Dr. Rüdiger Jankowsky

Florio is a start-up company for digital health products for patients with rare/orphan diseases, e.g. haemophilia. Florio is part of Sobi, a Swedish biopharmaceutical company. Supervising the development, registration/certification, and market launch of several software medical devices for real-world patient data in the EU and the US. Leading Florio's 20+ agile integrated team of medical experts, designers, software engineers, and specialists for quality management, regulatory and data protection/GDPR.

OGen GmbH (now T-Balance Therapeutics) is a start-up company for the development of clinical-stage biopharmaceuticals for autoimmune diseases. Implemented the company structure for development. Commenced the Phase II clinical development of tregalizumab, a monoclonal antibody for the treatment of autoimmune diseases. Supervised the technical development/CMC, preclinical development, regulatory strategy, scientific advice from regulatory Health Authorities and clinical study preparation.

Cinfa Biotech was created as a startup company for development, manufacturing and commercialisation of biosimilars. Started and managed the development of Cinfa Biotech's biosimilar pipeline, consisting of Pelmeg(R), a biosimilar pegfilgrastim, and a monoclonal antibody. Led Cinfa Biotech's integrated cross-functional team of 30 experts. Development of Pelmeg(R) from start to EMA marketing authorisation. Established licensing partnerships. Successful sale of Cinfa Biotech to an industry partner in 2018.

Global program management of several biosimilar development projects based on monoclonal antibodies. Led the late-stage development of Erelzi (etanercept, a biosimilar to Enbrel), including CMC development, clinical development and interactions with health authorities in Europe and the US for regulatory strategies. Managed cross-functional international teams and chaired the Sandoz Biopharmaceuticals' Development Committee.

Managed the development of resminostat, a clinical-stage HDAC inhibitor for use in oncology. Matrix-managed the interdisciplinary drug development team. Created and implemented the development strategy including clinical studies in several oncological indications. Set up and maintained partner network for clinical development and regulatory affairs. Co-ordinated due diligence processes for license-out.

Program management of clinical and non-clinical development programs. Matrix-managed the development team for clinical development of vidofludimus, a therapeutic candidate for autoimmune diseases, and other product candidates. Installed state-of-the-art project management system.

Responsible for licensing-in and licensing-out of biopharmaceutical product candidates. Identified and evaluated new internal and external business opportunities, including profitability calculation and due diligences. Negotiated licensing agreements. Created business plans.

Responsible leader for diagnostics development

Biophysical investigations of recombinant prion protein

Analytische Chemie Radiopharmazeutische Chemie

Biochemie