Unlike many other industries, the pharmaceutical industry is characterized by a high level of regulation. This ensures that medicine / drugs are sufficiently understood in terms of their efficacy, safety and quality before they become widely available.
Due to the clearly defined framework conditions and the large amount of data required in the marketing authorization application, the pharmaceutical and biotech industry has some special features, such as long product development cycles.
We would like to give project managers from the pharmaceutical and biotech industry a platform to exchange experiences and make their daily work more efficient.
The community would like to address the following topics:
- What are the experiences in practice and how can we learn from them efficiently?
- How can the basic principles of PMI be applied especially in the pharma/biotech sector?
- Development of tools and templates especially for the target group in pharma/biotech
- How can the contribution of PMs to project success be made more visible?
We will work on an online knowledge base and develop and make available tools and templates. As we are in an early start-up phase, everything is in flux and will change with time, ideas from other members and other feedback from the community.
Events on various topics, regarding the direction of our community will take place at regular intervals in various forms.
We do not have fixed dates yet but will announce them in advance of planned events.
We are always interested in receiving suggestions for topics and/or active participation in the community. Feedback and suggestions are welcome. Simply contact us or apply for membership in our Community of Practice - Project Management in Pharma and Biotech using the following form.
Dr. Sandra Gohrbandt - Project management of gene therapy clinical trials - Why does it take so long!!!? (PMIFC Local Group Southwest on July 02, 2020).
This Community of Practice is organized by:
- Dr. Sandra Gohrbandt, PMP is a biologist, certified PMP and CDAP, PMI Frankfurt Local Group Southwest Officer, and a member of the PMI Frankfurt University Team. She completed her PhD on Highly Pathogenic Avian Influenza at the Federal Research Institute for Animal Health on the island of Riems.
Since then, she has been working as a project manager in the field of biotechnology and pharmaceuticals for several years, including at the WHO European Reference Laboratory for Measles and Rubella in Luxembourg. She currently supervises gene therapy clinical trials as Senior Project Manager at BioNTech IMFS.
- Stefan Brüning, MBA is a biologist and has been working in the pharmaceutical industry for more than eight years. After training as a paramedic (DE: Notfallsanitäter), he completed studies in molecular biology at RWTH Aachen University, Germany and the University of Nebraska-Lincoln, USA. Since then he was involved in the monitoring and management of clinical trials (phase I-IV) and later as project manager in pharmacovigilance. Currently, he is working as a senior consultant for life sciences companies in the areas of pharmacovigilance and regulatory affairs.