Regulatory Capacity Building Workshop: Vaccine Clinical Trial Review from Ebola to HIV GERMAN CENTRE FOR INFECTION RESEARCH (DZIF)
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1 Regulatory Capacity Building Workshop: Vaccine Clinical Trial Review from Ebola to HIV Kigali, Rwanda March 2015 GERMAN CENTRE FOR INFECTION RESEARCH (DZIF) Christoph Conrad Paul-Ehrlich-Institut Paul-Ehrlich-Strasse Langen GERMANY +49 (0) (0) Homepage:
2 German Centers for Translational Research (DZG) German Center for Infection Research (DZIF) German Center for Cardiovascular Research (DZHK) German Center for Lung Research (DZL) German Consortium for Translational Cancer Research (DZK) German Center for Diabetes Research (DZD) German Center for Neurodegenerative Diseases (DZNE) 2 German Centers for Translational Research
3 Decentralized Structure of DZG Cancer Heart Lung Neuro Diabetes Infection 3 German Centers for Translational Research
4 German Center for Infection Research (DZIF) 7 Partner Sites 32 Academic Institutions 4 German Center for Infection Research
5 Mission and Objectives Integrate the existing, but fragmented strength in infection research into a National Center for Translational Infection Research in Germany Close the gap in the translational chain in infection research Establish a product development structure Develop new approaches for the diagnosis, prevention and therapy of important infectious disease challenges Establish a clinical trial structure in DZIF Support career development in infection research and infectious diseases Establish DZIF as a new National Center for Infection Research 5 Mission and Objectives
6 DZIF Support of TTUs: Infrastructures Grand Challenges Emerging Global Immunocompromised Host Therapy-resistant 5.1 TTU Emerging 5.4 TTU HIV 5.7 TTU of the Immunocompromised Host 5.8 TTU Healthcareassociated 6.1 DZIF Product Development Unit 5.2 TTU Tuberculosis 5.5 TTU Hepatitis 5.9 TTU Novel Antiinfectives 6.6 DZIF Bioinformatics 6.2 DZIF Clinical Trial Unit 6.3 DZIF African Partner Sites 5.3 TTU Malaria 6.7 DZIF Academy 5.6 TTU Gastrointestinal 6.4 DZIF Biobanking 6.5 DZIF Natural Compound Library Thematic Translational Units Translational Infrastructures 6 Infrastructures
7 The Translational Mission DZIF-Product Development Unit (DZIF-PDU) Academia Translational GAP Pharmaceutical/ Biotech Industry DZIF-Product Development Unit (PDU) Translational Project Management Office Office for Scientific and Regulatory Advice (PEI) DZIF Infrastructure Clinical Trial Unit Discovery Preclinical Development Clinical Development Market 7 The Translational Mission
8 DZIF African Partner Sites Coordinators Jürgen May, Hamburg-Lübeck-Borstel (co-representing TTU Malaria) Christian Drosten, Bonn-Köln (co-representing TTU EI) Site representatives Peter Kremsner, Tübingen (representing TTU Malaria) Michael Hoelscher, München (co-representing TTU Tb) Rainer Sauerborn, Heidelberg Achim Hörauf, Bonn-Köln (co-representing TTU Novel Antiinfectives) Focus Sites Kumasi/Ghana Ellis Owusu-Dabo, Deputy Director, Kumasi Centre for Collaborative Research, Kumasi, Ghana Lambaréné/ Gabon A. Adegnika, Deputy Director, Medical Research Unit, Albert Schweizer Hospital Lambaréné, Gabon Mbeya/ Tanzania L. Maboko, Co- Director, Mbeya Medical Research Programme, Tanzania Nouna/ Burkina Faso A. Sié, Centre de Recherche en Sante de Nouna, Burkina Faso Partner Sites Hamburg-Lübeck- Borstel Bonn-Köln Tübingen München J. May B. Kreuels R. Krumkamp T. Tamminga C. Drosten A. Hörauf P. Kremsner B. Mordmüller M. Hoelscher N. Heinrich A. Kroidl E. Saathoff Heidelberg R. Sauerborn, T. Junghanss
9 The Translational Mission: From Bench to Bedside 9 The Translational Mission
10 Perspectives 2015 TTUs matured into centres of excellence New DZIF faculty recruited, infrastructures established and operating One to two anti-infectives / vaccines processed through preclinical studies and clinical phase I/II trials until 2015 Strategic Alliances with Industry, national and international Institutions DZIF will become a true National Center for Translational Infection Research in Germany 10 Perspectives 2015
11 Thank you for your attention!
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