Biorepository presentation - Boston VA Research Institute, Inc.

Report
The Veterans Affairs Central
Biorepository and MVP Highlights
Mary T. Brophy, MD, MPH
3rd 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
“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
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
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
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
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Types of biospecimens
Specialized collection techniques
Local or central processing
Storage and analytic needs
Million Veteran Program (MVP):
A Partnership with Veterans
Million Veteran Program:
A Partnership With Veterans
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
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
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
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
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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
Sample Processing
Automated Blood Fractionation
Automated DNA Extraction
• High-throughput DNA Extraction
Freezer Space
Current freezer storage
Additional Freezer Space
Future freezer storage
MVP Governance and Oversight
• Genomic Medicine Advisory Panel
• VA Central IRB
• Genomic Cooperative Studies Scientific
Evaluation Committee
• VA Genomic Medicine Program
• MVP Executive Committee
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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