The regulatory impact of IMI and IHI

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Impacting regulatory science with IHI and IMI projects – a word from our director

This month, the value that IHI and IMI projects can deliver by contributing to regulatory science and the legacy of our portfolio became clear.

We received some excellent news – the European Medicines Agency recommended marketing authorisation for an IMI-supported treatment - EMBLAVEO® - for severe infections and hospital-associated pneumonias caused by antibiotic-resistant bacteria. Congratulations to the IMI COMBACTE-CARE team on this fantastic result!

I attended IHI’s first Regulatory Science Summit, which took place at the end of February and provided a neutral forum for experts to come together and discuss how IHI projects can address regulatory challenges in the health space. The IMI T2EVOLVE project is a good example – they recently published a series of recommendations to speed up regulatory approval of cell and gene therapies.

One of IHI’s core strengths is the legacy of IMI projects. A recent special edition of Frontiers in Neurology highlighted a selection of IMI’s contributions to Alzheimer’s research, and IHI looks set to continue that tradition with new project AD-RIDDLE developing a toolbox to identify those at risk from Alzheimer’s.

Cross-sector research is another hallmark of IHI and IMI projects, and new IHI project SASICU is combining AI and behavioural science to improve recovery for patients and decrease the cognitive load on staff in intensive care units. I’m looking forward to seeing their results!

Niklas Blomberg, IHI Executive Director

IMI-supported treatment against drug-resistant bacteria gets positive opinion from EMA

3D illustration of anti-microbial resistance. Image by nobeastsofierce via Shutterstock.
The EMA’s Committee for Medicinal Products for Human Use recommendation for marketing authorisation means we are one step closer to treating adult patients with complicated intra-abdominal and urinary tract infections and hospital-acquired pneumonias caused by Gram-negative bacteria.
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IHI and IMI projects can address research gaps in regulatory science. Image credit: EtiAmmos via Shutterstock.
Future-proofing health innovation regulation
Held at the end of February, IHI’s Regulatory Science Summit provided a forum to discuss how IHI projects can help overcome current regulatory challenges and contribute to regulatory science.
T-Cell binding to a tumour cell using Chimeric Antigen Receptor (CAR). Image credit: Alpha Tauri 3D Graphics via Shutterstock.
T2EVOLVE publishes recommendations for cutting CAR-T therapy red tape
Making adjustments to the regulatory process in the EU could reduce the burden on manufacturers and shorten the waiting times for treatments to be approved for clinical trials.

Special issue of journal highlights impacts of IMI and IHI projects on Alzheimer’s disease

Medical staff discussing a brain scan on a computer screen. Image by Gorodenkoff via Shutterstock.
The series of papers in Frontiers in Neurology demonstrates how public-private collaborative research through IMI and now IHI is making a difference in the Alzheimer’s field.
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A group of three senior people doing Nordic walking on a wooden boardwalk in the countryside. Image by Jenny Sturm via Shutterstock.
AD-RIDDLE wants to revolutionise our approach to Alzheimer’s disease. Here’s how.
The new IHI project hopes its ‘toolbox platform’ will dramatically change the way we detect, diagnose, prevent and treat Alzheimer’s disease.
A healthcare worker working at a machine in an intensive care unit. Image by Peakstock via Shutterstock.
Shhh! SASICU strives for silence in intensive care
The new IHI project aims to make intensive care units more peaceful for staff and patients alike by using smart technologies to cut the number of alarms.
A representation of a checklist.  Image credit: MMD Creative via Shutterstock.
New! A guide for IMI and IHI projects and applicants on regulatory considerations
The guide is designed to raise awareness of the regulatory aspects to be considered during proposal preparation and project implementation, and guide users to relevant regulatory services.
16 April written on pebbles. Image by Yournameonstone via Shutterstock.
Deadline reminder: IHI call 6 closes on 16 April
The deadline for IHI call 6 is approaching fast! If you still have questions, send them to us as soon as possible, and don’t wait until the last minute to submit your short proposal.