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The Clinical Research Grid Project Overview

The Clinical Research Grid Project Overview. Joel Saltz, MD, PhD Chair, Biomedical Informatics Chief Information Officer The Ohio State University Medical Center. The Ohio State University Joel H. Saltz, M.D., Ph.D.  Umit Catalyurek, Ph.D. Albert de la Chapelle, M.D., Ph.D.   

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The Clinical Research Grid Project Overview

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  1. The Clinical Research GridProject Overview Joel Saltz, MD, PhD Chair, Biomedical Informatics Chief Information Officer The Ohio State University Medical Center

  2. The Ohio State University Joel H. Saltz, M.D., Ph.D.  Umit Catalyurek, Ph.D. Albert de la Chapelle, M.D., Ph.D.    Ramana Davuluri, Ph.D.   Charis Eng, M.D., Ph.D.   Tahsin Kurc, Ph.D. Wolfgang Sadee, Ph.D.  Mary Ellen Wewers, Ph.D., M.P.H., R.N. Haifeng Wu, M.D. Ohio Supercomputer Center Don Stredney, M.A Al Stutz, M.S. Pete Wycoff, Ph.D. Rescentris Adel Mikhail, Ph.D. Jeffrey Spitzner, Ph.D.   Joseph Spitzner, Ph.D. Biomedical Informatics Synthesis Platform

  3. Antony van Leeuwenhoek 1632-1723

  4. Helicobacter pyloridiscovered in 1982 by Barry Marshall and Robin Warren

  5. Translate dramatic advances in biology to medical treatments Decrease cost of clinical research Increase effectiveness of treatment Decrease time to cure! Goal

  6. Translate advances in functional genomics and imaging technology to advances in medical practice Leverage leading edge computer science technology Motivate development of new ideas in biomedicine and computer science Translational Research

  7. How to discover what is important? HUGE amounts of information Many types of data Data size Maintaining patient confidentiality Large number of participating institutions Challenges

  8. Clinical Research Grid: Types of Information • Radiological Studies • Pathology • Molecular (Proteomics, gene expression) • Genetic, Epigenetic (SNPs, haplotype analysis) • Laboratory, pharmacy, outcome data

  9. Grid based clinical trials supportWorldwide Scope for Clinical Research Studies • Multi-institutional studies • 1000’s of potential clinical research sites • Different studies involve different subsets of sites • Different sites can use different names for the same entity • Semantic grid • SNOMED, LOINC • Support for authentication, encryption, anonymization • Role based data access

  10. Clinical Research Software will Contribute to Economic Growth

  11. Drug development is too slow and too expensive today New drug revenues = $1 Billion/year = $3 Million/day But time = 5 - 12 yearsand cost >$550 Million(and cost of failure is high) Information Management solutions can make the >$50 Billion annual worldwide R&D expenditures in the life sciences more efficient

  12. From discovery to marketplace Discovery Research Clinical Approval Distributor Marketplace Biotech Academia CRO / CMO consulting Pharmaceutical Payer Hospital Physician Patient NIH Supplies / Services Databases / ASPs Concept Proof of Models Clinical FDA Distributor Marketplace PrincipalApproval 3-5 1-2 1-3 3-4 less than 1 years cost $2-10M 5-100M 300-500M

  13. NDA IND 5 1 Data sources/activities in the drug discovery process Compounds Approved Compounds in Trial Compounds Evaluated • Bioinformatics • Gene Expression • Medicinal Chemistry • Functional Biology • Disease Modeling • Bio-assays • Screening • Combinatorial • Proteomics • Experimental • Diagnostic • Patents • Publications • Regulatory • Pharmacology • Toxicology • Epidemiological • Trials • Marketing 5,000 I II III IV Safety Efficacy Post Research Research Development Clinical to the market Discovery years 3-5 1-2 2 3-5 $300 to $800 million, 8 to 14-year process

  14. OSU Research Projects Drive Software Development and Lead the Way in Fighting Tobacco Related Diseases

  15. Atherosclerotic process components Cholesterol metabolism and transport Inflammation Coagulation Drug response Statins Study employs SNP analysis, proteomics, cardiac catheterization data Molecular: Cardiovascular project: Pharmacogenomics of Lipid Lowering Therapies in Coronary Artery Disease Glen Cooke, Heart & Lung Research Institute Joel Saltz, Biomedical Informatics Heifeng Wu, Coagulation Clinics Bo Yuan, Genomics Wolfgang Sadee, Audrey Papp, Julia Pinsonneault, Pharmacology Clay Marsh, Heart & Lung Research Institute Avner Friedman, Biomathematical Sciences Institute

  16. 6th Most Common Cancer in World >161,000 New Cases Each Year in US >50,000 Deaths from HNSCC in 2001 Risk Factors: Tobacco and Alcohol Despite Much Progress in Diagnosis and Treatment, Survival Rates Not Improved in Last 20 Years Genetics: Head & Neck Squamous Cell Carcinomas (HNSCC)

  17. Existing Scientific Belief Stroma = Bystander Support Cells = Not Cancer Epithelium= The Cancer, which Has Genetic Alterations

  18. Our Study Hypothesis (Charis Eng) Stroma is Cancerous Too and Has Genetic Alterations Epithelium=Cancer

  19. Change Current Scientific Belief on HNSCC Stromal Genetic Alterations as New and Accurate Markers to Predict Clinical Outcome and Survival Stromal Genetic Alterations as New Targets of Treatment and Prevention If Project Successful, Then:

  20. The Ohio State University Joel H. Saltz, M.D., Ph.D.  Umit Catalyurek, Ph.D. Albert de la Chapelle, M.D., Ph.D.    Ramana Davuluri, Ph.D.   Charis Eng, M.D., Ph.D.   Tahsin Kurc, Ph.D. Wolfgang Sadee, Ph.D.  Mary Ellen Wewers, Ph.D., M.P.H., R.N. Haifeng Wu, M.D. Ohio Supercomputer Center Don Stredney, M.A Al Stutz, M.S. Pete Wycoff, Ph.D. Rescentris Adel Mikhail, Ph.D. Jeffrey Spitzner, Ph.D.   Joseph Spitzner, Ph.D. Biomedical Informatics Synthesis Platform

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