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http://www.oncotrack.eu/

An international consortium to develop and assess novel approaches to identify and characterize biological markers for colon cancer that will deepen the understanding of the variable make-up of tumors and how this affects the way patients respond to treatment. They will use cutting edge laboratory-based genome sequencing techniques coupled to novel computer modelling approaches to study both the biological heterogeneity of colon cancers (i.e. patient to patient variability) as well as tumor variation within the patient for example, by comparing primary tumors with metastases. This five year project brings together top scientists from European academic institutions offering a wide range of expertise, and partners them with pharmaceutical companies. The project is based on the premise that this genetic and epigenetic information, combined with a description of the molecular pathology of the tumor, will allow OncoTrack to generate a more accurate in-silico model of the cancer cell. This will facilitate the identification of predictive markers that can be used to guide the optimal therapy strategy at the level of the individual patient - and will also provide on-going prognostic guidance for the clinician. This project will not only advance understanding of the fundamental biology of colon cancers but will provide the means and approach for the identification of previously undetected biomarkers not only in the cancer under study, but potentially also in other solid cancers and, in doing so, open the door for personalized management of the oncology patient.

Proper citation: OncoTrack (RRID:SCR_003767) Copy   

•   Source: SciCrunch Registry

http://www.predict-tb.eu/

Consortium to accelerate the search for new, more effective combinations of treatments to tackle Tuberculosis and address pre-clinical research barriers to the discovery and development of new TB drug combinations. To overcome the challenges in Tuberculosis drug development they will create tools to accelerate PK-PD (Pharmacokinetic / Pharmacodynamic) analysis that are connected to clinical outcomes. By addressing the gaps in preclinical information, the consortium aims to provide a framework and tools to facilitate the transition of the best combinations of drugs to late phase development. They aim to develop an integrated set of laboratory-based models that will provide much-needed data to indicate the most appropriate doses and combinations of drugs for patients. In addition, the project will generate a comprehensive database of patient data from previous and on-going clinical trials for use as a reference for evaluating the performance of combination anti-TB drug regimens in these newly developed laboratory models. Ultimately, they aim to enable researchers to be able to use the information generated by the novel models to design better clinical trials involving TB patients. The aims of the consortium: * To systematically evaluate two successive panels of representative anti-tuberculosis drugs (licensed and novel) using a suite of standard, novel and enhanced preclinical model systems, with respect to performance in clinical trials * To refine the set of preclinical systems on the basis of these results in order to identify and define the currently optimal critical path in discovery and pre-clinical development for tuberculosis. * To develop an integrated PK-PD / Disease modelling and simulation framework for tuberculosis which will facilitate prediction of optimal combinations and design of clinical studies.

Proper citation: Predict-TB (RRID:SCR_003766) Copy   

•   Source: SciCrunch Registry

http://www.mip-dili.eu/

Consortium that brings together Europe's top industrial and academic experts to develop new tests that will help researchers detect potential liver toxicity issues much earlier in drug development, saving many patients from the trauma of liver failure. The team aims to deepen the understanding of the science behind drug-induced liver injury, and use that knowledge to overcome the many drawbacks of the tests currently used. A major focus will be on a systematic and evidence-based evaluation of both currently available and new laboratory test systems, including cultures of liver cells in one-dimensional and three dimensional configurations. The project will also develop models that take into account the natural differences between patients. This is important because factors such as certain genes, the liver's immune response, and viral infections have all been associated with an increased risk of DILI. The project will seek to address the current lack of human liver cells available to researchers by using induced pluripotent stem cells (iPSCs) generated from patients who are particularly sensitive to DILI. Another strand of the project will develop computer models to unravel the complex, often inter-related mechanisms behind DILI. Finally, the team will assess how accurate the results of laboratory tests are at predicting actual outcomes in patients.

Proper citation: MIP-DILI (RRID:SCR_003870) Copy   

•   Source: SciCrunch Registry

http://www.newmeds-europe.com/

Consortium that will develop new models and methods to enable novel treatments for schizophrenia and depression including three important missing tools that will facilitate the translation of scientific findings into benefits for patients. The project will focus on developing new animal models which use brain recording and behavioral tests to identify innovative and effective drugs for schizophrenia. The project will develop standardized paradigms, acquisition and analysis techniques to apply brain imaging, especially fMRI and PET imaging to drug development. It will examine how new genetic findings (duplication and deletion or changes in genes) influence the response to various drugs and whether this information can be used to choose the right drug for the right patient. And finally, it will try and develop new approaches for shorter and more efficient trials of new medication - trials that may require fewer patients and give faster results.

Proper citation: NEWMEDS (RRID:SCR_003872) Copy   

•   Source: SciCrunch Registry

http://www.imi.europa.eu/content/eu-aims

Consortium aiming to generate tools that will enhance understanding of autism spectrum disorders (ASD) and pave the way for the development of new, safe and effective treatments for use in both children and adults. For example, the team will gather samples from people bearing certain mutations associated with ASD; this will pave the way for the generation of cell lines that can be used to test treatments. Elsewhere, the researchers will advance the use of brain scans as a tool to boost ASD drug discovery and also identify which people with ASD might respond best to a given drug. The project will also create a pan-European network of clinical sites. As well as making it easier to run clinical trials, this network will create an interactive platform for those with ASD and professionals. By the end of the 5 year project they expect to provide novel validated cellular assays, animal models, new fMRI methods with dedicated analysis techniques, new PET radioligands, as well as new genetic and proteomic biomarkers for patient-segmentation or individual response prediction. They will provide a research network that can rapidly test new treatments in man. These tools should provide their EFPIA partners with an added competitive advantage in developing new drugs for ASD.

Proper citation: EU-AIMS (RRID:SCR_003861) Copy   

•   Source: SciCrunch Registry

http://www.alzheimer-europe.org/Research/PharmaCog

Project aiming to tackle bottlenecks in Alzheimer''''s disease research and drug discovery by developing and validating new tools to test candidate drugs for the treatment of symptoms and disease in a faster and more sensitive way. They will provide the tools needed to define more precisely the potential of a drug candidate, reduce the development time of new medicines and thus accelerate the approvals of promising new medicines. By bringing together databases of previously conducted clinical trials and combining the results from blood tests, brain scans and behavioral tests, the scientists will develop a ''''signature'''' that gives more accurate information on the progression of the disease and the effect of candidate drugs than current methods do. The scientists will conduct parallel studies in laboratory models, healthy volunteers and patients in order to better predict good new drugs as early as possible. This will enable them, for instance, to find out how memory loss in Alzheimer''''s disease can be simulated in healthy volunteers, for example with sleep deprivation or drugs that temporarily affect the memory, in order to test the effect of candidate-medicines early in the drug development process.

Proper citation: PharmaCog (RRID:SCR_003878) Copy   

•   Source: SciCrunch Registry

http://www.europeanlung.org/en/projects-and-research/projects/airprom/

Consortium focused on developing computer and physical models of the airway system for patients with asthma and chronic obstructive pulmonary disease (COPD). Developing accurate models will better predict how asthma and COPD develop, since current methods can only assess the severity of disease. They aim to bridge the gaps in clinical management of airways-based disease by providing reliable models that predict disease progression and the response to treatment for each person with asthma or COPD. A data management platform provides a secure and sustainable infrastructure that semantically integrates the clinical, physiological, genetic, and experimental data produced with existing biomedical knowledge from allied consortia and public databases. This resource will be available for analysis and modeling, and will facilitate sharing, collaboration and publication within AirPROM and with the broader community. Currently the AirPROM knowledge portal is only accessible by AirPROM partners.

Proper citation: AirPROM (RRID:SCR_003827) Copy   

•   Source: SciCrunch Registry

http://kongress.mh-hannover.de/biohybrid/

Consortium with the goal of repairing damaged nerve trunks that will engage in the preclinical development of an artificial biohybrid nerve device for the regenerative treatment of traumatic injuries of peripheral nerves. Based on the extensive basic and clinical experience within this consortium the artificial nerve device will be developed together with standardized application and evaluation parameters. A key objective of this study is to generate a protocol that serves as a template for future clinical trials in the regenerative therapy of damaged peripheral nerves. The results of the multidisciplinary research will feed into the establishment of artificial biohybrid devices as stand alone alternatives to accepted standard procedures and tools. Furthermore, standardized application guidelines and evaluation parameters will be set up to enable continuous progress and evaluation of the outcome of clinical application.

Proper citation: BIOHYBRID (RRID:SCR_003838) Copy   

•   Source: SciCrunch Registry

http://c3nproject.org/

Project designing, prototyping, optimizing, and evaluating a learning health system to improve clinical practice, patient self-management, and disease outcomes of patients with chronic illness. This open, peer production system combines the collective input of patients, clinicians and researchers. It combines large clinical data registries with patient entered data and makes them accessible and interactive. A platform allows researchers to design, test and implement new knowledge and innovations in patient care. To test their platform approach, C3N is working on a model of treating children with Inflammatory Bowel Disease using the ImproveCareNow Network of pediatric clinics. Following this demonstration phase, the goal is to apply the social, scientific and technical platform to transform the care of a variety of chronic illnesses. The C3N effort has the following goals: # Deploy and optimize an integrated set of engagement tools to make it easier for patients and care providers to collect and use the right information during the clinical encounter and in between visits. # Prototype novel interventions to re-design care delivery by promoting the development of tools for real-time and dynamic population management, "just-in time" scheduling of visits, virtual clinic visits, and measuring the impact of these interventions on health, care, and cost. # Pilot and deploy patient-focused technology to improve the flow of data between patients, clinicians and scientists to enable faster learning and improvement.

Proper citation: Collaborative Chronic Care Network (RRID:SCR_003708) Copy   

•   Source: SciCrunch Registry

http://cptrinitiative.org/

A collaboration of international pharmaceutical companies, public health experts, civil society organizations, and U.S., European, and other regulatory authorities to speed the development of new and improved drug regimens for tuberculosis (TB). Its goals include creating innovative tools, including TB data standards and databases. The Initiative is built around four operating arms: Regulatory Science Consortium, Drug Development Coalition, Research Resources Group, and Drug Susceptibility Testing Group. The focus of the consortium is to: * Develop and integrate data standards * Qualify biomarkers through the Food and Drug Administration (FDA) / European Medicines Authority (EMA) * Develop quantitative disease progression (natural history) models * Create disease response metrics, develop target product profiles and supporting assays, and * Develop new pharmacokinetic/dynamic measures of drug interactions Accomplishments include: * Engaged the FDA, which has released updated regulatory guide-lines for developing new TB drug regimens with efforts to create a more favorable environment for combination regimen development * TB Alliance launched the first-ever clinical trial of a novel combination drug regimen for TB, validating the approach to regimen development set forth by CPTR, and is moving to a phase III clinical trial named STAND. * Developed and published TB data standards in collaboration with the Clinical Data Interchange Standards Consortium (CDISC). * Expanded scope to include the CPTR Rapid Drug Susceptibility Testing (RDST) Consortium and an expanded Modeling and Simulation development program. * Pursued several regulatory pathways with the FDA for the Hollow Fiber System Model for TB (HFS-TB). * Submitted a dossier to the EMA on the HFS-TB for qualification opinion consideration. * Submitted a "briefing book" to the FDA via the pre-IND process to review CPTR's data analysis plan and data inventory for liquid culture, with emphasis on time-to-positivity, as a quantitative measure of long-term outcome. * Initiated planning to develop a database supporting the RDST Consortium's goal to develop a rapid TB drug susceptibility test.

Proper citation: Critical Path to TB Drug Regimens (RRID:SCR_003698) Copy   

•   Source: SciCrunch Registry

http://www.imidia.org/

Consortium aiming to improve pancreatic beta-cell function and identification of diagnostic biomarkers for treatment monitoring in diabetes. It brings together academic teams, pharmaceutical companies, and a Small to Medium Enterprises (SMEs), which provides a unique blend of expertise and forms a strong basis for a successful enterprise to ultimately improve industrial competitiveness and Public Health in Europe. The program aims at delivering: * Novel tools for the study of human beta-cell development, function and survival; their modulation by potential therapeutic compounds; and for in vivo beta-cell imaging. * Biomarkers for the diagnosis and prognosis of beta-cell failure and for monitoring diabetes progression and treatment. * Knowledge on novel molecular pathways and sites that control beta-cell life & death as well as mass and function.

Proper citation: IMIDIA (RRID:SCR_003865) Copy   

•   Source: SciCrunch Registry

https://www.imi.europa.eu/projects-results/project-factsheets/ddmore#:~:text=cases%20experimental%20data.-,',biological%20systems%20and%20drug%20actions

DDMoRe project to develop common standards and tools to allow scientists to share their models. Developed model repository which enables access to curated and shared knowledge for benefit of model informed drug discovery.

Proper citation: DDMoRe (RRID:SCR_003851) Copy   

•   Source: SciCrunch Registry