Marko Repic Email & Phone Number

Consultant fully integrated as a virtual team member of US and European biotech and pharmaceutical companies, covering non-clinical and regulatory functions. Taking responsibility for design and execution of product-tailored non-clinical development programs with focus on innovative treatment concepts.• Science-driven approach to design of non-clinical development strategies for a broad range of products: biologics, viral vectors (AAV, lenti- and retro- viruses), gene editing, CAR T cells, vaccines and immunotherapies • Detailed knowledge of European and US non-clinical regulatory landscape• Planning and execution of early regulatory meetings in Europe and US; scientific advice, pre-IND• Design of non-clinical pharmacology, pharmacokinetics, and pivotal toxicology studies• Planning and execution of non-clinical programs, cost and time estimates, oversight of non-clinical studies• Authoring of regulatory documentation: non-clinical study reports, briefing documents, non-clinical sections of Investigator’s Brochures, INDs / CTDs