Spring 2025
Introduction to the Business and Science of Biotechnology
Jaclyn Dunphy PhD, Senior Director of Strategy and Research Operations, Abiologics - Nicolas Labovitis ALM, Chief Executive Officer, Ibex Finance, LLC
This course explores the science, practice, and business of biotechnology. The impact and drawbacks in areas of modern biotechnology such as genetic engineering as well as the ethical implications of innovative biotechnology applications are covered. Throughout the semester, students are introduced to biotechnology as an applied science, policy and regulatory aspects of drug development, academic and small business innovation, technical biotechnology applications, opportunities to cross-train with focus on various career possibilities, and building fundraising and organizational resilience for uncertain funding environments. The goal of this course is to prepare students for the four core areas of study for the biotechnology degree.
Prerequisites: BIOS E-1a (offered previously) or BIOS E-1ax and BIOS E-12, or their equivalents.
Fall 2024
Introduction to the Business and Science of Biotechnology
Jaclyn Dunphy PhD, Senior Director of Strategy and Research Operations, Abiologics - Nicolas Labovitis ALM, Chief Executive Officer, Ibex Finance, LLC
This course explores the science, practice, and business of biotechnology. The impact and drawbacks in areas of modern biotechnology such as genetic engineering as well as the ethical implications of innovative biotechnology applications are covered. Throughout the semester, students are introduced to biotechnology as an applied science, policy and regulatory aspects of drug development, academic and small business innovation, technical biotechnology applications, opportunities to cross-train with focus on various career possibilities, and building fundraising and organizational resilience for uncertain funding environments. The goal of this course is to prepare students for the four core areas of study for the biotechnology degree.
Prerequisites: BIOS E-1a (offered previously) or BIOS E-1ax and BIOS E-12, or their equivalents.
Fall 2024
Introductory Bioinformatics
Soohyun Lee PhD, Senior Bioinformatics Scientist, Exact Sciences
This course is designed to cover an introductory level overview of bioinformatics. It covers commonly used bioinformatics tools and algorithms as well as standard formats, with the focus on DNA/RNA sequence and sequencing data analysis. The topics include sequence alignment, motif detection, conservation analysis, Markov models, short-read sequencing data alignment, variant detection and visualization, peak calling, clustering methods, standard formats, random access tools, and performance analysis. Web-based tools and databases are also covered. Pipeline development frameworks and cloud-based approaches are discussed briefly. This course does not include artificial intelligence or machine learning techniques or theoretical analysis of algorithms. Programming is not the focus of the course, but students are welcome to apply their programming skills to the course material.
Prerequisites: Basic knowledge of molecular biology (DNA, RNA, and protein) required. Knowledge in genomics and epigenetics a plus but not required. Statistics and programming skills a plus but not required.
Spring 2025
Bioinformatics: Fundamentals of Sequence Analysis
Michael Agostino PhD
With breakthroughs in biotechnology such as high-throughput and inexpensive DNA sequencing, we are collecting vast amounts of data that will be analyzed for years to come. The details of this data reveal basic information such as gene and protein structures and may lead us to major discoveries like gene-disease associations. This course teaches the bioinformatics skills used in academic, biotech, and pharmaceutical laboratories for analyzing individual DNA and protein sequences. This is not a programming course. Classes consist of lecture and extensive hands-on work using mainstream web-based bioinformatics tools. Students learn how to evaluate data sources and choose the correct paths to solutions. Throughout the semester, interesting biological questions are addressed by analyzing sequences, searching databases, using sophisticated software, and interpreting results. Upon completion of the course, students have extensive skills with sequence analysis tools and are prepared for their own laboratory projects or bioinformatics software creation.
Prerequisites: Fundamental knowledge of molecular biology (DNA, RNA, protein) and genomics required. More advanced knowledge a definite plus. No programming skills required.
Fall 2024
Ethics and Trends in Biotechnology
Timothy Furlan PhD, Burnett Family Distinguished Chair in Ethics, University of St. Thomas, Director, Center for Ethical Leadership, and Senior Editor, Pediatric Ethicscope
Biotechnology offers exciting and promising prospects for healing the sick and relieving suffering. But exactly because of their impressive powers to alter the workings of body and mind, the dual uses of the same technologies also make them attractive to people who are not sick, but who would use them to look younger, perform better, or feel happier. These applications of biotechnology are already presenting us with some unfamiliar and very difficult challenges. In this course, we consider such possible beyond therapy uses and explore both their scientific basis and the ethical and social issues they are likely to raise. We consider how pursuing the goals of better children, superior performance, ageless bodies, or happy souls might be aided or hindered, elevated or degraded, by seeking them through a wide variety of technological means. Among the biotechnological techniques considered are techniques for screening genes and testing embryos, choosing sex of children, modifying the behavior of children, augmenting muscle size and strength, enhancing athletic performance, slowing senescence, blunting painful memories, brightening mood, and altering basic temperaments. Toward the end of the course, we begin to ask what kinds of human beings and what sort of society we might be creating in the coming age of biotechnology.
Prerequisites: BIOS E-1a and BIOS E-1b (offered previously) or BIOS E-1ax and BIOS E-1bx, BIOS E-12, or the equivalents.
Spring 2025
Financial Analysis and Valuation in Biotechnology
Yong Suh MD, Lecturer, Center for Biotechnology Education, Johns Hopkins University
Success in biotechnology requires sound understanding of both science and business. Developing new therapeutic and diagnostic modalities demands vast amounts of funding raised through multiple rounds of financing to support activities such as research and development, manufacturing, and marketing. Thus, it is essential for leaders of biotechnology companies to understand the workings of capital markets, valuation of drug pipelines, and strategic considerations in partnerships and mergers and acquisitions. This introductory course aims to provide an overview of financial concepts that are necessary to understand revenue and expense forecasts, discounted cash flow, and real options, which are core components of biotechnology valuation. Valuation draws upon knowledge gained in other domains such as epidemiology, drug development and regulatory affairs, and manufacturing and quality control, and provides an opportunity for students to consolidate their knowledge base in biotechnology while learning to quantify and value the building blocks of a biotechnology enterprise.
Prerequisites: Students must have completed BIOT E-100. Though not required, it would be helpful for students to have undertaken prior coursework in finance or economics and to be familiar with concepts such as time value of money, revenue, cost, interest rate, compounding, and financial statements. Students should be comfortable using Microsoft Excel to perform arithmetic operations and have a basic understanding of financial modeling.
Spring 2025
Tissue Engineering for Clinical Applications
Sujata K. Bhatia PhD, MD, Professor of Microbiology and Immunology, Drexel University College of Medicine
Tissue engineering is now recognized as a way to lessen the global disease burden: novel methods for pancreatic islet regeneration can address diabetes; autologous cells for heart muscle regeneration can address coronary artery disease; and nerve regeneration technologies can be used to treat stroke. This course describes strategies of tissue engineering and focuses on the diseases tissue engineering can address. Each lecture identifies a specific disease (coronary artery disease, stroke, diabetes) and describes tissue-engineered scaffolds that can alleviate the disease. Students learn the underlying pathology of the disease, understand the latest advances in tissue engineering for treating the disease, and discuss prospective research areas for novel biomaterials to modify the disease process. In addition, students gain an appreciation of clinical trials of tissue-engineered scaffolds, as well as commercialization of tissue engineering. Students may not take both BIOT E-132 and ENSC E-132 for degree or certificate credit.
Prerequisites: Introductory biology and chemistry.
Fall 2024
RNA Biology and Therapeutics
Casey Roehrig PhD, Manager of Instructional Development, Office of the Vice Provost for Advances in Learning, Harvard University
RNA molecules can store and transfer genetic information, as well as regulate cellular processes through enzymatic activity and their interaction with other biomolecules. In the past decade, advances in next-generation sequencing have revealed new classes of RNAs and the multiple layers of information and functions they carry. The newly discovered functions of different classes of RNA molecules and their roles in human development and disease have led to the emergence of RNA therapeutics. This course explores the intersection of modern basic and translational research on RNA biology along with the biotechnology industry's drug development efforts around RNA therapeutics. The course offers a unique opportunity for students, researchers, and biotechnology innovators to expand their knowledge about the growing science of RNA therapeutics and to develop a deep understanding of RNA-focused drug development in the biotech industry. This course opens with an introduction to the RNA world, including evolutionary theories about biomolecules, fundamental concepts related to the structure and functions of RNAs, current classifications of RNA molecules, and modern tools and techniques for studying RNAs. The course then covers current classes of RNA molecules and their roles in normal biology and in disease. This course focuses on a number of classes of RNA therapeutics including drugs that target normal or abnormal RNA transcripts and drugs and vaccines composed of RNAs.
Prerequisites: BIOS E-12.
Spring 2025
Proseminar: Introduction to Graduate Studies in Biotechnology
Elizabeth Wiltrout Leary PhD, Senior Program Manager, Clinical and Translational Science Institute, Tufts Medical Center
In this proseminar, we focus on science writing, data interpretation, and collaborative and independent experimental design. Students who successfully complete the course are those who demonstrate an ability to assess information from the primary scientific literature, a command of oral and written communication skills, and the ability to generate a logical progression of experiments to help validate or nullify their hypothesis. Reading materials include publications on scientific writing, experimental design, and peer-reviewed journal articles. Because skills learned in this course are useful in subsequent courses, it is the first course that prospective Master of Liberal Arts (ALM) candidates should take toward the degree (or the second, if they are completing the expository writing prerequisite). While not designed to be a capstone proposal course, this course does serve as a foundation for eventual work on the capstone. This is the required admission course for the ALM in biotechnology. Students interested in the ALM in biology should enroll in BIOS E-200.
Prerequisites: Students without a background in life sciences should successfully complete BIOS E-1a (offered previously) or BIOS E-1ax, and BIOS E-12 or their equivalents before attempting to take BIOT E-200. EXPO E-42c is strongly recommended. Students must earn a satisfactory score on the mandatory test of critical reading and writing skills or a B or higher grade in the alternate expository writing course.
Fall 2024
Proseminar: Introduction to Graduate Studies in Biotechnology
Margaret A. Lynch PhD, Director of Undergraduate-Faculty Research Partnerships, Brandeis University
In this proseminar, we focus on science writing, data interpretation, and collaborative and independent experimental design. Students who successfully complete the course are those who demonstrate an ability to assess information from the primary scientific literature, a command of oral and written communication skills, and the ability to generate a logical progression of experiments to help validate or nullify their hypothesis. Reading materials include publications on scientific writing, experimental design, and peer-reviewed journal articles. Because skills learned in this course are useful in subsequent courses, it is the first course that prospective Master of Liberal Arts (ALM) candidates should take toward the degree (or the second, if they are completing the expository writing prerequisite). While not designed to be a capstone proposal course, this course does serve as a foundation for eventual work on the capstone. This is the required admission course for the ALM in biotechnology. Students interested in the ALM in biology should enroll in BIOS E-200.
Prerequisites: Students without a background in life sciences should successfully complete BIOS E-1a (offered previously) or BIOS E-1ax, and BIOS E-12 or their equivalents before attempting to take BIOT E-200. EXPO E-42c is strongly recommended. Students must earn a satisfactory score on the mandatory test of critical reading and writing skills or a B or higher grade in the alternate expository writing course.
Fall 2024
Commercial Functions in Biotechnology and Pharmaceutical Companies
Alex Pederson JD, Director of Regional Marketing, BeiGene
Innovative science and revolutionary therapeutics are the foundation of a successful biotechnology or pharmaceutical company, but once the registrational trials are complete, the commercial function must support any therapy for it to reach the right patients. This course explores marketing, market analytics, and sales for a biotechnology or pharmaceutical company and shares insight into how companies succeed once research and development and the core clinical trials are done. This course pulls back the curtain for students who are currently or are interested in working in one of those commercial functions; for students who work in partner functions who need an understanding of commercial functions to operate at their best (for example, medical affairs and clinical development); and other industry players who use commercial assumptions or insight regularly (for example, venture capital, private equity, or public investors and early-stage entrepreneurs). Topics covered for marketing include strategy, promotions, and key customer/key opinion leader (KOL) engagement. For marketing analytics, we examine market planning, long- and short-term forecasting, competitive intelligence, and marketing science. We explore sales overview and purpose, sales interaction with internal partners, and sales structure, direction, and incentives.
Spring 2025
Vaccinology: From Outbreak to Rollout
Catherine Jacob-Dolan PhD, Postdoctoral Research Fellow in the Departments of Basic Science and Vaccine and Infectious Disease, Fred Hutch Cancer Research Center
This course explores the process of creating a vaccine, from the initial identification of a pathogen through the design and testing process, and up through FDA approval. Through lectures, discussions, and critical reading of historical and modern sources, students learn the fundamentals of vaccine design, vaccine responses, preclinical testing of vaccines, clinical trials for vaccines, and the rollout of vaccines. This course also teaches students to assess the logistical and societal challenges facing vaccines at every step of the process, as well as teaching many of the new technologies that have revolutionized the world of vaccines in the past decades and years.
Spring 2025
Regulatory Aspects of Drug Development
Jonathon Parker PhD, Vice President, Head of Regulatory Neurology, Ultragenyx
The course provides an overview of the prescription drug development process and regulatory considerations for this process, including small molecules, biologics, and gene therapy. It focuses on the phases of pharmaceutical development, aspects influencing the pharmaceutical industry, and the regulatory themes and healthcare concepts that shape the decisions having an impact on the entire process.
Fall 2024
Biomedical Product Development
Sujata K. Bhatia PhD, MD, Professor of Microbiology and Immunology, Drexel University College of Medicine
This course examines the design and development of new therapeutic products. Students learn through case-based studies of product development for pharmaceuticals, biologics, medical devices, and combination therapies. The course describes the steps of biomedical product development, from conceptualization, to design, to manufacturing, to regulatory approval and commercialization. The course discusses both technical and business factors that contribute to the success or failure of new biomedical products. Appropriate design of preclinical and clinical trials is also included. Students gain an appreciation for emerging technologies in stem cells, gene therapy, tissue regeneration, personalized medicine, and targeted therapies. Additionally, students learn about the special challenges presented by emerging biomedical technologies. By the end of the course, each student completes a project to propose a new biomedical device and identify the regulatory strategy, technical milestones, and business milestones for the new device.
Prerequisites: Background in introductory biology and chemistry.
Spring 2025
Immunoassay Design and Development
Masha Fridkis-Hareli PhD, President, ATR, LLC
This introductory course explores assays commonly used in drug discovery and development. Immunoassays are key in characterization of drug candidates for efficacy and safety prior to market authorization. The overall goal of the course is to provide students with knowledge of different types of immunoassays including enzyme-linked immunosorbent assays (ELISA), flow cytometry, and cell-based assays. Topics include design and optimization process, reagent selection, assay validation, and implementation for various applications in drug profiling.
January 2025
Case Studies in Biotechnology
Casey Roehrig PhD, Manager of Instructional Development, Office of the Vice Provost for Advances in Learning, Harvard University - Beth Zielinski-Habershaw PhD, Professional Training Coordinator, MassBioEd Foundation
This discussion-based course explores the intersection of biology and business through real-world and hypothetical case studies in biotechnology. Students analyze cases that focus on scientific advances with implications across a range of industries including health care, agriculture, and environmental sustainability, as well as business cases that address the challenge of creating and capturing value through biotechnology. By engaging in discussions with their peers in real time, students develop critical thinking and problem-solving skills and consider the complex interplay of ethics, regulation, technology, and markets. By combining discussion of scientific principles and business strategy, this course equips students to navigate the complexities of the biotechnology landscape and prepares them for future challenges in the field.
Prerequisites: Students should have completed or be currently enrolled in BIOS E-1a (offered previously) or BIOS E-1ax.
January 2025
The Genetown-Harvard Experience
Nicolas Labovitis ALM, Chief Executive Officer, Ibex Finance, LLC - Steven Denkin PhD, Director and Research Advisor, Biotechnology, Harvard Extension School
Come to Harvard University for a one-week experience where students engage with industry leaders during visits to local incubators, accelerators, and companies, as well as academic research departments and institutions. The course focuses on the following questions: how did Kendall Square in Cambridge, MA, evolve from a salt marsh to become the epicenter of the biotechnology world? Why is Genetown a thriving hotbed for innovation and drug development? And where is the next Kendall Square?
Prerequisites: Students must have earned a B or higher grade in BIOT E-100 and BIOT E-200 in order to enroll in this course.
Fall 2024
Precapstone: Business Ideas and Entrepreneurial Innovation
Steven Denkin PhD, Director and Research Advisor, Biotechnology, Harvard Extension School - Nicolas Labovitis ALM, Chief Executive Officer, Ibex Finance, LLC
This precapstone course prepares students to write and present their business plan in the capstone. It is mandatory for candidates in the Master of Liberal Arts, biotechnology, who wish to register for BIOT E-599 in the spring. Through idea discovery, market research, and prototype development, students identify an innovative biotechnology product or application. In addition to idea generation and development, students receive guidance and advising to work effectively in teams to develop and propose a viable idea and outline a business plan. During the semester, students meet with industry experts to discuss best practices.
Prerequisites: Registration is limited to officially admitted candidates in Master of Liberal Arts, biotechnology, who are in their penultimate semester. Prospective candidates and students with pending admission applications are not eligible. Candidates must be in good academic standing and in the process of successfully completing all degree requirements except the capstone, BIOT E-599, which they must enroll in the upcoming spring term as their one and only final course (no other course registration is allowed simultaneously with the capstone). Candidates who do not meet these degree requirements are dropped from the course.
Spring 2025
Capstone: Business Ideas and Entrepreneurial Innovation
Steven Denkin PhD, Director and Research Advisor, Biotechnology, Harvard Extension School - Beth Zielinski-Habershaw PhD, Professional Training Coordinator, MassBioEd Foundation
This capstone course provides an opportunity for biotechnology professionals to create a business plan for a new biotechnology company, a ground-breaking drug, or an emerging technology such as a diagnostic or medical device. The biotech business plan includes background research on the idea and investigation of the following: market opportunity, market strategy, funding, intellectual property, patents, and management. In addition to the business plan report, each student writes their own executive summary. During the semester, students meet with industry experts to discuss best practices.
Prerequisites: Registration is limited to officially admitted candidates in the Master of Liberal Arts, biotechnology, capstone track. Candidates must be in good academic standing, ready to graduate in May with only the capstone left to complete (no other course registration is allowed simultaneously with the capstone). Prospective candidates and students with pending admission applications are not eligible. Candidates must have earned a B-minus or higher grade in BIOT E-597 in the prior fall term. Candidates who do not meet these requirements are dropped from the course.