UPDATE ON COMBACTE STATUS AND ACTIVITIES

Transcription

1 UPDATE ON COMBACTE STATUS AND ACTIVITIES MARC BONTEN APRIL 24TH, 2017

2 Program 18:30-18:50 Update on COMBACTE status and activities Prof. Dr. Marc Bonten (UMC Utrecht) 18:50-19:10 Studies on Clostridium difficle- ANTICIPATE study, COMBACTE-CDI Dr. Maria Vehreschild (University of Cologne) / Prof. Dr. Marc Wilcox (Leeds Teaching Hospitals NHS Trust) 19:10-19:30 Results from RESCUING study Dr. Miguel Pujol (Bellvitge Spain) 19:30-19:45 Update on ASPIRE-ICU/SSI Prof. Dr. Jan Kluytmans (Amphia Breda) 19:45-20:00 Update on the SAATELLITE and EVADE studies Dr. Bruno Francois (CHU Limoges)/Dr. Hasan Jafri (AstraZeneca/MedImmune) close 2

3 COMBACTE Meeting 25 Countries represented

4 COMBACTE Meeting 70 Specialities Clinical Microbiology Clinical Research Epidemiology Infectious Diseases Intensive care Internal Medicine Other Pharmaceutical Medicine Project Manager 4

5 COMBACTE: Combatting Bacterial Resistance in Europe Three consortia: CDI Create a self-sustaining antibacterial development network Expanding research and laboratory networks Optimal alignment of clinical trials with investigator sites Obtain clinical and epidemiological data Increase efficiency of antimicrobial drug development Align clinical trials with cutting edge molecular mehodologies and trial design Deliver clinical trials with various candidate compounds from pharmaceutical companies 5

6 Innovative Medicines Initiative (IMI): a new way to collaborate The largest public-private partnership in life science R&D IMI1 Started in 2008, ended in Calls launched IMI2 Started in 2015 EFPIA = European Federation of Pharmaceutical Industries and Associations 6

7 Innovative Medicines Initiative (IMI): a new way of working Main objectives: Accelerating the development of safer and more effective medicines for patients in Europe Boosting the biopharmaceutical sector in Europe Creating a collaborative environment for academia, industry, SMEs, regulators, patients ND4BB is part of the Action plan against the increased threats from AMR launched by the European Commission in November

8 ND4BB Vision: Delivering a pipeline of new antibacterial agents to patients Discovery Clinical Development Commercialisation Filling the pipeline Early Discovery Discovery & Preclinical Phase I Phase II Phase III Regulatory Review Phase IV Translocation ENABLE COMBACTE-NET DRIVE-AB COMBACTE-CARE COMBACTE-CDI COMBACTE-MAGNET iabc 8

9 Timeline and total budget estimation of the seven topics of the ND4BB programme (EFPIA contribution) 9

10 ND4BB-EFPIA Partners COMBACTE-NET COMBACTE-CARE COMBACTE-MAGNET TRANSLOCATION ENABLE DRIVE-AB i-abc GSK, AZ-Medi, Da Volterra, Medicines Company, Janssen AZ-Medi, GSK, Basilea AZ-Medi, Aicuris, Basilea, GSK, Sanofi GSK, Sanofi, AZ-Medi, Basilea, Janssen GSK, Sanofi, AZ-Medi, Basilea AZ-Medi, GSK, Astellas, Pfizer, Roche, Sanofi, Novartis, Basilea 10

11 COMBACTE s ambition 2-3 years 11

12 COMBACTE Clinical studies COMBACTE NET COMBACTE CARE ASPIRE-ICU AZ/MI ICU_VAP Epi SAATELLITE AZ/MI ICU RCT ASPIRE-SSI AZ/MI Epi WP6E tbd AZ/MI ICU RCT ANTICIPATE DaV Epi WP8 MedComp ICU RCT EURECA AZ Epi REJUVENATE AZ ICU+ RCT WP2B AZ ICU+ RCT Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 593/ /270 15/ / / /40 COMBACTE MAGNET EVADE AZ/MI ICU_VAP RCT 34/285 WP4B AZ/MI ICU_VAP RCT /980 RESCUING Retro 1013 (recruitment completed) WP6G AiCuris cuti RCT /240 WP6H AiCuris ciai RCT PREPARE MERMAIDS ARBO Epi MERMAIDS ARI Epi REMAP-CAP ICU adaptrct 162/ /2000 5/4000 Shionogi CREDIBLE-CR RCT 14/150 MK-7655A Protocol 014 Merck RCT HABP/VABP CTTI Epi /1000 Colistin OVERCOME RCT 157/444 (outside o preparation phase trial period March 2016:

13 Participation COMBACTE studies Albania Bulgaria Croatia Czech Republic France Germany Greece Hungary Israel Italy Romania Serbia ANTICIPATE ASPIRE-ICU ASPIRE-SSI CTTI EURECA EVADE NIH RESCUING REJUVENATE SAATELLITE Spain The Netherlands Turkey United Kingdom

14 COMBACTE collaboration > 800 hospitals 55 academic partners 42 countries 8 EFPIA partners 14

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16 CLIN-Net is built on National coordinators Responsibilities/Role National Coordinator Ambassador for COMBACTE Assist in identification and recruitment of local sites for COMBACTE studies Advice on local recruitment strategies and local trial execution problems Support in local F2F and online GCP training Annual CLIN-Net National Coordinator meeting Regular country visits to consolidate the local network and role of the National Coordinator 2016: Greece, Bulgaria, Italy, Portugal and Hungary 2017: Romania, Czech Republic, Poland, Croatia, Serbia, Slovakia, Ireland 16

17 Third CLIN-Net National Coordinators meeting Amsterdam, 15 October 2016 OPTIONAL TEXT 17

18 GCP training essential tool of CLIN-Net Online or face-to-face in collaboration with EF-GCP PharmaTrain accredited and TransCelerate compliant Year Online GCP course Face to face GCP course Total

19 COMBACTE classification/certification system Member sites 1: sites who have been selected for one or more studies/trials Currently: 227 sites of which 114 are actively recruiting patients Further differentiation of these sites depending on performance on specific indicators Member sites 2: basic information provided by member site through a questionnaire or by being present at a COMBACTE country visit Currently: 424 sites Member sites 3: only contact details available Currently: 432 sites 19

20 COMBACTE classification/certification system 6 performance indicators (to be determined): Enrollment rates: actual / predicted number of patients Turnaround time for EC/IRB approval Turnaround time for contract agreement Completion time for ecrfs Response time to ecrf queries Certified GCP training status of research team (Critical findings from audits/inspections) 20

21 COMBACTE context 21

22 Accountability through study dashboard 22

23 Improve updates COMBACTE-CARE COMBACTE-NET COMBACTE-MAGNET ALL PROJECTS 23

24 Stimulate collaboration between peers in visualizing the network 24

25 Next steps: July/August 2017 Overview of all publications Easier access to publications by creating publications library; add presentations, posters User research Continue user research with regards to our network. Developing new features based on user research Further dissemination of accountability Sharing all milestones, metrics study & project progress and achievements on a clear and inspiring timeline 25

26 COMBACTE Newsletter 26

27 A plan for the future European Clinical Research Alliance on Infectious Diseases ECRAID 27

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29 ECRAID services Site selection and training End point quality assurance Study design Protocol Statistical analysis plan (SAP) Database Training materials Interaction with regulatory agencies Study execution Data management Trial progress review Site monitoring Recruitment/reten- Safety monitoring tion strategies Protocol modification Protocol deviation review SAP validation Study report Statistical analysis Study report Manuscript Clinical research Laboratory research and support Epidemiological research and support Biobanking Training, education and capacity building Statistical analyses and support Supporting services ICT and datamanagement Service enabling capabilities

30 ECRAID networks design execution report Clinical research LAB-Net Laboratory research and support Training, education and capacity building EPI-Net Epidemiological research and support STAT-Net Statistical analyses and support ICT and datamanagement Biobanking

31 Thank you for your attention!