Michael Firgens

01 Interactions with Regulatory Authorities

• Preparation and management of scientific advice meetings and regulatory interactions including meeting request and briefing documentation, organization and management of procedure (EU national competent authorities, EMA, FDA, Health Canada)

• EU representative and primary contact in all dealings with EMA

02 Acceleration and Increasing Value Strategies

• Preparation of requests for regulatory expedited programs such as PRIME, breakthrough, RMAT designation

• Preparation of applications for orphan drug designation (ODD) and humanitarian use device (HUD) designation

• Acting as Interim Regulatory Affairs Professional in your team

03 Clinical Trial Documents

• Writing of investigational medicinal product dossier (IMPD), investigational new drug (IND) applications

• Writing of Investigator's Brochure

• Compilation and review of clinical trial application and IND packages

• GMO documentation for clinical trial applications in the EU, environmental risk assessment (ERA)

04 Support for Marketing Authorization Applications

• Writing of marketing authorization application (MAA) and biologics license application (BLA) dossiers

• Authoring of responses to questions and request for information (RFI)

• Comprehensive procedural support during marketing authorization procedures

• Management of Policy 0070 procedure (EMA) and preparation of document redactions

05 Establishing Your Strategy

• Preparation of integrated development strategy and definition of key development milestones for CMC, non-clinical, clinical, regulatory

• Preparation of global regulatory strategy till approval including strategic considerations and requirements for EU and US

• Assessment of options and scenarios to accelerate product development

• Target product profile (TPP) definition

• 20+ years product development experience in biotech and pharma in Europe, USA and Asia

  • Founded MF BIOTECH in 2019

  • Before, various international project management positions at Fresenius Healthcare Group, Biopharma Excellence (now Pharmalex), Dr. Kade, Sanofi-Aventis

• Cross-functional leadership of biopharmaceutical development programs driving CMC, pre-clinical, clinical, and regulatory strategy

• Experienced with regulatory interactions and agency meetings with EMA, national EU health authorities, FDA, Health Canada

• Writing of various regulatory submissions incl. orphan drug applications and PRIME designation

• Product-specific development strategies for various product types spanning from early stage to product launch

• Biochemist, MBA in General Management, PMP certified, trained as Clinical Research Associate/ Data Manager

• Memberships: CONELIS life science expert network; Project Management Institute (PMI) and Community of Practice Life Sciences; RePo4EU - The Euro-Global Platform for Drug Repurposing 

Education

Master of Biochemistry (“Diplom”)

Master of Business Administration in General Management

Project Management Professional (PMP)

Biopharmaceuticals & Product Types