Recommendations & Conclusions
7 items
1
Conclusion
First Report - The antimicrobial potent…
Acknowledged
The safety of phages has been well established mainly on the basis of observational evidence drawn from specific clinical interventions. However, as with all medicines, robust clinical trial data is important to provide and develop assurances around all aspects of patient safety, including the long-term impact of phages, especially their …
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The safety of phages has been well established mainly on the basis of observational evidence drawn from specific clinical interventions. However, as with all medicines, robust clinical trial data is important to provide and develop assurances around all aspects of patient safety, including the long-term impact of phages, especially their interaction with human immune systems, such as anaphylaxis and auto immune response.
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Government response AI summary
The government outlined ongoing engagement with phage stakeholders and monitoring of the research and clinical trial pipeline. It stated the upcoming 2024-2029 AMR National Action Plan will set out research priorities, including innovation for AMR.
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Department for Science, Innovation and Technology
4
Conclusion
First Report - The antimicrobial potent…
Acknowledged
Phages have been used as therapy for over a hundred years, and much of the fundamental science relating to phages is understood. However, there is still more that the global and UK research communities can learn. Further research will be able to establish key issues such as long-term interactions between …
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Phages have been used as therapy for over a hundred years, and much of the fundamental science relating to phages is understood. However, there is still more that the global and UK research communities can learn. Further research will be able to establish key issues such as long-term interactions between phages and human hosts and how phages can be engineered to maximum effect, to work alone or in combination with antibiotics. Such research will help hone phage therapeutics and clinical practice. The UK is well placed to conduct this research as it has a number of leading phage research centres and academics, and access to world class genomic sequencing and bioinformatic resources and experts.
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Government response AI summary
The government recognised the importance of research into non-traditional therapies like phages and committed to continuing to monitor the AMR clinical and research pipeline. It also stated it would not produce annual reports exclusively on phages but would regularly review the broader 5-year AMR National …
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Department for Science, Innovation and Technology
7
Conclusion
First Report - The antimicrobial potent…
Acknowledged
We were disappointed to hear that there is a translational phage research “gap” in the UK. We agree that funding, and especially public funding, should be awarded with care. However, we are concerned that, despite being included in the Government’s AMR strategy, if not properly supported, the potential of phages …
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We were disappointed to hear that there is a translational phage research “gap” in the UK. We agree that funding, and especially public funding, should be awarded with care. However, we are concerned that, despite being included in the Government’s AMR strategy, if not properly supported, the potential of phages to deliver therapeutics and commercial outputs will remain untested and untapped. There is a particular danger that translational phage research will be trapped in an impasse where it will miss out on research funding because it has not been able to prove its credibility, because of a lack of previous funding.
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Government response AI summary
The government acknowledges manufacturing challenges and points to existing and newly announced capital grant programmes for life sciences manufacturing. NHS England has also committed to consider whether its antimicrobial subscription model may be relevant to phage products and to review criteria if deemed appropriate in …
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Department for Science, Innovation and Technology
8
Recommendation
First Report - The antimicrobial potent…
Acknowledged
We recommend that the Department of Health and Social Care (DHSC) reviews the current funding arrangements for phage translational research and identifies what are the bottlenecks for such research. A review should consider what specific assistance phage translational research requires to increase the prospects of success for funding bids. It …
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We recommend that the Department of Health and Social Care (DHSC) reviews the current funding arrangements for phage translational research and identifies what are the bottlenecks for such research. A review should consider what specific assistance phage translational research requires to increase the prospects of success for funding bids. It should also consider whether specific funding is appropriate where it can deliver AMR priorities.
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Government response AI summary
The government explains that NIHR does not ringfence funding and awards depend on application quality, noting few past applications for phage research. It states that NIHR and DHSC are exploring approaches with UKRI to improve phage research capacity, but does not commit to a specific …
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Department for Science, Innovation and Technology
10
Conclusion
First Report - The antimicrobial potent…
Acknowledged
For the potential benefits of phages to be fully explored and, if possible, exploited in the UK, with competitive advantage, it is important that existing phage- related assets are properly aligned and integrated, connecting the various sectors, institutions, and actors so they can draw on shared resources, information, data, and …
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For the potential benefits of phages to be fully explored and, if possible, exploited in the UK, with competitive advantage, it is important that existing phage- related assets are properly aligned and integrated, connecting the various sectors, institutions, and actors so they can draw on shared resources, information, data, and expertise. This will also allow the development of additional shared assets, such as phage biobanks, as well as encouraging new relationships between universities, hospitals, the pharmaceutical industry, and other stakeholders. We were concerned to hear that the UK’s phage expertise and resources are ‘fragmented’. We therefore welcome Innovate UK’s Phage knowledge transfer initiative to bring phage stakeholders together to produce a roadmap to deliver a sustainable and integrated network for the transfer and sharing of phage-related knowledge for the benefit of all. (Paragraph 67) 58 The antimicrobial potential of bacteriophages
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Government response AI summary
The government welcomes the insights and acknowledges the importance of a robust network for phage-related knowledge sharing, expressing support for the existing UK KTN Phage Innovation Network and describing other relevant coordination efforts.
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Department for Science, Innovation and Technology
19
Conclusion
First Report - The antimicrobial potent…
Acknowledged
If the UK government supports the commercial production of genetically engineered (GE) phages, it will inevitably lead to regulatory divergence from the EU. However, we believe this divergence offers the UK an opportunity that should be pursued. This should be part of a clear regulatory and safety licensing regime for …
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If the UK government supports the commercial production of genetically engineered (GE) phages, it will inevitably lead to regulatory divergence from the EU. However, we believe this divergence offers the UK an opportunity that should be pursued. This should be part of a clear regulatory and safety licensing regime for phages, if phages are to be exploited for competitive advantage.
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Government response AI summary
The government acknowledges that genetic modifications influence regulatory frameworks and states that MHRA's upcoming non-binding advisory guidance will clarify this. The Veterinary Medicines Directorate is also reviewing existing requirements for genetically modified organisms in phage-based veterinary medicines.
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Department for Science, Innovation and Technology
21
Conclusion
First Report - The antimicrobial potent…
Acknowledged
Our evidence suggests that current regulations for clinical trials and the manufacturing of medicines are unlikely to be effective for phages as they are for other drugs or antibiotics. This is because the current regulatory approach to testing and manufacturing medicines is based on a single consistent formulation being shown …
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Our evidence suggests that current regulations for clinical trials and the manufacturing of medicines are unlikely to be effective for phages as they are for other drugs or antibiotics. This is because the current regulatory approach to testing and manufacturing medicines is based on a single consistent formulation being shown to have a demonstrable effect. This does not accord with the optimal use of phages which require considerable flexibility in terms of the specificity required for 60 The antimicrobial potential of bacteriophages individual patients. There are a number of different medical scenarios where the current regulations will struggle to cope with this need for specificity that mitigates against generic testing. These include: • the requirement for individual phage strains that are specific to the species and even strain genotype of the bacteria they seek to inhibit, which could be almost limitless and impossible to test in advance; • the need for multiple unique formulations of phages, often in conjunction with antibiotics and other drugs, to target infections in individual patients with specific microbiota, which might not be anticipated in traditional clinical trials; • in the future, pre-tested generic phages that have met regulatory standards may not be able to inhibit bacterial growth, necessitating adaptation which may be beyond inflexible regulations; • the specificity required to target a particular infection in a single human could require gene editing of phages, with current regulations implying that each new formulation would require full clinical trials each time, which would not be timely, cost effective, efficient or possible in terms of generating significant clinical data if each use is unique; • the use of double-blind clinical trials and control groups would be problematic if they related to a unique combination of phages produced for a single patient.
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Government response AI summary
The government acknowledges the issues with current regulations for phages, stating that new MHRA guidance under development will address safety testing, extrapolation between strains, and clarify that named-patient use requires GMP but not clinical trials.
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Department for Science, Innovation and Technology