Escher

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.

• Success and failure in the development and commercialization of ATMP products

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.

• Journal publications
• Theses
• Reports