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 17+ year 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 a guest speaker at Gläsernes Labor Akademie Berlin and 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 the Freie Universität in Berlin. During his studies, he did research internships at the Max Delbrück Centre for Molecular Medicine (Berlin), the Centre for Molecular Neurobiology (Hamburg), the Harvard University Medical School (Boston), and the Institut Químic de Sarrià (Barcelona). Michael wrote his Master’s thesis on the project “Mechanism of chromatin remodelling by ATP-dependent complexes” at the Centre for Genomic Regulation (Barcelona). After his studies, Michael was trained as a Clinical Research Associate/Clinical Data Manager at Parexel. Michael also holds an MBA in General Management from the 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 a 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
First-in-class therapies
Orphan drugs
Biosimilars
Combination products
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
MEMBERSHIPS & CERTIFICATIONS
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TESTIMONIALS.
“I can’t speak highly enough of the impact Michael had on our development program. From strategic planning to execution, Michael demonstrated a profound understanding of the development requirements for gene therapies, helping us overcome obstacles and achieve remarkable results.”
“Michael is our go-to-person for regulatory advice, and his regulatory writing skills are exceptional. Our trusted partner for regulatory submissions.”
“Working with Michael was a game-changer for our antibody development program. His development expertise and program leadership enabled us to accelerate the start of our clinical development program.”
“We are so lucky to have Michael as Program Manager leading several of our mRNA development projects from planning to execution – and he’s just fantastic colleague to work with.”