Session ID:

Managing Product Lifecycle 10237

Complexities in Pharma
Prepared by:
Arun Sharma : PLM Lead at
NexInfo
How Oracle Agile Could improve Subbu Panigrahi : Sr. Manager at
Gilead Science
the Compliance
04/24/2018

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AGENDA

• How to manage product life cycle in Pharma from Pre-Clinical trials to

Commercial Manufacturing

• Case study is based on implementation of Oracle Agile PLM for Big Pharma
manufacturers' Labeling/Packaging to ordering Raw Material, Supplier
Collaboration to integrating the whole commercial process with Oracle EBS.
 COMPLEX BUSINESS REQUIREMENTS

Clinical Item & BOM

CMOs and
CMO’s Supply Chain

CLINICAL COMMERICIAL COMMERICIAL

CMOs
Background - Sample of PLM Customers in Life
Sciences
COMPELLING BUSINESS DRIVERS

Scalability • Lack of Visibility

• More products, SKU’s, global markets
• 1000 artworks…and growing
Speed-to-Market
• Increasing complexity
• Difficult to hire, train and retain
Increasing Competitiveness
• Changing competitive landscape
• Process timeline…competitive differentiation
Maintain Compliance
• More complex regulatory requirements
• Need for compliance with regulatory bodies from new markets
• To materials and services provided by suppliers
• To suppliers and supplier Items for Item type
• To regulatory re filing status of CMOs across countries
• To FP Part Number
• Inability to Timely Source Materials
• Lead to drug stock out
• Impact Company’s reputation
• Lack of Collaboration
• Different functional groups use different nomenclature
• Different approval process across sites
• Different risk assessment performed by different sites
• Manual Process
• Distribution of Supplier Audit Schedule
• Incorrect Supplier Qualification leads to regulatory alert
Cost of Compliance
 Case Study Timeline

Project Approved in Mid 2015. Global Design Session, Business Case 2

2015 (FC & CPL), CRPs, SOPs, UAT
End User Training, Validation, Data Migration, Blackout, Cork Go-Live
2016 (March)
CRP 2 & 3, UAT, End User Training, SOPs, Validation, Data Migration,
2016 Blackout, FC Go-Live (November)

2016 POC for Clinical Items, Commercial Items, Product Profile

Phase – 4 Global Design Workshops, Business Case, Project Approval &
2017 Kick-off in April

Clinical Items, BOM, Product Profile, Commercial Items, Integration with EBS
2018 on-target for Go-Live (April)
 Case-Study Background

I N Manage
Discover N Develop D Manufacture Distribute
D A Product
Molecule Formulation Drug Product Promotion Reviews
Biologic Clinical Trials Supply Chain Logistics Complaints/ Recall

Gilead Product Lifecycle Management (GPLM):

PLM provides a common system to manage product information and knowledge from early development to product sunset.

GPLM Proof of Concept (PoC)

• Multiple Workshops conducted March  2016
• Mapped current state process (Inputs, Outputs, Roles)
• Process and Governance gaps identified
• Confirmed Agile PLM as solution for Gilead’s PLM capabilities

GPLM Implementation:
• Phase 1 implementation project approved in April 2017
• GPLM will be implemented on same platform as Label Management System
• 9 workshops conducted with focus group discussions to identify use cases, define future state business process requirements, and
deliver GPLM User Requirements Specification
BUSINESS PROCESSES EVALUATED

In 2016 Gilead evaluated expansion

of PLM capabilities beyond label
management:
• Proof of Concept (PoC) to
determine whether Agile PLM can
provide additional benefits
• Analyzed 19 business processes
involving over 70 stakeholders
across all Gilead sites
• Item, supplier and specification
management processes were
identified as good fits
 Deliverables

• Harmonize business processes, manage data and provide easy access to accurate information
supporting the lifecycle of a Gilead product to support 18 business functions across Clinical,
Commercial and Biologics operations at all Gilead sites.
• Alignment across business functions with respect to future definition, standards, process controls,
roles and responsibilities as it relates to part numbers and suppliers
• Create and maintain Clinical Part Numbers (RM, IP, PC, FP, MD)
• Commercial API items (ICN)
• Commercial DP items (Bulk, Britestock, FG)
• Establish relationships between Clinical Part Numbers, Suppliers, Clinical Studies
• Integrate PLM with EBS
• Migrate Clinical Items from Legacy Systems

• Migrate GxP Suppliers from Legacy Systems and other paper-based sources
 Oracle Agile Module Used
Executives & Program Office
Development
& Engineering
Compliance Office Agile Product Portfolio Management
Integrated product, program, resource & Agile Engineering
Agile Product portfolio management
Collaboration
Governance & Engineering desktop integration &
Compliance collaboration

Product & program

compliance against standards
& regulatory requirements Cross-Enterprise

Agile Enterprise
Quality Visualization
Professionals
Native document collaborative
visualization across the global
enterprise
Agile Quality
Management
Operations &
Supply Chain
Closed-loop product quality
management across the
extended enterprise
Procurement Professionals Agile Product
Collaboration
Agile Product Cost Management
Enterprise product record visibility,
Strategic sourcing and lifecycle cost & risk management & collaboration
management
Business Benefits

Clinical items Review and Approval (GPLM)

GPLM GPLM
Chang Chang
Initia
e Revi
e
Order EBS
te ew
Order
GPLM GPLM GPLM
QA
Chang Chang Co
Chang
e e e
Revi
Order
Appr
Order mpl
Order
ew oved ete
IQS
 Reduced cycle time

~ 8 Weeks

~ 6 Weeks
Cycle Time Data Integrity Accessibility
Storage Space Compliance Agility
Accuracy
Scalability Collaboration

Reduced cycle time due to efficiency, agility and greater visibility to project status
Single Source of Truth for all Clinical & Commercial Items

Item Template

Raw Materials
Clinical API
Clinical WIP (Bulk)
Clinical Britestock
Clinical Finished Good
Clinical Packaging & Labeling
Commercial API
Commercial Bulk (Tablet, Liquid)
Commercial Britestock
Commercial Finished Good
Commercial Packaging & Labeling
MRO
SIGNIFICANT BUSINESS BENEFITS

 Enhanced CFR Part 11 compliant system, coupled with easier access to information, positively
impacts audits and reduces compliance risk
 An integrated, single, global system where all Items, BoMs, Supplier information,
documentation, approvals & history captured for both Commercial and Clinical
 Completely automated process to improve speed-to-market and manage increasing volume
 Enhanced efficiency, productivity and integrity of data
 Workflow-enabled processes that allow for real-time visibility to change history
 Reduced cycle time due to improved efficiency, agility and greater visibility to product status
 Streamlined Clinical Items Process review and approval
 Single Source of Truth for all Clinical and Commercial Items
 Arun.sharma@nexinfo.com
Subbu.panigrahi@gilead.com
Session ID:
10237

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