Centre for Process Innovation

On 4 June 2025, the MHRA published ‘Regulatory considerations for therapeutic use of bacteriophages in the UK’. This was in response to recommendations made by the House of Commons Science, Innovation and Technology Committee Inquiry into the ‘The Antimicrobial Potential of Bacteriophages’. The MHRA Regulatory Considerations for phage therapeutic products (PTPs) outlines the relevant regulatory route and requirements to use PTPs as licensed or unlicensed medicines. While this guidance provides the necessary information, it is recognized that regulatory information can be inaccessible to academic and small- to medium-sized enterprise developers who are often unfamiliar with the language, terminology and location of such information. The MHRA, in consultation with the Innovate UK Phage Innovation Network, has therefore developed this interpretation to help PTP developers understand what the guidance is saying, and what evidence is required for regulatory assessment of a marketing authorization application. Examples have been included throughout to provide context and as an aid to understanding.

Physically trapped patients following motor vehicle collisions are at high risk of time-critical injuries and poor outcomes. Despite this, there is limited consensus on which injuries should be prioritised and which early interventions are both necessary and feasible in the prehospital setting. This study aims to develop expert consensus on injury categorisation and the delivery of early care interventions to guide clinical and operational decision-making at the scene. A modified Delphi method was used to gather consensus from a multidisciplinary panel of subject matter experts, including clinicians, paramedics, and members of fire and rescue services. In Round 1, participants contributed to the development of draft statements relating to injury time sensitivity, intervention prioritisation, and responder roles. In Rounds 2 and 3, participants rated their level of agreement with these refined statements. A final face-to-face consensus meeting was held to discuss statements that had not yet reached consensus, explore areas of disagreement, and conduct further voting where appropriate. Consensus was defined as ≥ 70% agreement. Consensus was achieved on 45 statements across the domains of injury categorisation, time-critical interventions, and multi-agency responsibilities. Participants strongly endorsed the early delivery of analgesia, tranexamic acid, and protection from environmental stressors, regardless of provider background, provided that appropriate training and governance are in place. There was broad support for expanding the scope of practice of non-clinical responders to meet urgent patient needs. This Delphi consensus provides a framework for prioritising early interventions in the care of trapped patients. It supports a patient-centred, capability-based approach to prehospital care, emphasising feasibility, urgency, and ethical responsibility. Findings should inform the development of standard operating procedures, triage tools, and training frameworks across emergency services, with further research needed to validate assessment heuristics and address barriers to implementation.

Operational modal analysis (OMA) has been increasingly applied to identify the modal parameters of a constructed structure, due to its high economy in implementation. However, due to the absence of loading information, the identified modal parameters are often associated with significantly higher uncertainty compared to their counterparts in free or forced vibration tests. Quantifying the identification uncertainty, and hence precision, is therefore especially relevant in OMA. On the other hand, it is also necessary to manage the uncertainty during the planning stage for an ambient vibration test. For example, to achieve a certain identification precision, how long should the data be collected? Contributing to uncertainty quantification and management in OMA, this paper presents work on full-scale vibration testing on a suspension bridge. Eight triaxial accelerometers were deployed for the test. Each was paired with a synchronised data logger capable of storing data locally in a distributed manner. ‘Uncertainty laws’, which are closed-form asymptotic expressions explaining identification uncertainty in terms of test configurations, were applied for planning the test. Four setups were carried out in the ambient vibration test to cover 26 measurement locations. Modal identification is challenged by the low signal/noise level due to the heavy double-deck girder and the first two vertical modes occurring at very close frequencies. A recently developed Bayesian multiple-setup approach is used to identify the modal properties in terms of their most probable value and identification uncertainty. The results are compared with those obtained by a conventional method. The test configuration is also assessed based on the computed uncertainties and uncertainty laws. Lessons learnt are discussed. • Ambient vibration test of Rainbow Suspension Bridge in Tokyo. • Multiple setups were designed based on ‘Uncertainty laws’. • Operational modal analysis was performed by a recently developed Bayesian multiple-setup approach. • Identification uncertainties of modal parameters were quantified. • Test configuration was assessed based on the computed uncertainties and uncertainty laws.

ObjectivesTo develop and validate a simplified Bleeding Audit Triage Trauma (sBATT) score for use by lay persons, or in areas and environments where physiological monitoring equipment may be unavailable or inappropriate.DesignThe sBATT was derived from the original BATT, which included prehospital systolic blood pressure (SBP), heart rate, respiratory rate, Glasgow Coma Scale (GCS), age and trauma mechanism. Variables suitable for lay interpretation without monitoring equipment were included (age, level of consciousness, absence of radial pulse, tachycardia and trapped status). The sBATT was validated using data from the UK Trauma Audit Research Network (TARN) registry.SettingData sourced from prehospital observations from multiple trauma systems in the UK.Participants70 027 motor vehicle collision (MVC) patients from the TARN registry (2012–2019). Participants included were those involved in MVCs, with exclusion criteria being incomplete data or non-trauma-related admissions.InterventionsNot applicable.Primary and secondary outcome measuresDeath within 24 hours of MVC. Secondary: need for trauma intervention.ResultsIn a cohort of 70 027 MVC patients, 1976 (3%) died within 24 hours. The sBATT showed an area under receiver operating characteristic curve of 0.90 (95% CI: 0.90 to 0.91) for predicting 24-hour mortality, surpassing other trauma scores such as the Shock Index and Assessment of Blood Consumption score. Sensitivity was 96% and specificity 72%, with a negative likelihood ratio below 0.1, indicating strong rule-out capability. Sensitivity analyses confirmed consistent performance across varying SBP and GCS thresholds. The sBATT was equally effective across sexes with no significant predictive discrepancies.ConclusionsThe sBATT is a novel, simplified tool that performs well at predicting early death in the TARN dataset. It demonstrates high predictive accuracy for 24-hour mortality and need for trauma intervention. Further research should validate sBATT in diverse populations and real-world scenarios to confirm its utility and applicability.

Biodegradable transient electronics, devices which easily breakdown to safe constituent parts at their end of life, are an important emerging research direction for tackling electronic waste, as well as enabling new applications such as wearable health monitors which can easily be washed off the body at the end of use. Pullulan is a widely used edible substrate which naturally biodegrades and has previously been used with Silver tracks for creating transient electronics. However, Silver tracks are not generally biodegradable. This paper demonstrates the creation of Zinc tracks for biodegradable transient devices, where the Zinc is approximately half of the recommended daily allowance to Zinc to be ingested. We demonstrate resistivities in the range 1-10 Ω/□ for potential use in electrode and antenna applications.