Genetic Alliance BioBank: A Virtual Tour of Registry Solutions to Accelerate Research February 22, 2010

Transcription

1 Genetic Alliance BioBank: A Virtual Tour of Registry Solutions to Accelerate Research February 22, 2010 Liz Horn Genetic Alliance Posted in the Resource Repository at: urofregistrysolutionstoaccelerateresearch/

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3 Our Vision We revolutionize access to information and resources to enable translation of research into services

4 Our Product We provide registry and biorepository solutions for advocacy organizations to catalyze research for treatments

5 Our Process Coop model allowing an extensible, interoperative, cost sharing model

6 Founded: October 14, 2003 BioBank Advisory Committee Sharon F. Terry, President & CEO, Genetic Alliance and PXE International Liz Horn, PhD, MBI, Director, Genetic Alliance BioBank Claire Driscoll, MS, National Human Genome Research Institute, NIH Owen Johnson, CEO, Inflammatory Breast Cancer Research Foundation Joan Scott, MS, Genetics and Public Policy Center Patrick F. Terry, PXE International, Genomic Health and Technic Solutions

7 Landscape Analysis and Needs Assessment 1994! 2000! 2006! 2009!

8 Disease Specific Organization! Data and Sample Management! Clinical Information Biological Samples Patient Enrollment! Disease! Sample and Clinical! Banking! Web based! Need a Registry Foundation (NRF) Boot camps Manuals Workbooks Wikis Webinars Informed Consent Robust Clinical Information Sample Collection & Tracking Data and Sample Query Data Management Electronic & Paper Records Security & Access Control

9 Phased Development Phase I = Biological Sample Repository = Launched October 2003! Phase II = Clinical Data Repository = Launched November 2006! Phase III = Online web questionnaire = Launched February 2008! Phase IV = Interoperability with dbgap = Launched March 2009! Phase V = Data management for natural history studies and clinical trials = Launched June 2009! Phase V = Dynamic private access directives and consent = Will launch March 2010!

10 GA BioBank - a Cooperative Research Consortium The Advisory Board, representing the organizational members, configures the best possible infrastructure, continually updating solutions as science and technology improve Members bring passion, skills and resources to the collective Members leverage collective resources, and as membership increases, more services are possible Members enable cross-disease research and maintain control of their collection

11 GA BioBank Members Receive Training/mentoring by experts in registries and biobanking Templates for all necessary documents and protocols to develop a BioBank IRB review of all documents & protocols Clinical data collection system with customizable, web-based interface for donor data entry Biological sample collection, processing, archiving, and distribution systems Web-applications for data and sample management Availability of multiple other genomic services

12 Central Core and Modules Registry TRIMS Biorepository Gene Logic Cell lines Rutgers Dynamic consenting, clinical trials recruitment, medical record management Private Access Data mining and analysis - Genesis

13 Modules Demonstrated Action request system web portal to enter donors, request and manage kits, and accession donors into TRIMS Clinical questionnaire admin system web portal to create and manage users, request users to complete questionnaires, and review questionnaires prior to data transfer to TRIMS Clinical questionnaire interface - web portal where donors complete clinical questionnaire TRIMS database where data, records, and sample info is stored Genesis data mining software

14 Example Successes The gene discovery for PXE and CFC have both come about as a result of GABB BioBanks. PXE has also licensed the diagnostic and proceeded to genomic, biochemical studies and clinical. Psoriasis Foundation has received NIH Challenge Grant to genotype BioBank samples. HAE Association uses it for adverse drug reporting in FDA approval.

15 Tools and Training Registry and Repository Boot Camp, January 10 Boot Camp documents in resourcerepository.org - search for boot camp BioBank Discussion Listserv - created to discuss issues surrounding registries and biorepositories - contact Liz Horn, lhorn@geneticalliance.org, to join

16 Becoming a Member of the GA BioBank Potential members complete an application to membership designed to ensure organizational health and support when entering this co-op model The application is reviewed and approved by a committee of the BioBank Board For more information, contact Liz Horn

17 Seldom is it that ordinary people like myself get to participate at any level in extraordinary events. I see donating blood to the BioBank as one of those events. ---Genetic Alliance BioBank Participant