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Personalized Medicine

The Veterans Affairs Central Biorepository and MVP Highlights Mary T. Brophy, MD, MPH 3 rd Annual BVARI Business Meeting August 12, 2011. Personalized Medicine. Emerging genomic technologies are critically dependent upon: well validated clinical data linked to high quality biospecimens.

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Personalized Medicine

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  1. The Veterans Affairs Central Biorepository and MVP HighlightsMary T. Brophy, MD, MPH3rd Annual BVARI Business MeetingAugust 12, 2011

  2. Personalized Medicine Emerging genomic technologies are critically dependent upon: well validated clinical data linked to high quality biospecimens

  3. “Health-care systems spend billions of dollars annually on biomarker research for personalized medicine. Success hinges on the quality of the biobank specimens and the data used to derive them, but a lack of quality control is polluting the scientific literature with flawed information that will take a long time to sort out.” “Leading journals are trend setter when it comes to defining publication criteria ……To uphold standards, all journals should insist on full details of biobanked specimens ” Simeon-Dubach, Perren A. Nature 457:454-455, July 2011

  4. Rationale for VA Central Biorepository • Program wide effort to standardize the methods for research using biospecimens in VA studies • Goals • To ensure the highest level of human protection • Maximize the scientific value of the bank

  5. VA Central Biorepository • Located at the Boston VA • Serves as a central biobank for VA studies • De-identified samples stored in a state of the art biorepository • ISBER and NCI guidelines for biorepositories • Assurance of the quality of the specimen and longevity of bank beyond the study

  6. VA Central Biorepository Operations • Developed standard operating procedures for biosample collection, processing and storage that could be used across studies • Meeting the study specific needs • Types of biospecimens • Specialized collection techniques • Local or central processing • Storage and analytic needs

  7. Million Veteran Program (MVP): A Partnership with Veterans Million Veteran Program: A Partnership With Veterans

  8. Million Veteran Program • MVP is a major research initiative that will create a longitudinal cohort of one million users of the VA Healthcare System to study genes and health • Designed to provide a better understanding of how genes affect health and illness • Goal of improving health care for Veterans and the nation

  9. MVP Background • 2006 – Genomic Medicine Program (GMP) • Genomic Medicine Advisory Panel comprised of private and public health, scientific, legal experts in field of genetics was established by the Secretary • 2007 to 2008 – Consultation project to assess veterans’ knowledge and attitudes about genomic medicine • Kathy Hudson, Genetics in Medicine; May 2008 • Study 931 participants • 83% said program should be developed; • 71% said they would participate

  10. Genomic Medicine Protocol • 2009 – Protocol planning and development • Consent allows for open-ended access to medical records, VA and non-VA databases • HIPPA authorization for use of personal health information • Biospecimens (blood, tissues, salvia) stored for use in future studies any disease • Samples and information may be made available to VA and other researcher • Approved by VA oversight committees • Participants may be re-contacted in the future • Participation in new research studies

  11. MVP Protocol • 2010 –Protocol approved by VA Central IRB • Enroll one million veterans over 5 to 7 years • Centralized recruitment • Study visits at VA Medical Centers • In person informed consent and HIPPA authorization • Baseline questionnaire • Blood sample -10ml ETDA tube • Optional lifestyle questionnaire • Information Security • Unique codes to identify data and specimen • GenISIS computing environment

  12. Sample Processing

  13. Automated Blood Fractionation

  14. Automated DNA Extraction • High-throughput DNA Extraction

  15. Freezer Space Current freezer storage

  16. Additional Freezer Space Future freezer storage

  17. MVP Governance and Oversight • Genomic Medicine Advisory Panel • VA Central IRB • Genomic Cooperative Studies Scientific Evaluation Committee • VA Genomic Medicine Program • MVP Executive Committee

  18. Summary • The Million Veteran Program is a major, new research initiative to create one of the largest databases of genomic, military exposure, lifestyle and health information • Collaborative effort of the VA research and clinical infrastructure • Iterative process to assure participation nationally, optimize processes for recruitment, data/specimen collection storage access and analysis • Ultimate goal of integration of the emerging genomic technologies in to the clinical healthcare system

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