Informatics SIG Document on Treating Analytical Data Disease
•Transferir como PPTX, PDF•
0 gostou•393 visualizações
The Allotrope Foundation led discussion on building an open framework for laboratory data - recommending a holistic approach to build upon & promote industry standards & best practices by providing software that instantiates them.
Recomendados
Mais conteúdo relacionado
Destaque
Destaque (20)
Semelhante a Informatics SIG Document on Treating Analytical Data Disease
Semelhante a Informatics SIG Document on Treating Analytical Data Disease (20)
Mais de SLAS (Society for Laboratory Automation and Screening)
Mais de SLAS (Society for Laboratory Automation and Screening) (7)
Informatics SIG Document on Treating Analytical Data Disease
- 1. Informatics Special Interest Group web: www.allotrope.org Jan-2013 mail: info@allotrope.org
- 2. We pay scientists to do what?!?! At work… At home… • we manually • computers give us compile and write button- static reports click, interactive, drill – candidate selection documents -down reports – internal technical reports – certificates of analysis – stability reports – specifications – release documents – IQ, OQ, PQ, PM – IND, NDA, MAA – et cetera Confidential Allotrope Foundation Internal Brief 2
- 3. Imagine a day when... Document Data Preparation Exchange Method / Data Transfer Confidential Allotrope Foundation Internal Brief 3
- 4. 7 symptoms at every company Document Data Data Errors Preparation Exchange Data Regulatory Innovation Management Compliance Constrained Data Silos • Costs affect nearly every person, department, and process in every company in our industry • Downstream effects go well beyond the traditional “analytical laboratory” Confidential Allotrope Foundation Internal Brief 4
- 5. Treat the disease… Document Data Data Errors Preparation Exchange Data Regulatory Innovation Management Compliance Constrained Symptoms Data Silos Disease Pathology Confidential Allotrope Foundation Internal Brief 5
- 6. The Framework treats the disease… Automated Eliminate Fast Data Documents Data Errors Exchange Better Data Regulatory Innovative Management Compliance Ecosystem Eliminate Data Silos Confidential Allotrope Foundation Internal Brief 6
- 7. How the Framework treats the disease… • Eliminates or •Class Libraries, SDK, web service attenuates cost of 7 •Compatible software symptoms • Lowers barriers to adoption • Scientists focus on science • Consistency across all platforms, department • Common data s, partners formats facilitate • Massive data mining & data exchange & knowledge innovation management opportunities Not a standards initiative, a holistic approach to instantiate them, imbed in software Confidential Allotrope Foundation Internal Brief 7
- 8. Simplify: one model for all analytical data supports hundreds of analytical Workflows in CMC, Discovery Confidential Allotrope Foundation Internal Brief 8
- 9. Current Scope: Analytical Chemistry for Our Industry Functional areas in CMC, Discovery • Drug substance, drug product release, stability • Compound registration • Development understanding • Process chemistry monitoring Analytical chemistry • Small molecules • Biopharmaceuticals Out of scope of current project • Gene expression, bio-assays, microarray, clinical data Confidential Allotrope Foundation Internal Brief 9
- 10. Real Deliverables Emergent Outcomes Not a ‘Standards Body”; A holistic approach to build upon & promote industry standards & best practices, by providing software that instantiates them software development starts this summer Confidential Allotrope Foundation Internal Brief
- 11. The elephant in the room • Every company spends lots of money and FTE resource treating or living with the symptoms… • The moment has arrived for the industry to embrace a pre- competitive approach to treat the underlying disease • Software development starts this summer, join us now to help shape the solution Document Data Data Errors Preparation Exchange Data Regulatory Innovation Management Compliance Constrained Data Silos
- 12. Why become a member of Allotrope Foundation? • Members of Allotrope Foundation can benefit from the opportunities beyond the use of the final deliverables. – In-depth understanding of the needs relating to the collection, formatting and transmittal of data; – “Members Only” solutions, early access to deliverables, including tools for data conversion from proprietary to open formats • Most importantly, participating in the Foundation will help ensure that the project has sufficient resources and substantive support to succeed. Confidential Allotrope Foundation Internal Brief 12
- 13. “If you want to go fast, go alone. If you want to go far, go together.” – African proverb Join us To join or learn more contact: Svetlana Lyapustina, Ph.D. Senior Science Advisor| Drinker Biddle & Reath LLP +1-202-230-5179 info@allotrope.org Svetlana.Lyapustina@dbr.com Confidential Allotrope Foundation Internal Brief 13
- 14. References – James M. Roberts, Mark F. Bean, Steve R. Cole, William K. Young, Helen E. Weston, Informatics in the Analytical Laboratory: Vision for a New Decade, American Pharmaceutical Review, September/October 2010. – James M. Roberts, Mark F. Bean, Chris Bizon, John C. Hollerton, William K. Young, The Adaptable Laboratory: A Holistic Informatics Architecture, American Pharmaceutical Review, January/February 2011. Confidential Allotrope Foundation Internal Brief 14
Notas do Editor
- Without adoption, a data standard alone is an abstract, esoteric idea that cannot alone create change. What’s required is a more holistic approach, a “framework” including information standards for experimental data, the meta-data associated with those data and their associated workflows, and a toolkit that enables the instrument & soft-ware providers to integrate the standards into their platforms The Framework will consist of 3 interacting components: Open document standards based on XML, JSON or other formats that support structured data. Open metadata repositories containing dictionaries to provide accurate metadata input into laboratory systems Open source class libraries and web services that will produce and consume content from components 1 & 2 above.
- This slide depicts the overall laboratory process decomposed into a chronological sequence of events, starting from left to right, that take place during the analysis of every sample in the laboratory, regardless of analytical technique, purpose, or complexity of the test or experiment. The logical model of the analytical laboratory process is that of a sequence of “unit processes” that are executed sequentially and in order (purple boxes). A “unit process”, in this context, performs a function that accepts well-defined pre-requisite input, required for its function, and produces at a minimum the output required for input into the adjacent unit process. Each unit process serves a single purpose in the chain of events that comprise the whole process (starting from the left, moving right). Unit processes (purple boxes) begin on the left with “Plan Analysis” and proceed sequentially to “Report Results”. Dashed lines represent optional unit processes. Red boxes represent the information (data and metadata) that must be captured before the next downstream unit process can be completed. Orange boxes represent actions that operate on the information represented by the red boxes. Wrapping the entire process is a “Document Experiment” capability that must be carried out to document the experiment.
- To drive and focus the development process, a novel, proof-of-concept (PoC) application will be built using the Framework. As a primary objective, the PoC Application will be designed to demonstrate the power and advantages of using the Framework. Additionally, the PoC Application will be an essential component of a real-world test bed that will be used to test and optimize the usability of the Framework during its development.