Sage Bionetworks Synapse Project – Webinar – Weds. 7 Sept. 2011
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Abstract:
The recent exponential growth of biological “omics” data has occurred concurrently with a decline in the number of New Molecular Entities approved by the FDA, proving that biological research productivity does not scale with biological data generation and the analysis and interpretation of genomic data is a bottleneck in the development of new treatments. Sage Bionetworks’ mission is to catalyze a cultural transition from the traditional single lab, single-company, and single-therapy R&D paradigm to a model with broad precompetitive collaboration on the analysis of large scale data in medical sciences. Part of Sage’s solution is Synapse, a platform for open, reproducible data-driven science, which will support the reusability of information facilitated by ontology-based services and applications directed at scientific researchers and data curators. Sage Bionetworks is actively pursuing the acquisition, curation, statistical quality control, and hosting of datasets that integrate both clinical phenotype and genomic data along with an intermediate molecular layer such as gene expression or proteomic data. We expect hosting these sorts of unique, integrative, high value datasets in the public domain on Synapse will seed a variety of analytical approaches to drive new treatments based on better understanding of disease states and the biological effects of existing drugs. In this webinar, Dr. Michael Kellen, Director of Technology at Sage Bionetworks will provide a demonstration of an alpha version of the Synapse platform, and discuss its application to clinical science.
Interesting claim about the decline in the number of New Molecular Entities (NMEs) approved by the FDA, see: NMEs approved by CDER. Approvals are on average about the same. But then applications for NMEs have to be filed in order to be approved.
Just for background reading, you might want to look at: New Chemical Entity over at Wikipedia.
Or, The Scope of New Chemical Entity Exclusivity and FDA’s “Umbrella” Exclusivity Policy
I don’t disagree that better data analysis tools are needed but remain puzzled what the FDA approval rate for NMEs has to do with the problem.