Biotherapeutics Drug Development
This course provides an overview of the drug development process and highlights crucial aspects of specific importance for the capability to develop biologically active macromolecules.
The scientific and commercial prominence of biotherapeutics is beyond dispute. Molecules obtained from expression systems, (semi)synthetic macromolecules as well as biological material intended for therapy or prophylaxis require specialization on all levels to overcome the great challenges and complexity in regard to pharmaceutical formulation design, technological processing, and assessment in the process of developing and regulating such novel safe medicines. In this course, leading experts in the field will present selected topics and case-based approaches will be used to introduce examples of some of the newest advances related to different parts of the drug development process.
This course provides an overview of the drug development process and highlights crucial aspects of specific importance for the capability to develop biologically active macromolecules like peptides, antibodies, oligonucleotides, and other biological material such as living organisms and stem cells into effective medicines.
At first sight, utilization of biotherapeutics as drugs appears straightforward since the pharmacological activity of endogenous compounds such as hormones and coagulation factors are given. Avenues of oligonucleotide and cell therapy may seem less obvious, but due to tremendous advances in understanding disease biology, new targets for biotherapeutics are continuously identified, and this overall excels novel opportunities for new and improved products. Provided that the potent macromolecules or other biological material is druggable. This requires efficient formulation designs and novel delivery approaches, which are continuously emerging. Also, due to the structural complexity and instability of the active material, drug development requires specific processes and models for efficacy testing and safety assessment.
Design and development of biotherapeutics
The course will address and highlight topics of relevance for the design and development of biotherapeutics. Experts from selected relevant fields will lecture on and discuss both fundamental concepts and specific selected issues related to biotherapeutics drug development.
Topics of special attention are picked from the discovery phase through development and assessment, and include e.g. molecular engineering, pharmaceutical drug design and formulation, experimental models, efficacy and safety assessment and regulatory aspects.
Case studies will form the basis for interactive discussion sessions.
During the course you will:
- Understand and address potential major challenges for biotherapeutics related to pharmaceutical formulation design, development, processing, efficacy, and safety
- Identify key challenges and suggest solutions for addressing critical issues in the development process for biotherapeutics
- Elaborate on novel interdisciplinary approaches to improve current practice in the development of biotherapeutics
- Communicate field-specific issues and solutions regarding development of biotherapeutics to other specialists in multi-disciplinary project teams
The course is aimed for professionals in the pharmaceutical industry and professionals, who need an interdisciplinary overview of the specific requirements for development of biotherapeutics. 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
Course directors
Hanne Mørck Nielsen, Professor, Department of Pharmacy, University of Copenhagen
Stine Rønholt, Postdoc, Department of Pharmacy, University of Copenhagen
Other course teachers
Guest lecturers include experts in 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: | 12-16 August 2024 |
| Frequency | Once every year |
| Place: | University of Copenhagen, Copenhagen, Denmark |
| Course fee: | 23,000 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 2024 |
| 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.