5 days course about the drug development process and the ability to develop biologically active macromolecules

Biopharmaceutical Drug Development

At first sight, utilizing biologically active macromolecules as drugs would appear to be pretty straightforward, since the biological effects of endogenous compounds such as peptides and proteins is well known (e.g. hormones, coagulation factors). Further, due to the recent tremendous advances in genetic profiling and increased knowledge of how protein functions in the biology of diseases, there has been a dramatic increase in the number of new opportunities for novel and improved biopharmaceuticals.
In addition, new insights into formulation design and delivery approaches are emerging all the time. Despite these major advances, however, the complexity of pharmaceutical formulation design, development and safety assessment still poses huge challenges in the overall development of novel biopharmaceuticals.

This course provides you with an overview of the stages involved in the drug development process and highlights aspects of crucial importance for our ability to develop biologically active macromolecules.

In order to help you fully understand these aspects, we have invited several leading experts in the field as guest lecturers. In addition, we take a case-based approach to introduce you to some of the latest advances in the development of effective biopharmaceuticals.

The course will highlight characteristics and procedures that are crucial for the effective design and development of biopharmaceuticals.

Through a mix of lectures and discussions, experts from relevant fields will share their knowledge on both fundamental concepts and specific selected issues related to biopharmaceutical drug development.

Key topics requiring special attention will be selected from the discovery phase through to the development and assessment phases, and will include: Peptide and protein engineering, pharmaceutical drug design and formulation, experimental models, efficacy and safety assessment, and regulatory aspects. Case studies will form the basis for discussion sessions.

The course is for professionals in the pharmaceutical industry who need an interdisciplinary overview of the specific requirements for the development of biopharmaceuticals. The University of Copenhagen has preapproved the course as an elective in the Master of Industrial Drug Development (MIND) programme and the Master of Medicines Regulatory Affairs (MRA) programme.

Participants must:

    • Hold a relevant bachelor degree or equivalent
    • Have a minimum 2 years of relevant job experience in drug development
    • Be proficient in English

 

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Testimonials

“I got a great overview of the topic and many great talks!”
Pier Giorgio Amendola, Postdoc, Biotech Research & Innovation Centre, University of Copenhagen

"It has been a very inspiring week!"
Nanna Maria Junker Nielsen, Principal Scientist, Novo Nordisk A/S

“Very Nice. Fantastic skills and ability to wrap up over the week.”
Thomas Gilberg, Outsourcing Manager,  LEO Pharma A/S

”Great course! I learned a lot and enjoyed discussing with  the other participants”
Paula Dencher, Scientific Data Specialist, Janssen Vaccines and Prevention B.V.

Course directors

Course information

Duration: 5 days
Dates and time: August 19-23, 2019, 9 am - 4.30 pm
Price: EUR 2,680 (DKK 19,900) excl. Danish VAT. The price includes tuition, course material and full board during the course.
Language: English
Location: South Campus, Faculty of Law, Njalsgade 76, DK-2300 Copenhagen S, Denmark
Registration deadline: May 31, 2019
Contact: Copenhagen Summer University
csu@adm.ku.dk
+45 3533 3423


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