Arrow Left Projects

Regulatory innovation

Arm’s length support for stakeholders with often conflicting interests, facilitating scientific discussions and improving access to therapeutic solutions

Many stakeholders involved in developing medical solutions share a common end goal: to develop and launch new products that improve society's wellbeing.

Regulatory bodies must also ensure the safety and efficacy of new products. Their need for independence means they are not able to work directly with industry. However, a more efficient and effective regulatory system benefits everyone: patients, public bodies, and private partners alike. Improvements can speed up innovation, improve resource allocation, and protect the interests of everyone involved.

By providing a neutral platform for all stakeholders, the Escher project, Lygature fosters common ground, mediates conflicting interests, and facilitates scientific discussions. Our work helps to drive joint efforts towards an improved and innovation-friendly regulatory framework. We initiate and conduct our own research into regulatory and HTA (Health Technology Assessment) topics, and also take on third-party proposals. The objective is to promote faster and more efficient development of medicines and medical technology.

Portfolio

Regulatory Science Network Netherlands (RSNN)

The Dutch network for experts from academia, government bodies, pharmaceutical industry, and patient organizations
Goal: To advance the regulatory system and to set the agenda for further research, by pooling the expertise of all stakeholders
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Escher

An independent, international research platform focused on regulatory and HTA topics.
Goal: To improve regulation and advance the development of socially valuable medicines.
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Non-Biological Complex Drugs (NBCD) Working Group

A group hosted by Lygature that addresses approval and post-approval standards for NBCDs.
Goal: To guarantee that NBCDs and follow-on products are safe and of benefit to patients.
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ADAPT SMART

An enabling platform for the coordination of Medicines Adaptive Pathways to Patients (MAPPs) activities. 
Goal: To accelerate early access to innovative medicines for appropriate patient groups
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RADAR-CNS

Pan-European research on the potential of wearable devices.
Goal: Helping to prevent and treat depression, multiple sclerosis and epilepsy.
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Health Innovation Netherlands (HI-NL)

HI-NL is a multi-stakeholder infrastructure where patients, doctors, health care-providers, methodologists, CE-experts, entrepreneurs, insurers, investors and regulatory authorities all contribute to faster deliver better medical devices.
Goal: To become the leading public-private infrastructure working to stimulate the development and implementation of safe, valuable, affordable and cost-effective health innovations.
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