Helmholtz Zentrum München, Deutsches Forschungszentrum für Gesundheit und Umwelt GmbH (HMGU)
Helmholtz Zentrum München is a research center with a mission to discover personalized medical solutions for the prevention and therapy for environmentally triggered diseases and promote a healthier society in a rapidly changing world. Helmholtz Zentrum München is headquartered in Neuherberg in the north of Munich with clinically oriented departments located closed to the University Hopitals, and has about 2,500 staff members. It is a member of the Helmholtz Association, the largest scientific organization in Germany with more than 40,000 employees at 19 research centers.
Role in TherVacB
HMGU is the Project Coordinator. The HMGU team is working on the development of a therapeutic hepatitis B vaccine candidate for more than five years and has designed the vaccine components and developed and IP protected the heterologous prime-boost scheme to be used in TherVacB. The immune monitoring group has established GLP-compliant SOPs for the management, processing and storage of biological samples from clinical studies and has validated immunoassays and SOPs for the monitoring of HBV-specific immune responses.
Based on its extensive expertise, the HMGU team will conduct TherVacB management; dissemination, exploitation, communication; preclinical testing and regulatory affairs as well as immune monitoring and biomarker identification.
Coordinator and Head of the Institute of Virology
She is full professor and Chair of Virology at Technical University of Munich (TUM), School of Medicine and Director of the Institute of Virology at Helmholtz Zentrum München and TUM. She has trained as hepatologist and as clinical virologist and is heading a virology diagnostics department serving the two university hospitals of TUM. Working for almost twenty years in infectious diseases and in viral hepatitis research, she has become a worldwide acknowledged and rewarded scientist for hepatitis B. She has published more than 130 original paper and 40 review articles, filed 8 patents and contributed to national and international recommendations and guidelines for Diagnosis, Prevention and Treatment of Hepatitis B and C Virus Infections. Ulrike Protzer has developed the therapeutic vaccine candidate TherVacB more than five years ago and has ever since led the scientific as well as strategic development of TherVacB. She initiated and coordinates the TherVacB consortium.
Project Manager Vaccine Components and Preclinical Studies
He was involved in the development and pre-clinical evaluation of the TherVacB vaccination strategy since its first beginning. He coordinates the pre-clinical GLP studies as well as the GMP production of the vaccine components.
He has experience in preclinical and clinical development of biological compounds, including establishing of manufacturing processes and quality control systems. Marian is responsible for the overall project management and is involved in regulatory affairs of TherVacB.
Head of the Immune Monitoring Group
She is specialist in immune monitoring of clinical trials. She is responsible for the immune monitoring of the TherVacB phase Ia clinical trial starting in 2020, preceding the current phase Ib/IIa trial. Tanja also contributes to the clinical trial management.
Communication / Disseminaton
She was involved in the development and pre-clinical evaluation of the TherVacB vaccination strategy since its first beginning. She has experience in quality control testing and GMP release of clinical trial material and is responsible for communication and dissemination of the TherVacB results.