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A collaboration to test an adaptive clinical trial model that would assess the efficacy of a candidate therapeutic earlier than traditional clinical trials, potentially enabling drugs to be developed and approved using fewer patients, less time and fewer resources. This trial focuses on women with newly diagnosed locally advanced breast cancer to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone. It uses genetic and biological markers from individual patients' tumors to screen several promising new treatments simultaneously and allows doctors to quickly measure the effectiveness of the treatment prior to removing the tumor. The experimental adaptive trial design uses patient outcomes to immediately inform treatment options for subsequent trial participants. The trial has 5 components that differentiate it from conventional clinical trial models. # I-SPY2 uses tissue and imaging biomarkers from individual cancer patients' tumors to determine eligibility, guide/screen promising new treatments and identify which treatments are most effective in specific tumor subtypes. # The trial's adaptive design allows the Team to learn as they go, enabling researchers to use data from patients early in the trial to guide decisions about which treatments might be more useful for patients who enter the trial earlier. I-SPY2 provides a scientific basis for researchers to eliminate ineffective treatments and graduate effective treatments more quickly. # The neoadjuvant treatment approach - in which chemotherapy is given to patients prior to surgery - allow the team to evaluate tumor response with MRI before removal. This approach is safe as treating after surgery, allowing tumors to shrink, and more importantly, it enables critical learning early on about how well treatments work. # The ability for the team to screen multiple drug candidates developed by multiple companies. New agents will be selected and added as those used initially and either graduate to Phase III, or are dropped, based on their efficacy in targeted patients. # The trials informatics system allows data to be collected, verified, and shared in real-time. This allows data to be assessed early and in an integrated fashion - with an aim to enhance and encourage collaboration
Proper citation: I-SPY 2 TRIAL (RRID:SCR_003713) Copy
Project to develop a drug safety database from the pharmaceutical industry legacy toxicology reports and public toxicology data; innovative in silico strategies and novel software tools to better predict the toxicological profiles of small molecules in early stages of the drug development pipeline. The project is creating this pharmaco-toxicological database with an aim to: * Reduce the number of animal tests * Decrease the attrition rates of new drug candidates * Increase the success rate of new molecular entities becoming drugs * Improve the safety of drugs on the market The project consists of three different systems, * eTOX VITIC Database a unified database containing all confidential and non-confidential data collected in eTOX (historical data from the pharmaceutical industry) * ChOX Database a unified database containing public data (literature and public database) * eTOXsys Query and Prediction System an interface providing a uniform access to the two databases (VITIC and ChOX) and to all developed prediction models and systems
Proper citation: eTOX (RRID:SCR_003712) Copy
The Electrophysiology Analysis Toolkit (Elephant) is a Python library that provides a modular framework for the analysis of experimental and simulated neuronal activity data, such as spike trains, local field potentials, and intracellular data. Elephant builds on the Neo data model to facilitate usability, to enable interoperability, and to support data from dozens of file formats and network simulation tools. Its analysis functions are continuously validated against reference implementations and reports in the literature. Visualizations of analysis results are made available via the Viziphant companion library. Elephant aims to act as a platform for sharing analysis methods across the field.
Proper citation: Elephant (RRID:SCR_003833) Copy
Consortium to identify, fund and support breakthrough technologies that will significantly enhance biopharmaceutical R&D productivity and accelerate the development of new safe and efficacious drugs. CQDM is a neutral ground that brings patient groups, academia, governments, biotech and the pharma industry together to work collaboratively on complex medical challenges. Projects supported by the consortium are highly relevant to the pharmaceutical sector and typically address: * Opportunity for new therapeutic approaches and research * Safe and effective new drug development * Enhancing the efficacy of already existing drugs * Reducing costs, time and risks associated with the discovery and development of new drugs Funded projects typically involve multidisciplinary collaborations between research teams that represent both the academic and the private sector, who are mentored by industry scientists provided by the consortium sponsors.
Proper citation: Quebec Consortium for Drug Discovery (RRID:SCR_003711) Copy
Serum / plasma biomarkers, Cardiac troponins T (cTnT) and I (cTnI), in safety assessment studies for rats, dogs, and monkeys are qualified biomarkers for the following contexts of use: # When there is previous indication of cardiac structural damage with a particular drug, cardiac troponin testing can help estimate a lowest toxic dose or a highest non-toxic dose to help choose doses for human testing. In this case, cardiac troponins may serve as a clinical chemistry correlate to the histology. For example, in a safety assessment study, lower doses without increases in cardiac troponins may be used to support a no observed effect level (NOEL) identified by histology. # When there is known cardiac structural damage with a particular pharmacologic class of a drug and histopathologic analyses do not reveal structural damage, circulating cardiac troponins may be used to support or refute the inference of low cardiotoxic potential. # When unexpected cardiac structural toxicity is found in a nonclinical study, the retroactive (reflex) examination of serum or plasma from that study for cardiac troponins can be used to help determine a no observed adverse effect level (NOAEL) or lowest observed adverse effect level (LOAEL). The results of this testing may support inclusion of cardiac troponin testing in subsequent safety assessment studies.
Proper citation: O'Brien Reagan York and Jacobsen Drug-induced Cardiotoxicity Biomarkers (RRID:SCR_003717) Copy
Urinary kidney biomarkers, Clusterin and Renal Papillary Antigen-1 (RPA-1), that sponsors may use to determine more conservative NOAELs for estimating starting doses in the initial human clinical trial of a drug that displays nonclinical nephrotoxicity as determined by histopathology. When tested with a limited number of nephrotoxic compounds, the Receiver Operating Characteristic (ROC) analyses showed that urinary clusterin and renal papillary antigen-1 (RPA-1) have better sensitivity and specificity than BUN and creatinine for the detection of specific kidney pathologies in male rats. Clusterin and RPA-1 provide additional and complementary information to BUN, serum creatinine (sCr), and histopathology for the detection of acute drug-induced nephrotoxicity in safety assessment studies.
Proper citation: ILSI HESI Drug-induced Nephrotoxicity Biomarkers (RRID:SCR_003716) Copy
Consortium bringing together academic and industry researchers to advance the understanding of disease causing factors and disease progression in Rheumatoid Arthritis (RA), with a focus on accelerating the development of new drugs. The efforts under this consortium aim to develop: (1) animal models; (2) human biobanks, databases and technologies; (3) research network to address critical biologic and clinical questions; (4) community to network patients and companies. The focus will be the development of new diagnostic methods to discover the early forms of RA as well as tools to separate the different forms of RA, where different molecular mechanisms are involved and where different therapies may be required. The ultimate goal for therapeutic development is to identify the disease-causing molecular events early in the disease and then influence immunity and inflammation so that functional deterioration is halted, immunity is re-regulated and the disease is cured. Samples from biobanks will be analysed in vitro and models will be aligned with different variants of human arthritis. In addition, new models will be established using similar molecular pathways as the relevant human arthritis subsets, leading to the understanding of the etiology and early pathology of the disease for a program aimed at early and curative treatment of RA and RA-like diseases. A major focus of these efforts will be to understand and subsequently alter the adaptive immune reactions in patients from a disease-inducing mode into either a protective mode against the disease or become asymptomatic.
Proper citation: Be The Cure (RRID:SCR_003746) Copy
https://www.shenandoah-bt.com/
An Antibody supplier
Proper citation: Shenandoah Biotechnology (RRID:SCR_003744) Copy
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
http://www.incf.org/activities/our-programs/pons/cumbo
Ontology of formal definitions (i.e., machine processable) for the types of structures commonly described in neuroanatomy.
Proper citation: Common Upper Mammalian Brain Ontology (RRID:SCR_003629) Copy
Oligonucleotide design software that calculates optimal oligonucleotides for a range of tasks: sequence assembly, differential expression, and microarrays (cDNA and spotted oligos)., THIS RESOURCE IS NO LONGER IN SERVICE. Documented on September 16,2025.
Proper citation: Osprey (RRID:SCR_003627) Copy
http://www.med.uc.edu/cardio_bio/
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.
Proper citation: University of Cincinnati Research and Training in Cardiovascular Biology (RRID:SCR_003860) Copy
http://www.nih.gov/science/amp/alzheimers.htm
The Alzheimer's disease arm of the Accelerating Medicines Partnership (AMP) that will identify biomarkers that can predict clinical outcomes, conduct a large scale analysis of human AD patient brain tissue samples to validate biological targets, and to increase the understanding of molecular pathways involved in the disease to identify new potential therapeutic targets. The initiative will deposit all data in a repository that will be accessible for use by the biomedical community. The five year endeavor, beginning in 2014, will result in several sets of project outcomes. For the biomarkers project, tau imaging and EEG data will be released in year two, as baseline data becomes available. Completed data from the randomized, blinded trials will be added after the end of the five year studies. This will include both imaging data and data from blood and spinal fluid biomarker studies. For the network analysis project, each project will general several network models of late onset AD (LOAD) and identify key drivers of disease pathogensis by the end of year three. Years four and five will be dedicated to validating the novel targets and refining the network models of LOAD, including screening novel compounds or drugs already in use for other conditions that may have the ability to modulate the likely targets.
Proper citation: Accelerating Medicines Partnership - Alzheimers (RRID:SCR_003742) Copy
http://srna-tools.cmp.uea.ac.uk/
Software tools for the analysis of high-throughput small RNA data.
Proper citation: UEA sRNA toolkit (RRID:SCR_003620) Copy
Organization that drives the development of Ontario's economy by helping create new jobs, products, services, technologies and businesses by bridging academia and industry. The program suite covers almost all stages of business development and career advancement, covering three key areas: Industry-Academic R&D Collaboration; Commercialization; and Entrepreneurship. Other key initiatives are the IBM Smart Computing Initiative and Colleges Ontario Network for Industry Innovation (CONII). In partnership with industry, OCE co-invests to commercialize innovation originating in the province's publicly funded colleges, universities and research hospitals. They also support and invest in early-stage projects, where the probability of commercial success and potential total return on innovation are substantial. Another expanding focus for OCE is the development of the next generation of innovators through their entrepreneurship fellowships and programs for students and youth across Ontario. Their efforts are focused on sectors of the economy with the greatest potential to drive Ontario's future prosperity and global competitiveness: energy and environment (including water); advanced manufacturing; advanced health technologies; and information, communications technologies and digital media. A trusted partner of government in program delivery, they are committed to advancing a whole-of-government approach as a means of streamlining funding application processes for companies and entrepreneurs.
Proper citation: Ontario Centres of Excellence (RRID:SCR_003734) Copy
A non-profit network of allergy, asthma and Chronic Obstructive Pulmonary Disease (COPD) patients' organisations, representing 35 national associations in 22 countries and over 400,000 patients. They're dedicated to making Europe a place where people with allergies, asthma and COPD have the best quality care and a safe environment, live uncompromised lives and are actively involved in all decisions influencing their health. They work on behalf of patients to: * Promote awareness of allergies and airways diseases among policymakers and the general public. * Broaden our understanding of these conditions by increased collaboration between national patient associations. * Share knowledge and experience to beneficially educate both the public and EFA members. * Promote patient concerns and opinions within the European institutions and enable national patient associations to gain representation at EU level. * Improve their health and quality of life.
Proper citation: European Federation of Allergy and Airways Diseases Patients Associations (RRID:SCR_003855) Copy
http://www.lyonbiopole.com/index-en.html
A worldwide competitiveness cluster centered on pharmaceutical activities including the fight against human and animal infectious diseases and cancers. Designed as a tool interface and public / private approximation, the division has implemented measures to encourage collaborative R & D, help in setting up projects and find funding, increase strategic and financial partnerships for economic development and international companies, provide access to reception areas, technological shared platforms such as the Infectious Diseases Center Lyonbiop��le. It aims to strengthen the competitiveness of the sector health and the attractiveness of the Rh��ne-Alpes area, mainly on the Lyon-Grenoble axis. (adapted from the translated Wikipedia)
Proper citation: Lyonbiopole (RRID:SCR_003733) Copy
Consortium working to advance the development of potential antibiotics against Gram-negative bacteria, such as Escherichia coli. The project creates and manages a drug discovery engine for testing and optimizing molecules that are still in the earlier stages of drug discovery but have the potential to become future drug candidates capable of treating resistant Gram-negative infections. The project will focus on the discovery and pre-clinical stages of drug development, as well as (potentially) phase 1 clinical trials. ENABLE will run several drug discovery programs in parallel and the consortium seeks external hit and lead programs to join, through a series of open calls during the project. Researchers who have interesting molecules will have the opportunity to collaborate with a diverse range of experts in microbiology, pharmacology and chemistry to help advance their molecule through the drug development process until it is an attractive candidate for clinical testing. Specifically, the project is working towards: # identifying three antibacterial lead molecules which, following extensive testing, have been identified as having promising antimicrobial activity; # identifying two antibacterial clinical candidate molecules # advancing at least one compound into preclinical and phase 1 clinical studies, i.e. early clinical safety testing in humans.
Proper citation: European Gram Negative AntiBacterial Engine (RRID:SCR_003859) Copy
https://www.europeanleadfactory.eu/
Consortium that promotes the discovery of novel small molecule candidates suitable for subsequent optimization either to drug candidates or to high-quality pharmacological tools for the experimental validation of targets using open innovation and crowd sourcing. It is designed to provide best-in-class resources and funding-in-kind, to academics or small and medium enterprises (SMEs) who are working on promising biology targets or chemistry scaffolds. Screening of compounds to assess their activity is also funded and performed by the EU Lead Factory, with collaboration to help develop an Improved Hit List from the Qualified Hit List. They will provide collaborative screening of previously safeguarded, high quality corporate compounds. Around 300,000 compounds in the EFPIA Compound Collection, contributed by EFPIA members, will be screened against both commercially contributed biology targets and targets from public sources. The second phase of the consortium is to build a substantial new Public Compound Collection of around 200,000 compounds. Together, the EFPIA and Public compound collections will form a 500,000-strong Joint European Compound Collection. Target program owners and compound contributors will receive a Qualified Hit List (QHL) of up to 50 compounds complete with relevant information to help in the development of an Improved Hit List (IHL). Target program owners, will have exclusive access to threshold active compounds in their QHL. After the three-year exclusivity period, QHL/IHL information will be made public. Milestone payments are due if direct exploitation proceeds, not for research use. And owners and contributors will give EFPIA participants the right to submit a first bid (which they do not have to accept).
Proper citation: European Lead Factory (RRID:SCR_003858) Copy
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