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Ontology of experimental design for high-throughput mouse analysis pipelines.
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.
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/
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.
A web-based tool to screen for duplicate patients in clinical trials within and across studies, sponsors and therapeutic areas.
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.
Online instrument that estimates whether a biomarker predicting outcome of depression treatment is likely to be clinically significant.
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.
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.
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.
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.
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.
Consortium between several pharmaceutical companies to develop a database that shares clinical trial investigator information that each company has on file to reduce administrative burden for investigators and to increase visibility of qualified investigators to research sponsors. Hosted by a 3rd party, DrugDev, it is the one place where pharmaceutical companies can share investigator and site information and investigators can view, edit, and comment on their own information. Industry members will be able share information from their clinical trial management systems including investigator / site contact details, GCP training records, past trial participation, and recruitment history. Upon investigator opt-in, this information is used by each participating company to identify sites for upcoming studies; to help set recruitment targets and timelines; and to share start-up documents such as CV, GCP, and site profile forms. The Databank has grown to include nearly 180,000 investigators (May 2014) and is already bringing benefits to its member companies in identifying qualified investigators for their studies. It also reported the inclusion of 7,335 protocols and 50K sites, representing a patient population around 1.9M.
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.
Application ontology for entities related to insecticide resistance in mosquitos
A non-profit collection of biological samples and detailed associated clinical data, designed to facilitate medical research into vitiligo, a devastating skin disease that is much neglected. They collect, store and analyze biological samples throughout the network of collaborators in 11 countries, using standard collection protocols and unified patient record, which are then made available to the scientific community and research organizations investigating pathogeneses, diagnostics, new treatments, and ultimately a cure for vitiligo. The core asset is a large collection of well-organized hair, blood, serum and DNA samples, integrated with comprehensive and anonymized patient records.
Consortium that aims to improve the efficiency of the medicine development process by better incorporating estimates of relative effectiveness into drug development and to enrich decision-making by regulatory authorities and health technology assessment (HTA) bodies through: * Bringing together regulators, HTA bodies, academics, companies, patients and other societal stakeholders; * Assessing existing processes, methodologies, and key research issues; * Proposing innovative (and more pragmatic) trial designs and assessing the value of information; * Proposing and testing innovative analytical and predictive modelling approaches; * Assessing operational, ethical, regulatory issues and proposing and testing solutions; * Creating new decision making frameworks, and building open tools to allow for the evaluation of development programs and use in the assessment of the value of new medicines; * Sharing and discussing deliverables with, among others, Pharmaceutical companies, regulatory authorities, HTA / reimbursement agencies, clinicians and patient organizations; * Developing training activities for researchers, decision makers and societal stakeholders in the public and private sector in order to increase knowledge about various aspects of relative effectiveness. The expected impact is that it will contribute to the knowledge base, particularly to inform clinical decision making and improve the efficiency of the R&D process. GETREAL will help to generate a consensus on best practice in the timing, performance and use of real life clinical studies in regulatory and reimbursement decision-making. It will also help to create a strong platform for the communication of results and for future discussions in this important area.
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.
Our 24 faculty members approach the Research and Training in Cardiovascular Biology program from different subspecialties that include genetics, metabolism, development, cellular biology, systems biology, structural biology, biophysics, pharmacology, molecular biology, bioinformatics and biochemistry. While these subspecialties are clearly diverse, our faculty collaboratively leverages these areas toward the common goal of understanding cardiovascular disease from the gene all the way up to integrated organism function (systems biology). This diverse array of subspecialties provides a truly unique training environment that few centers can match. Another critical aspect of our training program is our steadfast commitment to a superior and nurturing training environment for our predoctoral trainees, postdoctoral trainees and clinician-scientists. Our training faculty are uniformly committed to monitoring our personnel for success in every way possible, to not only ensure their future placement in the academic ranks but to also build a stronger cardiovascular community around the country. The current National Institutes of Health-sponsored Research and Training in Cardiovascular Biology was instituted in 1978 by Arnold Schwartz, MD, PhD. This program has trained more than 120 scientists, who have pursued independent research careers and are holding prominent scientific positions worldwide. Our trainees have been distinguished as chairs of basic science departments, directors of centers or pharmaceutical companies, clinical directors and tenured faculty members in academic research. The overall emphasis continues to focus on integrative training and well-rounded knowledge of the fundamentals in biochemical, molecular, physiological and pharmacological underpinnings of cardiovascular disease. Dr. Schwartz has been a constant guiding force since the program was established. The University of Cincinnati, with Cincinnati Children's, has also developed a reputation as a leading center for the generation and analysis of genetically modified mouse models for interrogation of gene-disease relationships in the heart. This theme has been expanded to incorporate molecular genomics, proteomics and bioinformatics, as we continue to be among the leaders in the nation in molecular pathway analysis associated with single gene manipulations in the hearts of mice. Most faculty and trainees are using these approaches, but they are also well-versed in many other aspects of cardiovascular science, including excellence in basic physiology, pharmacology, biochemistry, structural biology and molecular biology. Thus, we are a rare conglomeration of faculty in which all aspects of cardiovascular biology are practiced, starting with cutting-edge molecular and genetic approaches, spanning more traditional cellular and whole animal approaches to build an integrated network of functional and disease-relevant data and extending to translational research incorporating cell therapy.