Managing Product Lifecycle Complexities in Pharma Session ID: 11229

How Oracle Agile could Prepared by: improve productivity and Arun Sharma compliance NexInfo Solutions

Remember to complete your evaluation for this session within the app! 04/08/2019 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

Basic Identification Discovery of Scrutiny of genomic of target seed lead drug Manufacturing Clinical New drug research molecules compounds candidates development Studies application

Highthrouput Estimation of Research on screening drug efficacy Manufacturing process orphan receptors, Functionalc c Clinical development ligands, disease- analysis evaluation and and quality Launch related genes, of genes new drug control and orphan Safety application enzymes Combinatorial evaluation and chemistry pharmacokineti c COMPLEX Compliance REQUIREMENTS Issues/Challenges • Lack of Visibility – To materials and services provided by Scalability suppliers • More products, SKU’s, global markets – To suppliers and supplier Items for Item type – To regulatory filing status of CMOs across • 1000 artworks…and growing countries Speed-to-Market – To FG Part Number • Increasing complexity • Inability to Timely Source Materials – Lead to drug stock out • Difficult to hire, train and retain – Impact Company’s reputation Increasing Competitiveness • Lack of Collaboration • Changing competitive landscape – Different functional groups use different nomenclature • Process timeline…competitive differentiation – Different approval process across sites Maintain Compliance – Different risk assessment performed by different sites • More complex regulatory requirements • Manual Process • Need for compliance with regulatory bodies – Distribution of Supplier Audit Schedule from new markets – Incorrect Supplier Qualification leads to regulatory alert

Case Study PLM Implementation at Gilead Sciences Case Study Timeline

Project Approved in Mid 2015. Global Design Session, 2015 Business Case 2 (FC & CPL), CRPs, SOPs, UAT End User Training, Validation, Data Migration, Blackout, 2016 Cork Go-Live (March) CRP 2 & 3, UAT, End User Training, SOPs, Validation, 2016 Data Migration, Blackout, FC Go-Live (November)

2016 POC for Clinical Items, Commercial Items, Product Profile Phase – 4 Global Design Workshops, Business Case, 2017 Project Approval & Kick-off in April

Clinical Items, BOM, Product Profile, Commercial Items, 2018 Integration with EBS Go-Live (May)

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 Manufacturing and Supply Chain Plan Create, Update and Retire process for: • Create Commercial Drug Product (DP) Inventory Plan • Create Commercial API Plan  Item Master Data • Create Production Plan (Site Specific)  Supplier Master Data Supply Chain Execution  Product Structure • Execute Drug Product/Finished Good Production Plan • Execute API/Drug Substance Production Plan • Product Specifications • Create and Issue Work Orders  Create Product Profile • Serialization  Packaging and Labeling (Clinical and Commercial) Batch Records and Supplier • QA Disposition of GMP Materials Management • Shipping and Distribution • Initiate, Approve, Issue Master Batch Regulatory / CMC Records (MBRs) • Submission Management and Product Registratio • Create, Review, Approve Lots/Batch Records  Supplier Qualification Case-Study : Gilead Product Lifecycle Management (GPLM)

Manage Discover Develop Manufacture Distribute Product

Molecule Formulation Drug Product Supply Chain Reviews Biology Clinical Trials Supply Chain Logistics Complaints/ Recall

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. Relationship between Items.Mfrs. Programs

Items GxP Suppliers Programs

Finished Products (FP) Finished Goods (FG) Contract Manufacturers (CMOs)

Contract Test Laboratories (CTLs) Clinical Labels Commercial Labels

Component Suppliers

Packaging Britestocks Configuration (PC) Contract Packager and Labeler

Active Placebo Bulk Tablet / Liquid Tablets (IP) Contract Service Provider

Market Partner APIs (IP) APIs / ICNs

Raw Material Supplier

In-Process (IP) WIP * Warehouse / Distributor

Raw Material (RM) (includes RSM, excipients, desiccants, etc.) Medical Device Supplier Oracle Modules 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 Cross-Enterprise requirements Agile Enterprise Quality Visualization Professionals Native document collaborative visualization across the global

Agile Quality enterprise Management

Operations & Supply Chain Closed -loop product quality management across the extended Procurement Professionals Agile Product enterprise Collaboration Agile Product Cost Management Enterprise product record Strategic sourcing and lifecycle cost & risk visibility, management & management collaboration

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

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Session ID: 1129

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