From Bench to Bedside: Applications to Drug Discovery and Development

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From Bench to Bedside: Applications to Drug Discovery and Development Eric Neumann W3C HCLSIG co-seat Teranode Corporation HCLSIG F2F Cambridge MA

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Knowledge " - is the human limit (both potential and real) to make successful move in changed and dubious circumstances. "

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Need to use Knowledge all the more viably Drug Innovation and the Technology Gap

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Drug R&D Trends from Innovation or Stagnation , FDA Report March 2004

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from Innovation or Stagnation , FDA Report March 2004

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Tox/Efficacy New Regulatory Issues Confronting Pharmaceuticals ADME Optim from Innovation or Stagnation , FDA Report March 2004

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Translational Medicine Enable doctors to all the more successfully decipher important discoveries and speculations into treatments for human wellbeing Support the mixing of tremendous volumes of clinical research and phenotypic information with genomic inquire about information Apply that learning to patients lastly make individualized, protection medication a reality for maladies that have a hereditary premise

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Role of Informatics John Glaser, CIO Partners Healthcare Providing high caliber and productive social insurance isn't conceivable any longer without a modern marriage of data innovation and cutting edge science . Uniting these to illuminate understanding consideration is a huge undertaking… the full cluster of new data gave by genomic look into must be tackled and made genuine for specialists and patients A Framework for leading clinical research in and crosswise over extensive multidisciplinary scholarly medicinal focuses is intended to set up a "new" biomedicine to "fully misuses the product of the genomic upheaval for clinical practice and permits clinical care to be utilized to propel fundamental natural research .

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Challenges for Drug D&D Counteracting the legacy of "Storehouses" How to split far from the DD "transport line model" to the "Interpretation demonstrate" picking up and sharing bits of knowledge all through the procedure The Benefit of New Targets for New Diseases How to best recognize wellbeing and adequacy issues at an early stage, so that cost and disappointment are diminished A D 3 Knowledge-base: Drugability and Safety

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Qualified Targets Lead Generation Lead Optimization Toxicity & Safety Biomarkers Molecular Mechanisms Pharmacogenomics Clinical Trials Drug Discovery & Development Knowledge K D

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Drug Discovery & Development Knowledge Qualified Targets Molecular Mechanisms Lead Generation Toxicity & Safety Lead Optimization Pharmacogenomics Biomarkers Clinical Trials Launch

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Communities and Interoperability Semantic interoperability is straightforwardly fixing to CoP: "Inside a group or area, relative homogeneity decreases interoperability challenges.  Heterogeneity increments as one moves outside of a central group/space, and interoperability is likely [to be] all the more exorbitant and hard to accomplish" Moen, 2001 Meanings encoded in a blueprint are normally helpful for stand out (unique) group - hard to stretch out to others! Database utility more troublesome if gathering is heterogeneous

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Disease Polymorphisms Disease Group Protein Person Chemical substance Multiple Ontologies Used Together UMLS OMIM SNP Drug target cosmology FOAF UniProt BioPAX PubChem Patent metaphysics Extant ontologies Under advancement Bridge idea

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Disease Descriptions Clinical Obs Applications Mechanisms IRB Molecules Potential Linked Clinical Ontologies SNOMED CDISC ICD10 Clinical Trials philosophy RCRIM (HL7) Disease Models Pathways (BioPAX) Tox Genomics Extant ontologies Under improvement Bridge idea

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Toxicity Indication Drug Safety Knowledge Genomic Profile Standards set by Regulatory Agencies To be a piece of NDA (New Drug Applications) How will Reviewers be engaged to handle such vast amaount sof new information? Human Hepato-Toxicity Study Hepato-Toxicity Lens

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CDISC and the Semantic Web? Lessen the need to compose information parsers to any CDISC XML Schema Make utilization of ontologies and phrasings specifically utilizing RDF Easier consideration of Genomic information Use Semantic Lenses for Reviewers Easier acknowledgment by industry with their momentum innovations

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Developing Standards Exchange Implementation Design

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Semantic Web-based Specifications Developing Standards Design Implementation Exchange

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Support Full Information Integration: incorporate and oversee information from sources, EDC frameworks, Clinical Data Management Systems , labs and CROs Analysis and reporting: Accurately and auspicious systematic reports from study information, for use in basic leadership; simpler results imparting to analysts and commentators Discovery: Use extending research data as a learning base for fast examinations concerning basic medication wellbeing issues, new promoting claims, and distinguish product offering augmentations.

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Thank You