Biopharmaceuticals Drug Development

The commercial and scientific prominence of biopharmaceuticals is beyond dispute. This course provides an overview of the drug development process and highlights crucial aspects of specific importance for our ability to develop biologically active macromolecules into effective biopharmaceuticals.

At first sight, utilization of biologically active macromolecules for as drugs appears straightforward since the biology of endogenous compounds, such as peptides and proteins, are given (e.g. hormones, coagulation factors). Further, due to the tremendous recent advances in genetic understanding and knowledge of protein function in the biology of diseases, an explosion of novel opportunities for development of biopharmaceuticals has occurred. Advanced (bio)technological tools provide opportunities for tailoring macromolecules to improve drug-ability of these compounds, and new insight into formulation design and delivery approaches are continuously emerging. However, due to the structural complexity of these high molecular weight, labile compounds, drug development including efficacy and safety assessment in appropriate models still pose significant challenges in the overall development of novel biopharmaceuticals.

The course will address and highlight characteristics and procedures of relevance for the design and development of biopharmaceuticals. Experts from in relevant fields will lecture on and discuss both fundamental concepts and specific selected issues related to biopharmaceuticals drug development. Topics of special attention are picked from the discovery phase through development and assessment, and include protein engineering, pharmaceutical drug design, efficacy and safety assessment and regulatory aspects. Case studies will form the basis for interactive discussion sessions.