Executive Education

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

Any questions?

Get in touch!

Steffen Biedenkapp

 +49 69 79833518

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Course Format

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.

Learning
Objectives

Upon completion of this course, you will be able to:

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.

Key
Concepts

In order to achieve the goals of this course, you must master the following key concepts:

  • Medical Affairs organizational evolution
  • Late phase data generation formats, insight gathering tools and medical education spectrum as key value-generating medical pillars
  • Relevant medical stakeholders and medical/scientific interactions
  • Integrate the acquired knowledge to draft a medical launch plan.

 

Faculty

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.

Key Facts

Course materials

Course materials will be provided in electronic form.

Language

English

Venue

On Campus Westend of Goethe University Frankfurt and partially online via Zoom.

Certificate of participation

A GBS certificate of participation is awarded upon completion of the course.

Course Fee*

€ 1.900 (fee is exempt from VAT). The fee for GBS students or alumni amounts to € 800.

*Withdrawal and fee refund
In case the course withdrawal request is received two weeks prior to the start of classes, GBS will retain a withdrawal fee of €50. In case the course withdrawal request is received less than two weeks prior to the start of classes, GBS will retain 50% of the payment made.

Course Schedule
Date Session
Fri., Jan. 27, 2022 13:00 - 15:00; 15:30 - 17:30; 18:00 - 20:00
Sat., Jan. 28, 2022 09:00 - 11:00; 11:30 - 13:30; 14:30 - 16:30
Fri., Feb. 10, 2022 13:00 - 15:00; 15:30 - 17:30; 18:00 - 20:00
Sat., Feb 11, 2022 09:00 - 11:00; 11:30 - 13:30; 14:30 - 16:30
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There are two main things which make returning for Open Programs such a valuable and worthwhile experience. The first is being back on campus – meeting the current students, returning to campus again, the whole experience was just so pleasant. The second is the level of quality in the courses – the faculty teaching are absolute experts.

Stephan KieneDuke-Goethe Executive MBA Class of 2009
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