business value of sw in drug discovery eric neumann, w3c hclsig co-chair teranode corporation f2f...
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Business Value of SW in Business Value of SW in Drug DiscoveryDrug Discovery
Eric Neumann, W3C HCLSIG co-chair
Teranode Corporation
F2F
Cambridge MA
New Regulatory Issues New Regulatory Issues Confronting PharmaceuticalsConfronting Pharmaceuticals
from Innovation or Stagnation, FDA Report March 2004
Tox/EfficacyADME Optim
Drug Discovery CostsDrug Discovery Costs
~$1.5 Billion / drug80% failure rate during development–mainly Toxicity, Efficacy
Clinical Trials 60-70% costRegulatory SubmissionsPost-Launch Costs
Some Drug Development FactsSome 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
Areas benefiting from InformationAreas benefiting from Information
Discovery R&D (Targets and Leads)Preclinical/SafetyClinical TrialsPharmacovigilancePatent PortfoliosIn-licensing and AlliancesCompetitive Analysis
Drug Discovery & Development KnowledgeDrug Discovery & Development Knowledge
Qualified Targets
Lead Generation Toxicity &
Safety
Biomarkers
Pharmacogenomics
Clinical Trials
Molecular Mechanisms
Lead Optimization
Launch
Pharmaceutical IT CostsPharmaceutical 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
Information ChallengesInformation 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.
Informatics ROI from SWInformatics 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)
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Multiple Ontologies Used TogetherMultiple Ontologies Used Together
Drug targetontologyFOAF
Patentontology
OMIM
Person
Group
Chemicalentity
Disease
SNP
BioPAX
UniProt
Extant ontologies
Protein
Under development
Bridge concept
UMLS
DiseasePolymorphisms
PubChem
Potential Linked Clinical OntologiesPotential Linked Clinical Ontologies
Clinical Trialsontology
RCRIM(HL7)
Genomics
CDISC
IRB
Applications
Molecules
Clinical Obs
ICD10
Pathways(BioPAX)
DiseaseModels
Extant ontologies
Mechanisms
Under development
Bridge concept
SNOMED
DiseaseDescriptions
Tox