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 with 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). - 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 (day 2) Introduction to development processes from the perspective of the pharmaceutical industry. Why and how are decisions for drug development candidates made? What drives portfolio decisions of pharmaceutical companies? Besides stimulating lectures, the course also includes group work on interesting new drugs both from the class of small molecules as well as from biologicals. Drug Development (days 3 and 4): Introduction to the entire suite of drug product development processes in the pharmaceutical industry, 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.

Resources