Curator Dashboard

Consortium aiming to produce regulatory T cells that are compatible with a kidney transplant patient''''s immune system, as a measure to suppress the body''''s natural immune response against a transplanted organ. If successful, this approach will reduce a transplantation patient''''s life-long dependency on immune suppressing drugs, many of which are often associated with undesirable side effects and can limit the patient''''s daily routine. The consortium goals are to develop and conduct clinical trials of various immunoregulatory T-cell-based products in organ transplantation recipients, allowing a direct comparison of the safety, clinical practicality and therapeutic efficacy of each cell type. The central focus of the project is to: # Production and manufacture of distinct populations of hematopoietic immunoregulatory T cells # Comparatively study the tolerogenic characteristics of these regulatory cell types # Test these cell therapy products side by side in a clinical trial living donor renal transplant recipients The first workstream will work with different T regulatory cell, tolerogenic DC and suppressive macrophage cell products that are currently in development. In addition to these therapeutics, another goal of this workstream is to develop a cell tracking technology that assesses pharmacodynamics and pharmacokinetics of these cell-based therapies. The second workstream is focused on designing and conducting a cell therapy based clinical trial in renal transplantation, taking into consideration ethics, concurrent immunosuppressive drug use, state-of-the-art immune monitoring, innovative all-in-one data capturing systems, and pharmacovigilance. The goal is to have a comparative evaluation of hematopoietic cell therapy safety in renal transplantation. The third workstream aims to learn more about the specific comparative characteristics of suppressive cell types and to use this knowledge to improve later trial designs and foster novel ideas for new or improved suppressive / tolerogenic cell population.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

A global mediation model expressed as an ontology for use in the primary care domain. It uses a realist approach employing Basic Formal Ontology (BFO v1.1) as an upper ontology. Other ontologies were imported or specialized to give deeper definition to the concepts in the domain. These included OGMS, IAO and VSO. The CDIM ontology includes concepts that are especially important to primary care (e.g. episode of care or reason for encounter), but also others to handle temporality in queries (e.g. the start and beginning of processes). The owl file provided for download is the merged file created directly in Prot��g�� through the Refactor/Merge ontologies tool in order to facilitate the load of CDIM in LexEVS for use in the unified interoperability framework.

• Resource
• SciCrunch
• 12 years ago - by Anonymous

Consortium to accelerate new breakthrough DNA sequencing technologies and methods to enhance existing analysis methods. The ultimate aim is to advance DNA sequencing technologies to a level where a human genome can be analyzed at high resolution for less than 1000 euros in less than one day. The goals of the consortium are to revolutionize nucleic acid analysis methods by improving elements necessary to use the currently emerging generation of nucleic acid sequencers in a meaningful and accessible way, providing methods that allow in situ nucleic acid analysis and methods capable of selectively characterizing mutant DNA in a high background of wildtype DNA, combining RNA and DNA analysis in a single analytical device, providing technology to efficiently analyze DNA methylation (genome-wide, with high resolution and in its long-range context), implementing novel concepts for high-throughput HLA-screening, developing fully integrated solutions for mutational screening of small target regions (such as for screening newborns for cystic fibrosis mutations), developing a device for screening multiple target regions with high accuracy and implementing strategies for effective and high-resolution genotyping of copy number variations. READNA was awarded the Stars of Europe prize in December 2013.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

Project that aims to create more appropriate in vitro platforms for target validation and drug discovery for breast, prostate and lung cancers. Laboratory platforms to validate whether target modulation would provide a clinical benefit are usually highly reductionist, often using long-established cell lines growing in 2 dimensions in vitro. These models do not reflect the complexity and heterogeneity of a tumor in situ, where biochemical pathways are wired with connections to the complex tumor environment provided by the stroma. PREDECT has the goal of comparing the pathological and molecular profiles of novel in vitro platforms with those of human tumors. Because obtention of clinical material presents both logistics and quality problems for ongoing and intense studies of target validation, PREDECT aims to use material from genetically engineered mouse models, and some advanced xenografts, whose pathology and molecular profiles closely match cohorts of human tumors. PREDECT hopes to provide more appropriate in vitro platforms both for target validation and subsequent preclinical studies which will replace a current cascade of tests which are poorly predictive of clinical activity. The project is expected to shift paradigms in cell biology as well as in preclinical target validation where it should permit greater predictivity of drug efficacy in patient cohorts.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

A project that will study 2,500 people with various systemic autoimmune diseases (SADs), gathering data on the molecular causes of their disease as well as their clinical symptoms, enabling them to pave the way for a new classification of these diseases. The goal is to use OMICs and bioinformatics to identify new classifications for diseases known to share common pathophysiological mechanisms. Results will be shared to deliver a new molecular taxonomy of systemic autoimmune diseases. In order to achieve this, PRECISEADS is informing on a regular basis on the project implementation and results, and involving stakeholders from Europe in its activities in order to broaden the project impact and increase opportunities for cooperation.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

THIS RESOURCE IS NO LONGER IN SERVICE. Documented on September 23,2022. InBase is a curated database devoted to inteins. It developed by a commercial laboratory, New England BioLabs, that also provides products related to enzyme digests on the same website. Users can access the Intein Registry, to discover properties of individual inteins. They can also submit intein data, browse intein motfis, and view mechanisms and introductions to protein splicing.

• Resource
• SciCrunch
• 17 years ago - by Anonymous

Consortium to develop efficient and safe strategies for the production of clinical-grade protein pharmaceuticals in plants, and to define the procedures needed for the production of these proteins in compliance with the strict regulatory standards that govern the manufacture of all pharmaceuticals. Ultimately the consortium aimed to take a candidate product all the way through the development pipeline culminating in a phase I human clinical trial. The consortium has a wide range of expertise spanning the areas of molecular biology, plant biology, immunology, recombinant protein expression technology, vaccinology, and plant biotechnology. The objectives listed at the beginning of the Pharma-Planta project are as follows: # To produce a recombinant pharmaceutical molecule in transgenic plants, which will be developed through all regulatory requirements, GMP (good manufacturing practice) standards and pre-clinical toxicity testing. This will then be evaluated in Phase I human clinical trials. # To develop robust risk assessment practices for recombinant pharmaceutical molecules produced in plants, based on health and environmental impact, working with regulatory authorities within the EU as well as public groups to ensure that the production systems are as safe and as acceptable as possible, and that they comply with all biosafety regulations. # To define and carry out a coordinated program for securing and managing intellectual property that will facilitate the availability of high priority plant-derived recombinant pharmaceuticals to the poor in developing countries while simultaneously allowing the products to be developed commercially in Europe and North America. # To develop and refine new strategies for the expression of recombinant pharmaceuticals in plants, which can be used on a generic basis for molecules that are normally expressed poorly. # To develop and generate transgenic plants expressing a second generation of recombinant molecules that will be used in future clinical trials. In 2011 they reached their benchmark for success launching a phase I clinical study of an antibody that neutralizes HIV, produced in and isolated from tobacco plants. This antibody could one day become an inexpensive component of a microbicide used to prevent the spread of HIV/AIDS. The project has also spun off many additional technologies that are being adopted by researchers all over the world, and has resulted in more than 100 publications in peer-reviewed scientific journals.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

Ontology of experimental design for high-throughput mouse analysis pipelines.

• Resource
• SciCrunch
• 13 years ago - by Anonymous

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.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

A three-member pharmaceutical industry consortium that aims to provide a new platform to improve access to information about clinical trials for patients and providers. The platform aims to enhance the existing clinicaltrials.gov by providing more detailed and patient-friendly information about available trials and embedding a machine-readable target health profile to improve the ability of healthcare software to match individual health profiles with applicable clinical trials. Using clinicaltrials.gov as its foundation and Eli Lilly''''s Application Programming Interface (API), the consortium is focused on creating an open platform to make this data more amenable to patients and providers, as well as creating an opportunity to integrate a patient''''s electronic health record into the clinical trial matching service. This feature will allow patients to search for trials using their own Blue Button data. The following features are planned add-ons to clinicaltrials.gov: * Target Profile is a machine readable query, that can be executed against an electronic file (or record) with patient health data such as an Electronic Health Record (EHR), an Electronic Medical Record (EMR) or Personally Controlled Health Record (PCHR) * Augmented Content is public, IRB approved information about the study that has not been published on clinicaltrials.gov, and that is shared with / targeted for patients with a matching Target Profile. The following are the incremental goals of the consortium: * Advancement of the Lilly API platform to support read/write interaction and additional data objects and information. * The initial 3 sponsor organizations - Lilly, Pfizer and Novartis - will upload Target Profiles for a select set of clinical trials. A Target Profile is a machine interpretable description of the characteristics of patients who may qualify for that trial i.e. a query that can be executed against a patient''''s electronic health record or personal health record. Additionally, sponsors of clinical research studies will also be able to upload Augmented Content to the Lilly Platform to supplement information on clinicaltrials.gov with additional, patient-focused information about the study, e.g., a study brochure and practical information on how to contact investigational sites. * A matching service, developed by Corengi, will compare Target Profiles to a de-dentified personally controlled health record (PCHR), represented by patient''''s Blue Button Plus CCDA XML document. * Integration into a patient community platform from Avado for providing the patient PCHR and presenting the results of the match service. The patient will be able to explore the respective matching studies for additional information and next steps such as contacting a nearby investigator clinic or hospital. The first demo of the prototype was made available on June 2014, built on a database of anonymized patient health records from different clinical research studies sponsored by Lilly, Novartis, and Pfizer. Other website: http://portal.lillycoi.com/

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

Project that aims to increase understanding of how orally-administered drugs are taken up from the gastrointestinal tract into the body, and apply this knowledge to create new laboratory tests and computer models that will better predict the performance of these drugs in patients over a range of clinically relevant conditions. The integration of in vitro and in silico approaches will provide a biopharmaceutics toolkit, validated using clinical data, to accelerate drug development. Ultimately, the project will help to facilitate and speed up the formulation development process and significantly reduce the need for animal experiments in this area as well as for human clinical studies in the future. For patients, the main benefit will be in the form of high quality medicines where the dose required is well calculated and is released in a way that consistently provides an optimal clinical effect.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

A web-based tool to screen for duplicate patients in clinical trials within and across studies, sponsors and therapeutic areas.

• Resource
• SciCrunch
• 12 years ago - by Anonymous

Software toolbox designed to provide machine learning methods for pre-processed imaging data allowing for two (or more) class classification in the context of drug development. The Toolbox includes implementations of Gaussian Process Classification, Support Vector Machines, Ordinal Regression and Sparse Multinomial Logistic Regression for fMRI, Structural and ASL imaging data.

• Resource
• SciCrunch
• 12 years ago - by Anonymous

Online instrument that estimates whether a biomarker predicting outcome of depression treatment is likely to be clinically significant.

• Resource
• SciCrunch
• 12 years ago - by Anonymous

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.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

A global organization that helps Philips introduce innovations that improve people's lives by providing technology options for innovations in the area of health and well-being, targeted at both developed and emerging markets. Positioned at the front-end of the innovation process, they work on everything from spotting trends and ideation to proof of concept and - where needed - first-of-a-kind product development.

• Resource
• SciCrunch
• 12 years ago - by Anonymous

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.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

Consortium that brings together the kidney community (patient advocacy groups, industry, government agencies, and professional organizations) to overcome existing challenges, including regulatory and nonregulatory barriers, and optimize the development and safety of products that impact kidney health including drugs, devices, biologics, and food products. The goals of the consortium are to: * Facilitate dialogue and research that informs regulatory processes with regard to the kidney health of patients being treated for kidney-related as well as other diseases. * Assess current medical therapies and diagnostics to identify areas in need of greater innovation and/or better defined regulatory pathways. * Develop innovative and efficient trial designs appropriate to answer the most important questions related to kidney health. * Establish expert consensus around common terminology and key definitions related to kidney health. * Develop approaches to the systematic collection of retrospective or prospective data, such as registries and/or global databases, and establishment of data standards. * Coordinate think tanks, public forums, educational exchanges, and other events to promote discussion and updates on topics in kidney health pertaining to drug, device, biologics, and food product development and evaluation. * Create transparent infrastructure and processes that facilitate collaboration and communication among the greater nephrology community and the FDA, including: * Seek input from all stakeholders (including nephrologists and other health professionals, patient groups, industry, the National Institutes of Health, the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, and other federal agencies). * Leverage previously conducted and ongoing clinical studies, research infrastructure, and databases. * Create an open and efficient mechanism for encouraging and objectively evaluating potential projects submitted to KHI. * Involve consortium members in the selection and execution of projects. * Establish systems to optimize post-market surveillance of products that affect kidney health, either intentionally or via adverse drug reactions. * Author journal articles and white papers regarding key issues, describing opportunities and challenges and proposing solutions, as well as promoting execution of these solutions.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

Project whose goal is to improve understanding of how potential drugs bind with their target, and develop methods and tools to allow researchers to study drug-target interactions with greater ease. These tools would help researchers to determine whether a drug candidate is likely to be safe and effective much earlier in the drug development process. The first goal of the team is to enhance understanding of binding kinetics; exactly how do small molecules interact with their targets? Ultimately, the project aims to develop a range of robust techniques, methods and models that could be easily incorporated into the drug development pathway and enable scientists and drug designers worldwide to reliably predict a molecule's kinetic properties (its "kinotype"). This information will allow drug developers to more easily determine the safety and efficacy of a molecule and will weed out ineffective or unsafe molecules earlier in the drug development process. Eventually, the project also hopes to raise awareness of the importance of considering the kinetic aspects of drug-target interactions throughout drug development.

• Organization
• Consortia-pedia, a FasterCures Project
• 12 years ago - by Anonymous

• Organization
• SciCrunch
• 16 years ago - submitted by Stephen Larson