Biopharmaceuticals Drug Development
Get an overview of the stages involved in the drug development process and aspects of crucial importance for our ability to develop biologically active macromolecules.
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.
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.
The stages of drug development
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.
After the course, you will be able to
- Understand and address major issues in the development of biopharmaceuticals including pharmaceutical formulation development, safety and efficacy testing
- Identify key challenges and suggest solutions for addressing critical issues in the development and testing of biopharmaceuticals
- Design and develop novel interdisciplinary approaches, thereby improving current practice in the development of biopharmaceuticals
- Communicate field-specific issues and solutions in the development of biopharmaceuticals to other specialists and project stakeholders
- Cooperate within a multi-disciplinary development project team
Professionals in need of interdisciplinary overview
The course is for professionals in the pharmaceutical industry who need an interdisciplinary overview of the specific requirements for the development of biopharmaceuticals.
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
Find detailed information about the admission criteria.
Course directors
Hanne Mørck Nielsen, Professor, Department of Pharmacy, University of Copenhagen
Stine Harloff-Helleberg, Postdoc, Department of Pharmacy, University of Copenhagen
Lene Jørgensen, Associate Professor, Department of Pharmacy, University of Copenhagen
Other course teachers
Guest lecturers include experts in biopharmaceutical drug development from the Nordic pharmaceutical industry, authorities/agencies and academia.
This course is offered as an elective course in Master of Industrial Drug Development and in Master of Medicines Regulatory Affairs.
Priority is given to students enrolled on Master of Industrial Drug Development and Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Course details
| Duration: | 5 days |
| Dates: | 14-18 August 2023 |
| Frequency | Once every year |
| Place: | University of Copenhagen, Copenhagen, Denmark |
| Course fee: | 22,500 DKK
Fee includes teaching, course materials, all meals during course hours and examination. |
| Level and credit: | Master course; 3 ECTS |
| Examination date: | Please consult the exam schedule |
| Application deadline: | 31 May 2023 |
| Admission: | To be admitted, you must meet the admission criteria for Master of Industrial Drug Development |
Course dates and application deadlines are announced via the programme newsletter.
Download course curriculum