Archives: Partners

PsychoGenics is a preclinical CRO with expertise in CNS and orphan disorders. Our mission is to provide the best-validated disease models and comprehensive preclinical capabilities to help companies discover the next generation of treatments for severely disabling CNS and orphan disorders, and reduce the attrition rate in clinical development. We are known for our cutting-edge translational approach to research, our customized solutions, the breadth and quality of our work, as well as for our ability to identify statistically relevant phenotypic changes that help our clients quantify the efficacy of their treatments before they move into the clinic. With an extensive portfolio of highly predictive disease models and unparalleled experience performing studies for biopharmaceutical companies of all sizes, we enable clients to deliver much-needed superior clinical candidates to patients. Our capabilities include behavioral testing, electrophysiology, translational EEG, quantitative histology, molecular biology, and microdialysis. We offer a variety of validated mouse models including in-licensed transgenic models that support research in areas such as Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, autism spectrum disorders, psychosis and schizophrenia, spinal muscular atrophy, muscular dystrophy, and a broad array of pain models.

In PRISM 2, we are involved in the preclinical back-translation and biological validation (WP4), specifically validating the association of social deficit with EEG readouts and the back-translation of the patient cluster phenotype to a disease-related preclinical model.

Cohen Veterans Bioscience (CVB) is a U.S.-based nonprofit 501(c)(3) biomedical research and technology organisation dedicated to advancing brain health by fast-tracking precision diagnostics and tailored therapeutics. By building enabling platforms with strategic partners, CVB has adopted a team science approach to accelerating the field. CVB’s translational tools include biomarkers, preclinical modeling, biorepositories, and reference libraries. To cultivate the integration of big data across brain disorders and apply AI to build predictive models, CVB supports a data-sharing platform with the capacity to store, secure and analyse petabyte levels of data. In addition, CVB is working to optimise digital health platforms and clinical trial design.

The department of data science aims to generate novel insights into brain health and wellbeing by using advanced machine learning and AI-based technologies to investigate multi-modal datasets in both healthy populations and patients with diseases such as post-traumatic stress disorder, traumatic brain injury, and Parkinson’s. Here we focus our methods on applying a ‘systems’ approach that enables us to directly bridge between different levels of data to understand the underlying biology that cuts across existing diagnoses and better describes these disorders from a transdiagnostic perspective, enabling translation to precision diagnosis and treatment.

In the BRAINCommons, we have created a cloud-accessible and secure digital ecosystem to enable and stimulate data sharing and analysis in both public and private domains, fueling discovery and collaboration across the multidisciplinary research community, and driving diagnostic and therapeutic innovation to reduce the burden of brain-based disorders.

Cohen Veterans Bioscience (CVB) is joining the PRISM 2 project as an EFPIA Associated Partner providing funding and in-kind contributions as well as bioinformatics and technology expertise to the program.  The focus of the PRISM 2 project aligns with our own mission to advance a quantitative, transdiagnostic neurobiological approach to the understanding of neuropsychiatric disorders.  CVB will participate in the Steering Committee (SC) as part of Work Package (WP) 1 – Project Management and Governance as well as co-lead WP2 Data management, sustainability, and analysis, in the program.  In WP2, we are responsible for enabling the storage, sharing, and analytics of the PRISM 2 data on the BRAINCommons (our cloud-enabled data and analytics platform).  We will develop a data management and sustainability plan, and facilitate access to data for and beyond the duration of the project. All consortia data sets will be curated, harmonised, and uploaded to the BRAIN Commons for selective access by consortium members (Zone 3), and then at the appropriate time, made available to the broader qualified researcher community (Zone 2), as per Consortium agreement. CVB will additionally generate data pipelines and work with partners on multi-modal analysis as part of the Data & Analysis Core. As part of WP6 – Dissemination, communication, exploitation, and training, we will serve as a liaison to relevant US-based initiatives to enable the dissemination of findings for replication and validation of program results.

ECNP is Europe’s leading independent forum for the science of central nervous system (CNS) treatments. The annual ECNP Congress showcases the world’s best disease-oriented brain research, annually attracting more than 5,000 neuroscientists, psychiatrists, neurologists and psychologists. ECNP’s wide range of scientific and educational activities, programmes and events make it the largest non-institutional supporter of applied and translational neuroscience research and education in Europe. In PRISM 2, we lead WP6 (dissemination, communication, exploitation, and training).

Leiden University Medical Center (LUMC) is a modern academic center for research, education and patient care with a high profile and a strong scientific and international reputation. It’s unique research practice, ranging from pure fundamental medical research to applied clinical research, places LUMC among world leaders. The intensive collaboration between LUMC, Leiden University, and the large Leiden Bio Science Park, with amongst others the Center for Human Drug Research (CHDR), creates unique possibilities for medical innovation.

The LUMC Department of Psychiatry was also a partner in PRISM. We have specialized inpatient and outpatient clinics for mood, anxiety, OCS spectrum- and neuropsychiatric disorders, as well as clinical and experimental research units. Our research focuses on the treatment, phenomenology,f and neurobiology of disorders of affective disorders and their course and development over the lifespan. Our research program is embedded in the LUMC Neuroscience theme and the Leiden Institute for Brain and Cognition (LIBC).

Our department and our close collaborators have ample experience in conducting clinical studies as well as cohort studies with extensive phenotypical and neurobiological assessments. This fits well with the main tasks foreseen for the LUMC Psychiatry team in the PRISM 2 proposal. We will recruit and extensively phenotype patients with MDD, AD, and SX. We will be involved in the development of the clinical and experimental protocols and data analyses.

concentris research management gmbh is a service company specialised in the organisation and controlling of medium- and large-scale EC projects in H2020 and IMI. Our Project managers have a sound knowledge of the guidelines and know how to apply contractual provisions. From our longstanding, hands-on expertise in the management of EU Framework projects, we understand how to communicate effectively with all involved stakeholders (i.e. EU project officers, university administration staff, scientists). We actively facilitate the day-by-day processes of research projects and funding regardless of whether it concerns the reporting to the EU or the organisation of conferences, project meetings, training and workshops. Building teams of people, moderating international groups, bringing about decisions in order to deliver real results, are other key strengths.

concentris will support the coordinator and the project leader in WP1 (project management) and will take on responsibility for contractual and communication management, project controlling and reporting, finance controlling and reporting, and will organise all project meetings. Furthermore, concentris will be involved in WP6 dissemination activities.

SBGneuro Ltd. brings together leading neuro-imaging experts to enable functional and structural MRI to fulfil its rich potential as a powerful, non-invasive biomarker for a wide range of diseases and disease treatments. We offer expertise in basic image acquisition methodology, imaging data analysis, and clinical neuroscience. Our services include pre-trial consulting, study design and acquisition optimization, definition of a priori outcome measures, data quality control, integrated functional and structural data analysis, post-trial interpretation, and dissemination of results.

In the first phases of PRISM 2, SBGneuro will work with project partner Cohen Veterans Bioscience Inc. (CVB) to focus on the management of existing study data, developing a data sustainability plan, and supervision of first-level magnetic resonance imaging (MRI) endpoints. In next-level analyses, we will test the reproducibility and generalisability of PRISM endpoints across disorders.

Biotrial is a full-service CRO with over 30 years of experience in conducting non-clinical and clinical trials from Phase I through to Phase IV for a global client base of pharmaceutical and biotech companies. The Biotrial EEG Core Lab has extensive experience and an excellent track record in EEG clinical trials in diverse clinical settings throughout the drug development process.

In PRISM 2, Biotrial is in charge of multiple-site EEG data collection uniformity (i.e. by providing identical EEG setup and training to the clinical sites) and centralized EEG data collection and analysis (signal processing, data extraction, data management, statistical analysis, and reporting).

VUMC represents one of the 8 unique University Medical Centers in the Netherlands, where teaching, research, and patient care are fully integrated into one organisation. VUMC hosts approximately 2400 students and approximately 700 scientific staff members. VUMC currently has a management alliance with the other university medical center in Amsterdam, collaborating intensively under the name Amsterdam UMC. Prime research institutes of the VUMC are the Amsterdam Neuroscience (AN) and Amsterdam Public Health (APH).

The departments of psychiatry and neurology of VUMC, participate in the PRISM 2 project. The psychiatry group mainly focuses on depressive disorders, and the neurology group houses the Alzheimer’s Center Amsterdam. In PRISM 2, they will contribute to the clinical data collection and data analyses of data generated in both the PRISM and the PRISM 2 projects.

The Psychiatry Section comprises approximately 15 psychiatric beds, in addition to a large Outpatients Unit covering the Bologna area. Residents and postdocs work within this environment performing both clinical and research activities. The Section focuses on clinical and genetic studies which produce an average of 30 papers per year published in high Impact Factor journals.

We will participate in WP2 and will lead together with Radboudumc Task 5, the Mendelian randomization study, to test the causality of default mode network (DMN) activity and structural integrity on sociability in large-scale, publicly available population-based samples using Mendelian randomisation.

CIBERSAM is a publicly-funded research network based in Spain which aims to improve the quality of life of patients with mental disorders through coordinated multi-center research, which currently includes 23 multidisciplinary research groups. Of these, two CIBERSAM research groups from Madrid will be involved in PRISM 2, namely the group at Hospital General Universitario Gregorio Marañón, which is led by Dr. Celso Arango, and the group at Hospital Universitario La Princesa, which is led by Dr. José Luis Ayuso.

With regard to our involvement in PRISM 2, CIBERSAM will support WP3, during which we will recruit and assess Alzheimer Disease (AD) patients (n=20), Schizophrenia (SZ) patients (n=20), as well as healthy controls (HCs, n=30) at both sites. In addition, CIBERSAM will lead WP5 regarding the compliance with ethics requirements and engagement with regulatory groups, agencies, and other stakeholders. In WP2, we will contribute to the analysis and management of the data generated in both the PRISM and the PRISM 2 project, including assessment of the reproducibility and sustainability.