Dr. Marco Springer

- Project management for conceptional research & development up to validation of innovative tools for immunomonitoring of preclinical and clinical samples (e.g. on the proprietary ELISpot platform), GLP/GCLP - Set up and supervision of a new AID service unit for immunomonitoring of preclinical and clinical samples according to international regulatory requirements (GCLP)

Please contact me if you need specialist expert knowledge in the following fields of drug development: - Bioanalytical and preclinical consultancy (monoclonal antibodies, biosimilars, tumor vaccines (DNA/RNA), biomaterials) for regulated drug development and bioanalytics - Third party CRO management

Corporate Development and Project Management for drug products, medical devices. Focus on immunomonitoring (ELISpot, Luminex, MSD).

Project Management for development of oral cancer vaccines, also in combination with checkpoint Inhibitors. Preclinics: regulatory toxicology / pharmacodynamics in vivo and in vitro. Bioanalytics: Immunomonitoring, Pharmakokinetics, Immunogenicity, Biomarker, CMC assay development according to GLP / GMP. Regulatory: Compilation of regulatory documents Development of universal vaccination platform based on attenuated Salmonella vectors. Other: Project Management of governmental grants.

Project Management and coordination of bioanalytics for biosimilar development projects (EpoRatio, (PEG)-Filgrastim and others) from preclinics to Phase IV (e.g. in vitro and in vivo assay development/validation/usage for Pharmacokinetics/Toxicokinetics, immunogenicity / ADA) in collaboration with external CROs.

Planning and coordination of preclinical studies in vivo and in vitro (including PK, immunogenicity, bioassays) for therapeutic human antibodies (MOR103 and MOR202), in collaboration with internal departments and external CROs/CMOs, coordination of IMPD compilation to start clinical phase I study.

Coordination and planning of R&D activities of new galenic formulations for an osteogenic medical device based on osteoinductive xenogenic collagen. Support for a 510k FDA application.

Diplom am DKFZ Heidelberg / ATV (Abteilung Prof. Dr. Harald zur Hausen, Nobelpreis 2008)