Michael Firgens, MBA, PMP

Founder · Program Manager · Principal Consultant


PROFESSIONAL BACKGROUND

Michael is the founder of MF BIOTECH and advises and supports biotech and pharma companies on the development and approval of innovative biopharmaceutical products.

Michael has a 15+ years track record of managing development projects in the biotech and pharma industry. Since 2007, he has led and supported numerous biopharmaceutical development projects to successfully achieve key development milestones from early stage development to approval.

In 2019, Michael founded MF BIOTECH with the vision to provide best-in-class development support for innovative medicines. He has provided project leadership and tailored project solutions to companies from emerging startups to big pharma and has shaped high-performing project teams. He has established and executed product-specific development strategies for various biopharmaceutical product types, all at the forefront of medical innovation. Michael brings in practical hands-on experience for all technical areas to facilitate project execution. Michael is an invited speaker at Gläsernes Labor Akademie Berlin and is a member of the CONELIS life science expert network.

Prior to founding MF BIOTECH, Michael worked in different international program management positions related to drug development and manufacturing within Fresenius Healthcare Group. He also worked as a Senior Consultant at Biopharma Excellence (now Pharmalex) where he contributed to numerous projects for innovative biotech products and significantly contributed to the company’s growth. Michael started his career in the area of clinical research as Clinical Project Manager and Clinical Research Associate at Sanofi-Aventis and Dr. Kade.

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“. Michael is a certified Project Management Professional and member of the Project Management Institute (PMI) as well as core member of the PMI Community of Practice Life Science.


AREAS OF EXPERTISE

  • Preparation of integrated and product-specific development strategies

  • Project and program management

  • Preparation and conduct of scientific advice meetings and agency interactions (Europe, USA, Canada)

  • Orphan drug designations (Europe, USA)

  • Clinical trial applications, INDs (including submission management, IMPD, benefit-risk assessment, GMO documentation, responses to agency questions)

  • Marketing authorization applications (including submission management, QOS, Module 3, responses to agency questions during MAA procedures)


BIOPHARMACEUTICALS & PRODUCT TYPES

  • Protein drugs, monoclonal antibodies, fusion proteins

  • mRNA-based drugs and vaccines

  • Gene therapies, genetically modified organisms (GMOs), genome editing

  • Cellular immunotherapies

  • Regenerative therapies

  • Oncolytic viruses

  • Bacteriophages

  • Small molecules

  • First-in-class therapies

  • Orphan drugs

  • Biosimilars

  • Combination products


MEMBERSHIPS & CERTIFICATIONS


Let’s work together.