Michael Firgens

MIchael Firgens

Senior Consultant

Michael has a track record of over 10 years in the biopharmaceutical industry and completed several international assignments in the US and Asia.

Michael worked on a broad range of biopharmaceuticals and product types including ATMPs, monoclonal antibodies, bacteriophages, small molecules as well as first-in-class therapies, biosimilars and orphan drugs. He supported a variety of projects to prepare product specific development strategies and to achieve key development milestones. Michael prepared various documents for regulatory submission such as clinical trial applications, orphan drug designations and marketing authorizations (e.g. IMPD, IND, benefit-risk assessment, QOS, responses during authorization procedures, GMO documentation). He also prepared and managed numerous scientific advice meetings and agency interactions in Europe and the USA.

Prior to joining Biopharma Excellence, Michael worked in different global positions related to drug development and manufacturing within Fresenius Healthcare Group. He was responsible for the project management of a biopharmaceutical development program and was deeply involved in all development areas, such as CMC, pre-clinical, clinical, and regulatory strategy. He also prepared and led Scientific Advice Meetings in the EU. As a major achievement, Michael contributed to the establishment of a new manufacturing site in Asia. He directed international tech transfer programs for sterile products and installed tech transfer processes and project management systems. Moreover, he worked on biopharmaceutical portfolio strategies, evaluated in-licensing opportunities, and participated in due diligence processes, including contract negotiations.

Michael started his career in the area of clinical research as Clinical Project Manager and Clinical Research Associate at Sanofi-Aventis and Dr. Kade. In this function, he worked on a Phase III trial of an innovative gene therapy.

Michael received his Master’s degree in Biochemistry from Freie Universität, Berlin. During his studies, he did research internships at Max Delbrück Centre for Molecular Medicine (Berlin), Centre for Molecular Neurobiology (Hamburg), Harvard Medical School (Boston), and Institut Químic de Sarrià (Barcelona). Michael graduated with the thesis on the project “Mechanism of chromatin remodelling by ATP-dependent complexes”, Centre for Genomic Regulation (Barcelona). After his studies, Michael was trained as Clinical Research Associate/ Clinical Data Manager at Parexel.

Michael also holds an MBA degree in General Management from Wissenschaftliche Hochschule, Lahr. He graduated with the MBA Master Thesis “The Management of Ideas in the Front End of Innovation – a Case Study about the Creation of Innovation in the Pharmaceutical Industry“.