Latest project updates
- Improvements needed in recording brand and batch numbers for biological medicines to ensure patient safety
- New Leading Article about the challenges and opportunities for the traceability of (biological) medicinal products
- Disconnect between European and national regulation major barrier for advancing innovative medical therapies
Escher was launched in 2007 by TI Pharma – now Lygature – with the aim of helping to bring about a more efficient and effective regulatory system. It offers an independent research platform, with a pan-European focus, that promotes multi-stakeholder dialogue.
18+
scientific publications
16
PhD theses published
The Escher platform
Escher’s mission is to promote research and international debate in the field of policy and regulations, relating to development, market authorization, reimbursement, and use of medicines and medical technology. To this end, Escher initiates and conducts its own research into regulatory and health technology assessment topics. The platform also plays an active role in assignments undertaken by Lygature for external parties, for example within the ADAPT SMART project. In all cases, outcomes are translated into publications and/or practical proposals for regulatory and policy innovation, in order to facilitate patient access to medicines that address public health needs.
Providing neutral ground for multi-stakeholder dialogue and research
Scientific research and collaboration between public and private partners have been essential to Escher from the start. The platform reaches out to many different stakeholders, with partners from industry academia, government, NGOs and elsewhere. The broad range of activities that TI Pharma provided to support multi-stakeholder dialogue and research will be continued under the Lygature brand from January 2016, and include:
- Governance and coordination. Lygature is the legal entity responsible for the Escher platform and provides the chair of the Steering Committee, which decides whether and how a research project should be executed. Lygature also involves Escher when coordinating third-party assignments on regulatory topics, such as ADAPT SMART.
- Research activities. The Escher platform can offer an independent perspective on policy and regulatory topics. It initiates and conducts research projects, such as ‘Improving the EU system for marketing authorization’ and ‘Traceability of biologics’ (both now completed).
- Platform for dialogue. Lygature allows Escher to provide a multi-stakeholder home for regulatory innovation. The platform promotes dialogue on relevant policy topics, fueled by the evidence generated during research projects.
Escher is a unique platform that brings together a wide variety of stakeholders in strategic policy projects and research initiatives. It generates benefits by applying an understanding of both scientific and regulatory issues. Escher is a significant component in the wider Lygature mission to coordinate multi-stakeholder dialogue, and to help create more efficient and effective regulatory system.
Current projects
Escher is currently working on one large project, executed in collaboration with research institutions in the Escher network and supported by expertise and data from public and private stakeholders. Still more projects are progressing through the planning phase.
Completed projects
In order to maintain a strategic focus, Escher concentrates on projects that align with four main research themes. Within each main theme, a number of projects have been completed:
- The UK BIO-TRAC study: An evaluation of product and batch traceability in UK clinical practice and reporting of adverse drug reactions
- Evidence generation methods and evidence requirements
- Scientific dialogue and stakeholder interaction
- The decision-making process and benefit-risk assessment
- Evaluating the regulatory system
Outputs from Escher
Escher is focused not only on generating new evidence, but also on disseminating it as effectively as possible. The goal is always to do everything possible to help translate research findings into real-world regulatory improvements, creating benefits for patients.
Results are therefore presented in many different ways. These include formal scientific papers in leading journals and PhD theses, but they extend much further. Events are hosted to encourage face-to-face discussion, policy reports are written to stimulate debate and press releases raise awareness of the progress made in the projects.
Project updates
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Escher recently published a paper in Drug Safety on the traceability of biologics in clinical practice and adverse drug reaction (ADR) reporting
Escher recently published a paper in Drug Safety on the traceability of biologics in clinical practice and adverse drug reaction (ADR) reporting. This paper concludes that in the Netherlands, brand names are not routinely recorded in clinical practice and batch numbers are poorly recorded. The findings suggest that the limited traceability of brand names and batch numbers in ADR reports for biologics may be primarily caused by the shortcomings in the recording and tracing of information in clinical practice.
Efforts to address the systems for information recording and sharing in clinical practice are needed. The implementation of a barcode on the single unit dose that contains both brand name and batch number information could contribute to improving the traceability of (biological) medicinal products in clinical practice.The paper is the result of the Escher project "Pharmacovigilance of biologics". Escher evaluated systems and practices in the Dutch community and hospital setting for recording and tracing medicinal product information, such as brand names and batch numbers, jointly with the Royal Dutch Pharmacists Association (KNMP) and the Dutch Association of Hospital Pharmacists (NVZA). In collaboration with the Netherlands Pharmacovigilance Centre Lareb, the traceability of biologics in spontaneous ADR reports from the Dutch ADR database was assessed, comparing ADR reports originating from the community and hospital setting with other report sources.
The full publication can be found here
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New publication on classification of recombinant biologics in EU Member States
Escher conducted a study together with Utrecht University on the classification of biologics in EU Member States. Although biologics are authorized through the centralized procedure within the EMA, member states set up systems for reporting adverse drug reactions at the national level. This information is then analyses and interpreted at the EU level again.
As this study shows, there are considerable discrepancies between Members States in the classification of which medicinal products are biologics, which may influence the quality and quantity of the available aggregated data and hence may hamper tailored pharmacovigilance for biologics. Although this divergence can be (and should be) easily resolved, we would like to encourage policy makers to consider how we can make sure that EU regulation in the area of medicines, which depends on aligned actions by Member States to achieve public health objectives, leads to practices that are able to fulfil all of the requirements of such regulations in an appropriate, pragmatic, and feasible manner.
Of the 146 recombinant biologics on our sample list, 87 were available on the national markets of all five Member States. Fifty-one (59 %) of these 87 recombinant biologics were classified as biologics by all five Member States. Of the remaining 36 recombinant biologics, 25 were classified as biologics by four Member States, seven by three Member States, and four by two Member States. The Fleiss kappa value for these 87 recombinant biologics is 0.0782. We interpret this as poor agreement among the Member States regarding the classification of these 87 recombinant biologics that are marketed in all five Member States.
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Escher at the DIA Biosimilars Conference 2015
Pieter Stolk from Escher was invited to speak at the DIA Biosimilars Conference 2015 in London on recent work by Escher on the pharmacovigilance of biologics, in particular, the traceability of products in clinical practice. The conference will take place on November 4th, and will feature speakers from WHO, EMA, industry and academia. For more information, please visit the conference website.