USA Partnering Award: Building globally leading partnership in biofilm standardisation between USA and UK's biofilm innovation centres.
Lead Research Organisation:
University of Southampton
Department Name: Sch of Biological Sciences
Abstract
Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.
Publications
National Biofilms Innovation Centre
(2022)
Biofilm Standards and Regulations in Pharma and Medical Devices Sectors. Workshop Report
| Description | In partnership with the US Centre for Biofilm Engineering (CBE), we hosted a workshop on Biofilm Regulations and Standardisation in Medical Devices and Pharma sectors, which took place in Birmingham, UK, on 29 April 2022. The meeting was unique, bringing together over 40 representatives from industry, academia, metrology and standardisation and regulatory bodies to map the current landscape, needs, trends and expectations in biofilm standardisation within the UK and to establish industry and regulatory participation in a forward working group. Discussions were very candid, open and stimulating, with the aim of working together as a community to advance the field. The presence of international delegates was very useful and provided additional international context to the discussions. The meeting was supported by the BBSRC Global Partnering Award and closely aligned to the mission of the International Biofilm Standards Task Group (of which both NBIC and CBE are co-founders): "To drive the international development and acceptance of standardised biofilm test methods in health care, the built environment and industrial systems." As pre-work and during the workshop, we posed two questions to be considered and debated: What do you see as the current needs with respect to standards and regulations in your setting and business relating to biofilms? What do you believe should be (i) done in terms of concrete next steps by this group? and (ii) the overall long-term goals? The report is now published and available for download. Please forward this to others in your organisation who may find it useful. |
| Exploitation Route | The participants shared a plethora of different experiences, needs, ideas and unique views on the subject. Nevertheless, several clear points emerged, both from the pre-work feedback and from the in-person discussions: There is both the opportunity and desire from the community to make progress in creating biofilm-related standards. There is a strong need for a comprehensive review of standards, methods and practices that are currently in use by the community. Such a review would provide a basis for a gap analysis and identification of a pathway for biofilm standards development. It is clear that 'one size will not fit all' due to diverse sectors and applications and the complexity of the biofilms themselves. It would be more practical to build a 'component approach', consisting of a base set of standards and guidance on how and when to use them. It is crucial that regulators are part of the standardisation activities and engaged from the beginning. |
| Sectors | Healthcare,Government, Democracy and Justice,Pharmaceuticals and Medical Biotechnology |
| URL | https://www.biofilms.ac.uk/biofilm-standards-and-regulations-report/ |
| Description | The report of this workshop has been published and we are now working with all of our stakeholders to develop biofilm standards and inform regulatory processes. |
| First Year Of Impact | 2022 |
| Sector | Healthcare,Government, Democracy and Justice,Pharmaceuticals and Medical Biotechnology |
| Impact Types | Societal,Economic,Policy & public services |
| Description | Invited presentation titled: "The UK's standpoint on biofilm claims and methods in the medical devices sector" at the annual CBE Regulatory Pathways Meeting |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Industry/Business |
| Results and Impact | Invited presentation titled: "The UK's standpoint on biofilm claims and methods in the medical devices sector" given at the annual CBE Regulatory Pathways Meeting. Also, several other delegates from NBIC network attended the meeting to learn about regulatory frameworks in the USA and discuss plans for future collaborations in the area of harmonised biofilm standards and methods. |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://biofilm.montana.edu/news/article.html?id=22471 |
| Description | NBIC Biofilm Standards and Regulatory Needs - Industry Feedback Session |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Industry/Business |
| Results and Impact | Date: 17/01/22 Delegates: 17 There are a lack of standard biofilm models and standardised measurement / test methods. NBIC and CBE as part of the IBSTG has reached the consensus that Our national and international academic-industry road-mapping has consistently identified the establishment of global standards in biofilms as a priority need.[ref to NBIC reports] Availability of standards would facilitate translational innovation and stimulate business growth by allowing industries to make claims for their products and support global societal, environmental and healthcare challenges.The main objective of this US-UK partnership is to address the need for standardization in biofilm field and to bring together complementary expertise (academic, industrial, metrology, standardization and regulatory). We initially aim to hold a workshop focused on one sector / area and have chosen health. Objective The purpose of this first workshop is to understand the needs and current status in this sector considering both Medical Devices and Pharma and establish industry and regulatory participation in a forward task /working group. In parallel CBE and NBIC (and the IBSTG) will pursue approaches to establishing a Joint programme in biofilm standardisation and prenormative activities informed by the outputs of this meeting with the goal of progressing to normative activities and international standardisation. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Workshop on Biofilm Regulations and Standardisation in Medical Devices and Pharma Sectors |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Industry/Business |
| Results and Impact | The meeting brought together a mix of representatives from industry, academia, metrology and standardisation and regulatory bodies to map the current landscape, needs, trends and expectations in biofilm standardisation within the UK and to establish industry and regulatory participation in a forward working group. Following this workshop, NBIC commissioned a review on current biofilm methods best practices, existing standards and regulatory requirements in medical devices sector (report pending) with the review of pharma sector planned for 2023. This forms a part of a larger project by the International Biofilms Standards Task Group, who are working to set up a central database of all current methodologies and standards that already exist across different sectors and regardless of the term(s) they use for biofilms e.g. "slime" and the "microbiome." |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://www.biofilms.ac.uk/biofilm-standards-and-regulations-report/ |