Course Syllabus

Medical Biotechnology and Drug Development

 

Semester & Location:	Summer 2024 Session 2- DIS Copenhagen
Credits:	3 credits
Study Tour:	Denmark
Major Disciplines:	Biology, Biomedicine / Biotechnology, Pre-Medicine / Health Science
Prerequisites:	One year of biology and one year of chemistry at the university level
Faculty Member:	Jeanette Erbo Wern (please use the Canvas Inbox when mailing me)
Program Director:	Susana Dietrich
Time & Place:	9:00 - 15:30 & V10-A32

Faculty

Jeanette Erbo Wern M.Sc. 2001 (Inst. of International Health, Immunology and Microbiology, University of Copenhagen, Ph.D. Immunology 2005 (Inst. Of International Health, Immunology and Microbiology, University of Copenhagen, Denmark). Post doc 2006-2009 (ISIM, UCPH). Senior Scientist 2010-2013 (Immune Targeting Group, Bioneer, Cph, Denmark). Senior Scientist 2013-2017 (Dept. of Infectious Disease Immunology, Statens Serum Institute, Cph, Denmark). With DIS since 2017. Faculty and Senior  Research Manager of DIS Research

Course Description

This course focuses on biomedicine and the drug discovery & development process, with a special emphasis on the European pharmaceutical and biotech research landscape.

You will gain a solid understanding of the fundamental principles of drug discovery and development, including safety, toxicology, formulation, and clinical trials. The course will also delve into emerging biotechnological innovations in medicine, such as novel biologics, gene therapy, personalized medicine, delivery challenges, and stem cell therapies.

Through academic visits in Denmark and Edinburgh, you will have the unique opportunity to explore the diverse players involved in drug development — from research institutions and start-up biotech companies to hospitals and contract research organizations.

Class activities include collaborative group work and culminate in a group project focused on drug development in Scandinavia, where you will prepare and present a research paper. Working together allows you to combine your varied academic backgrounds and experiences, enhancing the quality of your work. Moreover, teamwork is a vital skill that will serve you well in your future professional career.

Expected Learning Outcomes

Upon completion of this course, you will be able to:

• Give a basic explanation of biomedical drug discovery and development
• Review characteristics and principles of  biotechnological tools, methods, and classes of drugs

• Research biotechnological information and present it in a clear and critical way
• Participate actively and critically in discussions of biotechnology and different types of drugs in class and with biomedical professionals
• Assess the challenges that researchers and people working in the biopharmaceutical area are faced with when dealing with drug discovery and development 

Required Reading

• Pharmaceutical Biotechnology – Fundamentals and Applications.  Edited by Daan J. A. Crommeling, Robert D. Sinclair and Bernd Meibohm. Springer, Sixth Edition, 2024 (hereafter referred to as PB)
• Drug discovery and development – technology in transition. Edited by Raymond G. Hill and Duncan B. Richards. Churchill Livingstone/Elsevier, 3rd edition, 2021 (hereafter referred to as DDD)
• Pharmacology in Drug Discovery and Development - Understanding Drug Responses. Edited by Terry P. Kenakin. Elsevier, 3rd edition, 2024 (hereafter referred to as PDDD)

In addition to the textbooks listed above, the course will be supplemented with relevant publications, articles, and other resources posted on Canvas throughout the semester. These materials will be selected to reflect current developments and emerging topics in the field.

Evaluation and Grading

Participation	15%
Wegovy: A Case Study in DDD	20%
Drug Development Assignment (DDA)	30%
Study Tour Assignments (STA)	35%

 

 

 

Elements

Lectures, including guest lecturers, class discussions, problem solving sessions (alone/groups), case studies, group projects with presentations and field studies visiting research institutions and biotech industry bridging theory and real-life practices.

Wegovy Case Study Assignment

There will be an in-class group assignment focusing on the Drug Discovery and Development (DDD) process using Wegovy, a drug developed by Novo Nordisk, as a real-world case study.

You will apply concepts from the DDD module to analyze key aspects of the drug, including pharmacology, regulatory status, and clinical use. This exercise bridges theory and practice by critically examining a current example from the pharmaceutical landscape.

Study Tour Assignment (STA)

You will work in teams to choose a topic, develop a research question, and prepare a Fact Sheet on one academic visit before the study tour. During the tour, you will gather observations to help answer your research question. Your team will present your findings and insights in a final STA presentation during the wrap-up session after the study tour. The STA grading will include your Fact Sheet, research question, and the argumentation you present in the final group presentation.

Drug Development Assignment (DDA)

As a group, you will research a Scandinavian biopharmaceutical company of your choice, focusing on one or more candidate drugs in their pipeline. You will investigate the disease area targeted, the drug’s mode of action, its stage in development, and the company’s competitive position, including existing treatments and intellectual property. Your research should be based on reliable, independent sources beyond company marketing materials.

The assignment culminates in a 15-18 minute group presentation during the final week, where you will “pitch” your drug to the class acting as venture capitalists. The presentation will be graded on planning, content, and delivery, with the final grade reflecting both group effort and individual performance.

Participation

Participation is determined by attendance, tardiness, and engagement in class. You are expected to attend all DIS classes and planned activities when scheduled, and we will actively monitor attendance. Absences will jeopardize your grade and your standing at DIS. Allowances will be made in cases of illness, but you will need to email your instructor in advance. If you miss multiple classes the Director of Academic Support and the Director of Student Affairs will be notified and they will follow-up with you to make sure that all is well.

To prepare for each day, you are required to do all assigned readings and assignments. The Science & Health department faculty and staff have put many hours into selecting and organizing the readings and material for this course. Please make sure to read all the material assigned; the reading material and the websites have been carefully chosen and are pertinent to your success in Medical Biotechnology and Drug Development. You have an obligation to your fellow classmates and yourself to come prepared to class. 

A hugh part of the participation grade is also that you participate actively in class as well as on field study & study tour by coming up with ideas and input to topics and being part of discussions. 

Study Tour

The study tour is an integral part of the summer course as we take the classroom on the road and see how theory presented in the classroom is translated to practice in the field. You will travel with your classmates and DIS faculty/staff during the second week of the summer course.

Learning objectives of the study tour:

• To learn about the newest and most innovative biotechnology-based methods for diagnosis and treatment of disease through academic visits
• To observe the dynamics of drug discovery and development through visiting biomedicine and biotech research facilities
• To meet some of the players active in the transfer of technology from university to business and explore their work
• To explore the differences between Denmark and the US within the Biomedicine field
• To visit cultural landmarks and institutions in the historical city of Edinburgh
• To develop questions for further learning/research
• To engage in your personal learning process outside the classroom by actively participating and challenging your current ideas and assumptions.
• To get to know your fellow students and professor in an educational and social setting outside DIS. 

While on a study tour DIS will provide hostel/hotel accommodation, transportation to/from the destination(s), approx. 2 meals per day and entrances, guides, and visits relevant to your area of study or the destination. You will receive a more detailed itinerary prior to departure.  

Travel policies

You are required to travel with your group to the destination. If you have to deviate from the group travel plans, you need approval from the program director and the study tours office. On the study tour you are expected to:

• Participate in all activities
• Engage in discussions, ask questions, and contribute to achieving the learning objectives
• Respect the destination, the speakers, DIS staff, and your fellow classmates
• Represent yourself, your home university and DIS in a positive light 

Workload

This is an intensive course, and in just three weeks, you will receive three credits. In order to merit this you should expect a high workload. You should expect to use on average 1-2 hours preparing for each day of classes.

Policies

Use of Laptops or Phones in Class

Use of phones in class is not allowed. Laptop use is allowed for group and project work only and when authorized. 

Policy on late papers and/or assignments

Late assignments will be accepted, but your grade for the assignment will be reduced by half a letter grade for each day it's late. 

DIS Contacts

Susana Dietrich, Program Director, shsuport@dis.dk 
Science & Health Program Office: Vestergade 7-37

Academic Regulations  

Please make sure to read the Academic Regulations on the DIS website. There you will find regulations on:

• Course Enrollment and Grading
• Academic Expectations and Honor Code

 DIS - Study Abroad in Scandinavia - www.DISabroad.org