laboratory informatics
The route to platform independence Allotrope Foundation’s strategy is to take a vendor-agnostic approach to the design of a holistic ‘framework’ for laboratory data. To take on the task of implementing this solution, Allotrope Foundation hired Osthus, a soſtware services firm known internationally for its systems integration expertise. Soon thereaſter, the Allotrope Framework went from an ambitious aspiration to a reality. Following extensive evaluation of technologies and standards, and proof-of-concept work with Allotrope Subject Matter Experts (SMEs), the Osthus team brought forward a design focused on the data itself – creating a unified, common data representation that can handle output from any laboratory instrument, and that is portable, allowing use by soſtware applications independently of those instruments. Te end result is an
advanced data structure called
the Allotrope Data Format (ADF). It features the ability to store machine-generated
datasets of unlimited size in a single file, organised as n-dimensional arrays to ensure that the details of the most complex data are recorded. Te ADF is capable of storing the metadata describing each test and measurement event as well. Te ADF
Allotrope Foundation. This impartiality places the Secretariat in the best position to manage the Foundation’s projects on a day-to-day basis; facilitate consensus-building among all participating members as well as between the Foundation and external stakeholders; enable steady progress; anonymise input when necessary; and ensure consistent applications of policies set by the Foundation. Throughout the Allotrope project,
the staff scientists within the Secretariat (Science Advisors) help prepare materials for Allotrope Foundation meetings, peer- reviewed publications and technical reports; establish and maintain the website, online collaborative tools and member directories; attend to minutes, agendas, and other record-keeping; publish internal and external newsletters; interact with external agencies on behalf of the Foundation; carry out requested
www.scientific-computing.com l
research; conduct confidential surveys and data gathering; construct and maintain databases; oversee collaborative development and joint testing. In addition, the Science Advisors along with DBR Regulatory Affairs professionals facilitate work on regulatory matters, which are crucial
LEGAL SERVICES ARE NEEDED TO ENSURE COMPLIANCE
for pharmaceutical/biotech and other industries subject to government regulation.
One of the critical needs of any
consortium is appropriate legal counsel. Legal services are needed to ensure compliance with national, international, federal, and local laws, covering issues ranging from antitrust compliance (intended to
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is portable, allowing easy file transfer and use across operating system and vendor platforms.
Simple and elegant Te Allotrope Framework itself is a soſtware toolkit that enables the manufacturers of analytical equipment and commercial soſtware vendors to render their machine output in the ADF. As more vendors adopt the ADF, the readily accessible and easily usable data generated by their soſtware will eliminate
FROM THE OUTSET, ALLOTROPE FOUNDATION HAS FOCUSED ON THE REALITY OF THE SCIENTIST’S DAY-TO-DAY WORK
much of the friction that exists in collaborative efforts by teams of scientists and the organisations they work with. Te Framework coupled with the ADF indeed presents several advantages over other integration techniques: l Broad data accessibility. Te ADF creates a comprehensive and extensible data representation, eliminating the need for specific vendor-to-vendor technology integration. Tat will make it easier to access and share the data output from any vendor’s equipment or soſtware.
prevent anticompetitive behaviour), to tax and privacy laws, to licensing and patents, to trademarking and copyright laws, and others. In the context of Allotrope Foundation, where the stakeholders include a wide range of entities (pharma/biotech companies, instrument and software vendors, regulators, other industries using analytical instrumentation, academic and non-profit research centres, etc.) and where the output (the Framework) is intended to be directly implementable in companies’ laboratories and vendors’ instruments, scrupulous attention to legal aspects throughout the development and implementation of the Framework is particularly important. Such counsel is provided by the Secretariat, increasing the overall efficiency in terms of time responsiveness and resource use, since the attorneys are integrated in the Secretariat team serving all aspects of the Foundation.
➤
In summary, Allotrope Foundation was formed to pool resources, expertise, and perspectives of various stakeholders. Engaging a neutral, experienced, multidisciplinary team such as the Secretariat was important to the Foundation from the very beginning from both a tactical and strategic point of view. Beyond providing the services and expertise described above, the Secretariat facilitated and supported the Foundation’s incubation within the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), helping to bring together like minded individuals, building consensus and ultimately achieving the critical mass to launch Allotrope Foundation.
l Svetlana Lyapustina, Terrence P. Tougas, and James M. Vergis are Science Advisors in Allotrope Foundation Secretariat
AUGUST/SEPTEMBER 2015 9
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