October 12, 2014

Pharma of the Future Historical Timeline

Year MilestoneActivity Deliverable
1997Collaboration 1.0Developed software to help scientists organize data, analysis programs, graphics, and text, into one electronic documentPERSPECTIVE Hypertext Data Analysis Mapping software released
1999Real Time PK and PD Data Assembly Services initiatedIdentified critical information required to deliver timely and accurate analysis-ready datasets for M&S effortsFormal policies and procedures for receiving treatment codes and working with clinical trial data during study execution before database lock
2001Installed NONMEM Grid EngineMoved from desktop installations to fully automated grid engine for managing computationsSavings in time required to manage modeling and simulation activities on the grid
2002NONMEM moves to the cloudDeveloped validated web interface for NONMEM to facilitate model development for academic institutions First generation PANDA software released
2003Pharma of the Future initiative beginsInvestigated the Factory of the Future program and its implications for Pharma R&DStandardized the M&S workflow 
2004Cognigen becomes a laboratoryImplemented research and training initiatives to reduce flow times, improve quality and consistency of work productsDefinition of systematic, process,  and informatic needs of M&S activities
2005M&S process formalizationIdentified the primary tasks, defined the critical inputs, and standardized the outputsCompany-wide standards for M&S project execution. 
2006Refined Data Assembly process workflowDefined the tasks, procedures, and interactions for building an analysis-ready dataset “Guide to NONMEM® Dataset Creation” training manual published for Cognigen data programmers 
2006Knowledge Portals implemented Secure, virtual private networks establish for client communications and data transfers
2007Data assembly process improvementImplemented continuous process improvement techniques and forensic tools to identify root causes of rework in data assemblyReduce time required to deliver high quality analysis-ready datasets with less errors
2008Graph Library establishedAnalyzed commonly-used graphs to identify critical elements required to produce graphs more efficientlyProvide the right graphs at the right time, with the right information, to tell the story of the data analysis effort
2009Focus on Integrated Project TeamsInvestigated strategies to more fully engage interdisciplinary teams in model definition and use of M&S resultsUse of conceptual schemas as a blueprint for model development
2010Forensic PharmacometricsDeveloped a systematic approach to independent peer review of model efforts and reportsPre-submission reviews of regulatory documentation and reports 
2011PANDA grows upRedeveloped PANDA to provide a model development platform for global teamsFirst enterprise license for KIWI software sold to global pharmaceutical company
2012Progressive Reporting StrategyInvestigated knowledge threads across M&S project execution life-cycleCanonical document library: project justification and resource allocation, analysis plans, and technical reports
2012Scientific Workflows Refined workflow structure and requirements for common analysis activitiesFormalized workflow definitions for logistic regression and time to event analyses
2013Cognigen move to new headquartersUpgraded computer systems, automated off-site backup storage, installed green technology to reduce computer cooling costsFully validated, secure IT infrastructure and business continuance strategy
2014The Paradox of Scientific ExcellenceInvestigated enterprise barriers to innovation and the source of silo-thinking Model-based framework for fostering interdisciplinary collaboration
2014Data Assembly Automation InitiativeCreated code library and programming templates and developed enhanced data definition documentationData assembly process formalization and automation modules
2015+The Pursuit of Excellence in model-driven R&D beginsInvestigating strategies for using mechanistic models as a basis for accelerating scientific innovations to improve R&D productivityWait and see…



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Pharma of the Future Historical Timeline

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