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NIHBI Launch Event. 6 th June 2005 John Stageman VP Information & Sciences, Global Discovery. Short Agenda. Importance and potential impact of NIHBI Current challenges for Pharma R&D Informatics progress in AstraZeneca Current active interfaces Changing boundaries Opportunities.
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NIHBI Launch Event 6th June 2005 John Stageman VP Information & Sciences, Global Discovery World Pharma IT Congress
Short Agenda • Importance and potential impact of NIHBI • Current challenges for Pharma R&D • Informatics progress in AstraZeneca • Current active interfaces • Changing boundaries • Opportunities World Pharma IT Congress
Common challenges for Pharma R&D • Increasing cost and attrition • Decreasing overall productivity • Risk-averse Political and Regulatory environment • Loss of public trust and understanding of positive contribution to human health • Unprecedented technology and science opportunity • Expanding universe of relevant information World Pharma IT Congress
In-house, External, Structured, Unstructured, Tacit, Explicit Public information & Commodity technology Core In-house Collaborations Qs: How will the boundaries move? How to govern information crossing boundaries? How to balance integration in-house vs. external Information? World Pharma IT Congress
Submission HitIdentifica-tion LeadIdentifica-tion LeadOptimisa-tion CDPrenomi-nation Target Identification ConceptTesting Development for launch LaunchPhase Launch Informatics Need Across the R & D Pipeline Bioinformatics, Cheminformatics, Lead Informatics, Discovery Informatics… Clinical Informatics, Medical Informatics, Development Informatics, R&D Informatics…
Paradigm Shift in Biology Leads to Data Explosion • Comprehensive DNA sequence information • Microarray and other measurement technologies • High content biology • -Omics • Genomics • Proteomics • Metabonomics • Lipidomics • Carbodomics • Cellomics • Imaging, Histopathology, etc. World Pharma IT Congress
New Directions in Chemical Research • Combinatorial chemistry • High-throughput synthesis and screening • Chemical mixtures • Structural Genomics and rational design • International data and systems • More compound databases • Virtual screening • Physical and DMPK property modelling World Pharma IT Congress
Robotics and Miniaturization Generate Lots of Data in Discovery R2 = 0.85
More Studies and More Data in Clinical • eClinical: Electronic Data Capture in Clinical trials • Electronic ECG recording and analysis • Biomedical Imaging: MRI, PET scans • Pharmacogenetics • -omics and Biomarkers World Pharma IT Congress
Submission HitIdentifica-tion LeadIdentifica-tion LeadOptimisa-tion CDPrenomi-nation Target Identification ConceptTesting Development for launch LaunchPhase Launch MouseBase Informatics Tools World Pharma IT Congress
Animal Models Tissue Histopath Disease Clinical Data Biomarker Biomedial Image Target Literature DMPK -omic data Make Connections: Build and Visualize Relationships Projects Time Compounds Genes World Pharma IT Congress
Opportunities for Bioinformatics to Impact • Translational Science • Linking Clinical outcome data to target biology • Linking targets and compounds to AEs / liabilities • Molecular markers of disease • Early efficacy and dose response relationships • Animal and human model relationships • Clinical trial • PK/PD modeling and simulations • Adaptive design for clinical trials • Knowledge sharing of disease information across projects World Pharma IT Congress
Specific Areas of focus within Drug Development • Understand Disease, understand drug activity • Disease reclassification • Identification of disease sub-classes • Identification of Biomarkers for disease subclasses. • Biomarkers for early detection. • Patient stratification • Identification of appropriate groups in clinical trials. • Disease staging for treatment options. • Prognosis of disease progression / severity. • Drug mechanism, effect, metabolism and transport • Toxicology and side effects • Dose studies • Efficacy and adverse events World Pharma IT Congress
Drug Discovery Process is Not Really a Linear Process World Pharma IT Congress
Phe Ge Che Must Understand Relationship World Pharma IT Congress
Understanding Complexity of Biological Systems E-CELL -- Masaru Tomita, Keio U. World Pharma IT Congress
Data Links Between Diverse Structures and Processes World Pharma IT Congress
Opportunities in partnership • Rapid progression of systems biology approach to understanding disease mechanisms and drug actions • Common challenges of medical data capture, secure archiving and accessibility for research • Developing the clinical research informatics platform for ‘Ge’+’Phe’+’Che’ correlations • Improving systems for monitoring therapy compliance, impact and safety • Exploring changing the boundaries and paradigms for Phase 3,4 clinical development (can UK/NW lead the world?) • ……+many more! World Pharma IT Congress