Collaboration in Biobanking: sustaining R&D activities of the Pharmaceutical Industry  Julie Corfield, AstraZeneca R&D Cha...
  Patients………Patients………Patients………Patients Unmet needs Cancer, Brain disorders, Inflammatory, Metabolic and Infectious di...
Sustaining R&D activities in Pharma? Providing the foundation for the treatments of today and the cures of tomorrow Time R...
The big picture Discovery research Preclinical develop. Translational medicine Clinical develop. Pharmaco - vigilance Disc...
Definitions <ul><li>Biobank:  </li></ul><ul><li>is a place, a room, or container where human biological samples are physic...
AstraZeneca global biobank organisation and local biobanks at R&D sites <ul><li>Research Areas: </li></ul><ul><li>Cardiova...
Collaboration in biobanking………
AZ biobank……..a capability from collaborations Sample Sources Healthy Commercial suppliers Post  mortem Patients Legacy AZ...
RA/OA disease area biobanks: 2001 to 2006 <ul><li>Profile </li></ul><ul><ul><li>2 collaborations in 2000; 12 collaboration...
Profile   of biobanks/collections   <ul><li>Biobanks </li></ul><ul><li>Coded samples </li></ul><ul><li>Dynamic not static/...
Identification/validation of efficacy biomarkers for Chronic Obstructive Pulmonary Disease  AstraZeneca R&D Lund The  M al...
Fostering Collaboration AZ Biobanks Internal  Collaboration  MD/Phd Qualifications Academic research Publications Better u...
Opportunities for collaboration ………to sustain R& D? <ul><li>Sample collections </li></ul><ul><li>Use of retrospective samp...
What can be done to enable more collaboration? <ul><li>More broadly   </li></ul><ul><li>Ethics/regulation </li></ul><ul><l...
Priorities to be addressed <ul><li>Ethical and legal issues……obstacle to collaboration; consent does not routinely allow s...
The Future Thank you
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Julie Corfield

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  • To cover: The relevance of biobanking to this, what do our customers want? What do we mean by sustaining R&amp;D What do we mean by collaboration in AZ perspective and wider What is needed to foster more collaboration to sustain R&amp;D
  • Just to remind ourselves the big picture .............the steps to getting a drug to market as well as the continue monitoring of its safety once it is there None of this could be acheived without collaboration and more specifcially in biobanking
  • Today……I ig
  • How it started?
  • Julie Corfield

    1. 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. 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. 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. 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
    5. 5. Definitions <ul><li>Biobank: </li></ul><ul><li>is a place, a room, or container where human biological samples are physically stored, indefinitely or for a specified time. (This is distinct from the term ‘biobank’ when defined as a “collection of human biological samples” in some legislation). </li></ul><ul><li>Biobanking: </li></ul><ul><li>the capability that covers the governance and infrastructure of biobanks with associated facilities and personnel who are engaged in the lifecycle management of human biological samples from acquisition and use for a defined purpose(s) and through to disposal. </li></ul>
    6. 6. AstraZeneca global biobank organisation and local biobanks at R&D sites <ul><li>Research Areas: </li></ul><ul><li>Cardiovascular; Cancer; Infection; Gastrointestinal; </li></ul><ul><li>Neuroscience (Central Nervous System; Pain Control/Anaesthesia) </li></ul><ul><li>Respiratory (COPD/Asthma) and Inflammation (Rheumatoid arthritis) </li></ul>Montreal Shanghai Charnwood Boston Alderley Bangalore Mölndal Lund Wilmington Södertälje Global Head Local Head Biobank operations manager Department operations manager Sample owner Custodian Sample User
    7. 7. Collaboration in biobanking………
    8. 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
    9. 9. RA/OA disease area biobanks: 2001 to 2006 <ul><li>Profile </li></ul><ul><ul><li>2 collaborations in 2000; 12 collaborations in 2006 </li></ul></ul><ul><ul><li>2 R&D sites </li></ul></ul><ul><li>Collaborations </li></ul><ul><ul><li>UK: RA/OA joint replacement surgery </li></ul></ul><ul><ul><li>UK: Post mortem (knees) </li></ul></ul><ul><ul><li>UK: Case-controlled large joint OA; interaction of genes and environment </li></ul></ul><ul><ul><li>UK and Australia: OA biomarkers </li></ul></ul><ul><ul><li>Sweden: early RA </li></ul></ul><ul><ul><li>Sweden: biomarker validation in healthy volunteers </li></ul></ul><ul><ul><li>Nederlands: early RA </li></ul></ul><ul><ul><li>US: OA TI/TV, biomarkers </li></ul></ul><ul><ul><li>Commercial suppliers </li></ul></ul>
    10. 10. Profile of biobanks/collections <ul><li>Biobanks </li></ul><ul><li>Coded samples </li></ul><ul><li>Dynamic not static/stock- piled </li></ul><ul><li>Controlled release/access; custodians </li></ul><ul><li>Quality/molecular characterisation/library </li></ul><ul><li>Donor characteristics </li></ul><ul><li>Medical history, concurrent disease, current/past medication, MRI, X-ray </li></ul><ul><ul><li>Plus lifestyle/environment </li></ul></ul><ul><li>Sample Types </li></ul><ul><li>Synovium, cartilage, meniscus, bone, tendons, synovial fluid, blood (plasma;serum; DNA), urine; </li></ul><ul><li>Sample Format </li></ul><ul><li>Fresh, arthroscopic samples; paraffin embedded; fresh frozen </li></ul>
    11. 11. Identification/validation of efficacy biomarkers for Chronic Obstructive Pulmonary Disease AstraZeneca R&D Lund The M almö S moking I nduced S ystemic Inflammation Study ( MSIS ) MSIS: An exploratory study of endothelial progenitor cells, circulating endothelia cells, endothelial function, inflammatory blood markers and physical exercise capacity in subjects with chronic obstructive pulmonary disease (COPD) and lung-healthy never-smokers <ul><li>Patient flow </li></ul><ul><li>57 included (randomised) </li></ul><ul><li>10 severe COPD patients </li></ul><ul><li>10 moderate COPD patients </li></ul><ul><li>13 mild COPD patients </li></ul><ul><li>12 healthy smokers </li></ul><ul><li>12 healthy non-smokers </li></ul>Biomarkers in plasma: Nine out of thirty-one plasma markers are elevated in COPD patients in comparison with lung healthy individuals
    12. 12. Fostering Collaboration AZ Biobanks Internal Collaboration MD/Phd Qualifications Academic research Publications Better understanding of disease New targets
    13. 13. Opportunities for collaboration ………to sustain R& D? <ul><li>Sample collections </li></ul><ul><li>Use of retrospective sample collections? </li></ul><ul><ul><li>Retrospective samples adequate quality? </li></ul></ul><ul><ul><li>Prospective samples costly </li></ul></ul><ul><li>Visibility/transparency of existing pre-competitive collections </li></ul><ul><li>Not an unlimited supply of subjects to provide samples……need to engage patient groups </li></ul><ul><li>More ‘networks’ to provide access to existing biobanks </li></ul><ul><li>Standards </li></ul><ul><li>Standardised protocols/laboratory manuals </li></ul><ul><li>Adopt consistent approaches/technologies for analysis of samples </li></ul><ul><li>Information standards </li></ul><ul><li>Storage capability </li></ul>
    14. 14. What can be done to enable more collaboration? <ul><li>More broadly </li></ul><ul><li>Ethics/regulation </li></ul><ul><li>Harmonisation of regulations </li></ul><ul><li>Greater consistency in process for informed consent and ethics committee process……….broad consent </li></ul><ul><li>Infrastructure/approach </li></ul><ul><li>Access to experts/different skills and knowledge/centres of excellence </li></ul><ul><li>Creation of translational and multidisciplinary research collaborations to overcome cultural differences </li></ul><ul><li>Translational research to validate initial findings and explore practical use </li></ul><ul><li>Greater co-ordination of activities across Europe and elsewhere </li></ul><ul><ul><li>Infrastructure development for large scale population studies…to enable implementation of protocols; collection of data and samples </li></ul></ul><ul><li>Continuing technology development </li></ul><ul><li>Training ‘gap’ </li></ul>
    15. 15. Priorities to be addressed <ul><li>Ethical and legal issues……obstacle to collaboration; consent does not routinely allow sharing </li></ul><ul><li>Governance to enable sharing and exchange of material </li></ul><ul><li>Data and samples contained in biobanks are variable: content and quality </li></ul><ul><li>Few standardised quality controlled protocols for data collection, sample storage and analysis and access. </li></ul><ul><ul><li>Difficult to pool data </li></ul></ul>Customer Needs
    16. 16. The Future Thank you

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