Course Syllabus
SYLLABUS
Medical Biotechnology and Drug Development A
Semester & Location: |
Fall 2026 - DIS Copenhagen |
| Type & Credits: | Core course - 3 credits |
Study Tours: | This core course includes a mandatory study tour to Paris during Travel Week 1. |
Faculty: |
Jeanette Erbo Wern
|
Time and Classroom: |
Mondays 08:30-09:50 (classroom N7-B12) |
Major Disciplines: |
Biology, Biomedicine / Biotechnology, Pre-Medicine / Health Science |
Related Disciplines: | |
Prerequisites: | One year each of biology and chemistry at university level. |
Program Contact: |
Science and Health Department: shsupport@dis.dk |
Faculty
Jeanette Erbo Wern, Ph.D.
Jeanette holds an M.Sc. and Ph.D. in Immunology from the University of Copenhagen and brings over 15 years of academic research and industry experience to the classroom. She has worked as a Senior Scientist at Bioneer, where she provided pre-clinical services to international pharmaceutical companies, research institutions, and hospitals and developed drug screening models for inflammatory and autoimmune diseases. At Statens Serum Institut, she contributed to the development of a Chlamydia Trachomatis vaccine through to human trials. She joined DIS in 2017, where she teaches Medical Biotechnology, and Drug Development, and serves as Senior Research Manager overseeing DIS's research program.
Course Description
This course introduces you to biomedicine and the principles of drug discovery and development within the European pharmaceutical and biotechnology landscape.
You will learn about the key stages of the drug development pipeline, including target identification and validation, preclinical safety and toxicology, regulatory considerations, and the design and execution of clinical trials and market approval. 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 gene and cell 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, which includes visiting 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 in real world settings while developing transferable skills in scientific communication, 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
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.
Course Elements
This course combines a variety of learning formats to give you both a strong theoretical foundation and direct exposure to the real world of drug development. You will attend lectures and hear from guest lecturers active in the field, participate in class discussions and problem-solving sessions, and work on collaborative group projects and case studies. A highlight of the course are the field studies, where you will visit academic research institutions and biotech companies bringing course concepts to life through direct interaction with researchers, clinicians, and industry professionals.
Evaluation and Grading
| Participation Grade | 15 % |
| Presentation of Study Questions in class | 15% |
|
Wegovy: A Case Study in DDD |
15% |
Test on Biopharmaceuticals and Advanced Therapy Medicinal Products |
15% |
| Drug Development Assignment Report | 10 % |
| Drug Development Assignment Presentation | 10% |
| Study Tour Assignment | 20% |
Participation Grade
Participation is determined by attendance, punctuality, and active engagement in class. You are expected to attend all DIS classes and planned activities, and attendance will be actively monitored. Absences may affect your grade and your standing at DIS. In cases of illness, please 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 will follow up with you.
You are required to complete all assigned readings and preparation before each class. The course material has been carefully selected to support your success in Medical Biotechnology and Drug Development, and you have an obligation to your fellow classmates and yourself to come prepared.
A significant part of the participation grade reflects active engagement - contributing ideas, asking questions, and taking part in discussions both in the classroom and during field studies and the study tour.
Case Study in Drug Discovery and Development
In this in-class group assignment, you will use Wegovy (semaglutide) - a blockbuster weight loss drug developed by Danish pharmaceutical company Novo Nordisk - as a real-world case study to demonstrate your understanding of the full drug development pipeline, from target identification and preclinical studies through clinical trials, regulatory approval, and post-marketing surveillance. The exercise bridges theory and practice by critically examining a current and highly relevant example from the pharmaceutical landscape.
Final Test
This test assesses your understanding of the science behind some of the most rapidly evolving areas in modern medicine. Using multiple-choice and written response questions in an open-book format, it will cover both recall and conceptual understanding and across the following topics:
- Genetics & Genomics
- Gene & Cell Therapy
- Immunology & Immunogenicity
- Nucleotide-Based Therapies
- Antibodies as Therapies
- Vaccines
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.
DIS - Study Abroad in Scandinavia - www.DISabroad.org
DIS Academic Regulations
Please make sure to read the Academic Regulations on the DIS website. There you will find regulations on:
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