About us
Alcediag
ALCEDIAG is a French precision diagnostics company developing blood-based diagnostic solutions based on epigenetics biomarkers (RNA editing) powered by artificial intelligence. The company has a first focus on mental health. The tests and software developed by ALCEDIAG can help to characterize the psychiatric patient, from the initial diagnosis to the monitoring of the disease and the assessment of the response to treatment. In particular, ALCEDIAG has developed EDIT-B, a differential diagnostic blood test, which differentiates between unipolar and bipolar depressed patients.
Role in the EDIT-B Project
The company is engaged as project leader in the consortium, coordinates the project and is highly implicated in all work packages of the project. This includes the clinical study, EDIT-B kit development and its validation, IVDR CE marking, preparation of the product launch on the market and dissemination and communication work.
Alcen
ALCEN is a French diversified group active in five sectors: Health, Defense & Security, Energy, Aeronautics & Space, Large Scientific Instruments.
ALCEN’s ambition is to establish an ongoing policy of innovation applied first and foremost to its own products and services. To achieve this, ALCEN has developed a particularly extensive in-house technological base. It works closely with research and clinical centers, systematically transfers technological developments and feedback from one field to another and develops its technologies in specialized laboratories organized around a select number of top experts. ALCEN has built an original and fully-integrated technological model boasting exceptional productivity.
Role in the EDIT-B Project
ALCEN supports its subsidiary ALCEDIAG in the coordination of the EDIT-B project, and provides for example transversal services such as legal support or websites management.
Capital Region of Denmark
Mental Health Services in the Capital Region of Denmark (REGIONH) is a psychiatric hospital that has about 5,000 employees, and treats about 35,000 patients with mental disorders each year, which is about 40% of the total psychiatric treatment given in Denmark. The organization covers the entire Capital Region Copenhagen including a population of 1.8 million people. The organization consists of 10 Mental Health Centres each including bed inpatient units, outpatient Clinics, Community Mental Health Centres and Specialized treatment Clinics. The number of beds is 1270 and the budget more than 450 mill. dollars.
The EDIT-B project is undertaken in the Copenhagen Affective Disorder research Center in Psychiatric Center Copenhagen, which is the largest psychiatric center in the Capital Region of Denmark. CADIC is chaired by Professor Lars Vedel Kessing.
The overall scientific objective of the Copenhagen Affective Disorder research Center is to study genetic and environmental risk factors for the onset of affective disorders, the psychopathology, behavior, cognition and biology of affective disorders, the course and long-term outcome of affective disorders and the effect of treatments on affective disorders.
The research centre possesses scientific skills within clinical, epidemiological, neurobiological, neuropsychological, laboratory, preclinical, translational and brain imaging research in affective disorders.
The Copenhagen Affective Disorder research Center includes four larger research groups, namely, the Bipolar Illness Onset study (the BIO group), the Depression biology group, the Neurocognition and Emotion in Affective Disorders Group (NEAD group) and the Non-pharmacological interventions for depression (NID group).
Role in the EDIT-B Project
Capitol Region of Denmark participates in the design of the clinical study, the enrolment of the patients with collection of the detailed demographic baseline characteristics, clinical data, and blood sampling.
Investigator Dr Lars Kessing
Dr. Kessing has since 2002 been appointed as Professor in psychiatry at the Psychiatric Center Copenhagen, Rigshospitalet, and the University of Copenhagen, Faculty of Health and Medical Sciences, Denmark.
Dr. Kessing is Chair of the Copenhagen Affective Disorder research Center (CADIC). Dr. Kessing scientific contributions are within clinical, epidemiological including register-based, genetic and neurobiological research in bipolar and unipolar affective disorders.
Dr. Kessing is the author of more than 500 peer reviewed scientific papers on affective disorders and he has received a number of scientific prizes, including the US National Alliance for Research in Schizophrenia and Affective Disorders (NARSAD) Bipolar Mood Disorder Prize for “Outstanding Achievement in Bipolar Mood Disorder Research”and the Travelling Professor Award for the Royal Australian and New Zealand College of Psychiatrists.
Web of Science: H-index: 61.
GHU Paris Psychiatry & Neurosciences
On the first of January 2019, Sainte-Anne, Maison Blanche and Perray Vaucluse hospitals have merged into the University Hospital Group – Paris (Psychiatry & neurosciences), “GHU Paris” in french.
These 3 hospitals have been working closely together over the past years, defining a common medical strategy in mental health and neurological diseases for 2.2 million Parisians. The GHU Paris achieves the goal of becoming the first care player in Paris for mental and brain diseases.
The GHU Paris employs 5,600 healthcare professionals, including 600 doctors, with a 380 M€ budget. It provides outpatient care (representing 85% of its activity), inpatient care and crisis units as well in a hundredth of facilities distributed over the capital.
Overall, 60,000 Parisians seek assistance from the GHU Paris. The historical intricacy of psychiatric and neurosciences specialties, within the same hospital, is an important asset of this new GHU, thanks to Sainte-Anne legacy.
With 9 university departments, GHU Paris fosters three overlapping activities (clinical practice, education and research) which constitute the basis for innovative practices. GHU Paris specializes in early detection, brain tumors, strokes, epilepsy, drug resistant diseases, addictions, schizophrenia and bipolar disorders, and empowerment.
Role in the EDIT-B Project
The GHU Paris participates in the design of the clinical study and the enrolment of patients with collection of the detailed demographic baseline characteristics, clinical data, and blood sampling.
Investigator Dr Chantal Henry
Chantal Henry, MD, PhD. Professor of Psychiatry at the University of Paris, practices psychiatry at the GHU of Paris (Sainte-Anne site) and is involved in the neurosciences department of the Institut Pasteur (perception and memory unit). She coordinated the European Network of Centers of Excellence on Bipolar Disorders (ENBREC, funded by FP7), established the network of expert centers in France (bipolar, schizophrenia, resistant depression, asperger) and has joined in September the department that started modern psychiatry (discovery of the effects of neuroleptics by Delay and Deniker).
Hospítal Clinic de Barcelona and Fundació Clínic per a la Recerca Biomèdica (FCRB)
Fundació Clínic per a la Recerca Biomèdica (FCRB) was created in 1989 to manage, and promote the research activities of Hospital Clínic de Barcelona (HCB), one of the best hospitals in Spain. In addition, in 1996, Consorci Institut D’Investigacions Biomediques August Pi i Sunyer (IDIBAPS) was founded as a public research centre dedicated to translational research in the field of biomedicine with the mission of integrating the state of the art basic research and quality clinical research. Both, FCRB and IDIBAPS perform the research of HCB.
The group’s research is highly translational. That is to say, it is geared towards a better understanding of bipolar and depressive disorders and corresponding improvements in clinical practice. It employs a multidisciplinary approach, both to patient care and to teaching and research, and it investigates the neurobiological and anatomical-functional mechanisms that are involved in the clinical development and progression of these conditions, comorbidity (co-occurrence with other conditions), intervening neurocognitive mechanisms and the quest for new pharmacological, biophysical and psychosocial treatments.
Principal Investigator Dr Eduard Vieta
Dr Eduard Vieta is a Professor of Psychiatry at the University of Barcelona and Chair of the Department of Psychiatry and Psychology at the Hospital Clinic, where he leads the Bipolar and Depressive Disorders Unit and the Translational Psychiatry and Psychology group of IDIBAPS, in Barcelona, Catalonia, Spain. His unit is one of the worldwide leaders in clinical care, teaching and research on bipolar disorder. Currently, he is the Scientific Director of the Spanish Research Network on Mental Health. He has authored more than 1070 original articles and his h index is 141 and has over 78000 citations (Google Scholar). Furthermore, he is the Editor-in-Chief of European neuropsychopharmacology, and a member of the editorial board of many scientific journals and has served as invited professor at McLean Hospital and Harvard University. His research has focused on the neurobiological and anatomo-functional mechanisms involved in the development of bipolar disorder and depression and its relapses, the clinical course and neuropsychological consequences, the efficacy of drug treatments and novel therapies, and psychological interventions for the early detection of disease and prevention of recurrences. He is also one of the pioneers of Precision Psychiatry.
Role in the EDIT-B Project
FCRB and HCB participate in the design of the clinical study, the enrolment of the patients with collection of the detailed demographic baseline characteristics, clinical data, and blood sampling. Dr Eduard Vieta is the principal investigator of the clinical study.
Parc Sanitari Sant Joan de Déu and Funcació Sant Joan de Déu
Parc Sanitari Sant Joan de Déu (PSSJD) is a private non-profit institution that includes a General Hospital, acute inpatient units for individuals with mental health problems and intellectual disabilities and longer stay units for individuals with mental health chronic health conditions.
PSSJD belongs to the National Health Service, and the services provided are funded by the government, similarly to public hospitals. PSSJD is also a research and innovative institution affiliated with the University of Barcelona and offers specialized teaching for physicians, psychologists, nurses, and other health professionals.
The General Hospital is community-based with stable links with local agents, offering personalized, high-quality care. The hospital has different medical and surgical services and provides both inpatient and outpatient care with a catchment area of approximately one million people. It focuses on bringing together basic research scientists and clinicians in public health, mental disorders, ageing and disability.
Fundació Sant Joan de Déu (FSJD) is the entity that manages the research and innovation activity generated in PSSJD and other entities that belong to Sant Joan de Deu.
Role in the EDIT-B Project
PSSJD and FSJD participate in the design of the clinical study the enrolment of the participants in care in the PSSJD Health system with the collection of the detailed demographic baseline characteristics, clinical data, and blood sampling.
Investigator Dr Josep Maria Haro
Dr Josep Maria Haro (m), Psychiatrist and PhD in Public Health, is the Head of the Research, Innovation and Teaching Unit at PSSJD and Associate Professor of Medicine at the University of Barcelona. His main research areas are the epidemiology of mental disorders and treatment outcomes in mental health. He has conducted studies on the prevalence and impact of disorders in the general population and treating mental disorders in primary care. Recently, he has focused on the determinants of healthy ageing, analyzing both the impact of physical and mental disorders and the effect of societal and environmental aspects. In 2011, he received the best researcher award from the Spanish Society of Biological Psychiatry. He has coordinated 4 EU-funded projects: “Roadmap for mental health and wellbeing research in Europe” (ROAMER, GA282586), “Ageing Trajectories of Health: Longitudinal Opportunities and Synergies” (ATHLOS, GA 635316) and “SYNergies for Cohorts in Health: integrating the ROle of all Stakeholders” (SYNCHROS, GA 825884), European platform to Promote Wellbeing and Health in the workplace” (EMPOWER, GA848180). He also leads one of the most prominent research groups of CIBERSAM (Biomedical Research Networking Centres on Mental Health in Spain) (Group 11:”Impact, risk and prevention of physical and mental disorders”), financed by the Carlos III Health Institute and it is recognized as a consolidated research group by the Government of Catalonia (AGAUR – Agency for Administration of University and Research Grants) since 2009.
ProductLife Group
ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions.
Since almost 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 140 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, market access (pricing & reimbursement), vigilances and medical information, covering both established products and innovative therapeutics & diagnostics.
With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.
Role in the EDIT-B Project
ProductLife Group wants to bring to EIT Health community the best skilled and efficient support within its domains of expertise: regulatory intelligence, strategic advices and operational execution for the development and registration of new innovative medicinal or combination products like the EDIT-B product.
In the EDIT-B Consortium, PLG is helping in defining all the regulatory framework following the future IVD regulation EU 2017/746, supporting in implementing a Quality management system ISO 13485, drafting Quality Manual, setting up essential procedures and obtaining CE marking at the end of the process.
Synlab Italy
Synlab Italy is the most important provider of integrated diagnostic services in Italy and offers a wide range of laboratory medicine services for patients and doctors in public and private facilities.
Synlab Italy Central Laboratory, located in Castenedolo, performs over 15 million tests per year in all the fields of modern laboratory medicine. The specialist unit includes pathological anatomy, molecular biology and medical genetic.
In the molecular field the laboratory is strongly involved in research project, test validation and scientific publications.
Role in the EDIT-B Project
In the EDIT-B project Synlab Italy is involved in several activities. At laboratory level will assess the clinical performance of the EDIT-B kit based on Alcediag algorithm and will be in charge to be the central lab for the analysis of all collected clinical samples. Moreover, Synlab will assure that sample are managed properly (pre-analytical phase), we will also provide material and logistic support. Finally, Synlab will be partner for the marketing of the test and in the dissemination and communication plan.