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1. Defining the scope of the European Antimicrobial Resistance Surveillance network in Veterinary medicine (EARS-Vet): a bottom-up and One Health approach

Author

Mader, R., Demay, C., Jouvin-Marche, E., Ploy, M. -C., Barraud, O., Bernard, S., Lacotte, Y., Pulcini, C., Weinbach, J., Berling, C., Bouqueau, M., Hlava, A., Habl, C., Kernstock, E., Strauss, R., Muchl, R., Buhmann, V., Versporten, A., Ingenbleek, A., Vandael, E., Haelterman, G., De Raedt, L., Hunjak, B., Raickovic, B., Mackova, B., Niklova, E., Zemlickova, H., Hrivnakova, L., Jindrak, V., Kristensen, B., Lyndrup, M., Skovgaard, S., Wolf Sonksen, U., Aasmae, B., Ruut, J., Linnik, L., Sadikova, O., Martin, P., Zanuzdana, A., Kizilkaya-Guneser, G., Oezcelik, N., Eckmanns, T., Lambrou, A., Kontopidou, F., Papadaki, M., Tsana, M., Maroulis, N., Vatopoulos, A., Papadogiannakis, E., Kontarini, M., Gikas, A., Magkanaraki, A., Cozza, A., Martinelli, D., Fortunato, F., Prato, R., Marella, A. M., Pantosti, A., Prestinaci, F., Busani, L., Pezzoti, P., Creti, R., Martoccia, R. M., Brusaferro, S., Vilde, A., Jakovela, A., Langusa, E., Grudule, L., Grinsteine, M., Dumpis, U., Dambrauskiene, A., Vitkauskiene, A., Tirvaite, D., Cemnalianskis, L., Kazenaite, E., Lozoraitiene, I., Adomaitiene, R., Ambrazaitiene, R., Kiveryte, S., Maciulaityte, A., Kuklyte, J., Petrene, J., Valinteliene, R., Kanapeckiene, V., Razmiene, A., Kairiene, B., Aleksiene, G., Valinciute, G., Petraitis, R., Elsemulder, A., Nakched, A., Claessen, J., Gui, L., Kort, M. D., Peran, R., Van Leeuwen, A., Smeets, E., Mennen, M., Spruijt, P., Westerhof, R., Skulberg, A., Bakka, E. Ro., Miard, K., Henricsen, S. Ho., Pellerud, A., Kallberg, C., Ardal, C., Eriksen, H. -M., Kranstad, K., Molvik, M., Kacelnik, O., Sollund, P., Samuelsen, R., Bakke, T., Urdahl, A. M., Norstrom, M., Olczak-Pienkowska, A., Skoczynska, A., Zabicka, D., Bysiek, J., Rekawek, J., Lebre, A., Falcao, E., Scripcaru, G., Neves, I., Gomes, S., Pereira, N., Malutan, A. M., Iuhas, C., Szakacs, L., Kissiedou-Bob, M., Ciortea, R., Grilc, E., Klavs, I., Turk, K., Subelj, M., Vrdelja, M., Serdt, M., Jemec, N., Glavan, U., Simonovic, Z., Tamayo, A. N., Lopez Navas, A., Munoz Madero, C., Alonso Lebrero, J. L., Alonso Irujo, L., Santacreu Garcia, M., Crespo Robledo, P., Oliva, G., Massanes, M., Oliver Palomo, A., Garcia Pineda, A., Ferragut, E., Rojo, E., Castano, E., Perianez, L., Torres Cantero, A. M., Jimenez Guillen, C., Hukelova, H., Alcaraz, M., Carlos, M. A., Lopez Acuna, M. D. P., Gil Setas, A., Ibarrola Segura, A., Ezpeleta, C., Gahigiro Merino, C., Portillo Bordonabe, M. E., Fragoso, M., Beristain Rementeria, X., Penalva, G., Cisneros, J. M., Estevez, M., Monteau, S., Del Rio, L., Gonzalez De Suso, M. J., Gallego Berciano, P., Aranguren Oyarzabal, A., Alioto, D., Izquierdo Palomares, J. M., Calvo Alcantara, M. J., Gonzalez Perez, R., Havarria, T., Hulth, A., Carlin, K., Edman, L., Grape, M., Aspevall, O., Haggar, A., Lindal, E., Burgos, A., Ottoson, J., Ostman, M., Egervarn, M., Nordenfelt, A., Bengtsson, B., Soderman, I., Bjers, A., Jonsson, J. -I., Starborg, M., Laine, M., Fagerstedt, P., Metcalfe, A., Soder, J., Lytsy, B., Madec, J. Y., Collineau, L., Berger-Carbonne, A., Colomb-Cotinat, M., Bourely, C., Amat, J. -P., Broens, E. M., Callens, B., Crespo-Robledo, P., Damborg, P., Filippitzi, M. -E., Fitzgerald, W., Gronthal, T., Haenni, M., Heuvelink, A., Van Hout, J., Kaspar, H., Pedersen, K., Pokludova, L., Dal Pozzo, F., Slowey, R., Zafeiridis, C., Madec, J. -Y., and Departments of Faculty of Veterinary Medicine

Subjects
Microbiology (medical), Veterinary medicine, Staphylococcus pseudintermedius, 040301 veterinary sciences, Swine, Drug Resistance, 413 Veterinary science, 0403 veterinary science, Animals, Anti-Bacterial Agents, Bacteria, Cats, Cattle, Chickens, Dogs, Drug Resistance, Bacterial, Female, One Health, 03 medical and health sciences, Antibiotic resistance, Antimicrobial stewardship, Medicine, Pharmacology (medical), 2. Zero hunger, Streptococcus uberis, Pharmacology, 0303 health sciences, biology, 030306 microbiology, business.industry, Bacterial, 04 agricultural and veterinary sciences, biology.organism_classification, Antimicrobial, Food safety, 3. Good health, Infectious Diseases, business, Streptococcus dysgalactiae
Abstract

BackgroundBuilding the European Antimicrobial Resistance Surveillance network in Veterinary medicine (EARS-Vet) was proposed to strengthen the European One Health antimicrobial resistance (AMR) surveillance approach.ObjectivesThe objectives were to (i) define the combinations of animal species, production types, age categories, bacterial species, specimens and antimicrobials to be monitored in EARS-Vet and to (ii) determine antimicrobial test panels able to cover most combinations.MethodsThe EARS-Vet scope was defined by consensus between 26 European experts. Decisions were guided by a survey of the combinations that are relevant and feasible to monitor in diseased animals in 13 European countries (bottom-up approach). Experts also considered the One Health approach and the need for EARS-Vet to complement existing European AMR monitoring systems coordinated by the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA).ResultsEARS-Vet would monitor AMR in six animal species (cattle, swine, chicken (broiler and laying hen), turkey, cat and dog), for 11 bacterial species (Escherichia coli, Klebsiella pneumoniae, Mannheimia haemolytica, Pasteurella multocida, Actinobacillus pleuropneumoniae, Staphylococcus aureus, Staphylococcus pseudintermedius, Staphylococcus hyicus, Streptococcus uberis, Streptococcus dysgalactiae and Streptococcus suis). Relevant antimicrobials for their treatment were selected (e.g. tetracyclines) and complemented with antimicrobials of more specific public health interest (e.g. carbapenems). Three test panels of antimicrobials were proposed covering most EARS-Vet combinations of relevance for veterinary antimicrobial stewardship.ConclusionsWith this scope, EARS-Vet would enable to better address animal health in the strategy to mitigate AMR and better understand the multi-sectoral AMR epidemiology in Europe.

Published
2022
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3. Antibiotic research and development: business as usual?

Author

Harbarth, S., Theuretzbacher, U., Hackett, J., Adriaenssens, N., Anderson, J., Antonisse, A., Ardal, C., Baillon-Plot, N., Baraldi, E., Bhatti, T., Bradshaw, D., Brown, N., Carmeli, Y., Cars, O., Charbonneau, C., Cheng, S., Ciabuschi, F., Cirino, J., Clift, C., Colson, A., Dane, A., De-Lima, N., Dooa, M., Drabik, D., Eisenstein, B., Farquhar, R., Fidan, D., Galli, F., Gilchrist, K., Gilman, S., Goeschl, T., Goodall, J., Goossens, H., Gouglas, D., Guise, T., Gyssens, I., Hallerback, P., Heymann, D., Hoffman, S., Howell, J., Hulscher, M., Hunt, T., Huttner, B., Jantarada, F., Lindgren, E., Nolet, B., Schouten, J., Vink, P., Wesseler, J., Harbarth, S., Theuretzbacher, U., Hackett, J., Adriaenssens, N., Anderson, J., Antonisse, A., Ardal, C., Baillon-Plot, N., Baraldi, E., Bhatti, T., Bradshaw, D., Brown, N., Carmeli, Y., Cars, O., Charbonneau, C., Cheng, S., Ciabuschi, F., Cirino, J., Clift, C., Colson, A., Dane, A., De-Lima, N., Dooa, M., Drabik, D., Eisenstein, B., Farquhar, R., Fidan, D., Galli, F., Gilchrist, K., Gilman, S., Goeschl, T., Goodall, J., Goossens, H., Gouglas, D., Guise, T., Gyssens, I., Hallerback, P., Heymann, D., Hoffman, S., Howell, J., Hulscher, M., Hunt, T., Huttner, B., Jantarada, F., Lindgren, E., Nolet, B., Schouten, J., Vink, P., and Wesseler, J.

Abstract

The global burden of antibiotic resistance is tremendous and, without new anti-infective strategies, will continue to increase in the coming decades. Despite the growing need for new antibiotics, few pharmaceutical companies today retain active antibacterial drug discovery programmes. One reason is that it is scientifically challenging to discover new antibiotics that are active against the antibiotic-resistant bacteria of current clinical concern. However, the main hurdle is diminishing economic incentives. Increased global calls to minimize the overuse of antibiotics, the cost of meeting regulatory requirements and the low prices of currently marketed antibiotics are strong deterrents to antibacterial drug development programmes. New economic models that create incentives for the discovery of new antibiotics and yet reconcile these incentives with responsible antibiotic use are long overdue. DRIVE-AB is a €9.4 million public–private consortium, funded by the EU Innovative Medicines Initiative, that aims to define a standard for the responsible use of antibiotics and to develop, test and recommend new economic models to incentivize investment in producing new anti-infective agents.

Published
2015

5. Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations

Author

Ursula Theuretzbacher, Christine Årdal, Kevin Outterson, Francesco Ciabuschi, John-Arne Røttingen, Jens Plahte, Enrico Baraldi, Ardal C., Baraldi E., Theuretzbacher U., Outterson K., Plahte J., Ciabuschi F., and Rottingen J.-A.

Subjects
0301 basic medicine, DRIVE-AB, medicine.medical_specialty, lcsh:RS1-441, Pharmacy, Antimicrobial innovation, Business model, lcsh:Pharmacy and materia medica, 03 medical and health sciences, medicine, Marketing, Duration (project management), Business Administration, Företagsekonomi, business.industry, Health Policy, Public health, Research, lcsh:RM1-950, Stakeholder, Timeline, 030104 developmental biology, Incentive, lcsh:Therapeutics. Pharmacology, New product development, Antibacterial innovation, Business, Pharmaceutical research and development
Abstract

Background Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs’ targets, costs, and durations related to discovery and early phase development of antibacterial therapies. Methods DRIVE-AB, a project focused on developing new economic incentives to stimulate antibacterial innovation, held a European stakeholder meeting in February 2015. All SMEs invited to this meeting (n = 44) were subsequently sent a survey to gather more data regarding their areas of activity, completed and expected development costs and timelines, and business models. Results Twenty-five companies responded to the survey. Respondents were primarily small companies each focusing on developing 1 to 3 new antibiotics, focused on pathogens of public health importance. Most have not yet completed any clinical trials. They have reported ranges of discovery and development out-of-pocket costs that appear to be less expensive than other studies of general pharmaceutical research and development (R&D) costs. The duration ranges reported for completing each phase of R&D are highly variable when compared to previously published general pharmaceutical innovation average durations. However, our sample population is small and may not be fully representative of all relevant antibiotic SMEs. Conclusions The data collected by this study provide important insights and estimates about R&D in European SMEs focusing on antibiotics, which can be combined with other data to design incentives to stimulate antibacterial innovation. The variation implies that costs and durations are difficult to generalize due to the unique characteristics of each antibiotic project and depend on individual business strategies and circumstances.

Published
2018

6. To the G20: incentivising antibacterial research and development

Author

David Findlay, Laura J. V. Piddock, Christine Årdal, Francesco Ciabuschi, Enrico Baraldi, John H. Rex, Kevin Outterson, Ardal C., Baraldi E., Ciabuschi F., Outterson K., Rex J.H., Piddock L.J.V., and Findlay D.

Subjects
0301 basic medicine, Bacteria, Drug Industry, business.industry, International Cooperation, Research, Congresses as Topic, Public-Private Sector Partnerships, Anti-Bacterial Agents, Europe, 03 medical and health sciences, 030104 developmental biology, Infectious Diseases, Inventions, Drug Resistance, Multiple, Bacterial, Humans, Medicine, business, Environmental planning
Published
2017

7. Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory?

Author

Røttingen JA, Regmi S, Eide M, Young AJ, Viergever RF, Ardal C, Guzman J, Edwards D, Matlin SA, and Terry RF

Subjects
Biomedical Research economics, Clinical Trials as Topic statistics & numerical data, Data Collection, Developed Countries economics, Developed Countries statistics & numerical data, Developing Countries economics, Developing Countries statistics & numerical data, Global Health economics, Global Health statistics & numerical data, Humans, Information Dissemination, Needs Assessment statistics & numerical data, Publishing statistics & numerical data, Research Support as Topic economics, Research Support as Topic statistics & numerical data, Biomedical Research statistics & numerical data, Databases as Topic statistics & numerical data, Public Health statistics & numerical data
Abstract

The need to align investments in health research and development (R&D) with public health demands is one of the most pressing global public health challenges. We aim to provide a comprehensive description of available data sources, propose a set of indicators for monitoring the global landscape of health R&D, and present a sample of country indicators on research inputs (investments), processes (clinical trials), and outputs (publications), based on data from international databases. Total global investments in health R&D (both public and private sector) in 2009 reached US$240 billion. Of the US$214 billion invested in high-income countries, 60% of health R&D investments came from the business sector, 30% from the public sector, and about 10% from other sources (including private non-profit organisations). Only about 1% of all health R&D investments were allocated to neglected diseases in 2010. Diseases of relevance to high-income countries were investigated in clinical trials seven-to-eight-times more often than were diseases whose burden lies mainly in low-income and middle-income countries. This report confirms that substantial gaps in the global landscape of health R&D remain, especially for and in low-income and middle-income countries. Too few investments are targeted towards the health needs of these countries. Better data are needed to improve priority setting and coordination for health R&D, ultimately to ensure that resources are allocated to diseases and regions where they are needed the most. The establishment of a global observatory on health R&D, which is being discussed at WHO, could address the absence of a comprehensive and sustainable mechanism for regular global monitoring of health R&D., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Published
2013
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9. Common characteristics of open source software development and applicability for drug discovery: a systematic review.

Author

Ardal C, Alstadsæter A, and Røttingen JA

Abstract

Background: Innovation through an open source model has proven to be successful for software development. This success has led many to speculate if open source can be applied to other industries with similar success. We attempt to provide an understanding of open source software development characteristics for researchers, business leaders and government officials who may be interested in utilizing open source innovation in other contexts and with an emphasis on drug discovery., Methods: A systematic review was performed by searching relevant, multidisciplinary databases to extract empirical research regarding the common characteristics and barriers of initiating and maintaining an open source software development project., Results: Common characteristics to open source software development pertinent to open source drug discovery were extracted. The characteristics were then grouped into the areas of participant attraction, management of volunteers, control mechanisms, legal framework and physical constraints. Lastly, their applicability to drug discovery was examined., Conclusions: We believe that the open source model is viable for drug discovery, although it is unlikely that it will exactly follow the form used in software development. Hybrids will likely develop that suit the unique characteristics of drug discovery. We suggest potential motivations for organizations to join an open source drug discovery project. We also examine specific differences between software and medicines, specifically how the need for laboratories and physical goods will impact the model as well as the effect of patents.

Published
2011
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