Session ID:

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11229

Managing Product Lifecycle

Complexities in Pharma

How Oracle Agile could

improve productivity and

compliance

04/08/2019

Arun Sharma

NexInfo Solutions

Who is NexInfo?

SUMMARY

• Consulting company focused on helping clients achieve Operational Excellence via an optimal blend of Business Process &

Software consulting services

• Deep domain expertise, including: Integrated Business Planning (IBP/S&OP), Enterprise Resource Planning (ERP), Product

Lifecycle Management (PLM), Customer Relationship Management (CRM), Enterprise Planning Management (EPM), Human

Capital Management (HCM), Predictive Data Analytics, Security, & Business Transformations

• Founded in 1999 and managed by computer industry & business process professionals

• Clients include emerging companies and Fortune 1000 corporations

• Recognized in the industry, including features in Gartner Reports, The Silicon Review (50 Smartest Companies of the Year 2016

and 10 Fastest Growing Oracle Solution Providers 2017), and CIO Review (100 Most Promising Oracle Solution Providers 2015)

PARTNERS

CORPORATE INFO

• HQ in Orange County, CA with offices in Redmond, WA, Chicago, IL, Bridgewater, NJ, Dublin, Ireland, Chennai & Bangalore,

India

• Operations across the United States, Europe (Ireland, UK, Switzerland, Belgium) & India

Industry Experience

How to manage product lifecycle in

Pharma from Pre-Clinical trials to

Commercial Manufacturing

Case study based on implementation of

Oracle Agile PLM for Gilead’s Packaging

& Labeling to ordering Raw Material,

Supplier Collaboration to integrating the

whole commercial process with Oracle

EBS.

Drug Discovery Process

Launch

Research on

orphan receptors,

ligands, disease-

related genes,

and orphan

enzymes

Functional

analysis

of genes

Highthrouput

screening

Combinatorial

chemistry

Estimation of

drug efficacy

Safety

evaluation and

pharmacokineti

c

Manufacturing

process

development

and quality

control

Clinical

evaluation and

new drug

application

Basic

genomic

research

Identification

of target

molecules

Discovery of

seed lead

compounds

Scrutiny of

drug

candidates

Manufacturing

development Clinical

Studies New drug

application

c c

COMPLEX Compliance REQUIREMENTS

Issues/Challenges

Scalability

• 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

• Lack of Visibility – To materials and services provided by

suppliers

– To suppliers and supplier Items for Item type

– To regulatory filing status of CMOs across countries

– To FG 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

Case Study

PLM Implementation

at Gilead Sciences

Case Study Timeline

2015 Project Approved in Mid 2015. Global Design Session,

Business Case 2 (FC & CPL), CRPs, SOPs, UAT

End User Training, Validation, Data Migration, Blackout,

Cork Go-Live (March)

CRP 2 & 3, UAT, End User Training, SOPs, Validation,

Data Migration, Blackout, FC Go-Live (November)

Phase – 4 Global Design Workshops, Business Case,

Project Approval & Kick-off in April

Clinical Items, BOM, Product Profile, Commercial Items,

Integration with EBS Go-Live (May)

2016

2016

2016

2017

2018

POC for Clinical Items, Commercial Items, Product Profile

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

19 Business Processes Evaluated for GPLM

Master Data Management Create, Update and Retire process for:

Item Master Data

Supplier Master Data

Product Structure

• Product Specifications

Create Product Profile

Batch Records and Supplier Management

• Initiate, Approve, Issue Master Batch Records (MBRs)

• Create, Review, Approve Lots/Batch Records

Supplier Qualification

Manufacturing and Supply Chain Plan • Create Commercial Drug Product (DP) Inventory Plan

• Create Commercial API Plan

• Create Production Plan (Site Specific)

Supply Chain Execution • Execute Drug Product/Finished Good Production Plan

• Execute API/Drug Substance Production Plan

• Create and Issue Work Orders

• Serialization

Packaging and Labeling (Clinical and Commercial)

• QA Disposition of GMP Materials

• Shipping and Distribution

Regulatory / CMC • Submission Management and Product Registratio

Case-Study : Gilead Product Lifecycle Management (GPLM)

GPLM provides a common system to manage product information and knowledge

from early development to product sunset.

Examples include:

• Items – Every Gilead product and all of the components that go into making that product has a unique item number.

Examples: Raw Materials, APIs/ICNs, Bulk, Britestocks and FGs.

• Suppliers – Any entity that provides GxP material or services to Gilead. Examples: Contract Manufacturing

Organizations (CMOs), Contract Test Labs (CTLs), Distributors etc.

• Product Structures – Clinical Bill of Materials and Product Profile; Commercial BOMs

• Specifications – Our products are released against specifications. Example: GSPECs, MSPECs, QSPECs etc.

Discover Develop Manufacture Distribute Manage Product

Molecule

Biology

Formulation

Clinical Trials

Drug Product

Supply Chain

Supply Chain

Logistics

Reviews

Complaints/ Recall

Relationship between Items.Mfrs. Programs

Finished Products (FP)

Items

Clinical Labels

Packaging Configuration (PC)

Active Placebo Tablets (IP)

APIs (IP)

In-Process (IP)

Finished Goods (FG)

Commercial Labels

Britestocks

Bulk Tablet / Liquid

APIs / ICNs

WIP *

Raw Material (RM) (includes RSM, excipients, desiccants, etc.) Medical Device Supplier

GxP Suppliers

Contract Manufacturers (CMOs)

Contract Test Laboratories (CTLs)

Component Suppliers

Contract Packager and Labeler

Contract Service Provider

Market Partner

Raw Material Supplier

Warehouse / Distributor

Programs

Oracle Modules Used

Agile Product

Collaboration

Operations & Supply Chain

Enterprise product record

visibility, management &

collaboration

Agile Enterprise

Visualization

Native document collaborative

visualization across the global

enterprise

Cross-Enterprise

Agile Engineering

Collaboration

Engineering desktop integration &

collaboration

Development & Engineering

Agile Product Cost Management

Strategic sourcing and lifecycle cost & risk

management

Procurement Professionals

Agile Product Portfolio Management

Integrated product, program, resource &

portfolio management

Executives & Program Office

Agile Product

Governance &

Compliance

Product & program

compliance against

standards & regulatory

requirements

Compliance Office

Closed-loop product

quality management

across the extended

enterprise

Quality Professionals

Agile Quality

Management

Start with Raw Material for Drug Substance/Drug Product

Processes Enabled: • Internal/External Collaboration

• Approved

Suppliers/Manufacturers

• Revision Controlled

• Where Used/Mass Update

• Workflow/Approval Teams

• Parametric Searching

Combine Specifications into Multi-Level Bills of Material

Processes Enabled: • Structured Multi-Level Bill of

Material

• Change History for

Traceability/Audits

• Component Where Used for

Impact Analysis

• Component Mass

Update/Redlining

• Synchronize to Internal Systems

Add Primary Packaging

Processes Enabled:

• Packaging Specifications

• Parametric Searching

• Cross Functional Collaboration

• Mass Update many SKUs

• Roles & Privileges Control -> Selective Access

Add Artwork/Labels

Processes Enabled:

• Label/Artwork Specifications

• Digital Asset Repository

• Supplier Collaboration (Example Esko)

• Proof Read/Markups

• Component Where Used

• Component Mass Update/Redlining

• Country Specific SKUs/Labels

Add Secondary Packaging

Processes Enabled: • Packaging Specifications (Cartons,

Die-line)

• Structured Multi-Level Bill of Material

• Validate Approved Components

• Change History for Traceability

• Component Where Used

Country Specific Configurations

Processes Enabled: • Country Specific BOMs/Materials

• Country Specific Labels/Artwork

• Country Specific Packaging

• Product License Tracking/Expiry

Go from Unstructured Paper to Structured Specifications

Unstructured Papers to Integrated Global System

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

GPLM KPI Metrics

The system has been in production for over 150 days and has more than 1,000 users across five Gilead

sites. The diagram below summarizes the clinical and commercial components that have been

processed and released or are currently in-progress in GPLM.

Phase 1 Benefits Implementing standardized and automation-assisted item processing and transfer of master data

to downstream manufacturing systems has resulted in the following benefits.

• Reduced the commercial item request-to-approval cycle time

• Eliminated more than 256 paper documents

• Automated flow of data to ERP, GVault and IQS has replaced manual transcription

• Digitally linking 264 part numbers to suppliers has significantly simplified and accelerated the review process

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

Session ID:

Remember to complete your evaluation for this session within the app!

1129

Arun.sharma@nexinfo.com