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1 Solution Architecture Overview Submission Management 1

2 Submission Management Overview Sources of Record MDM Manually Captured Lifecycle Events PLM Repository Data Domain Objects supporting Submission Process *Only* Patent Approval Lifecycle Events Product Supplier Submission Object Submission Components Defect Management Causal Factor Analysis Plant Information Plant Equipment Inventory Pre-Submission Submission Post-Submission Document Collection Document Review Deficiencies (Types 1, 2, 3) Responses / Amendments Continuous Improvement Organization Clock FDA Clock

3 Pre-Submission Overview Currently, this content is captured through a variety of means in a document-centric manner. All docs are iterated and placed into Documentum. Traceability between content (docs) is done manually and via limited automation within Documentum. All activities associated with the presubmission activities need to be captured in Documentum or in a change management tool for lifecycle reporting (event management). All defects associated with these processes need to be captured in Documentum or in a separate Defect Management Tool for consolidated tracking (must capture causality & resolution for each defect). Commodity Requirements Drug Product Test Mfg. Technical Notes Stability Document Collection Formulation Drug Substance Test Method Pre-Submission Document Review Drug Product Test Method Drug Substance Safety / Hazardous Classification Method Validation 3

4 Sources of Record MyPortfolio Documentum Spreadsheets SAP (NA instance) LIMS Lorenz Submission Content (DMF & CTD) Defect Management (includes Deficiencies) Product Lifecycle Event Management Events Content Traceability Causality (WHY) Quality (for submissions) Regulatory Tools FDA s Panorama Manually Captured Lifecycle Events MDM 4

5 MDM Overview Manually Captured Lifecycle Events Sources of Record MDM MDM Repository PLM Repository Data Domain Objects supporting Submission Process *Only* Patent Approval Lifecycle Events Product Supplier Submission Object Submission Components Defect Management Causal Factor Analysis Plant Information Plant Equipment Inventory golden record for all mastered data within each Data Domain Data Acquisition - Connects to all sources - pulls in data based on schedule or pre-defined triggers. Data Mastering & Data Extraction & Search Warehousing - Access to the MDM Repository can be - Matching, Transforming, provisioned by an automated push into Aligning, De-Duping, the PLM Repository or by pulls initiated - Staging golden records by the PLM via a service 5

6 Measures Model The measures need to address the WHAT, WHY (causality), WHEN, & WHO across the submission lifecycle (sub-portion of the PLM. Overall Goal: Submission First (first submission is right and requires little if any remediation) Measure Dimensions may include: Quality - of Submission throughout the lifecycle Responsiveness - of teams when deficiencies are found Effort - required to produce a single submission Scale ability to address gradual and/or peak volume Cost to capture, manage, remediate, and deliver Forecasting demand, delivery, revenues, & risks Impacts from changes (planned & unplanned) 6

7 High Level Overview & Estimates SOLUTION ARCHITECTURE 7

8 Solution Architecture Overview q At first glance, this appears to be nothing more than a need to collect a few data points and provide reporting. Upon further review (using an enterprise lens), the problem space is much larger. The potential impacts to the company s revenue stream is significant if the organization can t meet it s commitments for First to File while minimizing any chance for slippage. There are many factors that can impact the submission timeline, so the initial solution needs to be aware of the factor that can be controlled and those the need to be improved. q The following slides provide a bit more insight into the solution space and how we may want to approach both a short term solution while laying the foundation for a sustainable (and scalable) set of capabilities. 8

9 Solution Architecture Capabilities q Product Lifecycle Management q Event Management q Defect Management q Causal Factor Analysis q Predictive Failure Mode Analytics q Scenario Driven Impact Analysis q Data Acquisition q Data Quality q Data Lifecycle Management q Workflow q Content Management q Content Assembly q Orchestration (incl. scheduling) q Escalation Management q Regulatory / Matter Management q Data Security (CIA) q Data Warehousing q Measure Management 9

10 Solution Architecture (Conceptual View) 3 rd Party Mfg. Legal Global Procurement Event Mgmt. (Front End) Defect Mgmt. (Front End) Supply Chain Regulatory R&D MDM (Acquisition Hub) Events Mgmt. Defect Mgmt. Submissio n Mgmt. SAP (Analytics Dashboard) Quality Finance Metadata (Domains) FDA s Panorama Metadata (Context) 10

11 Solution Architecture (WBS snapshot) Note: This is not a work plan as dependencies & opportunities for parallel activities are not identified. 11

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