Presentation of the Strategic Research Agenda Herman Goossens Chair Scientific Advisory Board
Members of the SAB Herman Goossens (Chair) Antoine Andremont Hajo Grundmann Fernando Baquero Stephan Harbarth Birgitta Henriques Normark Marc Bonten Yehuda Carmeli Patrice Nordmann (till 09/2013) Niels Frimodt-Møller Arnfinn Sundsfjord Petra Gastmeier (10/2013) Timothy Walsh Bruno Gonzalez-Zorn Paul Williams
Mission Statement The SRA of the JPI on AMR will develop integrated approaches to pursue unique world-class research on AMR that will be translated into new prevention and intervention strategies that improve the public health and wellbeing of populations, and delivers economic and societal benefit throughout Europe and beyond.
Overall Goals To reduce the burden of AMR by: • Identifying gaps, obstacles and opportunities for understanding and controlling AMR. • Stimulating research into the causes, prevention, diagnosis and treatment of infections caused by resistant organisms. • Generating novel approaches for improved healthcare. • Translating this knowledge into step changes in policy and practice to safeguard future generations.
Criteria for Selecting Research Priorities • Be ambitious and broad • Be groundbreaking at European level • Have high expected returns • Be of urgency for Europe and other regions • Reinforce Europe’s contribution to global public health • Provide guidance for developing the research agenda in Europe and globally • Be complementary, with clear links and synergies within and across themes
Development Process of the Strategic Research Agenda • Five meetings of the Scientific Advisory Board • A consultation process with stakeholders • A series of expert workshops • An online public consultation process (1st September – 15 October 2013) – 44 questionnaires – 11 national advices of participating countries
Six Research Priorities to Reduce AMR Minimizing antimicrobial resistance Interventions Therapeutics Transmission Environment Surveillance Diagnostics Enabling activities
Research Priorities (A-C) • Development of novel antibiotics and alternatives for antibiotics – from basic research to the market. • Design strategies to improve treatment and prevention of infections by developing new diagnostics. • Standardisation and extension of surveillance systems to establish a global surveillance program on antibiotic resistance and antibiotic use.
Research Priorities (D-F) • Transmission dynamics. • The role of the environment as a source for the selection for and spread of AMR. • Designing and testing interventions to prevent acquisition, transmission and infection caused by AMR. Agenda: Discuss each priority (background and objectives)
Research Priority A: Development of novel antibiotics and alternatives for antibiotics – from basic research to the market New systemic antibacterial agents approved by the US FDA per 5-year period Boucher et al, Clin Infect Dis 2013; 56:1685--94
Research Priority A: Development of novel antibiotics and alternatives for antibiotics – from basic research to the market Objectives • New antibiotics and alternatives to antibiotics (e.g. Immunotherapy, anti-virulence and anti- colonisation approaches) • Improve existing antibiotics, including optimisation of drug use, dosage and delivery • Regulatory and economic aspects, in close collaboration with private (e.g. EFPIA) and public (e.g. EMA, FDA) bodies
Research Priority B: Design strategies to improve treatment and prevention of infections by developing new diagnostics Fenn et al 2008; Harvard Business Press, Cambridge Becker, 2009; Lab Chip 9, 2119 – 2122
Innovation Pathway for Appropriate Diagnostics Epidemiology Genetics & Genomics Proteomics Pathogenesis Regulatory Approval: 2 – 5 Years Immunology Animal models Diagnostic Targets Test introduction: Proof of Product Lab & field Test implementation Target Product Principle Prototype evaluations adoption research Profile Technology platform Microscopy Serology Policy and Uptake: 5 – 7 years Microfluidics Nanotechnology Adapted from Okeke et al, Drug Res Updates, 2011
Research Priority B: Design strategies to improve treatment and prevention of infections by developing new diagnostics Objectives • Roadmap for the development of rapid diagnostics • Sustainable business models • Clinical validity, clinical utility and cost- effectiveness • Identifying barriers for acceptance of rapid diagnostic tests
Research Priority C: Standardisation and extension of surveillance systems to establish a global surveillance program on antibiotic resistance and antibiotic use % ESBL-Producing E. coli - 2012 (EARS-Net) % ESBL-Producing Enterobacteriaceae (AAC 2009; 53:3280-4)
Research Priority C: Standardisation and extension of surveillance systems to establish a global surveillance program on antibiotic resistance and antibiotic use Versporten et al, LID , 20 March 2014
Antibiotic prescriptions, per age- groups, 1987-2013, Sweden.
Lack of Standardisation of Surveillance of Antibiotic Use in Hospitals • Numerator: – Weight (g or kg or units of treatment) – Vials – Agent days – Courses – Treatment periods – Percentage of patients exposed to antimicrobials – Antibiotic days or Days of Treatment (DOT) – DDD (Defined Daily Dose) – PDD (Prescribed Daily Dose) • Denominator: – Per month or year – Per 1000 inhabitants-days – Per 100 or 1,000 patient-days – Per 100 or 1,000 administrative bed-days – Per 100 or 1,000 occupied bed-days – Per 100 or 1,000 admissions – Per 100 or 1,000 discharges – Per month/occupied bed – Per Thousand Finished Consultant Episodes
Research Priority C: Standardisation and extension of surveillance systems to establish a global surveillance program on antibiotic resistance and antibiotic use Objectives • Operational research on the standardisation and extension of surveillance systems, in collaboration with WHO • Pilot study regarding a global surveillance programme, based on new technologies (e.g. genomic sequencing) • Surveillance on antibiotic use in humans, agriculture and aquaculture
Research Priority D: Transmission dynamics household members travel & pets animals food
Emergence of Carbapenemase: Story of Pandemics of Clones, Plasmids and Genes, but Why…??? • Example of clonal spread: – Klebsiella pneumoniae ST258 with KPC gene • Example of plasmid spread: – IncL/M plasmid with OXA-48 gene • Example of gene spread: – NDM-1 carbapenemase gene
Research Priority 4: Transmission dynamics Objectives • Unravel the complex dynamics of selection and transmission of antibiotic resistance • Identifying factors for the persistence and spread of resistant organisms and resistance genes • Understanding the different systems of health care, animal production and global trade and their impact on AMR
Research Priority E: The role of the environment as a source for the selection for and spread of antimicrobial resistance
Research Priority E: The role of the environment as a source for the selection for and spread of antimicrobial resistance Objectives • Identification of interventions that reduce the burden of AMR in the environment • Risk assessment to estimate key environmental transmission pathways • Understanding the basic biological processes • Development of industrial systems to reduce AMR in the environment
Research Priority F: Designing and testing interventions to prevent acquisition, transmission and infection caused by AMR % Invasive MRSA 2002 - 2012 Reasons for success? • Hand hygiene campaigns? • Improvements of contact isolation and environmental control, with reduced cross transmissions? • Screening for MRSA carriage? • Antibiotic policies with reduced antibiotic selective pressure? • Natural fluctuation of certain clones with regression to the mean?
“One Health” 0.5 National reduction in “4C” Prescriptions per 1000 population per day antibacterials in primary care in 0.4 Scotland SAPG guidance on 0.3 antibiacterials with a higher (Scottish Antimicrobial risk of C difficile infection Prescribing Group Primary Care 0.2 Prescribing Indicators reports, 0.1 2010 and 2012-13) 0 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12 2012/13
Research Priority F: Designing and testing interventions to prevent acquisition, transmission and infection caused by AMR Objectives • Research into effectiveness of AMR prevention and control strategies (e.g. cluster-randomized trials) • Comparing and combining AMR prevention and control practices (including cost-efficacy trails) • Real-world implementation (e.g. testing clinical algorithms)
Enabling activities to strengthen the impact • Developing a publicly accessible database of research activities in the EU: – ensure that research is complementary and that there are no major overlaps, – aid in identifying gaps and research opportunities – assist in decision making for the different funding bodies, – enable the monitoring of the impact of research.
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