Drug Discovery & Development Course Descriptions
16:137:602 Fundamentals of Biological Chemistry in the Biotech Industry (Fall, 3)
The course is intended to provide graduate students with the knowledge, applications and appreciation of biochemical and molecular biology principles to modern biomedical and biotechnology problems. Completion of the course will enable students to pursue careers in diverse areas within the pharmaceutical and biotechnology industries.
16:137:510 Drug Development from Concept to Market (Fall, 3)
This course provides an overview of the pharmaceutical industry, ranging from early drug discovery to bringing new small molecule and biological pharmaceutical products to the market. In addition to learning about key areas of the pharmaceutical industry from experts in the field, students will work in teams to investigate and present on several topics including: the features of a drug label; project management; the biological basis of novel therapeutics; reviewing therapeutic areas; and examining product portfolios for several pharmaceutical companies.
16:137:511 Drug Discovery through Preclinical Development (Spring, 3)
Prerequisites: 16:137:510 (Drug Development: From Concept to Market
This course provides an in-depth study of the pharmaceutical industry from target identification through preclinical development. In addition to lectures led by the instructor and several guest lecturers, students will participate on project teams to evaluate a potential drug target, and then advance the project through lead discovery, lead optimization and preclinical development to the IND stage. Students will participate in a series of group presentations where project teams will discuss how they dealt with real-life problems encountered by drug discovery and development teams and assemble a summary IND document.
16:137:580 Practical Aspects of Clinical Trial Design/Conduct (will include Oracle Clinical) (Fall, 3)
This course is designed to provide extensive training in clinical research and clinical data management. It incorporates end-to-end training for all Clinical research areas with a special focus on clinical data management processes, documentation and clinical data management systems. The course includes extensive practical sessions to provide rigorous hands-on experience on a Clinical Data Management system (CDMS), which is widely used in the pharmaceutical industry today. It also provides hands-on experience in Protocol Development, Case Report Form development, clinical database planning, database design, clinical data entry, clinical data definition, discrepancy management, and writing validation procedures.
16:137:581 Statistics in Clinical and Translational Research (will include SAS lab component) (Spring, 3)
This course provides extensive training in the use of statistical procedures to analyze data from clinical and translational research studies using a standard statistical package. Through writing and executing program in SAS, students will gain an appreciation of the concepts of random variation and bias. The course provides opportunities to gain experience with a wide range of bio-statistical methods, and applying these methods to problems in medicine and public health. In addition, students will learn to recognize pitfalls in interpreting biomedical and public health data.
16:137:582 Fundamentals of Regulatory Affairs (Spring, 3)
An overview of the laws, regulations, and regulatory agencies governing Pharmaceuticals, Devices, Biologics and Combination Products marketed in the US and in the world. The course also discusses the historical context in which the FDA evolved; its structure and its relationship with other US regulatory agencies. The course will provide an overview of market clearance pathways for drugs, biologics, medical devices and combination products so that the development and delivery of safe and effective healthcare products can be expedited. This course will emphasize teamwork, oral communication skills, and written communication skills.
16:137:585 Generic Regulations in US (Fall, 3)
This course on Generics is intended to be a follow on for students who have taken the Fundamental course. As approximately 85% of all prescriptions in the US are filled with a generic product, knowledge of the regulatory space related to Generics will be key for persons contemplating a career in regulatory affairs. The course on generics builds on the lifecycle of the overall drug development process by focusing on what happens to a new drug as the underlying patent expires or is challenged. It covers the barriers, or the lack thereof, of submitting an Abbreviated New Drug Application (ANDA) and the recent changes made by the FDA’s Office of Generic Drugs (OGD) to ensure robust ANDAs.
16:137:615 Concepts in Biotechnology and Genomics (Fall, 3)
This will be the introductory survey course. It will cover a broad range of topics with an emphasis on applications in research and industry, along with a focus on the impact of these technologies on science and society. Mike Lawton will develop this course and be the instructor.
16:137:616 NextGen Biotechnology & Genomics (Spring, 3)
This course will comprise 5-6 modules, each focused on a particular technology (DNA sequencing, proteomics, metabolomics, imaging, synthetic biology (for example -these will change each year)). The course will bring in experts from industry and academia to discuss the scientific foundations of the technology and its applications. Students will work in teams of ~5 on one of the module subjects to develop a project that will be set up by the instructor (e.g. develop a genomics-based approach to identify non-responders to a drug; develop and design scale-up plant for algal-based biofuels). These projects will take into account scientific, economic, market, business and social factors.
16:137:617 Bioinformatics: Tools for Genomic Analysis (Spring, 3)
The course is applications-based, with a focus on solving biological problems using bioinformatic approaches. It is designed to introduce current data analysis in areas such as drug discovery, disease characterization and phylogenetics. Students will learn to use existing bioinformatics analysis packages in a lecture and lab format. The approaches taught in this course are generally applicable to many areas in biology, including the agricultural, natural and environmental sciences.
16:765:585 Bioinformatics (Fall, 3)
This course is designed to introduce biologists to utilizing UNIX, perl and R in bioinformatics. The concepts, principles and tools of bioinformatics will be introduced in the framework of basic shell scripting. Students will learn how to script, install programs and navigate in the UNIX shell. Students will learn how to setup and use command line BLAST. Students will learn basic perl scripting and handling of large datasets. Finally, students will be introduced to the statistical package R, and learn basic functions such as file handling, analysis and graphing.
16:125:509 Medical Device Development (Spring, 3)
Development of medical devices that employ primarily polymeric materials in their construction. Materials selection, feasibility studies, prototype fabrication, functionality testing, prototype final selection, biocompatibility considerations, efficacy testing, sterilization validation, FDA regulatory approaches, writing of IDE, SID(K) and PMAs, device production, and record keeping.
16:137:552 Python Methodologies (Fall, Spring, 3)
Python is becoming one of the most popular programming languages in the world. Used to teach programming at six of the top ten computer science programs in the U.S., Python has a reputation for being a well-supported language that is ideal for education. This support and quick learning curve has also made it popular among scientists. This course acts as an introduction to computer programming with the Python programming language. The basics of imperative programming will be covered as well as selected areas of computer science, object oriented programming and data structures. Computer programming is about problem solving so we will begin to think about how to solve problems in discrete steps like computers do. After the beginning of the course, when we have our sea legs, we will begin to introduce ideas from Data Science and use what we have learned about computer programming and problem solving in this area.
16:710:555 Neurobiology (Fall, 4)
Introductory survey emphasizing experimental approaches to the study of invertebrate and vertebrate nervous systems. Molecular, biophysical, and biochemical bases of nerve cell function. Higher-level functions shown as emerging from nerve cell properties, anatomical development, and mature connections.
16:718:680 Cellular and Molecular Pharmacology: Principles of Drug Action and Targeting (Fall, 3)
Molecular basis of pharmacologic selectivity, drug targets, adaptive responses to drugs, disposition of drugs, and genetic and molecular approaches to drug therapy.
16:125:590 Drug Delivery Fundamentals and Applications (Fall, 3)
This course will discuss the engineering of novel pharmaceutical delivery systems with enhanced efficacy and safety profiles, with an emphasis on the design and application of materials that overcome drug delivery barriers or challenges. Topics will include drug delivery fundamentals and transport mechanisms, materials and formulations for drug delivery, and applications.
16:125:571 Biosignal Processing (Fall, 3)
Application of basic signal analysis to biological signals and the analysis of medical image. Extensive use of the MATLAB language in example and problems.
16:681:530 Molecular Medicine (Fall, 3)
The emerging field of molecular medicine provides deeper understanding of diseases and offers opportunities for designing rational therapies. "Introduction to Molecular Medicine" is designed to introduce students to topics in human health and disease from a molecular biology perspective. Basic principles that promote an understanding of the human genome, gene regulation and expression, and genetic engineering will be applied to the diagnosis and treatment of human disease. Lectures will be followed by discussion of a published article of interest. Format will be two classes per week, with the lecture in one class followed by a discussion on prescribed papers in the next class.
16:720:614 Molecular Cell Pharmacology (Spring, 3)
Cellular response to drugs in different dosage forms and drug delivery systems. Transport through biological barriers of different drug delivery forms, the main cellular signaling pathways triggered by various drugs and drug formulations, types of cell death induced by various types of modern drugs, cellular adaptation to drug exposure, cellular mechanisms of multidrug resistance, interaction between drugs and DNA. Principles of pharmacogenomics and pharmacogenetics.
16:718:600 Cancer Pharmacology (Spring, 3)
Mechanisms of actions of anti-tumor agents, design and discovery of anti-cancer drugs, and discovery of basic signaling mechanisms that constitute the targets of molecules used for cancer therapy. Novel strategies for cancer drug discovery.
22:799:691 Project Management (3)
This course will present the traditional foundations of project management and introduce students to the world of real life project problems. Upon completion of this course, students will understand the basic concepts and critical factors of initiating, planning, organizing, controlling, and running a project. They will be able to develop a project plan and adopt their project management style to the unique project characteristics. The course will prepare them to take the PMP Exam of the Project Management Institute and become Professional Project Managers.