Course Syllabus
Medical Biotechnology andDrug Development |
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| Semester & Location: |
Spring 2026 - DIS Copenhagen |
| Type & Credits: |
Core Course - 3 credits |
| Core Course Study Tours: |
Western Denmark and Paris |
| 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 (current students please use the canvas inbox to contact) |
| Program contact: |
Science and Health Department |
| Program Director: | Susana Dietrich |
| Time & Place: |
Mondays and Thursdays 8:30-9:50 CET, Classroom N7 - B12 |
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 introduces you to biomedicine and the principles of drug discovery and development within the European pharmaceutical and biotechnology environment.
You will learn about the key stages of the drug development pipeline, including target identification and validation, preclinical safety and toxicology, formulation, regulatory considerations, and the design and execution of clinical trials. The course also addresses the scientific, technological, and translational challenges associated with modern biotechnology in medicine, with a focus on biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs) such as cell therapies, gene therapies, and advanced drug delivery systems.
The course integrates academic and industry site visits in Denmark and another European country (e.g., London, Paris, Lisbon/Porto, or Madrid/Barcelona, depending on the semester), giving you direct exposure to a wide range of stakeholders involved in drug discovery and development. These include academic research laboratories, biotechnology start-ups, contract research organizations, and established pharmaceutical and biotechnology companies. Through these visits and interactions, you will gain insight into the organizational, scientific, and regulatory frameworks that support translational biomedical drug development, as well as an overview of the diverse career paths and job opportunities within the field.
Course activities emphasize collaborative, project-based learning. You will work in groups on a project focused on drug development in Scandinavia, which includes visiting and interviewing a company active in the drug discovery or development process. Based on this engagement, your group will write a paper and deliver an in-class oral presentation. This project is designed to reinforce course content while developing transferable skills in scientific communication, teamwork, critical analysis, and professional interaction relevant to careers in biomedical research and the life sciences industry.
Expected Learning Outcomes
Upon successful completion of this course, you will be able to:
- Explain the fundamental principles of biomedical drug discovery and development
- Describe key characteristics and underlying principles of biotechnological tools, methods, and major classes of drugs
- Research biotechnological and pharmaceutical topics and present information in a clear, structured, and critical manner
- Apply concepts from drug discovery and development to real-world case studies and industry practices
- Participate actively and thoughtfully in discussions related to biotechnology and drug development, both in class and in dialogue with biomedical professionals
- Assess the scientific, technological, regulatory, and organizational challenges faced by researchers and professionals working in the biopharmaceutical field
- Communicate drug development concepts effectively in written reports and oral presentations within a collaborative team setting
- Reflect on ethical and societal considerations associated with biotechnological drug development and advanced therapies
Required Readings
-
Pharmaceutical Biotechnology (PB): Fundamentals and Applications
Edited by Daan J. A. Crommelin, Robert D. Sinclair, and Bernd Meibohm.
Springer, 6th Edition, 2024. -
Drug Discovery and Development (DDD): Technology in Transition
Edited by Raymond G. Hill and Duncan B. Richards.
Churchill Livingstone / Elsevier, 3rd Edition, 2021. -
Pharmacology in Drug Discovery and Development (PDDD): Understanding Drug Responses
Edited by Terry P. Kenakin.
Elsevier, 3rd Edition, 2024.
In addition to the textbooks listed above, the course will be supplemented with selected scientific publications, review articles, and other resources provided on Canvas throughout the semester. These materials will reflect current developments, emerging technologies, and contemporary challenges in biomedical research and drug development.
Evaluation and Grading
| Attendance Grade | 7.5 % |
| Participation Grade | 7.5 % |
| Study Question in class Presentation | 15% |
|
Wegovy: A Case Study in DDD |
15% |
Test on Biopharmaceuticals and Advanced Therapy Medicinal Products |
15% |
| Drug Development Assignment (DDA) Report | 10 % |
| Drug Development Assignment (DDA) Presentation | 10% |
| Study Tour Assignment (STA) | 20% |
Course Elements and Assignments
This course combines lectures, class discussions, solution sessions (individual and group), case studies, group presentations, field studies at pharmaceutical and biotechnology companies, and a group project with a final presentation.
Attendance Grade
Attendance is mandatory for all scheduled class sessions, field studies, all five days of Core Course Week (CCW) activities, and all six days of Long Study Tour (LST) activities.
Regardless of the reason of absence
- Each absence from a class session or field study will automatically result in a deduction of 10 points from your attendance grade (out of 100 total points).
- This attendance policy also applies to required activities during Core Course Week (CCW) and Long Study Tours. Missing multiple activities on the same day will result in multiple deductions (e.g., missing two activities in one day results in a total deduction of 20 points). Required activities may include academic, social, or cultural components of the program.
- Exceptions to this point deduction policy can only be made if supported by prior approval from DIS Academic Support (e.g., for serious personal or family matters).
Participation Grade
Your participation grade reflects your level of preparation, engagement, and active contribution to class discussions, field studies, and study tours.
You are expected to come prepared for each class and academic activity by completing all assigned readings, reflecting on the material, preparing required assignments, and being aware of topics you find challenging. Active participation also includes asking questions, contributing to discussions, and engaging thoughtfully with peers and instructors.
As part of the evaluation of participation and preparation, you will be asked to prepare responses to study questions and present them in class.
Case Study in Drug Discovery and Development
This case study focuses on the drug discovery and development process using Wegovy, developed by Novo Nordisk, as an example.
Working in groups, you will analyze different aspects of the drug and apply concepts learned in the DDD module. Guided questions will help you explore key areas, including pharmacology, regulatory status, and clinical applications.
Final Test
The final test will cover Biopharmaceuticals and Advanced Therapy Medicinal Products including:
- Genetics & Genomics
- Gene & Cell Therapy
- Immunology & Immunogenicity
- Nucleotide-Based Therapies
- Antibodies as Therapies
- Vaccines
The test will combine multiple-choice questions and written responses, assessing recall, conceptual understanding, and problem-solving skills.
Drug Development Assignment (DDA)
In groups, you will investigate the drug development process of a biopharmaceutical company you visit, focusing on a current or recent product. You will explore the science, research, and challenges involved, culminating in a written report and a class presentation.
At the end of the semester, your group will present the company to the class in a role-play scenario: the class will act as venture capitalists evaluating whether to invest in “your” company. Exact company assignments will be announced later.
Core Course Week and Study Tours
Core Course Week and the Long Study Tour are integral components of the course, providing opportunities to see how classroom theory translates into practice.
You will travel with classmates and DIS faculty/staff on a short study tour in Denmark during CCW and a long study tour (LST) to a European destination
DIS provides accommodation, transportation, approximately two meals per day, and access to relevant visits, guides, and activities. A detailed itinerary will be provided before departure.
Study Tour Assignment (STA)
Before your short study tour, you will be organized into teams. With your team, you will create a fact sheet and a short presentation on an academic visit during the tour.
Each team will also choose a focus topic for the final presentation and develop a research question.
Possible areas include:
- An in-depth exploration of a biotech research topic encountered on the tours
- Relationships between academia and private enterprise
- Collaboration and/or competition among different players in drug development
- Careers and work-life in biotechnology: roles, education, and career paths
These activities will culminate in a comprehensive final presentation based on your learning from both CCW and LST. Additional instructions will be provided prior to Core Course Week
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 papers will be accepted, but your grade for the paper will be reduced by half a letter grade for each day that it is late.
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.
Academic Regulations
Please make sure to read the Academic Regulations on the DIS website. There you will find regulations on:
DIS - Study Abroad in Scandinavia - www.DISabroad.org
Course Summary:
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