Interview with Dr. Bruno Steinkraus, Chief Scientific Officer at Hummingbird Diagnostics GmbH
On 9 May, the members of the Neuronet (Efficiently Networking European Neurodegeneration Research) programme were pleased to announce the launch of an updated version of their Decision Tool to support engagement with Regulatory and Health Technology Assessment (HTA) bodies. The Decision Tool now provides a clickable overview of the processes and procedures for HTA and regulatory interactions at different stages of the development pipeline. This will help ensure that the outputs being developed by projects are relevant for regulatory and HTA settings, where applicable.
Neuronet is a Coordination and Support Action aiming to support and better integrate projects of the Innovative Medicines Initiative’s (IMI) neurodegeneration (ND) research portfolio including the EPAD project. One of Neuronet’s workstreams aims to develop tools and services to support IMI ND projects in areas where unmet needs have been identified, which include the need for further support for interactions with HTA and regulatory agencies.
Representatives of the Neuronet project partner, NICE (UK National Institute for Health and Care Excellence) have performed a general update of the Decision Tool that went live on 9 May. This involved updating the signposting information and text to include any changes to organisations and processes and providing case studies from projects within the Neuronet portfolio that have been through HTA or regulatory processes and procedures. Additional signposting information on relevant agencies, organisations, tools and projects was also incorporated.
The Decision Tool can be accessed through the Neuronet Knowledge Base, here: https://kb.imi-neuronet.org/
“The timing of engagement with regulators and which procedures to follow are important considerations to maximize the value of feedback received for research strategies. Neuronet’s interactive tool can help in making such fit-for-purpose decisions”, Dr Lennert Steukers, Neuronet Project Leader and Associate Director, Clinical Scientist, Janssen Pharmaceutica NV, a member of the Neuronet Project.
Acknowledgement
The Neuronet project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 821513. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and Parkinson’s UK.
Disclaimer
This communication reflects the views of the Neuronet Consortium and neither IMI nor the European Union and EFPIA or any Associated Partners are liable for any use that may be made of the information contained herein.
Contact info@imi-neuronet.org for further information.
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