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