Drug Discovery and Development

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 which require active participation of the students.

Objective

Students - Understand the drug discovery process and can explain major approaches and relevant technical terms (for details see lecture notes). - Can critically assess applications and limits of AI-methods used in drug discovery such as 3D-structure prediction methods (eg. Alpha fold) for proteins and biomolecules, in the design of clinical studies, the evaluation of results of clinical studies as well as the search of large databases for drug safety signals / pharmacovigilance. - Understand and appreciate the content and timing of drug development process steps, development phases and decision criteria for the continuation or termination of drug development projects. - 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 for drug development and approval between the EU and USA pharma markets with regard to legal and regulatory requirements.

Content

Course unit comprises weekly lectures covering the early phases of target and drug discovery (535-0901-01 S "From A to Z in Drug Discovery and Development I") with group work in the area of Drug Development (511-0000-00 G). The latter course lasts 2 full days (Days 1 and 2) and comprises both lectures and group work: inter alia an introduction to the entire suite of drug product development processes in the pharmaceutical industry, covering 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 briefly discussed at the end of day 2 of the course.

Resources