12 Dec 2011
Reference:Global-Research-E001:In-Vitro Platform of Human Organ Constructs
It is envisioned that the data generate from this platform could be
utilized to support in vivo testing
and evaluation plans for investigational products. Upon maturity of the platform, it could reduce the overall
burden of in vivo testing in the development and management of products
for human use. Excluded from consideration is research that
re-purposes existing technology (i.e., cell culture analogues, devices
utilizing cell-based technologies, transformed cells, monolayers, etc.)
designed to evaluate organ specific sequelae following administration of a
product.
Prior to administration of therapeutics to individuals enrolled in clinical trials, the safety, efficacy and pharmacokinetics of therapeutics must be characterized in pre-clinical studies. Current methods for obtaining safety data rely, almost exclusively, on models (in vitro and in vivo, including animal models) that frequently have limited congruency to the human condition and often do not accurately predict clinical safety, efficacy and tolerability. Advances in technologies utilizing isolated primary human cells organized in a physiological relevant manner, could provide additional and improved information on the expected pharmacodynamics response in humans exposed to infections or other diseases agents and treated with therepeutics. Recently, innovative research has shown three-dimensional, organotypic in vitro constructs comprised of multiple primary cell types experiencing physiological relevant conditions that reasonably reproduce the human condition. e2eBioSys is co-ordinating capabilities globally for a platform comprised of in vitro human organ constructs in communication with each other [(i.e., liver, lung, heart, kidney, vasculature and Blood Brain Barrier (BBB) with neuronal component] that will accurately assess efficacy, toxicity, and pharmacokinetics of drugs in a way that is relevant to humans. Duration of Research.It is estimated that this work may be phased over a 5 year period. Colloboration,Intellectual Property. Due to the complex nature of the research, it is anticipated that more than one party will be involved and for optimal results, multiple teams may have to be formed. Supplemental Information: Interested parties are requested to provide the following information in a word format document:
1. Team composition (to include subcontractors, partners.) and level of understanding of and most experience with—in vitro organ modules. This may include curriculum vitae (CV) of the principal investigator and key personnel. 2. Copies of previously published papers from peer reviewed journals. Proposals must address the following five technical areas. 1. Platform Engineering/Analytic Capability 2. Human Organ Constructs 3. Blood Surrogate 4. Prediction and Analytical Proof-of-Concept and 5. Biological/Chemical Agent in vitro models. Submission timeline 1. White Papers - due on 20 January 2012 2.Invitations for Full Proposals sent NLT 5 February 2012. 3.Full Proposals are due 30 March 2012 Interested parties may respond via email to rfp@e2ebiosys.com. Confidential and proprietary material will require a CDA prior to submission.Interested parties will send their mutual CDA. Where there is a possibility of filing patent, e2eBioSys will provide US Patent agent services at no cost for this research. 
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