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 meets CBG
The annual Science Day of February 6, 2015 of the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen) will have as title “Escher meets CBG, regulatory efficiency from theory to practice”.
At this meeting regulatory science will be the main topic, covering research executed within the Medicines Evaluation Board and by Escher, TI Pharma’s platform for regulatory innovation.
People interested in this meeting are referred to the website of the Medicines Evaluation Board. There are still some seats available.
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Escher launches new project 'Pharmacovigilance of biologics'
Escher, the TI Pharma platform for regulatory innovation, launched a new project, ‘Pharmacovigilance of biologics’ in November 2014. It will address the challenges of product and batch traceability in adverse drug reaction reporting.
Biologics are medicinal products obtained from natural sources such as humans, animals or micro-organisms. Biologics are much larger and more complex than small molecule medicines, as well as that they are more difficult to manufacture. Biologics can sometimes be more sensitive to small alterations in the manufacturing process, which can influence product characteristics and result in batch-to-batch variations. The EU pharmacovigilance legislation specifically calls out the need to report adverse drug reactions (ADRs) for these products by brand name and batch number to ensure that ADRs are accurately ascribed to the correct causative product. However, recent studies have found that only about 20% of ADR reports for biologics contained the batch numbers.
Working within community and hospital settings, the objectives of this new project are to evaluate practices and health information systems for tracking biological product information and the ADR reporting processes in the EU. This project will also be estimating the potential impact of misclassification of products during ADR reporting on safety signals for biologics.
The project is executed in collaboration with Utrecht University and Exon Consultancy. For the investigation of the practices in the Netherlands, Escher is collaborating with the Royal Dutch Pharmacists Association, the Dutch Association of Hospital Pharmacists and the Netherlands Pharmacovigilance Centre Lareb. The project is supported by an unrestricted research grant of the European Biopharmaceutical Enterprises (EBE).
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New Escher report: Regulatory system for medicines can be used more effectively
A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the current regulatory system for medicines in Europe can be used in a more efficient and effective manner. André Broekmans, chairman of Escher: “ Overall, the EU regulatory system operates well, however important recent changes had not yet been evaluated. One of our conclusions is that pathways that were intended to bring important new medicines faster to the market are not used in the right way. We are therefore missing opportunities to make medicines available to patients earlier.”
Escher collaborated with researchers from Utrecht University to look into a number of areas that might be improved, namely pharmacovigilance, conditional approval, paediatric investigation plans and decentralized authorisation procedures. The research shows that some parts of the regulations are not yet fully achieving the effects they were intended to have. For example, the conditional marketing authorisation pathway was created to bring much-needed products such as new cancer treatments to the market faster. The researchers found that this pathway has often been used in actual practice as a backup for the ‘normal’ approval pathway. This is because requesting conditional approval has some perceived drawbacks, for example potential reimbursement issues and the level of post-marketing obligations. Escher also identified opportunities for making the regulatory system more efficient without compromising public health, for example by adjusting the timing of submissions and the level of detail in plans for the investigation of medicines in children.
Broekmans stated that such discrepancies between initial legislation objectives and the effects of regulatory instruments in real-world practice should be better monitored: “The way in which formal assessments of regulatory instruments are conducted needs to be strengthened. Also, one of the main messages from our report is that the effectiveness of regulatory instruments can be increased by reflecting on how primary legislation is being interpreted and implemented. Companies and authorities need to learn together how to better use opportunities that the current system provides. This is especially important as we are heading towards a future with more adaptive approaches to regulation and medicines with different profiles and characteristics.”
Richard Bergström, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), noted: “Our latest learning from genomics and our improved understanding of human biology have resulted in a record number of promising break-through medicines in development. When entering a new era of personalised medicine, the current model for medicines development and approval may not be appropriate. Against this background, EFPIA decided to provide an unrestricted research grant to the Escher platform to explore if the model is fit for purpose.”
Hubertus Cranz, Director General of the Association of the European Self-Medication Industry (AESGP), which also funded the research, highlighted another important conclusion of the report: “The research from Escher shows that many areas can be improved without having to adapt the legislation itself, but rather by working on better implementation.”
Andre Broekmans said collaboration was key: “There was a real value in working together with multiple stakeholders via the Escher platform. We were able to ensure independent research, while at the same time interacting very productively with companies, regulatory authorities and other societal stakeholders. Their contributions of data, expertise and experience enabled us to gain valuable insights into the development and authorisation process for new medicines.”