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Business Value of SW in Drug Discovery

Business Value of SW in Drug Discovery. Eric Neumann, W3C HCLSIG co-chair Teranode Corporation F2F Cambridge MA. Tox/Efficacy. New Regulatory Issues Confronting Pharmaceuticals. ADME Optim. from Innovation or Stagnation , FDA Report March 2004. Drug Discovery Costs.

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Business Value of SW in Drug Discovery

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  1. Business Value of SW in Drug Discovery Eric Neumann, W3C HCLSIG co-chair Teranode Corporation F2F Cambridge MA

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

  3. Drug Discovery Costs • ~$1.5 Billion / drug • 80% failure rate during development • mainly Toxicity, Efficacy • Clinical Trials 60-70% cost • Regulatory Submissions • Post-Launch Costs

  4. Some Drug Development Facts • One major reason for increased costs and lower ROI is a dramatic decline in productivity. • Only one compound now reaches the market for every thirteen discovered and placed in preclinical trials, compared to one for every eight between 1995 and 2000. • Attrition has been particularly severe in Phase III development. • Average development costs per compound have increased from $131 million to $200 million, while the chances of each compound receiving approval has fallen from 73% to 59%. • Post-Launch Costs - can be extreme

  5. Areas benefiting from Information • Discovery R&D (Targets and Leads) • Preclinical/Safety • Clinical Trials • Pharmacovigilance • Patent Portfolios • In-licensing and Alliances • Competitive Analysis

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

  7. Pharmaceutical IT Costs • Some opinions: • $43 billion worldwide market for informatics by 2004 (Sun Microsystems) • $2 billion by 2002 (Frost & Sullivan 1997 report) • $1.2 billion by 2005 (Front Line Consulting) • $110 million by 2004 for bioinformatics (Silico Research) • Average Pharma IT ~$200 million/yr • Compared to revenue ~$10-50B/yr

  8. Information Challenges • Data volume is exploding as more information is being generated about more targets and compounds. • Data is being captured and stored by different systems in different formats which do not readily communicate with each other. • Decisions must be made faster, based on creating, capturing, and reusing data from disparate sources. • Information must be transmitted seamlessly and automatically among a company's labs, which may be located in different countries. • In this era of Pharma mergers, information from two different corporate cultures must be consolidated and evaluated to set future directions.

  9. Informatics ROI from SW • Status Quo - no change in R&D • 10% improve on $100M  $10M/yr savings • Engaging Translation Research • Savings on DD (10% = $250M/yr) • Reduce Post-launch failures (>>$M)

  10. DiseasePolymorphisms Disease Group Protein Person Chemicalentity Multiple Ontologies Used Together UMLS OMIM SNP Drug target ontology FOAF UniProt BioPAX PubChem Patent ontology Extant ontologies Under development Bridge concept

  11. DiseaseDescriptions Clinical Obs Applications Mechanisms IRB Molecules Potential Linked Clinical Ontologies SNOMED CDISC ICD10 Clinical Trials ontology RCRIM (HL7) Disease Models Pathways(BioPAX) Tox Genomics Extant ontologies Under development Bridge concept

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