Pharmaceutical research and development is uniquely challenging due to its complexity, interdisciplinary demands, strict regulations, high costs, and the significant risk of failure. This course addresses these complexities, focusing on risk management in drug R&D, from discovery to clinical trials. Participants will explore disease biology, the iterative R&D process, and how precision medicine, big data, and digitalization are reshaping drug development. Core topics include translating lab research to clinical applications, formulating active ingredients, preclinical testing, scaling production, regulatory requirements, and ethical considerations. The course also covers the history of drug discovery, key risks in R&D, and essential strategies for project planning and risk mitigation.
Medical Affairs has transformed from a support role into a central business partner within pharmaceutical organizations. As the landscape of scientific innovation and drug targets expands, Medical Affairs now bridges R&D and business functions and leads as a primary contact for scientific collaborations. This evolution demands that Medical Affairs professionals stay ahead in biomedical science, digital technology, and big data. Today, Medical Affairs is integral to cross-functional launch activities, playing a critical role in delivering coordinated, science-driven programs that align with both scientific advancements and business objectives
- Distinguish between the different pathways that can be taken to develop a drug
- Know the tasks that need to be performed at each development stage
- Understand the different types of risks and mitigation strategies
- Define the critical path of activities that must be carried out to move forward from one development milestone to the next
- Identify the most relevant formulation strategies applied to pharmaceuticals
- Know the challenges to drug development within current regulations
- Identify the clinical studies to be performed
- Understand the concept of precision medicine and the impact of big data and biomarkers on pharma R&D
- Critically assess Medical Affairs strategies, organizational aspects and key capabilities
- Overlook the spectrum of medical activities and provide an integrated medical launch plan
- Differentiate various formats of scientific interactions to leverage partnerships at any phase of the product life-cycle
This course is part of the prestigious part-time Pharma MBA program, conducted in English on Fridays and Saturdays on Campus Westend. It offers a valuable opportunity to network and gain expertise without committing to a full degree program. As the number of seats is limited, we recommend to register early. If you're a GBS or Goethe University alumni, explore our attractive alumni discount options.
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Participants have the choice of completing the course with a qualified certificate or attending as a guest auditor. As an auditor, you are not required to complete assignments, take exams or earn academic credits.
| ECTS | Certificate | |
|---|---|---|
| Guest auditor | - | Certificate of Participation |
| Full participant | 5 CP | Qualified Certificate |
PD. Dr. Aimo Kannt
PD Dr. Aimo Kannt is Head of Drug Discovery at the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP. Aimo was trained as a biochemist at the Universities of Tübingen and Cambridge (UK) and did his PhD work at the Max-Planck-Institute of Biophysics. He has 19 years of drug discovery experience in different positions at Sanofi and its predecessor companies. Aimo teaches medical students at the Universities of Frankfurt and Heidelberg.
Dr. med. Matthias Meergans
Dr. med. Matthias Meergans is Senior Medical Director at Merck since March 2019, a member of the European Medical leadership team and responsible for the German Medical Affairs team in Darmstadt. After almost 20 industry-years in local, regional and global roles in medical, R&D and commercial functions with growing responsibility, Matthias collected a broad pharma expertise from positions at MSD, Novartis and Biogen prior to Merck. Matthias studied medicine in Berlin and Tübingen; he is a board-certified internal medicine specialist and holds a master´s degree in pharmaceutical medicine from University Witten-Herdecke.