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.
- 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 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 | |
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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.
Date | Session |
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Fri., January 24, 2025 | 13:00-15:00; 15:30-17:30; 18:00-20:00 |
Sat., January 25, 2025 | 09:00-11:00; 11:30-13:30; 14:30-16:30 |
Fri., February 07, 2025 | 13:00-15:00; 15:30-17:30; 18:00-20:00 |
Sat., February 08, 2025 | 09:00-11:00; 11:30-13:30; 14:30-16:30 |