SAP Advanced Track and Trace for Pharmaceuticals

SAP Advanced Track and Trace for Pharmaceuticals
Dr. Oliver Nürnberg Product Owner SAP Life Sciences July 28, 2015 Customer

Legal disclaimer The following slides describe a planned solution to support the legal requirements for pharmaceutical manufacturers regarding serialization of pharmaceutical products. SAP intends to develop this solution as shown in the subsequent slides. All information is Customer Confidential. Safe Harbor Statement: Any statements contained in this document that are not historical facts are forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to SAP are intended to identify such forward-looking statements. SAP undertakes no obligation to publicly update or revise any forward-looking statements. All forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. The factors that could affect SAP’s future financial results are discussed more fully in SAP’s filings with the U.S. Securities and Exchange Commission (“SEC”), including SAP’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates.

Track & Trace Challenges

External Challenges … Legislation Volumes Collaboration
Existing legislation is understood and can be handled (Turkey, China, Argentina, India). Some legislation is well understood and is currently being detailed out (EU FMD, US DSCSA) others bear some or many uncertainties (Korea, Brazil). Regulations are evolving right now: India just published guidance for reporting by Oct. 2015! No Specs! China: may add veterinary drugs Korea defines regulatory reporting to become active in 2015! No Specs! Brazil “Network” to be defined -> recent GS1 publication Ukraine, Jordan, Saudi, Japan?? Volumes Especially generics manufacturers have to deal with excessively large numbers of units Aggregation requirements multiply the number of events by a factor 5 Number of Messages explodes if several messages have to be exchanged between stakeholders: Brazil: number of messages ~ number of units * length of supply chain Collaboration Collaboration with regulatory agencies can be handled fairly easily: 1 connection per country Collaboration along the supply chain adds a new level of complexity 100s – 1000s of connections Very different players ($10m CMO -> $100b US Wholesaler) Additional message choreography (Brazil) creates a message mayhem if not managed properly

… Drive Process Changes!
Packaging Lines High investments required to make existing packaging lines ready for serialization ($250k per line) and aggregation (+ $250k per line) Downtime for changes to buildings & packaging lines Reduced OEE initially - potentially increase OEE over time Warehouse Management If aggregation is required warehouse processes will change significantly Requires an integrated application that allows to handle serialized and non-serialized items together - by the same people - at the same time - on the same device - in the same transaction. Contract Manufacturing Some CMOs might not be ready – other CMOs might execute serialization and aggregation on your behalf Ensure collaboration on all levels with key CMOs but also ensure flexibility to switch to in-house production. IT Management Message transmission & content require monitoring by both IT and business users Huge data volumes require dedicated archiving strategy

SAP Market Overview & Customer Base
(Serialization Focus)

Where is SAP coming from with regards to “Track & Trace”
Mid 2013: 14 of the top 20 pharma companies world-wide run SAP solutions for “Track & Trace” Existing solution: OER/Aii Some customers live / most implementing Generic Solution capable of handling the requirements in pharma track & trace SAP has established a customer consortium, called the “SAP Serialization Round Table” About 40+ members, incl. 14 of the top 20 Pharma Co’s and 1 top 3 US Wholesaler September 2013: Round Table raised a strong demand for additional capabilities and especially a roadmap for OER/Aii including a commitment for future regulatory reporting content.

Customer pushed for a solution to accommodate expected serialization volumes and missing functionality Expected volumes of serialized drugs Customers requested SAP to deliver a future-proof solution that can scale to the volumes expected: Expected serialized drug volume of a large Pharma Customer 2016 2 bn 2018 4 bn 2022 7 bn 2028 15 bn Current Volumes communicated by a large Pharma wholesaler: 2,5bn p.a. Missing functionality expected by Customers CMO Integration/ Messaging Compliant Messaging to Authorities (commitment) Warehouse Integration Randomization Improved Master Data Integration Improved Analytics

Track and Trace for Pharma - What happened since then -
Journey Investment plan Onboard co-innovation customers Co-innovation workshop 1 Solution options Co-Innovation workshop 2 Development scope and high level design Nov 2013 – Investment plan to build the required capabilities in customer co-innovation mode Dec 2013 – Call for co-innovation customers Jan/Feb 2014 – Onboarding of co-innovation customers 10 companies participating (6 of top 20 pharma + 1 top 3 US Wholesaler) Feb 2014 – First co-innovation workshop Focus: Regulatory reporting and US-DQSA Mar 2014 – Second co-innovation workshop Focus: Serial number management, warehouse integration, shop floor integration Apr 2014 – Interpret feedback from Co-Innovation workshops and evaluate options to best meet requirements

Adv. T&T Development Project Status Details
SAP took the decision in April 2014 to create a new pharma-specific solution based on market changes and customer feedback: Advanced Track and Trace for Pharmaceuticals Continued Co-Innovation 2014 August/September: Specs sent and feedback gathered (~200 feedback items) September 25/26: 1 Workshop (DE) with demo, data model deep dive, final spec review, user experience session Nov Now 13 companies co- innovating (9 of top 20 pharma + 1 top 3 US Wholesaler) Co-Innovation 2015 Last Session just executed January with 19 participants from 11 companies: Data Migration Authorization Concept Rule Framework Regulatory Reporting Development Update and Demo Joint testing in July 2015 Agile Development (Sprints) Sprint 12 of 12 finished! Development Close June 12! All E2E processes working well in the system! Current focus is on full E2E-Testing with real customer data. Emergency Correction Close Aug. 3 Availability for Adv. T&T is scheduled for September 15, 2015.

SAP Advanced Track & Trace Architecture and Platform

Main Characteristics of Advanced Track & Trace
One Component … compared to the existing bundle of OER (Object Event Repository) Aii (Auto ID Infrastructure) EM (Event Management) GS1 compliant EPCIS 1.1 CBV 1.1 (Core Business Vocabulary) TDS 1.9 (Tag Data Standard) Industry Specific Solution … compared to generic solution that can be configured to work for Pharma Designed to work for MAHs, CMOs and US Wholesalers Capable to handle any upcoming legislation Roadmap for future legal requirements Minimum Footprint Lean Data Model Designed for volume & speed HANA optimized Reduced TCO Minimized footprint Deployment & commercial model that works for the entire industry: 1m items -> 10b items / year

SAP Advanced Track and Trace for Pharmaceuticals – MAH view
Government Any middleware ERP/ WM SAP Advanced Track and Trace for Pharmaceuticals 3PLs, CMOs wholesalers Any middleware (optional) Any middleware In development Any middleware (optional) Application interface framework (AIF – restricted license included in SAP Advanced Track and Trace for Pharmaceuticals) Pack line/device AIF content shipped for regulatory reporting and CMO/wholesaler messaging

HANA Enterprise Cloud (HEC)
Advanced Track & Trace can be deployed on NetWeaver, HANA or HANA Enterprise Cloud Native development environment NetWeaver Default deployment option Allows co-deployment on ERP Adds HANA capabilities HANA On-premise deployment HANA Enterprise Cloud (HEC) Adds HANA capabilities Availability tbd. Adds Cloud capabilities

Potential Implementation Options
Adv. T&T Components Serial Number Management Object & Event Repository Packaging Line Integrations Warehouse Mgmt. Integration Regulatory Reporting ERP Integration Adv. T&T Option 1 central deployment only Option 2 central & regional/ local deployment Adv. T&T Components Central Serial Number Management Central Object & Event Repository Regulatory Reporting ERP Integration Local Serial Number Management Local Object & Event Repository Packaging Line Integrations Warehouse Mgmt. Integration Adv. T&T Adv. T&T ATT local/regional ATT local/regional

Potential Migration Options from OER/Aii
Adv. T&T Option 1 central deployment only ATT local/regional Adv. T&T Option 2 central & regional/ local deployment

Potential Migration Options from OER/Aii
SAP AII SAP OER EM Adv. T&T Option 1 central deployment only Option 2 central & regional/local deployment Option 2 central & regional/ local deployment AII (a) Adv. T&T SAP AII AII ATT local/regional Adv. T&T SAP AII (b) (c) ATT local/regional Adv. T&T

… another migration option
Serial Number Management ONLY Create Serialization Profile for Target Country Create GTINs for selected products only Create Number Range Definitions and Ranges Assign Packaging Lines to Number ranges and GTINs Push randomized Serial Number lists to packaging lines ERP/ WM SAP OER SAP Advanced Track and Trace for Pharmaceuticals Serial Number Management only AII EM SAP AII Commissioned Data pushed to OER/Aii As before! WM Integration and reporting stays in Aii and OER Any middleware (optional) Pack line/device

Introduction to SAP Advanced Track & Trace Functionality

Different Requirements of US Pharma Supply Chain Participants
Contract Manufacturers 3PL Pharma MAH Authorities Wholesaler Send Regulatory Reporting Messages to Gov. Agencies Request & receive serial numbers (lists & ranges) from MAH Hospitals Pharmacies Provide Traceability Data Access via Portal Send serial number status info - send commissioned serial numbers Send Messages along the supply chain Send Messages along the supply chain CMO Collaboration Packaging Line Integration Warehouse Operations Audits & Internal Reporting Compliant Messaging CMO Often small companies with limited IT capabilities Need to manage externally generated serial numbers Ensure timely and correct communication with customers both for raw as well as commissioned serial numbers MAH Huge variety (1mio – 10b units/year) Often act as CMO also Need to manage external (e.g. China) and internal serial numbers Requires full functional scope Ultimately responsible that everything works OK Wholesaler (US, …) Huge volumes Only requires very limited functional scope but WM-integration is key Hospitals/Pharmacies Very different … large retail pharmacies as well as small hospitals Only requires very limited functional scope

Core MAH / CMO Business Processes
Serial Number Management Serialized Item Management Regulatory Reporting Manage number ranges and raw serial numbers lists Execute randomization Assign and send ranges and lists to “consumers”, e.g. packaging line servers, site servers or CMOs Manage external serial numbers from customers (acting as a CMO) or China Manage EPCIS and PML-type messages from packaging lines or CMOs Closely integrate with warehouse operations to keep aggregations in sync Execute rules and checks to ensure data integrity Closely integrate to ERP to catch reporting triggers like outbound deliveries Manage rules to ensure consistent and correct reporting to authorities Keep data for audit purposes

Repository and Regulatory Reporting (MAH View)
Turkey …. Regulatory Reporting China Wholesalers EPCIS Repository Packaging Line Business Rule Framework Warehouse Activities CMO Supply Chain Processes …… ……

SAP Advanced Track and Trace for Pharmaceuticals
Functional overview SAP Advanced Track and Trace for Pharmaceuticals ERP integration Material, customer, vendor, location master Inbound and outbound Deliveries, production orders Batch/lot Toolkit for WMS integration Seamless integration into warehouse processes Real-time verification with data in repository Integration with receiving, internal movement and goods issues, cycle counting and bin locations EPCIS repository Capture and store objects, events and transactions (for example, SAP ERP docs) Ad hoc reporting with repository browser Ability to post manual events Rules engine (including regulatory reporting) Capture external triggers for message creation Execute rules during data mapping and message handling Execute rule upon message receipt Serial number management Define number formats Import numbers for China Randomization and list creation Assign ranges and S/N lists to consumers Receive lists and ranges SAP Application Interface Framework Integral part of SAP Advanced Track and Trace for Pharmaceuticals – restricted license included Integration to business partners, packaging line, ERP, LES, WMS and regulatory reporting, EPCIS capture interface Monitoring of all messages with restart option in case of transmission failure Packaging line integration PML or EPCIS capture

ERP Integration Master Data covered Transactional Data
Integration Paradigm Integration with ERP is available but still all Master Data required can be maintained in Adv. T&T Master Data Structures can be enhanced in Adv. T&T to accommodate customer-specific processes. Integration can be enhanced to accommodate customer-specific data and processes. Master Data covered Material Master Including mass maintenance Business Partners Vendors Customers Locations Batches/Lots Transactional Data Inbound & Outbound Deliveries Production Orders / Process Orders ERP Material Master Enhancements Basic Data 1 Serialization Type Synchronization Timestamp Add Data -> Units of Measure New GTIN field New National Code Field New Registration Code Field Serialization Indicator Work Scheduling (Plant Level) Validity date for serialization

Serial Number Management (1/2)
> Range Definitions define the way how serial numbers are being created and are assigned to one or more trade items. Range Definitions ca be created or assigned automatically. Range Definitions Theoretical space definition Serial Number format definition Definition whether managed internally or externally (e.g. CMO) S/N Randomization definition S/N Uniqueness definition single GTIN Country Portfolio Global Definition of re-use horizon Randomization Options Non-Randomized Randomized 1:100 Randomized 1:1000 Randomized 1:10000 Combined Seq. + 3 Digit Randomized Combined Seq. + 4 Digit Randomized Randomized Manually (e.g. China) Randomized Externally (external randomizer, e.g. BayCoder) Format Options Numeric Alphanumeric (capital letters) Alphanumeric (case sensitive) Alphanumeric (case sensitive) with exclusion list Length up to 40 digits

Serial Number Management (2/2)
> Ranges are subsets of Range Definitions and allow to specify from which area of the theoretical space serial numbers should be generated depending on usage, e.g. packaging line vs. CMO. Ranges Subsets of the theoretical space Either explicitly assigned to pack lines, sites or CMOs or unassigned Definition whether Serial Numbers from this Range are delivered in Lists or Ranges or both. Serial Number Statistics are managed on this level Defines the amount of serial numbers to be created “on stock” Range & List Requests Actual requests for ranges or lists requested from and delivered to packaging lines or CMOs Allows a full audit trail for all requests Allows to review the actual range or serial number list sent to receiver Serial Numbers Created within a range Always created “on stock” to enable a fast delivery of serial numbers on request Serial Number Threshold defines minimum number of serial numbers to be in stock “lot size” defines amount of serial numbers to be created once threshold is reached

EPCIS Repository Repository Data Model Objects covered Events
Only store what is required! All affected objects inherit an event. Encoding/decoding based on coded logic instead of customized rules. Searchable attributes at header level of the respective business objects. DB access optimized for fast pre- validation of event activity. All attributes optimized with regards to compression capabilities and DB clustering. Processing logic uses buffers and supports mass data handling. Objects covered SGTINs (EPCs) SSCCs LGTINS (Lots) Events Reporting Events Transactions Inbound and Outbound Deliveries Production Orders Repository Browser Full Ad-hoc reporting and navigation capabilities Allows to search for serialized items by GTIN, batch, location, transaction, status, disposition, … Allows to search for events, SSCCs etc. Allows back-and-forth navigation Allows to display any hierarchy ad- hoc from any starting point

Rules Engine Adv. T&T will handle regulatory reporting rules and business rules together in one framework. Adv. T&T will use a standard event processing logic which is based on the EPCIS inbound event message Automatically creates events, objects, transactions and the relations between the entities Offers BADIs for customer specific extensions of the standard processing Handles conversion from PML to EPCIS Rules will be defined as code within rule function modules Regulatory Reporting modularization & configuration is done via rule definition Country Group: defines which target countries are affected (e.g. allows to collect several countries in one rule: EU) Location Group: defines which read points may trigger which rule Rule Type: defines which function to executed (see next slide) Customer Condition: allows to add additional conditions for rules to be executes Rule Sequence: defines the sequence in which several rules that match the criteria shall be executed

Delivered Rules Reg reporting Rules for Argentina
RR_AR_SEND_ALERT Send Alert RR_AR_SEND_CANC_PART Send Partial Cancellation RR_AR_SEND_CONF Send Confirmation RR_AR_SEND_MDC Send Medicamentos Reg reporting Rules for China RR_CN_CHECKWHOUT Send Check Warehouse Out Message RR_CN_CODEREPL Send Code Replace Message RR_CN_DESTROYWHOUT Send Destroy Warehouse Out Message RR_CN_PURCHASEWHIN Send Purchase Warehouse In Message RR_CN_RELCREA Send Relation Create Message RR_CN_RETURNWHIN Send Return Warehouse In Message RR_CN_SALESWHOUT Send Sales Warehouse Out Message Reg reporting Rules to inform Supply Chain Recipient (e.g. US DQSA or CMO-processes) SR_INFORM_SUCC Supply Chain Partner: Inform Successor Reg Reporting Rules for Turkey RR_TR_DEAC_NTF_ITS Send deactivation notification to Turkey (ITS) RR_TR_DISP_NTF_ITS Send dispatch notification to Turkey (ITS) RR_TR_DPCL_NTF_ITS Send dispatch cancel notification to Turkey (ITS) RR_TR_EXPT_NTF_ITS Send exportation notification to Turkey (ITS) RR_TR_PACK_NTF_PTS Send package information to Turkey (PTS) RR_TR_PROD_NTF_ITS Send production notification to Turkey (ITS) RR_TR_PRPC_NTF_ITS Send product purch. notification to Turkey (ITS) RR_TR_PRRT_NTF_ITS Send product return notification to Turkey (ITS) RR_TR_PRTO_NTF_ITS Send product turnov. notification to Turkey (ITS) RR_TR_PTOC_NTF_ITS Send prod. turnov. cncl. notif. to Turkey (ITS) Business Rules BR_BATCH_RELEASE Send messages on hold after batch is released BR_DISTR_DM Distribution of transaction data BR_UNPACK_DECOM Unpack complete and decomission of hierarchy obj

Transactional data and batch integration (simplified view)
ECC Adv. T&T Prod Order RFC Transaction Outbound Del RFC Inbound Del RFC Object LGTIN Batch Web Service Event SGTIN Packaging Line EPCIS with transaction relation and batch information SSCC Web Service

Transactional data and batch integration (Production Order - Create)
ECC Adv. T&T Prod Order RFC Create Transaction Update (status, confirmed quantity) Outbound Del RFC Inbound Del RFC Object LGTIN Batch Web Service Event SGTIN Packaging Line EPCIS with transaction relation and batch information SSCC Web Service

Transactional data and batch integration (Batch Creation)
ECC Adv. T&T Prod Order RFC Transaction Outbound Del RFC Inbound Del RFC Object Event Create LGTIN Batch Web Service Create update, goods movements SGTIN Packaging Line EPCIS with transaction relation and batch information SSCC Web Service

Transactional data and batch integration (EPCIS Message)
ECC Adv. T&T Prod Order RFC Transaction Outbound Del RFC Inbound Del RFC Object LGTIN Batch Web Service SGTIN Packaging Line Event EPCIS with transaction relation and batch information Web Service SSCC

Packaging Line Integration
Serial Number Request Request for Number Ranges and Lists Response containing Number Ranges or List Commissioned Data PML and EPCIS PML is transformed into EPCIS before rules are executed and data are posted into repository Integration monitored via AIF Configuration Group “Device Controller ID” into a Device Group and map against a GLN Define Command Mapping per GLN to Event Type, Event Action, Business Step and Disposition

Warehouse Management Integration
ECC WM Integration Toolbox (vs. Out-of-the-box solution) to support highly configured WM-implementations as well as non-SAP warehouse mgmt solutions and customer-specific processes Quick Validation service for fast validation of WM activities EWM-Integration on the roadmap Non-SAP Warehouse Mgmt. Integration Native use of provided Services incl. Quick Validation service for fast validation of WM activities Call Adv. T&T Function Modules to create and validate EPCIS files within Adv. T&T ECC Functions for ECC WM Native services Inbound Processes Internal Processes Outbound Processes Adv. T&T Functions for Repository Access VALIDATE_ACTIVITY GET_HIERARCHY_COUNT GET_HIERARCHY_CONTENTS GET_HIERARCHY_STRUCTURE GET_LOCATION_CONTENTS GET_DOCUMENT_CONTENTS GET_SERIAL WHS_RECEIVE_DOCUMENT WHS_RECEIVE_CONTAINER WHS_PUTAWAY WHS_UNPACK WHS_PACK WHS_PICK WHS_SAMPLE (destructive sampling & non-destructive sampling) WHS_INSPECT WHS_INSPECT_HIERARCHY WHS_COUNTING WHS_PICK2PALLET WHS_CREATE WHS_PICK2PALLET WHS_LOAD WHS_SHIP_CONTAINER WHS_SHIP_DOCUMENT Interfaces to post into Repository VALIDATE_ACTIVITY GET_HIERARCHY_COUNT GET_HIERARCHY_CONTENTS GET_HIERARCHY_STRUCTURE GET_LOCATION_CONTENTS GET_DOCUMENT_CONTENTS GET_SERIAL

Regulatory Reporting All regulatory requirements shared & aligned among Round Table participants! Regulatory Reporting: planned scope for Version 1 China, Turkey, Argentina US Lot Level EPCIS & standard item Level EPCIS in pilot mode, Lot Level eASN created in ECC supported India – no government reporting required so far Korea – no government reporting required so far Brazil: overall approach still not clear, no final spec available  no delivery within Release 1 EU: access to specification since Jan 7  delivery probably with SP1 All requirements for serial number and barcode formatting, encoding / decoding, randomization etc. are planned to be supported for the countries mentioned above! SAP plans to support future regulatory requirements as aligned with the Serialization Round Table and ship the required content via support packages!

Overall Integration Capabilities & AIF

Integration Capabilities (Overview – work in progress)
Inbound Outbound SOAP Service oData Service RFC HTTP Post Remarks ERP Master Data Business Partners (Vendors, Customers), Locations, Trade Items (Materials with assigned GTINs) X ERP Transaction Data Inbound Deliveries, Outbound Deliveries, Production Orders Serial Number Mgmt Range Request, Number Request, Serial number Status Information, ATT Functions WHS Toolbox Functions (Activity Validation, Get Hierarchy, …), eASN handling, Serial Number Request EPCIS Messages Only inbound Also used for Supply Chain Partner Notifications PML Messages Regulatory Reporting Notification to Authorities Request data from Authorities (TR PTS, …) File Handling for China Replication between Central & Local instance Customizing, Master Data, Range Definitions, Repository Objects

SAP Advanced Track and Trace for Pharmaceuticals – level 1 solution view

Holistic Interface Handling by SAP Application Interface Framework
A powerful framework for interface implementation, monitoring and error handling A proven solution with more than seven years of development and customer history A cross-industry solution with customers from 25 industries Interface Implementation (Design Time) Interface implementation mainly through Customizing menus Easy access to relevant data or functions of underlying SAP application Re-use of interface components (e.g. checks, mappings, actions) Supports variants of interfaces (exceptions or additional steps) Independent implementation and testing of interface components and interface variants Monitoring and Error-Handling (Runtime & Operations) Business user monitoring (power user) Customizable authorizations for interface access Overview of interface status Error monitoring with focus on business users Framework for interface implementation Interfaces SAP Application Interface Framework

SAP Application Interface Framework Architecture Overview
PI SAP Advanced Track & Trace Application Log Technical Basis Integration (e.g. IDOC, Proxy, BDOC, Files) SAP Application Interface Framework BAPI (BAPI®) Alert Management SAP Advanced Track & Trace ___ Data and Functions Security/Authorizations Checks Field Mappings Standard Function Value Mappings Actions Local Variants Customer Function Customizing (Interface-specific) Monitoring and Error Handling BPM File Interface Implementation (Technical User) Monitoring and Error Handling (Business User) Alerting (Business User) … Legend: SAP Basis SAP Application Interface Framework SAP Standard Application

Advantages in the Area of Compliance
Restrict visibility of interface data In contrary to many traditional monitoring transactions, the monitoring in AIF is role based and access to data can be restricted by customizable authorizations Authorizations can be restricted on interface level and based on interface data (e.g. plant, company code) Structures and/or fields with sensitive data can be hidden by customizing Restrict changes to interface data Interface data changes can be restricted down to individual field level (e.g. in financial documents bank account number and value not changeable) Compliance reporting A central compliance report exists where all interface data changes can be reviewed centrally (e.g. if auditor requests list of changes) Ensure consistency of data generated from interfaces Build-in re-start logic ensures that correct interface version and mapping values are used even if in multi-actions subsequent steps of the interfaces are restarted after a new interface version has been activated or new mapping values are active

SAP Pharma Network for Track & Trace
Dr. Oliver Nürnberg Product Owner SAP Life Sciences SAP Application Innovation May 12, 2015 Customer

SAP Advanced Track and Trace for Pharmaceuticals – level 1 solution view

World-wide Pharma Supply Chain
Contract manufacturers 3PL Request and receive serial numbers (lists and ranges) from MAH Send serial number status info - send commissioned serial numbers CMO/3PL collaboration Packaging line integration Warehouse operations Authorities Send regulatory reporting messages to authorities Compliant messaging Audits and internal reporting Pharma MAH serialized products for all target markets Non-US Supply Chain (EU, Turkey, China, Brazil…) Wholesaler Exchange messages with wholesalers Hospitals Pharmacies Exchange messages with PoD US/Brazil Supply Chain Opportunity for SAP Advanced Track and Trace for (nearly) all supply chain members Opportunity for pharma network

SAP solution offering for pharma track and trace
Government Any middleware Pharma Network Built in co-innovation mode as “Cloud-CDP” Built on SAP HANA Cloud Platform using SAP HANA Cloud Integration ERP/ WM SAP Advanced Track and Trace for Pharmaceuticals 3PLs, CMOs wholesalers Any middleware (optional) Any middleware In development planned Any middleware (optional) Application interface framework (AIF – restricted license included in SAP Advanced Track and Trace for Pharmaceuticals) Pack line/device AIF content shipped for regulatory reporting and CMO/wholesaler messaging

Requirements & Key Characteristics of the Pharma Network
> Securely handle huge amounts of business critical data flowing between supply chain partners Easily accessible through onboarding services & scalable to handle large number of members Interoperable with other networks following industry standards Basic architecture available today A network Public cloud offering Re-use Blueprint from Financial Services Network (FSN) Start now and enhance over time with new capabilities or entirely new scenarios Depends on a large number of members to onboard (g network effect) Needs easy access (on-ramps) Needs interoperability to other networks Subscription-based SAP-offered onboarding services Additional service offerings (data mapping, …)

Process Scope Scenario Sender Receiver Process 2015 Project Scope
US Supply Chain Integration MAH Wholesaler Wholesaler Hospital/Pharmacy Transmit Item-Level Traceability Data from MAH -> Wholesaler -> Hospital/Pharmacy according to US DSCSA. CMO Integration CMO MAH Serial number Request Process between CMO and MAH Send Commissioned Data from CMO -> MAH (EPCIS, PML or other format) Includes a Portal UI for small CMOs to request and receive Serial Numbers and to send commissioned data 3PL Integration 3PL Send-item Level data from MAH -> 3PL -> MAH (EPCIS or other format – same CMO-Integration) Brazil Legislation Support All Support Message Orchestration Provide Cloud Repository to store messages from the supply chain Provide access for Anvisa International Regulatory Reporting Support Regulatory Agency European Hub other Send regulatory reporting data from MAH to Gov. Agency or European Hub or other targets via the network Initially readily formatted messages only, may add transformation from standard EPCIS into country-specific formats later 2015 Project Scope Looking for co- innovation partner

Services Overview (draft – work in progress)
Scenario Mandatory? Process Onboarding Yes Enable new members to quickly access / connect to the network Support alignment between parties on message content Messaging Transmit messages via the network according to SLAs Message Monitoring Ensure that errors during message transmission are either corrected by SAP or addressed to the sender Message Mapping No Optional service that provides message mapping capabilities within the EPCIS message, or from PML or other formats to EPCIS Optional service that maps serial number requests and responses from/to line/site server specific formats …

Thank you Product Owner SAP Life Sciences SAP Application Innovation
Dr. Oliver Nürnberg Product Owner SAP Life Sciences SAP Application Innovation SAP SE Dietmar-Hopp-Allee 16 69190 Walldorf, Germany T E Thank you

SAP Advanced Track and Trace for Pharmaceuticals

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