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<ul><li>International Biobanking:  </li></ul><ul><li>Oportunities and Challenges for  </li></ul><ul><li>Private-Public Col...
FUNDEMENTAL PRINCIPLES OF INTERNATIONAL BIOBANKING <ul><li>Open access with wide-scale data sharing and collaboration acro...
Biobanks and the Pharmaceutical Industry Disease as opposed to population focus Clinical trial-related translational resea...
Key Insights <ul><li>The pharmaceutical industry needs to engage the broader scientific and healthcare community in a more...
Phase 2 Survival Remains a Major Challenge to Increasing R&D Productivity <ul><li>Unsustainable economics: </li></ul><ul><...
Reducing Drug Attrition   Clinical Outcome <ul><li>Clinic to target: </li></ul><ul><ul><li>Defined unmet clinical need </l...
The SNP Consortium International HapMap Project Genotyping Chips Adapted from David Altshuler, Harvard Medical School, 2007
Human Genetics-Based Approaches Differ on Scale and Focus <ul><li>Large population strategy: </li></ul><ul><ul><li>Interna...
Major Challenges <ul><li>Linking biobank materials to multiple sources of healthcare information, while protecting all sta...
The Public Has Mixed Feelings  Regarding Genetic Research
NCAA's sickle cell test plan raises fears Erin Allday, Chronicle Staff Writer Monday, September 14, 2009 A recent NCAA rec...
Key Priorities Going Forward <ul><li>Harmonization as opposed to standardization </li></ul><ul><li>Linking biobanks with m...
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International Biobanking: Oportunities and Challenges for Private-Public Collaboration

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David R. Cox M.D.,Ph.D.
Senior Vice President and Chief Scientific Officer
Biotherapeutics and Bioinnovation Center
Pfizer Inc

Published in: Technology, Business
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Transcript of "International Biobanking: Oportunities and Challenges for Private-Public Collaboration "

  1. 1. <ul><li>International Biobanking: </li></ul><ul><li>Oportunities and Challenges for </li></ul><ul><li>Private-Public Collaboration </li></ul><ul><li>David R. Cox M.D.,Ph.D. </li></ul><ul><li>Senior Vice President and Chief Scientific Officer </li></ul><ul><li>Biotherapeutics and Bioinnovation Center </li></ul><ul><li>Pfizer Inc </li></ul>
  2. 2. FUNDEMENTAL PRINCIPLES OF INTERNATIONAL BIOBANKING <ul><li>Open access with wide-scale data sharing and collaboration across countries </li></ul><ul><li>Altruism, with promotion of the common good </li></ul><ul><li>Consent, with respect for cultural diversity </li></ul><ul><li>Protect of the interests of a diverse array of stakeholders </li></ul>
  3. 3. Biobanks and the Pharmaceutical Industry Disease as opposed to population focus Clinical trial-related translational research Valuable information regarding treatment outcomes Private
  4. 4. Key Insights <ul><li>The pharmaceutical industry needs to engage the broader scientific and healthcare community in a more collaborative fashion in order to achieve its goals </li></ul><ul><li>Money alone does not provide access to the critical collaborative relationships </li></ul>
  5. 5. Phase 2 Survival Remains a Major Challenge to Increasing R&D Productivity <ul><li>Unsustainable economics: </li></ul><ul><ul><li>Industry average cost per NME >$2.3 B (2007) </li></ul></ul><ul><ul><li>~35 NCE into the clinic to yield 1 NME </li></ul></ul>
  6. 6. Reducing Drug Attrition Clinical Outcome <ul><li>Clinic to target: </li></ul><ul><ul><li>Defined unmet clinical need </li></ul></ul><ul><ul><li>Quantitative translation from human genetic insights, to optimized therapy based on </li></ul></ul><ul><ul><li>an understanding of biology </li></ul></ul>Human Genetics Traditional Discovery VS. Molecular Targets <ul><li>Target to clinic: </li></ul><ul><ul><li>Poor alignment of molecular understanding to clinical need </li></ul></ul><ul><ul><li>Animal models inconsistently predictive of human disease and outcomes </li></ul></ul>
  7. 7. The SNP Consortium International HapMap Project Genotyping Chips Adapted from David Altshuler, Harvard Medical School, 2007
  8. 8. Human Genetics-Based Approaches Differ on Scale and Focus <ul><li>Large population strategy: </li></ul><ul><ul><li>International Hap Map Project – genomic atlas from “normal individuals” </li></ul></ul><ul><ul><li>Catalog human variability to identify patterns of genes linked to health and disease </li></ul></ul><ul><ul><li>Common genetic variants with modest genetic effects </li></ul></ul><ul><ul><li>Sampling strategy requiring 10,000 to 300,000 samples </li></ul></ul><ul><ul><li>Utilize large existing disease cohorts with limited clinical outcome data </li></ul></ul><ul><ul><li>Significant data already exists for common disorders that now requires additional biology to fully characterize optimal target space </li></ul></ul><ul><li>Rare DNA variant strategy: </li></ul><ul><ul><li>Focus on humans with traits of interest – patients with extreme phenotypes of a clinical outcome </li></ul></ul><ul><ul><li>Variant will better identify pathophysiological pathways that are the basis of the disorder </li></ul></ul><ul><ul><li>Rare variants yield larger genetic effects than common variants enabling study of a wide range of clinical outcomes </li></ul></ul><ul><ul><li>Loss-of-function variant defines direction of therapeutic perturbation </li></ul></ul><ul><ul><li>Sampling strategy requiring 200 to 300 individuals for each trait </li></ul></ul><ul><ul><li>Utilize existing, well characterized disease cohorts with the most important clinical outcomes </li></ul></ul>
  9. 9. Major Challenges <ul><li>Linking biobank materials to multiple sources of healthcare information, while protecting all stakeholders </li></ul><ul><li>Reconciling altruism and open collaboration with intellectual property and profit </li></ul>
  10. 10. The Public Has Mixed Feelings Regarding Genetic Research
  11. 11. NCAA's sickle cell test plan raises fears Erin Allday, Chronicle Staff Writer Monday, September 14, 2009 A recent NCAA recommendation to screen college athletes for sickle cell trait - the gene that can cause sickle cell disease - is raising the hackles of some experts who say testing is probably unnecessary, and may even lead to inadvertent discrimination against minority players. Sickle cell disease is a blood disorder that can cause severe pain, stroke and death, but sickle cell trait is almost always benign, and many people never know whether they carry the gene. About 8 percent of black people and about 1 percent of Latinos have sickle cell trait, but it's rare among white people, affecting only about 1 in 10,000. The United States has a long history of discrimination against people with sickle cell trait, said Troy Duster, a sociologist at UC Berkeley and New York University. In the 1960s, people who tested positive weren't allowed into the Air Force Academy, and into the '70s people were denied insurance or certain jobs, he said. It's irresponsible to screen people when there's little scientific evidence that the gene causes death and no specific precautions athletes can take to protect themselves, Duster said. &quot;When you screen someone, the question is, for what? What are you going to do with that information?&quot; Duster said. &quot;The NCAA is saying they want education, but education requires research, and there's no research.&quot;
  12. 12.
  13. 13. Key Priorities Going Forward <ul><li>Harmonization as opposed to standardization </li></ul><ul><li>Linking biobanks with mutliple sources of health information </li></ul><ul><li>Harmonizing the legal and ethical frameworks of multiple countries </li></ul><ul><li>Public engagement </li></ul><ul><li>Sustainability through the cooperation of mutliple diverse stakeholders </li></ul><ul><li>Private sector contributions of knowledge and data in addition to money </li></ul>
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