376-1664-00L Ethics in Drug Development
| Semester | Autumn Semester 2024 |
| Lecturers | A. Blasimme, M. Andreoletti, E. Vayena |
| Periodicity | yearly recurring course |
| Language of instruction | English |
| Abstract | This course provides a thorough exploration of drug development and involved ethical issues as well as critical analysis of ethical challenges and practical skills to resolve them. It includes elements of drug discovery, preclinical and clinical research ethics, alternative regulatory pathways and ethics of drug pricing and develops a solid grasp of ethical complexity as well as practical skills. |
| Learning objective | This course is tailored to D-HEST students who want to become familiar with pharmaceutical development and its ethical implications. By the end of this course, students will have developed a comprehensive understanding of the ethical complexities and challenges in drug development. They will be equipped with the knowledge and analytical skills to navigate ethical reasoning and contribute to the responsible advancement of pharmaceutical research. The specific learning objectives of the course are: • Discuss relevant legal and public policy frameworks in drug development, ensuring an understanding of the broader regulatory context within which policy and regulatory decisions are made. Recognize and identify ethical dilemmas inherent to drug development, fostering a heightened awareness of ethical considerations across various stages of the process. • Identify and discuss ethical issues in drug development in light of recent advances in the field of artificial intelligence. • Critically analyze ethical challenges within drug development, enabling them to discuss complex issues, evaluate competing ethical perspectives, and form reasoned judgments. • Understand the ethical theories and principles that underpin drug regulation. • Evaluate the ethical implications of alternative pathways, such as Accelerated Approval and Compassionate Use, equipping students to assess potential benefits, risks, and societal consequences. • Assess the ethical dimensions of drug pricing decisions and their impact on equity and accessibility, encouraging thoughtful reflection on the broader societal implications of pricing strategies. |
| Content | - Principles of biomedical ethics and how they relate pharmaceutical innovation - Introduction to drug development, with a focus on the Swiss regulatory ecosystem - Current trends and impediments to effective drug development, including the use of AI in drug discovery - Translational medicine and its ethical implications - Ethical Aspects of pre-clinical research, including animal replacement technologies like organoids and organ chips - Ethical aspects of clinical research - Special regulatory pathways: expanded access / compassionate use - Special regulatory pathways: accelerated approval - Drug development and public health. emergency use of new drugs - Drug pricing: introduction to its regulatory and ethical aspects |