly complex processes, many of which are not well characterized or controlled, and products are subjected to demanding regulatory scrutiny. This course aims to introduce the student to the industry as an engine of innovation. The course uses a comprehensive text supplemented with primary literature and case studies. Subjects covered include the history of the industry, the current emerging technologies and the business techniques used to bring bioscience ideas to commercial fruition. Topic areas are: Company creation, technology assessment and commercialization, product development, manufacturing, market assessment and development, and financing. BTEC 675 is a required course of the M.P.S.: Biotechnology degree and is the first course taken by degree seeking students.

This course is not limited to UMBC students and is open to the general public. This course is offered in our Live Online Synchronous format. All lectures will be recorded to accommodate international students and professionals with challenging schedules.

REGISTRATION FOR THIS CLASS IS CLOSED. This class is already in session.

This seminar-style, capstone course is an in-depth exploration of emerging technologies, innovations, and
new products that are noteworthy to the biotechnology industry. Each student will select an emerging technology within the biotechnology sector and prepare a research plan designed to bring that technology to commercial fruition. The students will give oral presentations on the technology that builds the case for the envisioned product. In addition, each student will prepare an SBIR grant application composed of the technical and commercialization plans for their invention. Students will also be expected to read the scientific literature in preparation for each of their classmates’ presentations with the goal of being sufficiently knowledgeable to participate in a scientific discussion. The objective of the course is to give the student insight into the process of translating scientific discovery into innovative products.

Prerequisite: BTEC 653

This course builds on general interest in the cutting-edge realms of pharma, specifically cell and gene therapies. Students will explore the new age of digital medicines, personalized medicines, single treatment (one and done) therapies and the requirements put upon the innovators and manufacturers of these products.

Course topics include:

• Recognize the development of the industry and the potential of advanced therapies specifically cell and gene therapies.
• Understand the regulatory landscape for the approval of cell and gene therapies
• Comprehend the differences in the types of therapies and how they are administered
• Keep up with the current thousand plus companies that are in pursuit of cell and gene therapies
• Understand the ethical and societal implications of technologies and methods deployed int cell and gene therapies

Students taking the course on a non-credit basis are not required to submit the various course assignments, although they are encouraged to do so. Non-credit students must attend 85% of the classes (13 sessions) in order to receive the continuing education certificate.

This course is listed as BTEC 691 SPECIAL TOPICS IN BIOTECHNOLOGY in the UMBC Course Catalog.

This course is not limited to UMBC students and is open to the general public. This course is offered in our Live Online Synchronous format. All lectures will be recorded to accommodate international students and professionals with challenging schedules.

CLINICAL TRIALS: This course is an introduction to clinical trials. Students will learn the ethical and scientific principles behind clinical trials, the elements of clinical trials as they relate to various phases of drug development, criteria for regulatory approval, how to implement and monitor the trial in different settings, how to analyze and report the trial results, and how to budget and manage the trial resources. The course includes an introduction to statistics necessary for critical analysis of clinical trial design, and critical interpretation of the safety and efficacy results. Students will also learn about common challenges and pitfalls in clinical trial design and conduct, and how to avoid them.

This course is open to the general public-not limited to UMBC students. The course is offered as an In-Person format. All lectures will be recorded to accommodate international students and professionals with challenging schedules.

DEVELOPMENT AND REGULATION OF BIOPHARMACEUTICALS: Students will learn about topics such as Quality by Design, Good Lab Practice, Molecule Design by QbD, Vaccine Potency Testing, Design of Clinical Trials, Vaccine Regulation and Preclinical Studies, cGMP Manufacturing and Compliance, and COVID-19 Disease and Biopharmaceutical Approaches.

Upon completion of this course students will be able to demonstrate:

• An in-depth understanding of the history and current organization of the Food and Drug Administration (FDA), the development of the regulatory process, the history of key regulations and how to obtain FDA clearance to initiate clinical trials on new biotechnology products.
• An understanding of the process of biotechnology product development, including clinical stages and design of clinical trials and the various regulatory submissions.
• An understanding of the submission requirements supporting clinical trials. Guest speakers include staff from AstraZeneca, FDA, and Glaxo SmithKline.

REGISTRATION FOR THIS CLASS IS CLOSED. This class is already in session.

This course introduces the basic concepts which underlie the design of experiments. The use of statistical methods to discriminate between real effects (those caused by changes in controlled variables) and experimental error in systems which are inherently noisy are taught. Statistically designed experimental programs which can help test many variables simultaneously are very efficient tools for developing empirical mathematical models which accurately describe physical and chemical processes. These techniques are readily applied to production plant, pilot plant and laboratory systems, and should be a part of every practicing life science professional's repertoire. At the end of this course, the student will be able to select an appropriate experimental design for the problem at hand, to set up, conduct and analyze the results of statistically designed experiments, and to understand the statistical basis for these techniques.

REGISTRATION FOR THIS CLASS IS CLOSED. This class is already in session.

REGISTRATION FOR THIS CLASS IS CLOSED. This class is already in session.

BTEC 670: This course offers an overview of legal issues affecting biotechnology and other science-based industries and frames basic philosophical and ethical considerations regarding genetic data and manipulation. The course includes a discussion of intellectual property issues.

This course is open to the general public-not limited to UMBC students.

Management, Leadership and Communication: In this course, students learn effective management and communication skills through case study-analysis, reading, class discussion and role-playing. The course covers topics such as effective listening, setting expectations, delegation, coaching, performance, evaluations, conflict management, negotiation with senior management and managing with integrity. This course is not limited to UMBC students and is open to the general public.

BTEC 685: In this course, students learn the fundamentals of managing projects in a systematic way. These fundamentals can be applied within any industry and work environment and will serve as the foundation for more specialized project management study. Principles and techniques are further reinforced through practical case studies and team projects in which students simulate project management processes and techniques.

This course is not limited to UMBC students and is open to the general public.

BTEC 664: In-depth coverage of the key issues associated with adequate quality-control systems, assays and stability for novel biotechnology products: quality concepts, product release testing and specifications, in-process testing, product characterization, quality assurance documentation and audits and vendor certification.

This course is not limited to UMBC students and is open to the general public.