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http://www.asn-online.org/khi/
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.
Proper citation: Kidney Health Initiative (RRID:SCR_003869) Copy
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.
Proper citation: PREDECT (RRID:SCR_003883) Copy
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