RESEARCH, DEVELOPMENT & MEDICAL AFFAIRS

Pharmaceutical research and development (R&D) is distinct from other industries due to its complexity, interdisciplinary nature, strict regulation, high costs, and significant risk of failure. Understanding the risks and challenges in drug R&D and developing strategies to mitigate these risks is essential. This course explores the complexity of disease biology and its influence on pharmaceutical approaches, the iterative nature of the R&D process from discovery to clinical trials, and the impact of precision medicine, big data, and digitalization on drug development. Topics include the translation from lab to clinic, formulation of active ingredients, preclinical development, toxicity testing, production scaling, regulatory requirements, and ethical considerations. Amongst other things, this course covers the history of drug discovery, fundamental R&D risks, risk mitigation strategies, and the planning and management of drug R&D projects.

Medical affairs have rapidly and substantially developed over the last few years, and they have evolved from a previous support function to become true business partners within pharmaceutical organizations. With a continuously changing stakeholder environment, an exponential growth of scientific innovations, and drugable target opportunities, medical affairs has become an essential function not only to overspan an enormous internal spectrum of interfaces from R&D to business-related functions but also to serve as the point of contact for scientific partnerships. With this evolution comes a responsibility to stay on track or even ahead of the curve of biomedical science developments, including digital technologies and big data approaches. Launch activities have become the new normal, with medical functions substantially driving cross-functionally integrated programs.