<Insert Picture Here>
Oracle Product Lifecycle Management (PLM)
for Pharmaceuticals Industry
Devendra Singh
Vice President Product Management
Agile PLM Solutions
Agenda
•Oracle Investment in Life Sciences
•Product Modules & Roadmap
Investing In Market Leaders
Oracle
A Systematic Acquisition Strategy… Acquires
BEA
Oracle
LS Acquisitions in 2009: Oracle becomes #1
Acquires with Best in
Agile Class:
Oracle Best in Middleware
Acquires Class:
Hyperion Product
Oracle Best in Lifecycle
Acquires Class: Mgmt
Stellent Analytics,
Oracle Best in Consumer
Acquires
Class: Insight
Oracle Demantra
Best in Class: Content
Acquires Mgmt
Siebel Demand
Best in Forecasting,
Class: Trade
Customer Optimization,
Relationship and S&OP
Management
Oracle Acquires IP Assets of Conformia
• Conformia products offer a comprehensive solution for pre-
clinical and clinical supply development as well as transfer to
commercialization
• Conformia products complement Oracle’s PLM functionality for
Pharma industry in packaging, enterprise quality & collaboration
• Combination creates unique single platform for the full PLM
process from drug development to commercialization
• Complements investments in Oracle Solutions for Clinical Trials
and Drug Safety solutions
• Key Conformia employees have joined Oracle
• Plan is to integrate Conformia IP into Agile PLM in CY 2010
Press Release: June 17, 2009: [Link]
Oracle Pharmaceutical Solutions
Customer Channels Sales & Marketing
Cust Portal Services Sales Marketing Trade Mgmt Sales Planning
Analytics CRM Clinical SCM HCM Financials
Development Mfg/SCM Clinical Dev Safety
Discovery Development
New Prod Development
Scientific Manufacturing
Computing New Prod Development Clinical Data
Quality Document Mgmt Management
Procurement Call Center
LIMS Quality Document
Packaging & Label Mgmt Mgmt
Asset Mgmt
Project Packaging & Label Mgmt Clinical Trials Adverse Event
Management Technology Transfer Reporting
Management
Design Formula & Recipe Logistics
Data Formula &
Experiments Recipe
Management
Aggregation Production/ Clinical Analysis
Product
Design Experiments Operation & Reporting
Process Dev Batch Mgmt Complaints
Data Mining Planning
Samples Corporate Administration
Management
CPM Financials Human Resources Facilities Management
Indirect Procurement Projects Compensation Helpdesk HR IT
Infrastructure
Oracle Analytics (e.g., Mobile Analytics, Delivers, Dashboards)
Hubs (Asset Hub, Product Hub) Universal Customer Master
ISV Partners
Integration Framework (e.g., BPEL)
Technology (e.g., Database, Application Server, RAC, Oblix, Time
sTen)
Drug Development Process
Research Early Development Late Development Commercial
Candidate Process Design & Tech Transfer
Discovery Clinical Supply Development
Process Optimization
Selection Development & Launch
Portfolio Planning and Resource Management
Active
Laboratory Pilot-Scale
Pharmaceutical Tech Transfer
Research Manufacturing
Ingredient
Large-Scale Full-Scale
Formulation Commercial
Clinical Trial
Development Manufacturing
Packaging, CROs / CMOs
CM&C
Labeling, Blinding, Collaborators
Submissions Distribution
Quality Assurance, Quality Control, and Process Validation
Oracle
Pharma PLM
Appr-
Pre-Clinical IND Phase 1 Phase 2 Phase 3 NDA
oval
Oracle Pharmaceutical PLM Solution
Comprehensive solution from Drug Development to Tech Transfer
Research Early Development Late Development Commercial
Product Management (PLM Solution)
Product Portfolio Management
ERP
Discovery Pre-Clinical Clinical Packaging & Label Mgmt
Packaging and
Tools Development Supply
DevelopmentLabel Packaging
Mgmt & labels specifications including
Design Experiments Formula , Recipesglobal variations regulatory control SCM
Lab Note Material Management and Equipment
Results tracking Management Technology Transfer
Book
Equipment Mgmt BOM and Bill of Central product record for all mfg and
QbD Substance
MES
ERP systems – “PLM-centric”
Enterprise Quality Management
LIMS
Product Record (eDR and eDHR)
Clinical Trial
Regulatory Submissions
Oracle Additional capabilities acquired through Conformia IP
25/10/23 acquisition, integrated in CY10
Agile PLM 9.3.1 RMW Launch
Product Record - Central Source of Truth
eDR: electronic Development Record
One location for all..
••Bills of Process
Bills of Process
••Bills of Material, Lots, Containers
Bills of Material, Lots, Containers
••Recipe Actions/Elements
Recipe Actions/Elements
••Experiments & Results
Experiments & Results
••Material Specification Plans
Material Specification Plans
••Bills of Equipment
Bills of Equipment
••Process Steps
Process Steps
••Campaigns
Campaigns
••Control Recipes
Control Recipes
••Work Requests
Work Requests
••Standard Operating Procedures
Standard Operating Procedures
••Actions, Outputs
Actions, Outputs
••Exceptions
Exceptions
•• Etc.
Etc.
Note: Screen shot is for illustration only. UI may be different in released product
Pre-Clinical & Clinical Supply Development
Full integration from Candidate to Commercial
Equipment Materials Recipe / Process
• Equipment definition and • Material definition and • Graphical recipe authoring
management management • Flexible recipe structure with
• Equipment Library • Material Library S-88 support for Technology
Transfer
• Equipment Qualification • Material Inventory Management
including qualification, allocation, • Re-useable recipe element
• Equipment Log disbursement, traceability templates for process
standardization
• Global Reservation of • Flexible specification of
Equipment materials using parameters • Integrated BOP, BOM, BOE,
BOA
• APIs for integration with • Integrated BOM management
master Equipment Systems • Deep support for Design of
• Change management (version,
Experiments
revision)
All fully integrated. 21CFR Part 11 compliant / e-signatures / workflows / alerts.
Non-GMP/GLP to Full GMP.
New Modules introduced with Agile PLM 9.3.1
Features Included in each module
Agile PLM Recipe and Material (RMW) Workspace
• Material and Equipment Management Module
• Material: Material Library, Inventory Management, Transactions
• Equipment :Equipment Library, Inventory Management, Transactions
• Standards :Library, Associations to Materials & Equipment
• Analytical & Environmental:
• Spec Plans, Parameters, Assays, Lot Release, CAS, Condition
• Platform Support
• Sites, Location, Roles, Users, Views, Attributes, Sub-views, Workflow, Alerts
• Recipe Management Module
• All of Material & Equipment Module plus
• Recipe library with actions, elements, variables
• Process
• Project, Campaign, Process Step, Control Recipe & Work Request
Launch Logistics
• E-delivery on September 16
• Press Release on September 20
• External communication cannot proceed until after Press Release
• Customer events planned post Press Release
• Internal / Partner Launch Webinars September 10, 14, 15, 16
• Recordings will be posted to Oracle University (OU)
• Brand new Demo environment developed
• Transfer of Information - TOI - (13 A9, 18 RMW) - OU / OPN
• APAC, EMEA, and North America Immersion Training in
October, focused on Pharma / RMW Training
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential
Demo Distribution
• Internal Oracle
• UPKs being developed for OOW, can be distributed quickly
• OOW Demo setup can be replicated for sales opportunities
• Merger of OOW Demo with standard Demo starting after OOW
• New VMs expected in October
• External (Partners)
• Establishing process to distribute UPK Demos
• Will distribute final Demo Database ASAP after completion
• Cannot distribute DDS VMs due to licensing and size (10-20 GB)
• Plan on installing A9 and Pharma, then loading Demo DBs
• Working with OPN for Partner Training VM
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential
931 Launch Webinar Series
• Day 1 – Deep dive into Material and Equipment Management
• (5 hours) exploring the new module, with coverage of the material library, material process
flows, material transactions, analytical, equipment and standards. [Charu Roy, Kathy
Kikoshima, Shane Goodwin]
• [Link]
• Day 2 – Deep dive into Recipe Management with high level discussion
on configuration within the Recipe and Material Workspace (RMW)
• (5 hours) Recipe Management including Campaigns, Projects, Process Steps, and Work
Requests [Charu Roy]; Mid level coverage of configuring RMW security, organizations,
sites, people, workflows, alerts, attributes, seed data, and views [Antony John, Charu Roy]
• [Link]
• Day 3 – Deep dive into Next Gen CAD and Document Publishing
• 8 AM to 9 AM - Next Generation CAD [John Sperling]
• 9 AM – 1 PM - Document Publishing - specific agenda to be determined, but will walk
through the new web services, how to configure a system using samples, and some details
on BI Publisher. Will address some specific use cases on how to leverage Document
Publishing. [Shane Goodwin]
• [Link]
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential
9.3.1 TOI Recordings for RMW
• 9.3.1 TOI: Agile PLM Release with RMW Solution Overview
• Material and Equipment Management Module:
• 9.3.1 TOI: Agile PLM Material and Equipment Management Product Overview
• 9.3.1 TOI: Agile PLM Material and Equipment Management Detail - Material Library and Process Flow
• 9.3.1 TOI: Agile PLM Material and Equipment Management Detail - Material Transactions
• 9.3.1 TOI: Agile PLM Material and Equipment Management Detail - Equipment and Standards
• 9.3.1 TOI: Agile PLM Material and Equipment Management Detail - Analytical
• Recipe Management Module:
• 9.3.1 TOI: Agile PLM Recipe Management Product Overview
• 9.3.1 TOI: Agile PLM Recipe Management Detail - Recipe Creation [2 parts]
• 9.3.1 TOI: Agile PLM Recipe Management Detail - Campaigns, Projects, and Process Steps
• 9.3.1 TOI: Agile PLM Recipe Management Detail - Work Requests
• RMW Infrastructure:
• 9.3.1 TOI: Agile PLM RMW Interfacing with Web Services and Samples
• 9.3.1 TOI: Agile PLM RMW Security Configuration
• 9.3.1 TOI: Agile PLM RMW Configuration of Workflows [Recorded Sept 14, 91182]
• 9.3.1 TOI: Agile PLM RMW Configuration of Attributes, Seed Data, and Views [Planned Sept 20, 91186]
• 9.3.1 TOI: Agile PLM with RMW Installation and Deployment Architecture [rescheduling]
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential
Object flows between PC and RMW
Agile PC Agile RMW
Part Subclass –
Materials Material
Part Subclass – Recipe Recipe
Supplier Supplier
Manufacturer Manufacturer
User User
Mappings controlled by configuration file
Process Flow – Material
Material
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential
Process Flow - Recipe
Agile PLM – Agile Pharma Target Material Integration – Trigger from Agile Pharma
Final Drug Product, Target or
Intermediate Material
Agile 9 Platform
Recipe will be attached as PDF or XML
AML/ASLfor sourcing
Material BOM is added to
Recipe Object. PDF and
XML are stored on the
attachment tab. Simplified
workflow on ECO will auto-
approve the Recipe
Daemon adds
Upon Release,
Material BOM ,
Updates Recipe
AML/ASL and Recipe PDF to Recipe Object.
status
Recipe is
‘Approved’. Daemon picks up
Recipe Created Recipe Publish Recipes ‘Ready to
status set to Publish’
‘Ready to Publish’
Agile Pharma
Recipe Publish
status is set
‘Success’ or
Procedures/Tasks ‘Failure’
Approved Materials
Equipment
Recipe Creation and Approval
Process Flow – Recipe
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential
Process Flow – Recipe
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential
Process Flow - Supplier
Process Flow - Manufacturer
Process Flow - Users
Oracle Pharmaceutical PLM Roadmap*
Addressing Key Strategic Initiatives
Better Collaboration & Cross Integrated Pre-Clinical & Adaptive Clinical Supply
Functional Program Clinical Supply Development Chain & Strategic
Management Operations Planning
Available pre 9.3.1 Available with 9.3.1 Mid Term (2-3 Years)
• Portfolio Management • Equipment Management • Deeper integrations for Project,
• Program Execution • Materials Management Quality & People Mgmt
• Drug Quality Management • Recipe Authoring • Quality by Design Analytics
• Supplier/CMO collaboration • Pre-Clinical Development • Advanced features in Recipe
• Packaging & Label Management • Clinical Supply Management Authoring
• Technology Transfer Management • Electronic Development Record (Full) • Focus on Design Experiment
• Product Record Management • Regulatory Compliance Monitoring execution
• Integration with Oracle Process • Integration with Oracle Clinical
Manufacturing solution Trials solution
• Foundation for Quality By Design
Note * Candidates for future releases, subject to change
Installing RMW with Agile PLM
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential
Running Agile PLM with Pharma in a
Demo situation using Weblogic / Windows
Web Client
Login
Proxy
Agile
Application RMW
JVM Instance Application
(port 7001) JVM Instance
Typically 1280MB Memory
(port 7003)
Agile PLM File Small 512MB Memory
Manager
Agile Database Instance
Agile DB RMW DB RMW User
Schema Schema (no schema,
just user)
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential
Start scripts for RMQ
Oracle Agile PLM 9.3.x - © 2010 Oracle Corporation – Proprietary and Confidential