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Slide 1: Transforming Technology Transfer and Recipe Management From Spreadsheets to Standardized Practices Paul Wlodarczyk, VP Solutions Consulting, JustSystems DocTrain Life Sciences 24 June 2008 ©2008 JustSystems Dynamic Information Now for Everyone
Slide 2: Business Imperative: Top Three Life Science Innovation Goals for 2012 1. 2. 3. Leverage scientific/ technological advances to assure superior therapeutic outcomes in their target patient population. Improve acquisitions/ alliance / licensing management processes to improve agility in bringing new products to market. Decrease the concept-to-patient lifecycle from the current 711 years to 5-7 years Survey respondents estimated 19% growth in Demand Supply spending on technology to support R&D in 2012; this is slightly higher among branded and generics with estimated growth of 23%. Product Mid-market Life Sciences companies also plan for more aggressive growth than their larger counterparts, they plan to increase their spending by nearly 30%. Source: AMR Research 2007 Life Sciences Survey ©2008 JustSystems Dynamic Information Now for Everyone 2
Slide 3: Product Life Cycle Users Project Operations Early Development Lab Scale Late Development Pilot Scale Commercial Commercial Scale Project Management PLM Development Management Electronic Lab Notebooks Tech Transfer Scientists Chemists Biologists Pharmacists Engineers Technicians Operators ERP MES Experiments Process Unit Procedures Process Definition Clinical I Clinical II Clinical III Support Analytical Quality Demand Supply LIMS / SDMS QMS / CAPA Product Source: Mike Power, BearingPoint Dynamic Information Now for Everyone 3 ©2008 JustSystems
Slide 4: Business Processes Impacting Time-to-Market: Early Stage Product and Process Innovation Early Stage Product and Process Development: Lab to Bench Scale Pilot Process Requirements • Meets cGMP? • Safe? • Commercially viable? Knowledge of Chemistry, Microbiology, Physics Knowledge of Future Manufacturing Environment Manage Process Knowledge Discovery common information models Rapid Iterations Demand Supply Product • Result = foundation of process knowledge • Goal = predict manufacturing performance under commercial operating conditions Dynamic Information Now for Everyone Manage Process Knowledge Creation Source: Alison Smith, AMR Research 4 ©2008 JustSystems
Slide 5: Business Processes Impacting Time-to-Market: Late Stage Process Development through Ramp to Commercial Manufacturing Opportunity! 12 – 36 mos. Pilot to Scale Up for Commercial Production Foundation of preliminary process knowledge Process Improvements • Improves yield? • Reduces variability? • Commercially viable? Experience in Existing Manufacturing Environment common information models Continuous Improvements / Refinements within Design Space Manage Process Knowledge Sharing Demand Supply Product Manage Process Knowledge Retention Dynamic Information Now for Everyone Manage Applying Process Knowledge Source: Alison Smith, AMR Research ©2008 JustSystems 5
Slide 6: “Master Data”: Coordination Points for Manufacturing include both Product and Process Opportunity to use ISA-88 recipe as the common information model for process definitions? Product Product Design/Formulation Order Acquisition & Management Sourcing & Procurement Demand E-Commerce Marketing Collateral Service Docs Data Sync Package Design/ Label Claims co m Process Engineering m Planning (mBOM, Routing) Supply Chain on Process Specifications in f or Maintenance Plans Recipe Management io of Materials Bill n m Bill of Equipment od el SOPs s m at Supply Bill of Compliance/ CoA Bill of Test Asset Maintenance Detailed Routing 6 Bill of Process Asset Performance Management ©2008 JustSystems Dynamic Information Now for Everyone
Slide 7: ISA-88 Operations Ice Cream Recipe Example The Blend Ingredients Operation eight phases associated with blending ingredients. Note there is no rule on running only one phase at a time. In fact, it is very common for multiple phases to be running simultaneously. Recipe represented in an industry standard ISA-88 SFC (sequential function chart) ©2008 JustSystems Dynamic Information Now for Everyone 7
Slide 8: A Solution for Faster Time to Market Development Process Library Common Steps & Actions Commercial Process Library Common Steps & Actions • Process Definition Management • Define all recipes in a common information model • Build a library of Reusable Manufacturing Actions • Assemble new Recipes from components in library Execution Systems Operator Instructions • Benefits: Submission Ready Components Contract Manufacturing Structured Data Sources • Standardize on Good Manufacturing Practices • Feedback loop from Manufacturing to Development • Improved technology transfer • Process Knowledge Management • Bottom line: Quality by Design, Faster time to market ©2008 JustSystems Dynamic Information Now for Everyone 8
Slide 9: Key Use Cases in Process Definition Management 1. Create Reusable Manufacturing Actions (RMAs) 2. Author Process Definitions (“Recipes”) 3. Document Process Parameters 4. Transfer Technology 5. Manage Knowledge Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge ©2008 JustSystems Dynamic Information Now for Everyone 9
Slide 10: Create Reusable Manufacturing Actions • Challenges: • Process Definition Management requires reuse of codified content (RMAs or recipe building blocks) • No best practice for representing recipes and RMAs outside of manufacturing • No method for implementing reuse Impacts: Benefits of recipe normalization are not achieved during Discovery and Clinical phases of lifecycle – time and money left on the table Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge ©2008 JustSystems Dynamic Information Now for Everyone 10
Slide 11: Author Process Definitions (“Recipes”) • Challenges: • No practice for representing process definitions outside of Batch Control (where ISA-88 is the standard) • No “purpose-built” tools – just spreadsheets and flowcharts • Automation requires custom development • Parameters and flows managed as large documents Impacts: Low authoring productivity. Authoring recipes takes months. Difficult to track changes at an elemental level. No audit trail Automation requires software development and maintenance Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge ©2008 JustSystems Dynamic Information Now for Everyone 11
Slide 12: Document Process Parameters • Challenges: • • • • Parameters authored separately from process flows Spreadsheets are the current best practice – but are 1000s of rows long No way to link to or standardize “Bills of X” No established best practice for regulatory reporting of CTQ / KTQs Impacts: Low authoring productivity, no way to track/maintain parameters No element-level change management or audit trail Disconnected from systems of record Difficulty supporting Quality by Design Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge ©2008 JustSystems Dynamic Information Now for Everyone 12
Slide 13: Technology Transfer • Challenges: • Process definitions are represented in human-readable documents, not available as data • Recipes need to be manually entered into Batch Control and execution systems Impact: Ineffective and inefficient technology transfer Quality Yield Cycle time Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge ©2008 JustSystems Dynamic Information Now for Everyone 13
Slide 14: Process Knowledge Management • Challenges: • Document-based approaches to recipe representation • Discovery requires full-text keyword search Impacts: Barriers to information discovery and knowledge sharing Sharing of Good Manufacturing Practices is manual, uneven – lost productivity, gains are not repeatable No common method of representing “manufacturing process IP” No mechanism for IP management Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge ©2008 JustSystems Dynamic Information Now for Everyone 14
Slide 15: What is the Recipe for Addressing these Issues? • Create a purpose-built process definition editor • Make documents “componentized” • Enable valuable content to be extracted and reused from recipes (for knowledge management, RMA, etc.) • Use SFC flowcharts as the means for navigating and accessing the process parameters • Make recipes “machine readable” ©2008 JustSystems Dynamic Information Now for Everyone 15
Slide 16: Solution: xfy Process Definition • ANSI/ISA 88 for standard look and feel for the “flowchart” user experience Click on flowchart elements to define critical parameters in forms-based dialogs BatchML for data representation Purpose-built process definition editor supports key use cases • • • Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge ©2008 JustSystems Dynamic Information Now for Everyone 16
Slide 17: What is ISA-88 (“S88”)? • Standard for: • Graphical representation of batch manufacturing processes • Data representation • • Three models: physical, process, and control Widely adopted in Batch Control and MES systems, so familiar to process engineers Impact: Easy to use notation Standardizes the representation of recipes upstream of manufacturing steps in the lifecycle ©2008 JustSystems Dynamic Information Now for Everyone 17
Slide 18: What is BatchML? • • • Standard maintained by the World Batch Forum for XML representation of data for all three ISA-88 models Machine readable – supports transfer of ISA-88 data between systems As an XML format, can be “rendered” to humanreadable forms (e.g. a user interface or documents or both) Impact: Captures all ISA-88 data including flows and parameters in a single format Can be rendered to GUI as ISA-88, trees, forms; or to documents including eCTD for submissions, batch records, etc. Provides a mechanism for content reuse – Recipe Building Blocks – which is critical to recipe normalization Solves the technology transfer problem ©2008 JustSystems Dynamic Information Now for Everyone 18
Slide 19: The xfy Process Definition Solution Double-click on BatchML storage of recipes and recipe building blocks shapes to drill down, add process parameters ISA-88 Editor for visual editing and navigation of Process Definitions Drawing palettes for ISA-88 shapes and reusable components Dynamic Information Now for Everyone 19 ©2008 JustSystems
Slide 20: Product Life Cycle Users Project Operations Early Development Lab Scale Late Development Commercial Process definitions transformed Commercial Scale into ISA-88 control recipes in MES or Batch Control System Manufacturing knowledge Scale Pilot transferred to development Project of reusable through library Management process actions PLM Scientists Chemists Biologists Pharmacists Engineers Technicians Operators Development Management Electronic Lab Notebooks 6 1 3 Experiments Process Unit Procedures 2 Clinical I Process Definition Clinical II Clinical III Tech Transfer ERP MES 4 5 Support Analytical Process definition tools Quality facilitate early process development Process definitions refined, tech transfer at every point of scale LIMS / SDMS ISA-88 recipesQMS / CAPA used for Tech transfer improved Description of Manufacturing through machine-readable Process & Process Controls BatchML (section 3.2.S.2.2) of CTD. Source: Mike Power, BearingPoint 20 ©2008 JustSystems Dynamic Information Now for Everyone
Slide 21: xfy Process Definition Editor Key Benefits • More rapidly create, edit, visualize, reuse data in recipes • Create / capture / reuse process knowledge • Facilitate Quality by Design • Improve CTD submissions • Improve technology transfer • Collaborate with CMOs • Accelerate time-to-market ©2008 JustSystems Dynamic Information Now for Everyone 21
Slide 22: JustSystems • Global Presence • 1,000 employees, FY ‘07 revenues of $110M • HQ in Japan, offices in North America (NJ, Vancouver) and Europe (London) 2,500 Customers, Marquee Brands • Our Experience • Established in 1979 • Market leader with over 2,500 customers • Our Expertise • Global provider of desktop productivity, information management, consumer & enterprise software • Framework for XML-based content creation, integration, visualization and delivery • Our Financial Strength • Established and growing company ©2008 JustSystems Dynamic Information Now for Everyone 22
Slide 23: For more information • Visit our website: • http://na.justsystems.com/lifesciences • Email us: • Sales@JustSystems.com • Call us: • (866) 793-1542 ©2008 JustSystems Dynamic Information Now for Everyone 23