Virology, Viral safety and vaccines expert
Dr. Jens-Peter Gregersen is an Independent Professional and Biomedicines Consultant with longstanding experience in applied virology, viral safety, and in vaccines and biomedicines development. During his industrial career he played a major role in the development and licensure of innovative medicinal products. He is a specialist and internationally recognized expert in technical vaccine development and in viral safety of biomedicinal products and processes.
Jens-Peter Gregersen received his DVM degree at the Free University in Berlin and holds a PhD in Virology. After 5 years in academic research, he changed to industry where he held various positions in human and veterinary medicinal research and Development(R&D).
His early occupations in industry include human and veterinary vaccine research, development, and product care at Behringwerke AG, heading the veterinary research at Hoechst AG with the development of veterinary drug products, and a position as R&D Consultant at Biotech Australia with responsibility for the development and licensing of the first recombinant parasite vaccine.
In 1994 he established a Virology and Preclinical Development team in Marburg/Germany as a core for the development of new vaccines for Chiron Vaccines, which in 2006 became Novartis Vaccines. During this time he started the development of a new influenza vaccine (Optaflu®/Flucelvax® or the pandemic Celtura® variant) form a permanent cell line that had been considered unlicensable. With much personal engagement and perseverance, thorough characterization of the cell line, the development of a new, encompassing viral safety concept, and accompanied with intensive interaction with authorities, licensing hurdles at the EDQM, EMEA and FDA could be overcome.
In his latest positions at Novartis and GSK, and based upon his extensive experience in those fields, Dr. Gregersen took over the Technical Stewardship for Viral Safety, serving all global sites of Novartis Vaccines, and also serving the Biopharma Operations. In addition he also acted as a Technical Steward for Innovation who developed and implemented new technologies and cared for patent applications. Dr. Gregersen retired in 2016 and founded his own consultancy business.
Areas of Specific Expertise
- Viral Safety: Viral safety concepts, risk assessments, raw materials, facility/process contamination and decontamination, contamination emergency planning
- General virology aspects and methods: Viral propagation, viral/microbial inactivation/reduction methods, virus testing
- Vaccine R&D and licensing: Preclinical/technical vaccine development, R&D transition, project evaluations and project risk management