Harmonizing International Biobanking

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Joint presentation by International Society for Biological and Environmental Repositories (ISBER) and European, Middle Eastern & African Society for Biopreservations & Biobanking (ESBB) at the EU Science: Global Challenges, Global Collaboration Conference held March 4-8, 2013 in Brussels, Belgium. The session on biobanking included presentations from BBMRI, P3G, ISBER/ESBB, BioShare, Nat. China Biobank and a discussion on ethical/legal issues in biobanking focusing on the current plan for the EU data protection regulations. The presentation was authored by Rita Lawlor, President ESBB; and Marianne Henderson, ISBER Past President.

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Harmonizing International Biobanking

  1. 1. - Harmonizing International Biobanking- Key to Global Science and Public HealthInternational Society for European, Middle Eastern andBiological and African Society forEnvironmental Repositories Biopreservation and Biobankingwww.isber.org www.esbb.orgRegional Chapter of ISBER March 6, 2013 EU Parliament Session 1
  2. 2. International Society for Biological and Environmental Repositoriesis the leading international forum that addresses thetechnical, legal, ethical, and managerial issues relevant torepositories of biological and environmental specimensOur mission is to create opportunities for sharing ideasinternationally, and harmonize approaches to evolvingchallenges in biobanking, and biological and environmentalrepository operation. ISBER fosters collaborations, createseducation and training opportunities, and provides aninternational showcase for state-of-the art policies, processes,and research
  3. 3. European, Middle Eastern&African Society forBiopreservation and Biobanking ESBB has an important regional focus for biobanking issueswithin the region of Europe, the Middle East and Africa
  4. 4. Major Goals of ISBER & ESBB• Disseminate information on repository management• Develop Best Practices• Educate and Train on biobanking disciplines• Provide a centralized information resource for repositories• Unite members to address "hot button" topics• Provide a voice for repositories to influence regulations to facilitate global research and collaboration
  5. 5. Our Members Represent a Wide Variety of Biorepositories • Clinical-based biobanks/ tissue banks • Population biobanks • Culture collections • Environmental biobanks • Museum biobanks • Biobanks of human, animal, plant and microbial samples
  6. 6. ISBER & ESBB Members Represent the Continuum of the Biobanking Chain in Health Care 1. Donors / Patients /Clinicans 2. Biobankers 3. Researchers / Academics / Industry 4. Vendors / Suppliers 5. Legal, Ethical, Social, Information Specialists
  7. 7. Collect/Process/Inventory/Store Biorepositoryobtains informed Search/Request consent Biorepository Collection Develop Life Cycle Evaluate UseNew research protocols Publish/ Submit to DistributeNew Clinical Application Regulatory body(diagnostic, prognostic, Analyze / Verify / therapeutic) Validate
  8. 8. 2012 ISBER Best Practices for Repositories• Specimen Collection, Processing, Storage And Retrieval• Legal And Ethical Issues in Biobanking• Specimen Access, Distribution, Use And Destruction• Repository Planning – Facilities – Storage Equipment And Environments – Quality Management – Safety Effective Practices – Records Management and Best Practices – Biological Material Tracking From Repositories Across the Globe• Training• Cost Management & Sustainability
  9. 9. Focus on Education and TrainingEducational workshops and webinars covering all areas of biobankingSelf assessment tool (SAT) to measure adherence to Best PracticesEncouraging the advancement and publication of quality biospecimen science on collection and handling practices.Education to increase awareness of ethical, legal and social policy that affects biobanking 9
  10. 10. Tools for Collaborative BiobankingSPREC - Standard PREanalyticalCode to annotatepreanalytical variations impacting biospecimen integrityBRISQ – BiospecimenReporting for Improved Study Qualityto provide consistent and standardized information to betterevaluate, interpret, compare, and reproduce experimentalresultsISBER Proficiency Testing – focus on Intra- and Inter-Laboratory Variability as well as sample variability to assurecomparability of samples and testing.
  11. 11. Global Working Initiatives – ISBER/ESBBFacilitate InternationalCollaborationthroughharmonizationof IT and DataforexchangePromotecollaborationamongAcademia / Industry /GovernmentIntegrate Environmentaland Animal specimencollectionpracticesProvideunique biospecimens locator for Rare DiseasesFocus on biobankinfrastructurebuilding in Africa and lowresourcecountries
  12. 12. World maps resized by a) population, b) burden of disease, c) density of medical schools, d) density of workforce
  13. 13. 21st Century Personalized Medicine20th Century (Not Sustainable) 21st Century Focus on treatment  Focus on predisposition, early detection and biological processes Diagnosis based on  Diagnosis based on molecular morphologic and pathologic characterization and biological analysis processes Expensive; perpetuates  Evidence-based; continually unsuccessful approaches assesses standard of care No systematic connection  Connects bench  bedside  between research, bench in seamless feedback loop preclinical trials and clinical care The Ideal: 21st Century Medicine that is Predictive, Pre-emptive, Personalized A.Barker, NCI
  14. 14. 21st Century Personalized Medicine It is vital that as a community, we harmonize our processes andprocedures for Global biobanking in the 21st century. At stake is the pace -- and the ultimate success -- of our shifttowardstruly personalized medicine A.Barker, NCI 14
  15. 15. Classification of Cancers
  16. 16. Cancer Phenotypes
  17. 17. Molecular Taxonomy Cancer “Biotypes”
  18. 18. From Generic to Precision Treatment
  19. 19. Industry Projections Initiation of Biomarker Driven Clinical Trials Demand for Biomaterials Outpacing Supply 60 1,600 $2,583 23.2%# of Clinical Trials with Biomarkers Non-commercial 1,400 50 CAGR Total Sales ($mm) Commercial 1,200 40 1,000 30 $840 800 20 600 10 400 - 200 <2009 2009 2010 2011 - 2009 2014 Source: Presentation by Biomerieux at the Biomarker World Congress Source: Visiongain. Biobanking for Medicine: Technology and 2012 (May 2012) Market 2010-2025. 2011
  20. 20. Enabling Global Collaboration EffectivelyInvestment in theharmonization of qualitybiobanking practices is thefuel for advancingsustainable global publichealth

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