The document discusses collaboration in biobanking to support pharmaceutical R&D activities. It notes that R&D costs are high and innovation is needed. Biobanks can help by providing samples for research into diseases. The document describes AstraZeneca's global biobank network and examples of collaborations on disease-specific biobanks for conditions like rheumatoid arthritis and COPD. It argues that more collaboration is needed through standards, infrastructure, addressing ethical issues, and meeting customer needs to sustain R&D activities.

1. Collaboration in Biobanking: sustaining R&D activities of the Pharmaceutical Industry Julie Corfield, AstraZeneca R&D Charnwood BBMRI: Stakeholders forum 16 th September 2009 Renaissance Hotel, Brussels

2. Patients………Patients………Patients………Patients Unmet needs Cancer, Brain disorders, Inflammatory, Metabolic and Infectious diseases R&D bottlenecks/IMI Belonging to Europe……….sustaining R&D

3. Sustaining R&D activities in Pharma? Providing the foundation for the treatments of today and the cures of tomorrow Time Risk Cost Change Discovery. Effective risk assessment, failing drugs faster and improving productivity and cost-efficiency are becoming even more important…… a walloping average €895 million on researching and developing a single new medicine. LEADERSHIP Revisit the Current R&D Model? Estimated > 90% of medicines in use today have been discovered or developed by the industry. Late-stage attrition, with increasing development costs . NEW OPERATING MODEL Industry’s best hope for survival lies in innovation , its traditional strength. The business model of a vertically integrated approach to developing, manufacturing and selling drugs changed in favour of outsourcing. INNOVATION, OUTSOURCING … ..unprecedented challenges. Business model is economically unsustainable and unsuited to act quickly enough to produce the types of innovative treatments that will be demanded. The industry requires a bold new vision and leaders who have the willingness to embrace a fundamentally new approach to their business NEW APPROACH ‘ Biomarkers increasingly important in development of new drugs ….conditions at molecular level . …..New molecular markers, new assays….to help us define new diseases, …… more specifically, more differentially.’ BETTER DEFINED DISEASES, BIOMARKERS, PERSONALISED MEDICINE BIOBANKS

4. The big picture Discovery research Preclinical develop. Translational medicine Clinical develop. Pharmaco - vigilance Discovery Research Preclinical Develop- ment Translational medicine Clinical development Pharmaco- vigilance Benefit/Risk Assessment Target ID Cell/Tissue Relevant to Disease Hit Target Validate Target Safety Efficacy Bench to bedside Biobanks Clinical Studies Biomarkers Discovery research Preclinical develop. Translational medicine Clinical develop. Pharmaco - vigilance

7. Collaboration in biobanking………

8. AZ biobank……..a capability from collaborations Sample Sources Healthy Commercial suppliers Post mortem Patients Legacy AZ Customers TI/TV Disease strategy PGx Collaborations/ Investigators Bespoke Clinical studies Living Archived 1999 2009 Reduced risk/fewer scandals Increased demand for samples in AZ Increasing scrutiny/regulation Wider scope for consent Increasingly competitive R&D Standardisation/best practice….global project Tactical Protocols Informed consent Ethics Contract Subject data Monitoring/Sample tracking Quality/acceptance criteria Biomarkers

12. Fostering Collaboration AZ Biobanks Internal Collaboration MD/Phd Qualifications Academic research Publications Better understanding of disease New targets

16. The Future Thank you