PRISM 2 · Project

Brain Biomarkers and Digital Tools to Classify Psychiatric Disorders for Drug Development

healthPrototypeTRL 4Thin data (2/5)

Right now, doctors diagnose conditions like Alzheimer's, schizophrenia, and depression mainly by observing symptoms — there's no blood test or brain scan that gives a clear-cut answer. PRISM 2 looked at whether measurable brain patterns, especially in a brain network active when we daydream, could explain why patients across these different diagnoses all struggle with social functioning. They also built a digital tool that objectively measures how well someone handles social situations, moving beyond subjective questionnaires. The goal is to give drug companies better biological targets to aim at when developing new treatments.

By the numbers

consortium partners across academia, industry, and patient organizations

countries represented in the consortium

neuropsychiatric disorders covered (schizophrenia, Alzheimer's, major depression)

SMEs participating in the consortium

56%

industry partner ratio in the consortium

total project deliverables produced

The business problem

What needed solving

Psychiatric drug development has one of the highest failure rates in pharma because current diagnostic categories don't reflect the actual biology of brain disorders. Two patients with the same diagnosis can have completely different underlying biology, and two patients with different diagnoses can share the same brain dysfunction. Without objective biological markers, drug companies are essentially shooting in the dark — running large, expensive trials that fail because patient groups are too heterogeneous to show a clear drug effect.

The solution

What was built

The project validated transdiagnostic biomarkers linking Default Mode Network integrity to social dysfunction across schizophrenia, Alzheimer's disease, and major depression. It also produced a digital tool for objectively measuring social function, a preclinical test battery for back-translation between animal models and clinical findings, and a Scientific Advice Letter on biomarker validation from regulators.

Audience

Who needs this

Pharmaceutical companies developing drugs for Alzheimer's, schizophrenia, or depressionDigital health companies building clinical assessment tools for psychiatryContract research organizations running CNS clinical trialsBiotech startups working on precision psychiatryRegulatory affairs teams seeking qualified biomarker endpoints

Business applications

Who can put this to work

Pharmaceutical R&D

enterprise

Target: Pharma companies developing CNS drugs

If you are a pharmaceutical company struggling with high failure rates in neuropsychiatric drug trials — this project validated transdiagnostic biomarkers linking Default Mode Network integrity to social dysfunction across schizophrenia, Alzheimer's disease, and major depression. These biological markers could help you stratify patients more precisely in clinical trials, reducing the noise that causes expensive late-stage failures. The consortium of 18 partners across 7 countries has already engaged regulators via a Scientific Advice Letter on biomarker validation.

Digital Health & Clinical Assessment

SME

Target: Digital therapeutics and clinical assessment tool companies

If you are a digital health company looking for validated digital endpoints for psychiatric conditions — this project developed a digital tool for objectively assessing social function that works across diagnostic categories. The tool provides quantitative readouts that correlate with neuroimaging and cognitive measures, offering something more reliable than patient self-reports. With 9 SMEs already in the consortium, there is a clear path toward commercializing digital assessment products.

Contract Research & Clinical Trials

mid-size

Target: CROs specializing in CNS clinical trials

If you are a contract research organization running psychiatric drug trials and facing patient heterogeneity problems — this project identified quantitative biological parameters that cut across traditional diagnostic labels. Using these transdiagnostic markers, you could offer sponsors better patient stratification services, potentially reducing trial sizes needed to show drug effects. The project's preclinical test battery also enables back-translation between animal models and human outcomes.

Frequently asked

Quick answers

What would it cost to license or use these biomarkers in our trials?

The project data does not include licensing terms or pricing. As an IMI2 project with 10 industry partners including EFPIA members, IP arrangements would have been defined in the consortium agreement. Contact the coordinator at Rijksuniversiteit Groningen to discuss access terms.

Can these biomarkers be used at industrial scale in multi-site clinical trials?

PRISM 2 was specifically designed to test reproducibility of findings from PRISM 1 across multiple sites in 7 countries. The transdiagnostic biomarkers based on Default Mode Network integrity and the digital social function tool were tested across schizophrenia, Alzheimer's disease, and major depression populations. However, full regulatory qualification as trial endpoints would require further steps beyond this project.

Who owns the IP on the digital assessment tool and biomarker data?

As an IMI2 (Innovative Medicines Initiative) project, IP is typically shared between academic and industry partners under specific IMI rules. With 10 industry partners and 9 SMEs in the consortium, commercial exploitation rights would be governed by the consortium agreement. The Scientific Advice Letter on biomarker validation suggests regulatory groundwork has been laid.

What regulatory validation do these biomarkers have?

The consortium produced a Scientific Advice Letter on the validation of biomarkers, indicating direct engagement with regulators. This is an early but important step — it means regulators have reviewed the biomarker strategy and provided formal feedback. Full regulatory qualification as drug development tools would still require additional validation studies.

How long before these tools could be integrated into our drug development pipeline?

The project ran from 2021 to 2024 and is now closed. The digital assessment tool and biomarker panels exist as research-validated prototypes. Integration into commercial drug development would depend on regulatory qualification status and licensing negotiations with the consortium. Based on available project data, the preclinical test battery is ready for back-translation studies.

Does this work with our existing clinical trial infrastructure?

The digital social function tool was designed to provide objective, quantitative readouts that complement standard neuroimaging and cognitive endpoints already used in CNS trials. The preclinical test battery uses homologs of clinical paradigms, so it should align with existing translational pipelines. Integration specifics would need to be discussed with the consortium.

Consortium

Who built it

PRISM 2 has an unusually strong industry presence for a research project, with 10 industry partners making up 56% of the 18-member consortium across 7 countries (DE, ES, FR, IT, NL, UK, US). Nine partners are SMEs, suggesting a mix of agile biotech and digital health companies alongside larger pharma players typical of IMI2 projects. The academic backbone includes 4 universities and 3 research organizations, led by Rijksuniversiteit Groningen in the Netherlands. The transatlantic spread including US partners is notable and suggests the results are designed for global pharmaceutical markets, not just European regulators. For a business looking to access these biomarkers or digital tools, the high industry ratio means commercial translation was built into the project from the start.

RIJKSUNIVERSITEIT GRONINGENCoordinator · NL
ACADEMISCH ZIEKENHUIS LEIDENparticipant · NL
STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUMparticipant · NL
SBGNEURO LTDparticipant · UK
STICHTING BURO ECNPparticipant · NL
STICHTING AMSTERDAM UMCparticipant · NL
BOEHRINGER INGELHEIM INTERNATIONALGMBHparticipant · DE
ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNAparticipant · IT
P1VITAL LIMITEDparticipant · UK
P1VITAL PRODUCTS LIMITEDthirdparty · UK
CONCENTRIS RESEARCH MANAGEMENT GMBHparticipant · DE
CONSORCIO CENTRO DE INVESTIGACION BIOMEDICA EN RED M.P.participant · ES
BIOTRIALparticipant · FR

How to reach the team

Rijksuniversiteit Groningen (Netherlands) — search for PRISM 2 project lead in their neuroscience or psychiatry department

Order a report on this consortium See RIJKSUNIVERSITEIT GRONINGEN profile →

Next steps

Talk to the team behind this work.

Want to explore how PRISM 2's transdiagnostic biomarkers or digital assessment tools could fit into your drug development pipeline? SciTransfer can arrange a direct introduction to the research team and help you evaluate licensing or collaboration options.

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