1. The Veterans Affairs Central Biorepository and MVP Highlights Mary T
The Veterans Affairs Central Biorepository and MVP Highlights Mary T. Brophy, MD, MPH 3rd Annual BVARI Business Meeting August 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: , 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:
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

13. Sample Processing

14. Automated Blood Fractionation

15. Automated DNA Extraction
High-throughput DNA Extraction

16. Current freezer storage
Freezer Space
Current freezer storage

17. Additional Freezer Space
Future freezer storage

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

20. 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