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SLAS Informatics SIG: SLAS2013 Presentation

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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.

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SLAS Informatics SIG: SLAS2013 Presentation

  1. 1. Informatics Special Interest Groupweb: www.allotrope.org Jan-2013mail: info@allotrope.org
  2. 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. 3. Imagine a day when... Document DataPreparation Exchange Method / Data Transfer Confidential Allotrope Foundation Internal Brief 3
  4. 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. 5. Treat the disease… Document Data Data Errors Preparation Exchange Data Regulatory Innovation Management Compliance ConstrainedSymptoms Data SilosDiseasePathology Confidential Allotrope Foundation Internal Brief 5
  6. 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. 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. 8. Simplify: one model for all analytical data supports hundreds of analytical Workflows in CMC, Discovery Confidential Allotrope Foundation Internal Brief 8
  9. 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. 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. 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. 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. 13. “If you want to go fast, go alone.If you want to go far, go together.” – African proverbJoin usTo 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. 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

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