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Course Description
In this course, we focus exclusively on the dominant role of biologic therapies in modern medicine. In 2020, six of the top 10 drugs by revenue were molecules of biologic origin, namely those manufactured primarily by biosynthetic rather than chemical means, with sales of the top selling therapy, the anti-TNFα monoclonal antibody adalimumab, falling just shy of the US$20 billion mark. The lucrative preeminence of biologics is set to continue, bolstered by the introduction of innovative molecular delivery strategies, such as antibody-targeted conjugates, fragments and fusions, as well as by the robust staying power of market leaders. The latter phenomenon is an inevitable consequence of the higher-than-usual regulatory hurdles faced by conventional generic manufacturers seeking to make biosimilars: intended copies of off-patent biologics that, having undergone a strict comparability exercise, are approved by regulatory agencies such as the EMA and the FDA.

This course will survey this changing landscape within an historical framework and will highlight critical scientific and process parameters unique to biologics, that set them apart from conventional small-molecule medicines, including their molecular architecture and mechanisms of action, manufacturing considerations, analytical and functional lot release assays and clinical trial design. We will explore some of the pitfalls by examining a roster of clinical case studies. The capacity of payers to afford these increasingly high-cost therapies in the face of current economic trends will be discussed.

The broad goals of the course are as follows—

› A detailed understanding of the complexities associated with biologic drugs;

› A broad familiarity with biologics manufacturing and its inherent variability;

› A critical understanding of the aspects of biosimilarity; and

› A familiarity with the clinical implic­ations emerging from the use of biologics.

Session: Winter (IMI2003HS) & Summer (IMI2003HY)
Instructor: Duncan Jones
Credits: 0·5

Course Description

A project involves planning and completing a series of tasks in order to achieve a desired outcome. Each project is a unique venture, with a beginning and an end. Whether at work or in your personal life, we have all undertaken projects. The effective management of a project is thus a key skill for its successful delivery, especially on time and on budget. The application of formal processes, tools, knowledge and experience can improve project success rates, especially for projects that are larger, more complex, costly, risky and in some cases critical.

Through a series of case studies and class discussions, this new elective explores this practice of project management across a range of industries. Various supporting tools and techniques will also be introduced. Through direct involvement in a project of choice, an opportunity is provided to further develop insights into the various technical and collaborative issues that can negatively impact a project as well as how to overcome them, mitigate them and prevent them in the future.

Course Description
In this course through a series of lectures and case discussions, students learn about the formation, financing, and manage­ment of early-stage ventures especially as it relates to the (bio)­tech­nology and associated medical device space. Topics include opportunity identifi­cation and assessment, preclinical and clinical phases, regulatory procedures and pathways, legal issues including patents and venture finance. Students will each be required to select a young, publicly-traded company in which to complete an in-depth analysis, presentation and report.

Recommended prep­aration for this course: These three essays by Paul Graham.

Course Description:
This laboratory-based course introduces fundamental experimental techniques commonly used in biomedical research and provides ‘hands-on’ experience working with nucleic acids and proteins over an intensive six-week schedule. Students receive a practical overview of key protocols over the first week and are provided with same-day, interactive technical demonstrations in a fully equipped ‘wet’ laboratory. This is followed by an extended research assignment in which students work in teams towards expressing and isolating a biomedically relevant, recombinant protein. Teams must design an appropriate research strategy, conduct experiments, collect and analyse data and submit their product with a final report to meet a tight deadline. The course concludes with a final presentation seminar day.

› Learn about graduate elective courses at IMI

› Under the auspices of the Institute of Management & Innovation (IMI), and in collaboration with colleagues hailing from other University departments, and from the private sector, I am one of IMI’s tenured Faculty that offers students enrolled in the IMI portfolio of professional graduate programs, and across UofT, a rich vein of modern and relevant electives from which to choose when completing their degree require­ments. Whatever courses you select to take, all of these course are designed to offer advanced learning opportunities at the interface of traditional disciplines, such as Business, Data Science and the Life Sciences, and serve as capstone experiences for UofT grad­uates as they launch their careers.

One of the goals of the electives program at IMI is to create learning environments for students across the different profess­ional graduate programs. The following table illustrates which elective offerings are automatically available to you, depend­ing on your particular program and or home department. Where a pawn (♟) is shown, please enquire with your home department.

› How to Enrol

Graduate students who wish to enroll in any of the courses on this page must—

Students CANNOT enrol themselves directly on Acorn/ROSI.