511-0000-00L Drug Discovery and Development
|Semester||Autumn Semester 2019|
|Lecturers||U. Thibaut, J. Hall|
|Periodicity||yearly recurring course|
|Language of instruction||English|
|Comment||Only for Pharmaceutical Sciences MSc.|
|Abstract||This course provides an overview over the concepts and processes employed in today's drug discovery and development. It has an introductory character but will also provide more detailed insights employing real life examples. The course combines lectures and interactive elements with active participation of the students.|
- Understand the drug discovery process and can explain major approaches and relevant technical terms (for details see lecture notes).
- Understand and appreciate the content and timing of drug development process steps, development phases and decision criteria.
- Understand the concepts underlying drug product development through all the phases from preclinical and clinical development to regulatory submission, approval and market launch.
- Can differentiate between small molecule drug development and biological drug development.
- Understand the most important differences between legal and regulatory requirements for drug development and approval for the major markets EU and USA.
|Content||Drug Discovery (day 1):|
Introduction to drug discovery: the concepts of drug target selection, ligands/leads, the developability of drug candidates;
Overview over the principal approaches to drug discovery: rational drug design, the natural product approach, serendipity, repurposing as well as chemical libraries and high-throughput screening.
Drug Development (days 2 and 3):
Introduction to the industrial drug product development processes covering the following phases: preclinical research and development, clinical development, regulatory processes and market launch.
R&D support processes such as project management, quality management, pharmacovigilance and pharmacoeconomics will be covered as well as organizational and governance aspects of the pharmaceutical industry.
In addition, important success factors for a later career in the pharmaceutical industry will be discussed and highlighted at the end of the course.
|Lecture notes||Will be published on "mystudies"|
|Literature||G. Nahler (Hrsg.) Dictionary of pharmaceutical medicine, Springer, Wien, 2013 (3rd edition)|
Further readings will be listed in the lecture notes.
|Prerequisites / Notice||This course provides the essential basic knowledge required for the industry-specific modules of the spring semester.|