Escher Insights

  • "Relevant learning-phase studies are valuable in reducing the number of failed marketing authorization applications for new medicinal products and for speeding up pharmaceutical innovation."

    Putzeist et al. 2012

  • "Cost-effectiveness analysis of drug regulatory measures is feasible and should be considered before developing such measures."

    Bouvy et al. 2012

  • "Taking safety issues into account in the approval process does not seem to impact on the time taken to perform the pre-approval clinical programme."

    Arnardottir et al. 2011

Multi-stakeholder home for regulatory innovation

The Escher mission is to optimize patient access to medicines and medical technology through regulatory and policy innovation.

Escher gathers, collates and digests scientific evidence, manages multi-stakeholder dialogue and generates robust and objective conclusions. We work with authorities, academic institutions, companies and NGOs in order to facilitate evidence-based solutions. > Read more

Evidence Generation Methods & Requirements

Escher looks at ways in which evidence generation can be improved, medicine development timelines shortened and costs reduced.

Evidence requirements are examined, and also the routes by which new scientific developments are incorporated into regulation. > Read more

Scientific Dialogue & Stakeholder Interaction

Approaches to improving dialogue between all stakeholders are explored within this theme, with a particular focus on interactions between pharmaceutical companies and regulators.

> Read more

Decision-Making Process & Benefit-Risk Assessment

Escher looks at how benefit-risk assessments for medicines are made in regulatory agencies and HTA bodies, and studies how these assessments affect development strategies in companies.

In addition Escher has developed tools for structured benefit-risk assessment. > Read more

HTA & Evaluating Societal Impact

Escher examines the economic, social and ethical implications of regulatory procedures.

It also considers how development can be optimized, by better aligning European marketing approval applications and HTA/reimbursement application procedures. > Read more


Escher article headline in GaBI Online Newsletter

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The Lygature (formerly known as TI Pharma) platform for regulatory innovation

Galileiweg 8
2333 BD Leiden
The Netherlands

Call +31 88 00 67 300