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Research Interests: Patient Safety, Clinical Trial, Informed Consent, Treatment Outcome, Medicine, and 14 moreBiological Sciences, Population, Humans, United States, Universities, Anti-Bacterial Agents, Drug evaluation, Intensive Care Medicine, Ventilator Associated Pneumonia, Drug Industry, Clinical Infectious Diseases, Clinical Trials as Topic, United States Food and Drug Administration, and Medical and Health Sciences
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Research Interests: Neurology, Surgery, Medical Microbiology, Forecasting, Medicine, and 13 moreHumans, Biomedical Research, Disease, Sepsis, Incidence, Clinical Sciences, Anti-Bacterial Agents, Intensive Care Medicine, Host Pathogen Interactions, Individualized Medicine, Disease Management, Molecular Targeted Therapy, and Clinical Trials as Topic
BACKGROUND Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). HABP/VABP trials are complex and difficult to conduct due to the large number of medical procedures,... more
BACKGROUND Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). HABP/VABP trials are complex and difficult to conduct due to the large number of medical procedures, adverse events, and concomitant medications involved. Differences in the legislative frameworks between different regions of the world may also lead to excessive data collection. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development (ABDD) by streamlining clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. METHODS In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with current data collection processes. Experts defined "data collection" as the act of capturing and reporting cer...
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With the recognition of the threat posed by bacterial multi-drug resistance, the bacteriophage treatment concept has been revived as an alternative in the armamentarium. Over the last decade, research efforts on bacteriophage therapy have... more
With the recognition of the threat posed by bacterial multi-drug resistance, the bacteriophage treatment concept has been revived as an alternative in the armamentarium. Over the last decade, research efforts on bacteriophage therapy have intensified, and stakeholders have called upon regulatory authorities in trying to define a bespoke licensing pathway for bacteriophages which would not adversely affect the standards required for quality, safety and efficacy. In this context, and in particular concerning the use of personalised phage cocktails, the concept of “hybrid licensing”, with patient-specific phage therapy selected from a local pre-authorised phage library, has recently been advanced. To date, however, and notwithstanding encouraging data, important knowledge gaps remain regarding the safe and effective administration of bacteriophages. Therefore, generation of further scientifically robust data concerning proposed bacteriophage therapies as well as extensive stakeholder c...
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Background Antimicrobial resistance (AMR) is a growing global problem to which the ongoing COVID-19 pandemic may further contribute. With resources deployed away from antimicrobial stewardship, evidence of substantial pre-emptive... more
Background Antimicrobial resistance (AMR) is a growing global problem to which the ongoing COVID-19 pandemic may further contribute. With resources deployed away from antimicrobial stewardship, evidence of substantial pre-emptive antibiotic use in COVID-19 patients and indirectly, with deteriorating economic conditions fuelling poverty potentially impacting on levels of resistance, AMR threat remains significant. Main body In this paper, main AMR countermeasures are revisited and priorities to tackle the issue are re-iterated. The need for collaboration is stressed, acknowledging the relationship between human health, animal health and environment (“One Health” approach). Among the stated priorities, the initiative by the European Medicines Regulatory Network to further strengthen the measures in combatting AMR is highlighted. Likewise, it is asserted that other emerging health threats require global collaboration with the One Health approach offering a valuable blueprint for action...
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Malaria remains a major public health challenge with almost half of the world's population exposed to the risk of contracting the illness. Prompt, effective and well tolerated treatment remains one of the cornerstones in the disease... more
Malaria remains a major public health challenge with almost half of the world's population exposed to the risk of contracting the illness. Prompt, effective and well tolerated treatment remains one of the cornerstones in the disease management, with artemisinin-based combination therapy the recommended option for non-severe malaria in endemic areas with predominant Plasmodium falciparum infections. Recent experience has been obtained at the European Medicines Agency with regulatory approval of two such antimalarial fixed combination products. For these cases, two different regulatory pathways were applied. As such, the present contribution describes this experience, emphasising main differences and applicability offered by these regulatory choices.
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With most interest we read the contribution made by Fauconnier on phage therapy regulation [...].
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Research Interests: Patient Safety, Treatment Outcome, Biological Sciences, Humans, United States, and 9 moreUniversities, Anti-Bacterial Agents, Drug evaluation, Ventilator Associated Pneumonia, Drug Industry, Clinical Infectious Diseases, Clinical Trials as Topic, United States Food and Drug Administration, and Medical and Health Sciences
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Despite the recognized problem of antibiotic multidrug resistance, very few antibacterial agents with new mechanisms of action are under development. Bacteriophage therapy could offer one alternative strategy to mitigate this challenge.... more
Despite the recognized problem of antibiotic multidrug resistance, very few antibacterial agents with new mechanisms of action are under development. Bacteriophage therapy could offer one alternative strategy to mitigate this challenge. Although widely used throughout the 20th century in Eastern Europe and the former Soviet Union, this potential therapy has not yet been investigated according to rigorous scientific standards. This paper reports on a multistakeholder meeting held at the EMA, which outlined the existing regulatory framework to which such therapy should adhere and reviewed the current obstacles and shortcomings in scientific development for bacteriophage therapy.