Biopharmaceuticals Drug Development – University of Copenhagen

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Biopharmaceuticals Drug Development

The complexity of drug development, in particular pharmaceutical development and safety assessment, still poses large challenges in the overall development of novel biopharmaceuticals. This course provides an interdisciplinary introduction to the newest advances in our ability to develop effective biopharmaceuticals.

Recent advances in genetics, biotechnology, and knowledge of protein function in the biology of diseases have provided an explosion of novel opportunities for development of biopharmaceuticals.

At first sight, development of biopharmaceuticals appears straightforward since the biology of endogenous compounds, such as proteins or peptides, and clinical proof of concept and safety profile often are given beforehand (e.g. insulin, growth hormone, coagulation factors). But although discovery and development of novel biopharmaceuticals may be void of typical small molecule pitfalls, the delivery and formulation challenges are complex and call for a high degree of interdisciplinary approaches.

A short introduction to the course (opens in a new window)

Course content

The course uses a high degree of case-based learning with cases based on real-life examples. It is a major aim of the course to provide an overview of the field to facilitate the ability to work in or lead project teams related to biopharmaceutical drug development.

The course will focus on characteristics and complexities specific to the development of biopharmaceuticals.

The focus will be on project initiation, discovery phase, including pharmacology and protein engineering. Particular emphasis will be given to pharmaceutical development and safety assessment of biopharmaceuticals. Regulatory aspects will be taught as well.

The days are split into two sessions: In the mornings, there will be lectures held by experts (industry, academia and authorities), who will introduce basic concepts and specific issues related to  biopharmaceuticals within their fields of expertise. In the afternoons, you will work on specific cases in small groups.


The course is aimed for professionals in the pharmaceutical industry who need an interdisciplinary overview of the specific requirements for development of biopharmaceuticals.

Course dates

5 days, 13 – 17 August 2018, 9:00 – 16:30 at the University of Copenhagen, Frederiksberg Campus, Bülowsvej 17, DK-1870 Frederiksberg, Denmark.

Course fee

DKK 19,900. Fee includes teaching, course materials, all meals during the course and examination.


The course has been preapproved as an elective in the MRA programmes at the University of Copenhagen. Read more on the examination.

NB: Course registration and contact must go through the course description on the Copenhagen Summer University website, as this course is provided under the Copenhagen Summer University concept this year.