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Preparedness for emerging pathogens: challenges and needs Menno de Jong Department of Medical Microbiology Academic Medical Center, University of Amsterdam & Centre for Tropical Medicine University of Oxford Conflict of interest disclosure ✓I have no, real or perceived, direct or indirect conflicts of interest that relate to this presentation. I have the following, real or perceived direct or indirect conflicts of interest that relate to this presentation: Affiliation / financial interest Nature of conflict / commercial company name Tobacco-industry and tobacco corporate affiliate related conflict of interest Grants/research support (to myself, my institution or department): Honoraria or consultation fees: Participation in a company sponsored bureau: Stock shareholder: Spouse/partner: Other support or other potential conflict of interest: This event is accredited for CME credits by EBAP and speakers are required to disclose their potential conflict of interest going back 3 years prior to this presentation. The intent of this disclosure is not to prevent a speaker with a conflict of interest (any significant financial relationship a speaker has with manufacturers or providers of any commercial products or services relevant to the talk) from making a presentation, but rather to provide listeners with information on which they can make their own judgment. It remains for audience members to determine whether the speaker’s interests or relationships may influence the presentation. Drug or device advertisement is strictly forbidden. SARS CoV 2003 Emerging infectious disease threats during the past decade Flu H5N1 2004 Flu H1N1 2009 MERS CoV 2012 Flu H7N9 2013 Ebola 2014 Pillars of epidemic preparedness • prediction – understanding emergence – surveillance – modelling • early recognition and containment – surveillance – clinical awareness – infection control • (pre)clinical research – pathogen & disease characterization – prevention & treatment • funding – rapid responses The risk of emergence of emerging infectious diseases is high in regions where capacity to recognize and contain these is low. Hotspots for (re-)emergence of zoonotic (a) or vector-borne (d) pathogens Jones KE et al. Drivers: - socio-economic (population density/growth) - environmental (latitude, rainfall) - ecological (richness wildlife species) There are many known unknowns.. MDR-TB CTX-M ESBLs …and how about the unknown unknowns? “Laboratory Medicine is the weakest component of Health systems” Laboratory capacity for EID threats: opportunities for cross-talk? Makerere University Kampala, Uganda Hospital Microbiology HIV program (Johns Hopkins) H. Adam Malik Hospital Medan, Indonesia Hospital Microbiology TB program (GFATM) MERS-CoV in South Korea Eurosurveillance, Volume 20, Issue 25, 25 June 2015 Ebola in Spain and the US Pillars of epidemic preparedness • prediction – understanding emergence – surveillance – modelling • early recognition and containment – surveillance – clinical awareness – infection control • (pre)clinical research – pathogen & disease characterization – prevention & treatment • funding – rapid responses Infected patients Clinical research response to ID outbreaks are usually fragmented and too late time Public Health response Preclinical research response clinical research response 16 Pandemic responses: influenza 1918 vs Public Health measures Pathogen characterization Clinical research JAMA. 1918;71:1311 2009 Clinical research is essential in the face of emerging epidemics • Observational studies – clinical and severity spectrum, risk factors – pathogen shedding and infection control – pathogenesis and clinical management • Intervention studies – optimize clinical management and prevention severe symptomatic asymptomatic Global hurdles for timely clinical research during epidemics • Health care capacity – clinical services unprepared and overwhelmed • Collaboration and coordination – fragmented observations, studies – academic careers • Ethical, administrative, regulatory, logistical – 621 days: the average time from development of a clinical research protocol to recruitment of a patient* * Academy of Medical Sciences UK. A new pathway for the regulation and governance of health research. 2011. Rare diseases European definition: < one person per 2,000 US definition: < 200,000 individuals in the US Fischer A, Borensztein P, Roussel C (2005) The European Rare Diseases Therapeutic Initiative. PLoS Med 2(9): e243. doi:10.1371/journal.pmed.0020243 Source: Eurodis. Rare Diseases in numbers. 359 SARS MERS-CoV H5N1 / H7N9 Source: Eurodis. Rare Diseases in numbers Unpredictable emergence Geographically dispersed globally…. …and locally MERS-CoV cases http://rambaut.github.io/MERS-Tools/cases2.html Accessed 03 Sept 2015 Clinical research in the context of epidemics needs a new paradigm: better prepared and ready to act. Identify and solve hurdles for rapid clinical research responses Advance development of standardized protocols, consent forms, case report forms and logistical plans. Available, translated, peer-reviewed, preapproved and readily adaptable. Open access and sharing throughout the process of research. Networking and building of trust in peace time for joint research during epidemics. Change in the approach of the academic community, funders, ethical committees, global agencies and local institutions. Build: Human capacity. Data systems. Laboratory capacity. Bio-banks. International Severe Acute Respiratory and Emerging Infection Consortium Federation of clinical networks Launched in 2011 Open access protocols Pre-approvals Outbreak clinical research PREPARE Platform foR European Preparedness Against (Re-)emerging Epidemics 2014-2019 27 partners: academia, clinical networks, societies, industry Coordinators: Herman Goossens University of Antwerp Menno de Jong University of Amsterdam OUR MISSION To establish PREPARE as the European clinical research framework for harmonised large-scale clinical research studies on infectious diseases prepared to rapidly respond to any severe infectious disease outbreak providing real-time evidence for clinical management of patients and for informing public health responses European clinical research network - from primary care to intensive care - European Community and Hospital care networks Primary Care Network > 600 general practitioners in 19 European countries Hospital Care Network > 700 hospitals in 35 European countries Embedded internationally European multi-center clinical trials, adding new arms to adaptive trial design as and when needed Fit-for-purpose patient oriented pathogenesis studies European diagnostic laboratory support Infected patients Fast-forward clinical research during epidemics to improve clinical and pulic health management time Public Health response clinical research response Preclinical research response Epidemic preparedness research: European Union-supported efforts • prediction – understanding emergence – surveillance – modelling a n t i g o ne 2009-2016 € 36 M • early recognition and containment – surveillance – clinical awareness – infection control 2015-2020 € 21 M • clinical research 2014-2019 € 24 M – pathogen & disease characterization – prevention & treatment • funding – rapid responses GloPID-R 2015-2020 €3M a n t i g o ne COllaborative Management Platform for detection and Analyses of (Re-) emerging and foodborne outbreaks in Europe An enabling platform for early recognition and containment of infectious disease outbreaks by generating, sharing and comparing genomic information of pathogens across sectors, time and locations, with contextual metadata. 2015-2020 29 partners Coordinators: Frank Aarestrup Technical University of Denmark Marion Koopmans Erasmus Medical Centre Acknowledgements PREPARE COMPARE ANTIGONE GloPID-R-sec