JANUARY 9, 2010
Executive Summary

Contact: Sharon F. Terry, President
Email: sterry@geneticalliance.org
Phone: 202.966.5557 x201
http://www.gabiobank.org/

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Executive Summary

The Genetic Alliance BioBank, a centralized, registry and sample repository that enables translational genomic research, was founded in 2003 by leaders in the disease research advocacy field. It was based on a proof of concept, single condition bank that has operated with excellent outcomes since 1995. It operates as a cooperative venture, extensible and responsive to the needs of the nonprofits engaged in the endeavor. The BioBank provides infrastructure for disease advocacy organizations to pursue sophisticated, novel research collaborations with academia and industry to develop new diagnostics and therapeutics to better understand and treat disease.

Our Vision: We revolutionize access to information and resources to enable translation of research into services while empowering participants to make informed decisions.

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

The BioBank performs the following key functions:

• Provides clinical data collection system with customizable, web-based interface for participant data entry. Controlled SNOMED vocabulary and minimum data sets provide enhanced data mining opportunities.
• Provides web-applications for ease of sample and data management by the member advocacy organization.
• Provides state-of-the-art storage facility and systems for collection, processing, archiving and distributing biological samples. Offers a la cart genetic and genomic analysis.
• Provides training and mentoring to disease advocacy organizations by experts in BioBanking¹ and templates for all necessary documents and protocols.
• Provides tools for disease advocacy organizations to recruit participants to the BioBank, using state-of-the art methods that emphasize trust, privacy protections, data security, empowerment of participants and the member advocacy groups, and ongoing education.²
• Provides a robust and dynamic process for informed donor decision-making, leading to truly informed consent, tailored to specific uses of the samples and related information.
• Provides a robust data mining system for querying and visualizing donor statistics and samples for cohort development.
• Facilitates collaboration between advocacy organization, academic, government and industry partners.³

The BioBank is governed by representatives of the participating disease advocacy organizations and experienced outside directors from a variety of disciplines. At present, seven foundations participate in this cooperative research consortium, banking more than 10,000 samples and thousands of clinical records. The BioBank collects, stores and distributes samples in accordance with the procedures and specifications determined by the Genetic Alliance BioBank´s Advisory Committee and approved by the Genetic Alliance BioBank´s Institutional Review Board, exceeding the requirements of all applicable federal, state and local laws, rules and regulations. The BioBank has received a Certificate of Confidentiality from the National Institutes of Health. The Genetic Alliance Board of Directors oversees the fiscal management and annual audit.

Selected Achievements:

• Gene discoveries for PXE^5-8 and CFC⁹
• PXE licensed a diagnostic¹⁰ and is proceeding to genomic and chemical studies
• National Psoriasis Foundation Challenge Grant Award
• HAEA to use infrastructure for adverse event reporting to FDA

The BioBank develops solutions for disease advocacy organizations to catalyze research⁴ in an efficient and accelerated manner, ultimately bringing therapies for genetic diseases closer to realization and creating a new research paradigm.

Genetic Alliance BioBank is a program of Genetic Alliance. For more information, visit www.biobank.org.

Genetic Alliance BioBank Advisory Board
Sharon F. Terry, MA, President, Genetic Alliance and PXE International
Liz Horn, PhD, MBI, Director, Genetic Alliance BioBank
Owen Johnson, CEO, Inflammatory Breast Cancer Research Foundation
Joan Scott, MS, Genetics and Public Policy Center
Patrick F. Terry, PXE International and Technic Solutions

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Image via Wikipedia

One of the better-kept secrets about the massive clinical research hospital at the National Institutes of Health (NIH) in Bethesda, Md., has been tucked away for half a century in Wing D of a building that dates to 1953. That is about to change.

The Pharmaceutical Development Section (PDS) is a corps of 20 chemists, pharmacists, pharmacokineticists and technicians who make investigational agents for many of the 1,500 clinical research studies running at any given moment at the NIH's Clinical Center. It is not a drug-discovery group, but rather a team of experts who churn out custom-made pills, vaccines, intravenous drugs and capsules, and even ointments and creams, for NIH investigators when the investigational agents they need aren't available.

Twenty-first century technology and government-mandated manufacturing standards have outpaced the equipment and capacities of the group's old, 743-square-metre workspace. But, if all goes according to schedule, in early June it will move seamlessly into a new, $12-million, 1,115-square-meter drug-making facility--a warren of rooms seven years in the planning that is tailor-made for the group's purposes.

The PDS's new digs are a reservoir of state-of-the-art machinery and minus 80 ºC freezers; high-efficiency particulate-absorbing filters populate the ceiling; and highly purified watercirculates through stainless-steel pipes that cost over $1,000 per meter. There are meticulous controls on air temperature, humidity and pressure. The facility's layout and structural materials are geared to maximum cleanliness--right down to the easily-scoured, porous epoxy floors."

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