Qualified biomarkers help to optimize drug development and patient safety, yet for the regulatory acceptance of safety biomarkers substantial sample sizes are needed to ensure adequate case and control numbers, and robust evidence sufficient for qualification. To address this challenge, a consortium of leading European research institutions and SMEs has been established. The consortium will generate exploratory and confirmatory data enabling regulatory qualification of new safety biomarkers for application in drug development; establish robust datasets on the DILI, DIKI, DIPI, DIVI and DINI biomarkers to enhance diagnosis of disease; develop and validate assays for new safety biomarkers; implement profiles of circulating miRNAs as tissue and mechanism specific diagnostic tool; have key safety biomarkers accepted as qualified drug development tools by EMA, FDA, and PMDA.

Given the significant expertise available across the consortium, the group will be able to tackle the key challenges related to successful biomarker qualification. A key driving principle of the consortium is cross-linking via existing networks of top profile research institutions, as well as capitalizing on existing data and resources. The Consortium is embedded into a network of international research collaborations such as the Pro-Euro-DILI-registry, TransQST, eTRANSAFE, the i2b2 tranSMART Foundation, the CIOMS DILI working group, EPoS, LITMUS, and BBMRI. To optimize regulatory interaction, we intend to continue our successful collaboration with non-European consortia such as PSTC, the FNIH Biomarkers Consortium, and US DILIN. A key expected result of the consortium will be a “Safety Biomarker Factory”, regularly qualifying new markers, with an associated “Safety Biomarker Warehouse”, providing to the scientific community, industry, and patients detailed data and information, and knowledge across a large spectrum of advanced safety biomarkers.

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The EU-funded ECRAID-Base project aims to generate concrete evidence to improve the prevention, diagnosis and treatment of infectious diseases and to better respond to emerging infectious disease threats. The project will establish a pan-European clinical research network to increase efficiency for testing and developing new diagnostic, preventive and/or therapeutic strategies and improving responsiveness to new public health threats. The network has already been successfully used during the COVID-19 pandemic, with valuable lessons learned.

Website of the Project

Bone fracture with delay or failure to heal is a condition with huge health impact. Although only a small proportion of long bone fractures evolve to non-union (5%), it is a first magnitude problem due to the number of new annual fractures and increasing incidence of complex fractures with high risk of non-consolidation, need for repeated procedures and years of patient disability. Bone autografts, autologous mesenchymal cells, or other complex interventions are used in this setting. The aim of this project is the development of a universal therapy for fractures with delay or failure to heal, aiming to a simple and wide access to allogenic cell therapy combined with biomaterial, in a broad number of patients. Rather than considering ATMP only as a last solution in established non-union fractures, this project advocates that the indication should be moved to an earlier timepoint. Patients will be treated with the combined ATMP as soon as the need for reoperation is identified due to delayed healing, with or without an added infectious component, to avoid long-term suffering for patients and their relatives, and prevent progression to more severe non-unions, with heavy personal, social and economic costs.

This approach is aligned with the real needs of patients and better fits with the usual practice in the EU, where reoperations are performed at 6 months or before, in an attempt to accelerate bone healing and avoid complications. The project will establish a master cell bank for a wide allogenic production with donors selection criteria of bone formation potential. Necessary preclinical and clinical information to support the EU approval of a specific combined ATMP will be obtained. Open access to scientific and regulatory information will be available for other EU medical device companies and cell therapy producers, so in addition to direct clinical benefit to patients and healthcare providers, other developers of combined ATMP products will get benefit.

The DADAP project aims to transform the diagnostic assessment process in the clinical care pathway of Child and Adolescent Psychiatry (CAP) by digitizing and automating it using an innovative AI-based solution which is explainable and that optimizes the delivery of health and care services across a multitude of different settings. In several recent national projects, Region Västmanland (RV), a hospital in Sweden, has developed two innovative instruments for digitizing the psychiatric assessment process. The first one is the Electronic Psychiatric Intake Questionnaire (EPIQ) and second one is the Electronic Psychiatric Semi-Structured Interview for Children and Adolescents (EPSI-C), to screen, triage, prioritize, and diagnose patients. As a result of using these instruments, the throughput of patients at the hospital has increased by 130%. Despite this initial success, the overall information gathering is still time-consuming, and the lead time for care needs to be further reduced, particularly due to the escalating number of patients seeking care. Consequently, we have gathered a strong international consortium from Sweden, Spain, Norway, and Romania to firstly, expand the usage of the existing instruments to new countries by translating and adapting them. This first step will contribute to validation of the concept pilot studies which in turn increases the project data. Secondly, by automating the process (potentially down
to 60% less manual work) using AI, we wish to increase the precision of diagnosis and treatment choices and improve patient satisfaction and trust in the healthcare system. We will verify whether we have achieved these goals in each pilot. Moreover, we estimate the social and economic impact of our proposed method in pilot countries. The DADAP project will also develop an AI-based screening and diagnosis system trained on standardized questions and
answers from care seekers and their relatives, clinically validated assessments, and psychiatric diagnoses. The proposed system aims to find and ask the questions that most effectively lead to the best possible basis for the diagnosis and treatment selection, thereby improving the efficiency of several steps in the assessment process. The project expects to achieve several impact goals related to the United Nations’ Agenda 2030, such as improved
availability and reduced waiting times for healthcare, reduced work-related stress for healthcare workers, less subjective and biased diagnosis, equal access to efficient diagnosis regardless of social status or location, and
reduced need for travel. This will contribute to a sustainable healthcare system that is future-proof. The success of this project could significantly benefit the societies it is deployed to by enabling healthcare systems to scale up and efficiently organize their operations, leading to better health outcomes, gender equality, decent work, economic growth, reduced inequality, and sustainable cities and communities.
The DADPAP project’s expected benefits include: – enhanced patient satisfaction, treatment, and trust in the healthcare system; – reduced stress of healthcare workers contributing to a healthier work environment; – increased efficiency and scalability of healthcare systems.

The consortium has key expertise and experience for:

• Supporting implementation of existing solutions on a large-scale, or in different settings,
• Development of innovative explainable AI based tools, including adaptation, testing and integration,
• Making health and care systems economically, socially, and environmentally sustainable, while keeping people at the center of the care process.

Overall, the DADAP project proposes an innovative solution to a long-standing problem in healthcare and we expect a significant positive impact on society as a result of deployment of our solution.

Website of the Project

Website of the Project

The identification of the molecular mechanisms that can positively or negatively influence a patient’s response to medical treatment is a key issue among health practitioners. A study promoted by 3TR, a consortium of university institutions, SMEs and leading pharmaceutical companies, will address this issue. This EU-funded project will apply bioinformatics and control methods to collect and analyse data from blood, tissues and other fluids during the entire treatment process. It will create a centralised data platform for better management and implement an inclusive molecular and clinical picture of patients experiencing similar diseases. The project intends to explain the role that our microbiome, genetics and regulatory genomics play during treatment.

Website of the Project

Website of the Project

Cumulative evidence suggests that food allergy (FA) is associated with a multitude of environmental factors including hygiene habits, antibiotic use, lifestyle changes and in particular, diet. Changes in nutrition can result in dysbiosis of the skin, gut and lung microbiota and generate changes in microbial metabolites produced, which may in turn produce epigenetic modifications. Current evidence supports the view that epigenetic mechanisms are involved in immune regulation and may represent a key-missing piece of the etiological puzzle for FA, at the interface between the environment and the genome. Dietary fiber can change the gut microbiota composition and therefore cause epigenome changes promoting health.

DIFAMEM aims to investigate the effects of FA treatment through intervention with a prebiotic dietary component, pectin, and using peach allergy as a model.

This project will advance our understanding on how the interaction between dietary components and gut microbiota composition leads to epigenetic changes that provoke the immune modulation, and establish new strategies for dietary intervention in FA, with potential applications for other immune-related diseases.

Publication Foods journal

Does the Food Ingredient Pectin Provide a Risk for Patients Allergic to Non-Specific Lipid-Transfer Proteins?

Abstract

Pectin, a dietary fiber, is a polysaccharide that is widely used in food industry as a gelling agent. In addition, prebiotic and beneficial immunomodulatory effects of pectin have been demonstrated, leading to increased importance as food supplement. However, as cases of anaphylactic reactions after consumption of pectin-supplemented foods have been reported, the present study aims to evaluate the allergy risk of pectin. This is of particular importance since most of the pectin used in the food industry is extracted from citrus or apple pomace. Both contain several allergens such as non-specific lipid transfer proteins (nsLTPs), known to induce severe allergic reactions, which could impair the use of pectins in nsLTP allergic patients. Therefore, the present study for the first time was performed to analyze residual nsLTP content in two commercial pectins using different detection methods. Results showed the analytical sensitivity was diminished by the pectin structure. Finally, spiking of pectin with allergenic peach nsLTP Pru p 3 led to the conclusion that the potential residual allergen content in both pectins is below the threshold to induce anaphylactic reactions in nsLTP-allergic patients. This data suggests that consumption of the investigated commercial pectin products provides no risk for inducing severe reactions in nsLTP-allergic patients.

Full-text

Publication Clinical Nutrition

Health outcomes associated with vegetarian diets: An umbrella review of systematic reviews and meta-analyses

Abstract

Several meta-analyses evaluated the association between vegetarian diets and health outcomes. To integrate the large amount of the available evidence, we performed an umbrella review of published meta-analyses that investigated the association between vegetarian diets and health outcomes.

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