RESEARCH, DEVELOPMENT & MEDICAL AFFAIRS

Pharma research and development differs in many aspects from R&D in other industries. The discovery and development of pharmaceuticals is a complex, interdisciplinary, highly regulated, extremely expensive process requiring many years to reach the market, and associated with a high risk of failure. Thus, it is crucial to understand the types of risks and challenges in drug R&D, and to develop mitigation strategies either to prevent failure or to fail early and inexpensively. We shall discuss the complexity of disease biology and the wide variety of pharmaceutical approaches, and how the former determine the latter. The iterative nature of the R&D process will be considered during its different phases from discovery through safety testing to clinical trials. A specific focus will be on the translation from the laboratory to the clinics, on precision medicine approaches and on how big data and digitalization have an impact on drug R&D. Research that needs to be carried out on the active pharmaceutical ingredients will be discussed together with the different ways in which the drug can be packaged (formulated) to provide optimal therapeutic benefit. Preclinical development, including toxicity testing, production upscaling and regulatory requirements for clinical trials will be addressed, together with ethical implications.

This part of the course covers the following topics: history of drug discovery and development, fundamental pharma R&D risks and risk mitigation strategies, planning and management of drug R&D projects, types of pharmaceuticals, drug targets and early discovery research, formulation of active pharmaceutical ingredients, toxicity testing and preparation for clinical trials.

Medical affairs has rapidly and substantially developed over the last years and evolved from a previous support function to become a true business partner within pharmaceutical organizations. With a continuously changing stakeholder environment, an exponential growth of scientific innovations and drugable target opportunities, medical affairs has become a key 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.

Thus, the objectives of this part of the course are to

• Provide a basic understanding of Medical Affairs, its roles and responsibilities, typical profiles and capabilities, organizational structures, processes and interfaces
• Give you a practical overview including exercises of the core value-generating medical pillars
• Exemplify a toolbox of medical and scientific interactions as part of a state-of-the-art Medical Affairs strategy and launch-planning