Projects

Escher

The Lygature platform for regulatory innovation

Completed

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.

Trendline
18+

scientific publications

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:

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


  • Chemical formula on paper

    Improvements needed in recording brand and batch numbers for biological medicines to ensure patient safety

    Health professionals need to improve how they record brand and batch numbers for biologic medicines to ensure patients stay safe, according to a new study carried out by Kevin Klein and Pieter Stolk from Lygature, and Lorna Hazell and Saad Shakir from UK’s Drug Safety Research Unit (DSRU). 

    The research, published in the journal Drug Safety, shows hospital pharmacists, doctors and nurses only recorded batch numbers for biologic medicines between 38 per cent and 58 per cent of the time during routine hospital practice.

    Read more here.

  • New Leading Article about the challenges and opportunities for the traceability of (biological) medicinal products

    In a recently published Leading Article in Drug Safety, researchers from the current Escher project UK BIO-TRAC (and previous Escher project “Pharmacovigilance of biologics”) provide an updated overview of the current challenges and opportunities for improving the traceability of (biological) medicinal products in the EU.

    The authors pointed out that the current barcoding standards for pharmaceuticals in the EU are not sufficient for allowing a full track-and-trace in EU healthcare settings. The currently used linear barcodes do not support the automatic recording of dynamic product information such as batch numbers and expiry dates, by means of electronic barcode scanning.

    To achieve a full track-and-trace, new barcoding standards, such as the two-dimensional DataMatrix, provided on both the primary and the secondary package are needed that facilitate the routine recording of (dynamic) product information throughout the entire supply chain. Alignment with other drug safety topics, such as the Falsified Medicines Directive and initiatives to reduce medication errors, are needed to increase the buy-in from all stakeholders and solve this important public health topic with a joint effort.

  • Disconnect between European and national regulation major barrier for advancing innovative medical therapies

    ATMPs are innovative treatments including gene and cell therapies and tissue engineered products. Patients can benefit greatly from these treatments compared to the more traditional therapies. Unfortunately, developers face many challenges because of the innovative character of ATMPs. The Escher ATMP project, carried out by Utrecht University and Lygature and supported by an unrestricted grant by EFPIA and EBE, identified a number of hurdles to ATMP development in Europe. 

    The Escher study identified 271 European ATMP developers. Over 100 ATMP developers responded and were consulted in the study. They encounter significant challenges both in the field of research & development and in the admission to the market. A major barrier for market entry is the disconnect between European regulation and national hurdles. For example, national requirements for clinical trials and the use of genetherapies lead to many additional information requests, delays and increased costs. SMEs (small and medium-sized companies) in general don’t have the resources to address country specific requirements. 

    Director of Escher, André Broekmans, sees this report as an important step to address these issues: “This study shows clearly that we need better alignment between the European Medicines Agency and the national authorities. We all need to make sure patients will get fast access to these promising new therapies.” 

    Renske ten Ham, PhD student at Utrecht University, carried out the study and will publish several scientific articles on these results. 


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