SAP Pharma Network deep dive - sapevent.ch. Oliver Nürnberg Product Owner SAP Life Sciences SAP...

Dr. Oliver NürnbergProduct Owner SAP Life Sciences

SAP Application Innovation

October 26, 2016

SAP Pharma Network deep dive

Customer

© 2016 SAP AG or an SAP affiliate company. All rights reserved. 2Customer

SAP Solution Offerings For Pharma Track And TraceATTP: Manage Serialization Within Company / Pharma Network: Exchange Serialization Externally

Pack line/device

ERP/

WM

Government

3PLs, CMOs

wholesalers

SAP

Advanced

Track and Trace

for Pharmaceuticals

Any middleware

Any middleware(optional)

An

y m

idd

lew

are

(op

tio

na

l)

Pharma

Network

Public Cloud

On SAP HANA

Cloud Platform

Early Adopter Modelavailable

Application interface framework

(AIF – restricted license included in SAP Advanced Track

and Trace for Pharmaceuticals)

AIF content shipped for regulatory reporting and

CMO/wholesaler messaging

An

y m

idd

lew

are

connection

managed by customer

1 connection

(op

tio

na

l) connections

managed by SAP

Business Processes &

2016 Baseline Scope


How It All Fits Together:Pharma Network Covers The 4 Main Track & Trace Collaboration Scenarios Within

World-Wide Pharma Supply Chain.

US Hospitals

Pharmacies

Commissioned IDs &

Aggregations according

DSCSA

Commissioned IDs &

Aggregations according DSCSA

Commissioned IDs &

Aggregations

Authorities

Regulatory Reporting

Messages

3b: US Supply Chain Scenario

4: International Regulatory Reporting Scenario

Commissioned IDs &

Aggregations

Serial Number Request

and Response

2: 3PL Scenario

1: CMO Scenario

3a: US Supply Chain Scenario

*simplified view: PN also supports messages from e.g. CMO to Hospital, MAH to Hospital, CMO to 3PL etc.

MAH = Market Authorization Holder’

SAP Advanced Track and Trace for Pharmaceuticals

Pharma Network (cloud)

CMO = Contract Manufacturing Organization

3PL = Third Party Logistic Provider

US Wholesaler

Verification request

& response for sellable returns

Pharma

MAH

CMO

3PL


Pharma

Network

1: CMO Scenario


Contract

Manufacturer

(CMO)

Market

Authorization

Holder (MAH)

Request SN Check Request

Determine SN List or Range

Send SN List or Range and

Return Code

Send commissioned SN ListImport SN List into

repository

Manage SN List/Range

Forward to Pack Line

Packaging

Send SN reconciliation

report

Import SN reconciliation

report

Commissioned Data

Transmission

SN reconciliation report

transmission (optional)

Portal

or B2B B2B(potentially

future portal)

Technology


The Pharma Network leverages SAP’s established Cloud Technology:

HANA Cloud Platform & HANA Cloud Integration

The Pharma Network is built on HANA Cloud Platform

(HCP) utilizing HANA Cloud Integration (HCI)

HCP is used to build any application and data persistency

HCI is used for message mapping and routing

The Pharma Network utilizes the Blueprint of existing

solutions like the FSN (Financial Services Network)

and Ariba

Overall architecture and technology

Encryption and security setup

Onboarding services

Ariba Supplier Directory

Disaster Recovery and Fail-over

Data Centers in Ashburn (VA) and Chandler (AZ) for US

Customers

Data Centers in St. Leon-Rot (DE) and Amsterdam (NL) for

European customers

Data centers for Asia-Pacific customers tbd.

HCP

HCI

Message

Orchestr

ation

Message

Mapping….

….AppsData

Storage

Member

Directory

User Access

through UI

B2B-Access through

middleware


Full Separation of Members makes all Participants independent of

other Participants Activities.

Members are totally separated

Full Tenant Separation and Isolation

Multiple services, e.g. Persistency, Identity

Management, Key Management

Message transformation and mapping executed

within the participants tenant into or from the internal

PN message format

Technical Communication Options:

Various connectivity options (e.g. https, sftp, AS2)

Multiple communication patterns (e.g. push-push,

push-pull)

Open and Closed Envelope

Portal Option

High security (multiple security layers)

Data is encrypted in-transfer …

Point-to-point Transport Level Security (TLS/SSH)

Message Level Security (PKCS#7, PGP)

… and at-rest

DB Encryption (AES 128)

Message Level Security (PKCS#7, PGP) on SFTP

server


Message transformation and mapping is executed within the

participants tenant to and from the internal PN message format!

transformation transformation

Member 1

Member 2 FormatInternal PN Format

Member 2

Member 2 Format


1: CMO Scenario

Message Transformation Mechanism


Contract

Manufacturer

(CMO)

Market

Authorization

Holder (MAH)




Return Code


repository



Packaging


report


report

Commissioned Data

Transmission



Portal


future portal)

Potential

mapping

Pharma

Network


1: CMO Scenario

no impact on MAH shall the CMO change his message format


Contract

Manufacturer

(CMO)

Market

Authorization

Holder (MAH)




Return Code


repository



Packaging


report


report

Commissioned Data

Transmission



Portal


future portal)Additional

transformation

development & test

Service Scope


Services Overview

Scenario Process

OnboardingEnable new members to quickly access / connect to the network incl. user management

Support alignment between parties on message content

Messaging

Transmit messages via the network according to SLAs providing 2 options:

• “Closed Envelope”: message is encrypted and will not be viewed or changed by SAP. Routing

information is added to the envelope by sender. No Message Mapping!

• “Open Envelope”: message will be opened and can be viewed to determine receiver. No

additional routing information required by sender. Message Mapping can be provided as an

option.

Message Monitoring

Ensure that errors during message transmission are either corrected by SAP or addressed to the

sender

Errors are automatically detected through a “watch dog”

Message Mapping

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


High Level – Phases & Main Activities

Deliver Questionnaire

Customer align with SAP

technical leads on

questionnaire

Questionnaire Signed Off

Kick-off meeting with

SAP Team and Customer

Team

Roles & Responsibilities

Discussed

Scope Explained

Collaboration Platform

Created

Pre-Onboarding Test Onboarding

Key and Certificate

Exchange

Customer TEST system

integrated to Network

Ping and Throughput

Testing

Content Testing

Prod Onboarding

Promotion of

configuration to PROD.

PROD key and

certificate exchange.

Ping and throughput

testing on Prod

Service Activation

Optional: Content

Testing / Validation

Tests

Maintenance &

Support

Customer Live

Support offering

engaged

Onboarding Post-Onboarding

Pharma Network Evolution

-- draft and under discussion --


PN in the context of Ariba Collaborative Supply ChainContract Manufacturing Collaboration Process - Vision

16

Benefits

• Allows buyer to leverage purchasing

power while maintaining visibility

and control into contract

manufacturing process

• Improves visibility into availability of

supply

• Drives greater efficiencies between

multiple supply chain parties

• Integration between Ariba Business

network and the Pharma Network

will provide full end-to-end visibility

of the sub-contracting process

Buyer

Subcontract Purchase Order

Component Inventory Data

Goods Receipt Notice

Supplier / Contract

Manufacturer

Component Receipt Notice

PO Confirmation

Component Consumption Notice

Advance Ship Notice

Self Billing/ERS Invoice

Component Ship Notice

Payment

Invoice

SN Response

SN Request

Commissioned IDs


Further CMO Processes that may be supported!

17

Benefits

• All CMO collaboration processes

work through one infrastructure

Buyer

General Document Exchange

Supplier / Contract

Manufacturer

CoA / Quality Data

Batch Record

General Document Exchange

Artwork Review & Approval

Artwork change

CPV Raw Data

Batch Release Information

Ingredients Information

Recipe Change

Ingredients Information

IDM

PM

an

ufa

ctu

ring

Data


Potential Additional Scenarios – not in 2016 baseline scope

Cloud Repository

Replicate a selected subset of traceability data into Pharma

Network and store in cloud repository

Make accessible for e.g. small hospitals / pharmacies

Allow access to third parties

Targeted Recall

Based on cloud repository

Allow to distribute recall messages

via the network which follow the

path of the original product

Authentication Portal


Allow authentication of single

units or even bundles/cases by

external users through a cloud

web-service

Analytics


Provide analytics against traceability

data

Include geo-special data

Utilize HANA predictive capabilities?

Summary & Value Proposition


Update on “Pharma Network Ecosystem”

# of Pharma Network Customers: 6

Top 3 US Wholesaler – go-live Nov´16

Top 5 Swiss Pharma – go-live Dec´16

Top 5 US Pharma – go-live Dec´16

Top 20 German Pharma – go-live Dec´16

Top 5 US Pharma – go-live Q1/17

SME Pharma – go-live Q1/17

6 global pharma in vendor selection process incl. 3 Top

10

# of SAP Advanced Track and Trace Customers:

31 (incl. 9 top 25) and 2 Top 3 US Wholesalers

2 live

Pharma Network is real!

Long Term Roadmap in preparation

Focus on traceability in 2016 and early 2017

Extend beyond traceability into batch data,

quality data and other industry specific data

exchange scenarios

Closely integrate with Ariba CSC


Our Unique Contributions Matter – SAP Pharma Network

PN is provided as a public cloud solution and is

completely operated under governance of SAP1

2

3

4

5

6

7

8

Increased Time-to-market and Growth by a faster

onboarding of new CMOs

PN runs in SAP’s world-class Data Centers

PN leverages all aspects of SAP’s HANA Cloud

Platform means scalability, performance and volume.

PN reduces risks by supporting pharma-specific

security standards

Managed Services – methods and tools supporting

from data discovery, maintenance, support to

monitoring of data traffic within PN

Free-up customer’s IT resources

Lower implementation efforts&time providing seemless

integration between SAP’s ATTP and PN

REDUCE COST

BOOST COMPLIANCE


© 2016 SAP AG or an SAP affiliate company. All rights reserved.

No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of SAP AG or an SAP affiliate company.

SAP and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP AG (or an SAP affiliate

company) in Germany and other countries. Please see http://global12.sap.com/corporate-en/legal/copyright/index.epx for additional trademark information and notices.

Some software products marketed by SAP AG and its distributors contain proprietary software components of other software vendors.

National product specifications may vary.

These materials are provided by SAP AG or an SAP affiliate company for informational purposes only, without representation or warranty of any kind, and SAP AG or its

affiliated companies shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP AG or SAP affiliate company products and services

are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an

additional warranty.

In particular, SAP AG or its affiliated companies have no obligation to pursue any course of business outlined in this document or any related presentation, or to develop or

release any functionality mentioned therein. This document, or any related presentation, and SAP AG’s or its affiliated companies’ strategy and possible future

developments, products, and/or platform directions and functionality are all subject to change and may be changed by SAP AG or its affiliated companies at any time for

any reason without notice. The information in this document is not a commitment, promise, or legal obligation to deliver any material, code, or functionality. All forward-

looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Readers are cautioned not to place

undue reliance on these forward-looking statements, which speak only as of their dates, and they should not be relied upon in making purchasing decisions.

http://global12.sap.com/corporate-en/legal/copyright/index.epx

SAP Pharma Network deep dive - sapevent.ch. Oliver Nürnberg Product Owner SAP Life Sciences SAP...

Documents

Transcript of SAP Pharma Network deep dive - sapevent.ch. Oliver Nürnberg Product Owner SAP Life Sciences SAP...