MBiotech Electives

 

BTC1860H: GAMBiT
Generations of Advanced Medicine
Biologics in Therapy

GAMBiTABOUT THE COURSE:
 
In this course, we focus exclusively on the dominant role of biologic therapies in modern medicine. In 2014, 7 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, cresting the $12.5 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 aside 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:

  1. A detailed understanding of the complexities associated with biologic drugs;

  2. A broad familiarity with biologics manufacturing and its inherent variability;

  3. A critical understanding of the aspects of biosimilarity; and

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

The detailed course outline will be available here once finalized (PDF format).
 
Date, Time and Location

Thursday evenings during the 2018 Winter semester. Location: St. George Campus. More details to follow.

How to enroll

Graduate students who wish to enroll in this course must complete a Course Add/Drop Form, have it authorized by the Graduate Coordinator at your home department, and submit the signed form via email to Alyssa Madrasto, MBiotech, a.madrasto@utoronto.ca 

Students can NOT register directly on ROSI.

ABOUT THE INSTRUCTOR:
 
Leigh Revers is currently Senior Lecturer in Biotechnology and Associate Director of the Master of Biotechnology (MBiotech) Program at the University of Toronto, Canada. He came to the program with an extensive background in biotechnology entrepreneurship, and he has almost 25 years of experience working in the life sciences sector, both in world-class academic institutions and in industry. Trained as a chemist and molecular biologist in the Dyson Perrins Laboratory, he first came to Canada in 1996 as the recipient of a Leverhulme Scholarship to work with Professor Harry Schachter on developmental enzymes involved in human diseases at Toronto’s Hospital for Sick Children. His research interests in complex carbohydrates as mediators of events at the cell-surface led to his interest in cancer. He joined Professor Jean Gariépy’s research team in 1999 to work on novel biologic toxins capable of exploiting cancerâ€┬Érelated carbohydrate signals. A long-held interest in entrepreneurship led in 2000 to his becoming a co-founder of Molecular Templates Inc. (MTI), a private biotechnology company focused on the development of novel toxin-based cancer therapeutics. In May 2006, he was appointed Assistant Director with the MBiotech Program at the University of Toronto. In 2007, Dr Revers co-founded a consulting practice, which provides specialist scientific and financial services to small and medium-sized enterprises in the life sciences. In 2009, he participated in a USD$2M Series A financing of MTI led by Santé Ventures, which saw the company relocate to Austin, Texas. Shortly afterwards, he co-founded a new Canadian company, D5Pharma Inc., based out of the Sunnybrook Research Institute, which is presently focused on developing aptamer and other biomacromolecular technologies for diagnostic and therapeutic applications. Over the past three years, he has spoken widely to healthcare professionals across Canada, and around the world, on the subject of biologics and biosimilars in the context of haematology, rheumatology and oncology. He is currently a member of prIME Oncology’s Global Expert Panel on Biosimilarity. Dr Revers holds Bachelor’s, Master’s, and Doctoral degrees in Physical Sciences from the University of Oxford in the United Kingdom.

BTC1840HF - Patent Law for the Life Sciences
(also LAW524HF for Faculty of Law students) - Not Currently Offered

PATENT LAW FOR THE LIFE SCIENCES (LAW524H1S) Ariel Katz & Jayson Parker

Classes held at the St. George Campus

Date, Time and Location

Not offered for the 2016-2017 academic year.

Deatiled course information can be found here.

How to Enroll

Life Science Graduate students cannot enrol directly via ROSI/ACORN but must complete a Course Add/Drop Form, have it authorized, and submit the form to: Alyssa Madrasto, MBiotech, a.madrasto@utoronto.ca

Enrolment: 40 students (law students and graduate life science students)

About The Course:

This course is intended for law students (ideally with some background in life science) and life science graduate students. The course introduces patent law in the first four lectures and then examines the application of this framework through a series of specific examples drawn from commercial examples of biotechnology and medical devices. Patent agents and lawyers working in specific areas of patent protection will participate in the latter part of the course. Lectures, through cases drawn through the industrial application of biotechnology and medical devices, will expand and build upon the legal basics set out in the introduction of the course. Guest speakers will either be patent agents or patent lawyers who work in the area in question.

Evaluation: Final sit-down closed book 2-hour exam (50%), major team project (40%, of which 20% written assignment 3,500 words; oral presentation 20%; all students in a team will receive the same grade adjusted to the different Faculty grading scales); class participation 10%.

Major project: Students will be randomly assigned to teams that will be responsible for putting together a short patent application for mock submission. A commercial example will be introduced in class where a specific set of 3 published peer reviewed papers will be designated as the prior art along with any media reports as appropriate. Students will treat any published findings outside this designated prior art as a “new discovery” from their labs. Student teams will then, upon a pre-set time, be able to register patent claims online on a web site upon submission of a patent filing. Once instructors have received this filing, these claims and the discovery become part of the prior art in the course other teams must negotiate in submitting their patent filings. Students will be limited by the fees associated with the number of claims they can make and what is appropriate for a single patent application. The online website (blackboard) will have a time stamp of each patent submission. The last session in the class will involve teams as they briefly present their claims and discuss in the context of other group declarations the possible infringement by others, the strength of their claims, freedom to operate and experimental support.

BTC1850HY - Creating Life Science Products - Not Currently Offered

Course Instructor: Dr. Jayson Parker

Classes held at the St. George campus.

Date, Time and Location

Not offered for the 2016-2017 academic year.

Course summary can be found here (PDF format).

How to Enroll: 

Life Science Graduate students cannot enrol directly via ROSI/ACORN but must complete a Course Add/Drop Form, have it authorized, and submit the form to: Alyssa Madrasto, MBiotech, a.madrasto@utoronto.ca

About The Course:

This course is about product development for the life sciences. No prior business, regulatory or biological knowledge is required. This is an interdisciplinary course open to graduate students from diverse departments ranging from biological sciences, engineering, business, computer science, psychology and law (to name a few). In addition, students from OCAD University are also invited to participate. Students are organized into cross-functional teams that focus on coming up with a commercially relevant improvement to a life science product on the market or a completely novel product that can generate revenue within 24 months from inception. It is possible that some student teams may register new companies, file trademarks or provisional patents. The types of technologies in the life sciences reviewed, but are not limited to, are: drugs, diagnostics, medical devices, herbal products, biomaterials, life science smart phone apps, wireless healthcare and life science software. At the completion of this course students should be able to:

· Understand the basic issues in trade mark registration, patent filings and new business registrations
· Basic regulatory knowledge of medical devices, software and drugs used by the US Food and Drug Administration
· Clinical validation issues for technologies across the commercial spectrum
· Appropriate use of treatment guidelines
· Creating effective proposals for a new life science products for industry

BTC2100Y, 2110H and 2120H - Topics in Biotechnology

These elective courses are restricted to MBiotech students and comprise either individual self-taught projects or participation in eligible science or business courses, supplemented by extra projects, subject to approval by the Director.

Independent study projects approved by the Program Directors. Such courses appear on the student's transcript under the BTC2100-series course codes. Electives falling into this category of course are subject to an internal series of academic requirements, as specified below.
 
(a) All independent study projects taken for credit as a part of the MBiotech Program must be approved by the Program Directors following written submission to the Program Officer of a short project description by the student's nominated Supervisor. The Supervisor must be a current, full-time academic appointee to the University.
 
(b) The Supervisor shall be responsible for adjudicating the student's performance during the course of independent study, in accordance with the University's policy on independent study projects taken for credit. The student will prepare and submit a Final Report on the work conducted to the Supervisor, who will then mark the report and submit the marked copy to the Program Officer no later than ONE WEEK before the semester is scheduled to end.
 
(c) Following receipt by the Program of the Final Report, the student shall give a final, oral presentation to an Academic Panel comprising the Supervisor and to at least ONE other member of Faculty, as approved by the Program Directors. The Panel, having reviewed the marked Final Report, and taking into account the student's performance during the oral presentation, as well as his/her ability to answer to their satisfaction questions pertinent to the work conducted, as they may in their sole discretion determine to be appropriate, shall provide a final grade for the course based on the aggregate of marks, in equal proportion, submitted by each member of the Panel. The Panel will submit the final grade to the Program Officer for submission to SGS in accordance with the relevant academic deadlines.

IMI3001HY - Biocommercialization: Analysis of Technology Driven Innovation 

In this course, students will learn about the formation, financing, and management of early-stage (bio) technology ventures. This process includes a series of close interactions with such start-ups and their potential seed investors. 

The course starts with a thorough introduction to frameworks and processes for analyzing early stage ventures, including the ‘3C’s + P framework’, and the ‘OUTSIDE-IMPACTS’ framework. 

We then turn the course focus on the product concept, development and commercialization phases which companies need to consider in bringing their product through the regulatory pathway. This course is delivered via lectures, small business presentations and team reports which evaluate the technical and business components of the presentations.  The primary aim of this course is to expose the students to a wide range of interdisciplinary elements that contribute to the start-up and functioning of a biotech corporation.  The secondary aims are to introduce the students to individuals currently working in the industry, and give them the opportunity to learn lessons based on real-life workplace experiences.

Ultimately, this will help students to develop the optimal strategy for a new venture.

Teams are expected to be drawn largely from the Master of Sustainability, Master of Management Innovation, and Master of Biotechnology programs. Depending on eth complement of students, we may also choose startup companies who are outside the Biotech arena. There will be two instructors in this course, hailing from both the business sector and science and technology. 

We anticipate working closely with ICube, RIC, MARs and local businesses in this course.

Classes will be held 1-2 times per month in the fall and winter 6:30-9:00 pm

Fall – Monday evenings

Recommended preparation for this course:

Three essays by Paul Graham, http://www.paulgraham.com/

How to enroll

Graduate students who wish to enroll in this course must complete a Course Add/Drop Form, have it authorized by the Graduate Coordinator at your home department, and submit the signed form via email to Alyssa Madrasto, MBiotech, a.madrasto@utoronto.ca

Students can NOT register directly on ROSI.

Electives offered by Other Programs

Please be sure to get electives approved by the MBiotech Program if you plan on taking courses through other programs/units. A Course Exemption Form must be approved by the Program Director, MBiotech, if you would like these courses, or any other courses, considered for use towards graduation requirements. 

Some courses that may be of interest to MBiotech students, that have been offered by other departments in recent terms, include:

CHL 5121H Genomics, Bioethics and Public Policy
ECE 1778 - Creative Applications for Mobile Devices
http://www.eecg.utoronto.ca/~jayar/ece1778/
HAD 5735H - The Commercialization of Health Research
Institute of Health Policy, Management and Evaluation (IHPME)

For more information about the above courses, please contact Alyssa Madrasto in the MBiotech office via a.madrasto@utoronto.ca

Courses at Other Universities

The Ontario Visting Graduate Student Application (OVGS) agreement permits a registered student to take the equivalent of up to 1 full credit towards their program course requirements at another Ontario university, without completing further admission formalities, when the course is not available at U of T. The student pays fees at U of T as per normal and is classified as a non-degree visiting student at the host university, where (s)he pays no fees. Courses taken through OVGS must be requirements of the U of T degree program. Normally graduate students should not participate in OVGS in their final year unless the official grade will be received by the SGS final grade and degree recommendation submission deadlines.

OVGS Application Link

For more information, please contact the MBiotech Program Office, 905-569-4737.