Curriculum | Tgpathms

Overview of TGP Curriculum

Description of TGP Core Courses and Electives

BCMP 230 Principles and Practice of Drug Development: Critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Foundations of Pharmacology. Drug regulation, Drug development cases, the structure of biopharma, Financing Drug invention, Incentives for Drug development, Manufacturing and the value chain, and The future of personalized medicine topics are discussed.

Chem 110 The Chemistry and Biology of Therapeutics: This course will cover the chemical and biological principles that govern small molecule therapeutics. We will discuss small molecule conformational analysis, chemical forces that drive small molecule-protein interactions, and small molecule binding to proteins to affect disease states. We will also discuss how protein targets are identified and the frontiers of modern small molecule therapeutics. Protein targets include, but are not limited to kinases, proteases, GTPases, scaffolding proteins, epigenetic modifiers, metabolic enzymes and transcription factors. This course will teach students how to use modern computer modeling applications to perform structure-based design of small molecule ligands.

CB 309qc The Basics of Translation: This year, our biotech/drug development course will focus on how a novel therapeutic modality has grown from a scientific curiosity to a promising and indeed proven therapeutic approach. Antisense nucleotides (ASOs) define along with small molecule drugs and biologicals (antibodies) a new therapeutic modality. The efficacy of this modality, the cell biology and chemistry of ASOs as new drug, will be discussed in the context of an ASO that has been shown to be efficacious in addressing two devastating diseases: Spinal Muscular Dystrophy (SMA) and Amyotrophic Lateral Sclerosis (ALS). We will also address the critical issue of clinical trials, including their design, the criteria of success and, using as a paradigm an antibody that in spite of early promise has yet to fulfill the criteria necessary to address Alzheimer’s , a disease that unlike SMA where patient numbers are relatively small, it affects hundreds of thousands if not millions of patients worldwide.

SCRB 197: Frontiers in Therapeutics: How realistic are promises to “eliminate” diseases and to “personalize” medicine? This course looks at biological principles underlying therapeutics, ranging from those described first in Egyptian papyri to those under development today (using chemicals, proteins, cells, and genetic manipulations) and based on traditional philosophies and on science.

MIT class 20.201 Fundamentals of Drug Development: Team-based exploration of the scientific basis for developing new drugs. First portion of term covers fundamentals of target identification, drug discovery, pharmacokinetics, pharmacodynamics, regulatory policy, and intellectual property. Industry experts and academic entrepreneurs then present case studies of specific drugs, drug classes, and therapeutic targets. In a term-long project, student teams develop novel therapeutics to solve major unmet medical needs, with a trajectory to a "start-up" company. Culminates with team presentations to a panel of industry and scientific leaders.

HSPH BST 217 Statistical and Quantitative methods for Pharmaceutical Regulatory Science: The goal of this course is to enable scientists and public health professionals who already have an introductory background in biostatistics and clinical trials to acquire the competencies in quantitative skills and systems thinking required to understand and participate in drug development and regulatory review processes. The course illustrates how statistical and quantitative methods are used to transform information into evidence demonstrating the safety, efficacy and effectiveness of drugs and devices over the course the product's life cycle from a regulatory perspective. Content is delivered using a blended-learning approach involving lectures, web-based media and selected case study examples derived from actual FDA decision-making and regulatory assessments to highlight and describe each phase of the regulatory drug approval process. Case studies will illustrate regulatory science in action and practice and will include content publicly available from the FDA's website that can be used in conjunction with FDA science-based guidance and decision precedents.

HMS AISC624.0 Medications and Evidence Prescription: drugs are the most commonly used and effective interventions in all of medicine, but their use can also raise important questions about adverse effects and affordability. This course will integrate clinical, epidemiological, and policy perspectives exposing students to cutting-edge developments on how evidence on medications is generated and used in health care.

IMMUN 315QC Therapeutic Human Antibody Engineering: This quarter course will focus on all aspects of therapeutic antibody (Ab) engineering from bench to bedside with an emphasis on translational research. Short lectures will introduce the topics of the day, reviews and seminal papers will be provided. Ab discovery will include readings on in vitro microbial discovery platforms such as Ab-phagemid and Ab yeast display as well as single B cell cloning strategies. Current state of the art of human Ig locus transgenic mice will be discussed. Engineering strategies will include chimeric, humanized and human Abs, and different formats including single chain Abs (scFvs), domain Abs, BITES and Bi-specific Abs. Human Fc engineering to increase or decrease immune-mediated clearance will be discussed including glycan engineering. Manipulating engineered Ab in vivo clearance through size and FcRn interactions will be discussed. We will also discuss nanobodies, antibody drug conjugates and immunotoxins and chimeric antigen receptors. Classes will start with short didactic lectures followed by discussion of 2-3 published papers.

NEUROBIO 319QC. Neurobiology of Psychiatric Disease: From Bench to Bedside: To provide clinical insight and critical analysis of basic and translational science approaches necessary for students to approach psychiatric disorders as scientific problems, and thus contribute future research work with clinical relevance. Each pair of lectures presents 1) basic neuroscience approaches to the neural circuitry, cell and molecular biology underlying disease, followed by 2) clinical neuroscience, genetics, neuroimaging, etc., including case studies of the disorders. The lectures will focus on a range of psychiatric disorders, neural systems underlying behavior, and translational approaches to novel interventions, while providing insight on disease characteristics, current, novel and translationally informed treatments, gene vs. environmental risk factors, animal models, and gaps in knowledge across the field. There will also be laboratory-based sessions (organized visits to McLean Hospital) to demonstrate examples of basic and human laboratory approaches to the study and treatment of psychiatric illness.

SCRB 167 Stem Cell Therapeutics: Exploring the Science and the Patient Experience. Stem cells are the basis for tissue maintenance and repair, thus, are essential elements of normal organ and tissue physiology. Stem cells are also targets for disease processes and through transplantation are important therapeutic agents. This course will allow advanced undergraduates to explore how stem cells and tissue regeneration impact human disease pathogenesis and how stem cells might be exploited to advance new therapies for disease.

GENETIC 228 Genetics in Medicine: From Bench to Bedside: Focus on translational medicine: the application of basic genetic discoveries to human disease. Each three-hour class will focus on a specific genetic disorder and the approaches currently used to speed the transfer of knowledge from the laboratory to the clinic. Each class will include a clinical discussion, a patient presentation if appropriate, followed by lectures, a detailed discussion of recent laboratory findings and a student led journal club. Lecturers will

MIT 20 .365 and 20.465: Engineering the Immune System in Cancer and Beyond: Examines strategies in clinical and preclinical development for manipulating the immune system to treat and protect against disease. Begins with brief review of immune system. Discusses interaction of tumors with the immune system, followed by approaches by which the immune system can be modulated to attack cancer. Also covers strategies based in biotechnology, chemistry, materials science, and molecular biology to induce immune responses to treat infection, transplantation, and autoimmunity. Students taking graduate version complete additional assignments.

GENED 1058 Tech Ethics: AI, Biotech, and the Future of Human Nature: The course explores the moral, social, and political implications of new technologies. Will biotechnology and AI enable us to hack humanity? Should we edit the genes of our children, extend the human lifespan, and genetically enhance our athletic ability and IQ? Can algorithms be fair? Will robots make work obsolete? Can smart machines outthink us? In an age of big data and social media, is privacy over? Is democracy? The course will ask how science and technology are transforming the way we work, learn, make friends, raise children, care for our health, conduct our politics, and understand what it means to be human.

HBS 1745 Entrepreneurial Failure: Most startups fail: about three-quarters of venture capital investments do not earn a positive return. Entrepreneurial Failure (EF) explores why startups fail; what entrepreneurs can do to avoid failure; and if they do fail, what founders can do to “fail well” - in ways that leave their relationships and integrity intact, facilitate learning from the experience, and position them for their next career move. The course may be of interest to students who plan to found or join a startup, and those who’ll invest in new ventures. Course content will overlap to some extent with topics covered in Founders’ Journey, Launching Technology Ventures, and Scaling Technology Ventures.

HBS 1755 Launching Technology Ventures: Launching Technology Ventures (LTV) is designed for students who will join startups, start their own companies, or work in larger technology firms. The industry focus is on technology-based ventures in the Internet, mobile, and enterprise software sectors. Business models covered range from subscription to SAAS to freemium to developer-driven. The course takes the perspective of founders in technology startups across all functional elements, with a particular focus on product, sales, marketing, growth and business development. For each function, we explore challenges that managers encounter before a startup achieves product-market fit, that is, a match between its product solution and market needs.

HBS 1540 Law, Management and Entrepreneurship: This course is designed to develop the legal literacy of MBA students by honing legal instincts that will help business leaders avoid legal pitfalls, attain a competitive edge and promote long-term success. Expanding well beyond the basic legal concepts introduced in LCA, the course will refine students’ understanding of how law affects all aspects of business, and develop a deeper appreciation of how legal systems operate and how to operate within the boundaries of legal systems. In response to increased student interest in private equity, a module of the course focuses on contracts and understanding legal documentation relating to private equity transactions.

HBS 1795 Managing Technology Ventures: Managing Technology Ventures (MTV) is designed for students who plan to join scaled digital technology ventures, who seek exposure to challenges of managing technology ventures at scale, or who plan to evaluate scaled technology ventures through a principal investing lens, with a particular emphasis on ventures in the consumer Internet and mobile sectors.

SysBio 204 Synthetic Biology: From Ideation to Commercialization: This course provides an introduction to synthetic biology, with an emphasis on medical applications. Topics will include (1) design principles of cells, organisms, and complex proteins, industry case studies, and analysis of the synthetic-biological literature; and (2) commercialization of biotechnology and synthetic biology, including conceptualization of commercializable research, financing mechanisms, intellectual property strategies, licensing, publicity, virtual companies, and the progression through pre-clinical and clinical research and development. Specific topics include design of bacterial and mammalian genetic circuits, CAR-T cells, whole genome recoding, artificial protein design, and gene therapy.

MIT Class Number: 23771, 23772, 23773 Science and Business of Biotechnology: Covers the new types of drugs and other therapeutics in current practice and under development, the financing and business structures of early-stage biotechnology companies, and the evaluation of their risk/reward profiles. Includes a series of live case studies with industry leaders of both established and emerging biotechnology companies as guest speakers, focusing on the underlying science and engineering as well as core financing and business issues. Students must possess a basic background in cellular and molecular biology.

HBS 6107 Lab to Market (formerly Commercializing Science): Harvard University has a significant footprint in conducting foundational and applied research in science and technology. Thousands of investigators, across the various universities and hospitals in greater Boston, secure billions of dollars in federal, state, non-profit and private funding to advance the frontiers of knowledge. The research efforts at these labs also yield nascent and promising concepts and projects that can be brought to market to solve important, unmet needs across the spectrum of individual consumers and companies. The Lab to Market field course is designed to outline the path from embryonic discoveries made in R&D labs to their development for commercial use and onwards to market launch. The course is designed for students who either want to start businesses that have science and technology intellectual property at their core or anticipate leading market launch teams in incumbent organizations. The course covers such issues as creating value from science and technology innovations, business model design, value capture strategies, portfolio strategy, regulation, financing, intellectual property and organizational models of science- and technology-based ventures.

HBS 6219 Field Course Transforming Health Care Delivery: At the root of the transformation occurring in the health care industry-both in the United States and internationally-is the fundamental challenge of improving clinical outcomes while controlling costs. Addressing this challenge will require dramatic improvements in the processes by which care is delivered to patients. This will, in turn, involve changing the organization of delivery, developing new approaches to performance measurement, and reimagining the ways in which providers are paid. This course will equip students with the tools required to design and implement these improvements.

HBS 2108 Innovating in Health Care: Students are required to prepare a business plan, which employs the framework of this course, to explore an entrepreneurial opportunity in health care, and to evaluate their classmates' plans. Innovating in Health Care (IHC) helps students to create successful entrepreneurial health care ventures by enabling them to: Identify the alignment between an entrepreneurial health care venture and the Six Forces that shape health care - structure, financing, technology, consumers, accountability, and public policy; Create a business model that responds appropriately to any misalignments. Innovating in Health Care embraces every part of the health care sector, including insurance, services, IT, medical devices, biotechnology, diagnostics, and pharmaceuticals. The course has a global focus with case studies set in Brazil, India, Spain, the U.K., and the U.S., among other countries.

BCMP 301 qc Translational Pharmacology: The Science of Therapeutic development: Modern Drug Discovery: JANUARY TERM bootcamp format. This intensive course, held during the first two weeks of January (nine days), covers principles of pharmacology and their translation into new drug development. Students participate in project groups composed of graduate students, medical students, and post-graduate M.D. fellows to propose a drug development strategy from target choice through clinical trials. Most mornings include two hours of lectures and/or panel discussions; most afternoons include (i) case studies presented by Harvard faculty and faculty from the pharmaceutical and biotechnology industries and/or (ii) time to work on the group project. Evaluation is based on written and oral presentations of the group project and on class participation. Enrollment may be limited.

BCMP 236 Modern Drug Discovery: From Principles to Patients: This course will familiarize students with central concepts in drug action and therapeutics: specifically we will cover concepts surrounding Pharmacokinetics (PK) and the intersection of PK and medicinal chemistry in both lectures and case based discussions. These concepts are central to modern drug development and evaluation. In the course we will cover drug-target interactions, Pharmacokinetics and Pharmacodynamics. This course will have a focus on modern approaches to therapeutic development for small molecules, protein based therapeutics, nucleic acid based drugs and antibacterial compounds as well new frontiers in therapeutic discovery.

Cell Bio 302 qc Experimental Design for Biologist: TThis course will focus on both the theory and practice of experimental design. The emphasis is on project planning and vetting, individual experimental design, and trouble-shooting. Special focus will be placed on methods to avoid experimental bias, and potential sources of inappropriate interpretation. Also the importance of system validation is especially emphasized. Instructed by David Glass (Novartis, HMS) and Randy King (Harvard Medical School