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
This course is offered in the part-time Master of Pharma Business Administration MBA program and may be attended on a “no credit” basis by individuals not enrolled in the program. Course participants are visitors who are not responsible for assignments and do not take an exam or earn academic credits. As the number of seats in the course is limited, we recommend to register online early.
Upon completion of this course, you will be able to:
In order to achieve the goals of this course, you must master the following key concepts:
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 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.
Course materials will be provided in electronic form.
English
On Campus Westend of Goethe University Frankfurt and partially online via Zoom.
A GBS certificate of participation is awarded upon completion of the course.
€ 1,900 (fee is exempt from VAT). The fee for GBS students or alumni amounts to € 800.
| Date | Session |
|---|---|
| Fri., Jan. 26, 2024 | 13:00 - 15:00; 15:30 - 17:30; 18:00 - 20:00 |
| Sat., Jan. 27, 2024 | 09:00 - 11:00; 11:30 - 13:30; 14:30 - 16:30 |
| Fri., Feb. 09, 2024 | 13:00 - 15:00; 15:30 - 17:30; 18:00 - 20:00 |
| Sat., Feb 10, 2024 | 09:00 - 11:00; 11:30 - 13:30; 14:30 - 16:30 |
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