life sciences partner overview & insight...enterprise management & support research...

SAP for Life Sciences

Life Sciences PartnerOverview & Insight

Jim Sabogal and Mandar ParalkarIBU Life Sciences

March 6, 2008

Statement of Confidentiality and Exceptions

No part of this publication may be reproduced or transmitted in any form or forany purpose without the express permission of SAPAG. The informationcontained herein may be changed without prior notice.

The furnishing of this document shall not be construed as an offer or asconstituting a binding agreement on the part of SAP to enter into anyrelationship. SAP provides this document as guidance only to estimated costsand benefits of the predicted delivery project.

These materials are: (i) based upon external and assumptions that are subjectto change; (ii) illustrations of potential performance and cost savings; (iii) notguaranties of future performance or cost savings; and (iv) provided solely forinternal review and use by the subject Company. SAP AG and its affiliatedcompanies ("SAP Group") make no representations or warranties of any kindwith respect to these materials, and SAP Group shall not be liable for errors oromissions with respect to the materials.

© SAP 2008 /

Disclaimer

The roadmaps in this presentation are preliminary versions and notsubject to your license agreement or any other agreement with SAP.This document contains only intended strategies, developments, andfunctionalities of the SAP® product and is not intended to be bindingupon SAP to any particular course of business, product strategy,and/or development. Please note that this document is subject tochange and may be changed by SAP at any time without notice.

SAP assumes no responsibility for errors or omissions in thisdocument

© SAP 2008 /

Goals for this session

What is the SAP strategy for developing new business processes?

Based on the current Solution Map what are the SAP whitespaces (gaps)?

Who are the key “powered by NetWeaver (PBNW)” partners that fulfillthese whitespaces for SAP?

Is there an example of future collaboration between SAP and its partners?

© SAP 2007 /

1. Overview of Life Sciences partners2. Examples of Partner Collaboration3. Summary

Agenda

© SAP 2008 /

Life Sciences Solution Map – White SpacesSuppliers,Partners &RegulatoryAgencies

Customers,Channels &RegulatoryAgencies

Discovery Commercialization Operations Sales & Marketing Service & Support

Enterprise Management & Support

ResearchIntellectual Property and Patent

ManagementAlliance Management

Design & DevelopmentR&D Administration

Process & Product Life Cycle ManagementClinical Trial Management

Clinical Trial Supply Management

Product SupplyProcure to Pay

Supply Chain PlanningCompliant Manufacturing

Enterprise LIMSEquipment MaintenanceWarehouse Management

Order to Cash

Sales & MarketingContract Management

MarketingField Sales

Sales Operations and Performance AnalyticsChannel Management

Support ServicesCustomer Service Management

Parts ManagementService Execution

Compliance & SafetyRegulatory SubmissionProduct Quality & CAPAProduct & Patient Safety

Secure Tracking & TracingRisk Management Product Complaints,

Adverse Events

Government Pricing

ePedigree, Capture EPC (Edge)

Cust. Event Mgmt, ePromotion,External Data Integration

Territory Optimization,Customer Master Data Mgmt,Promotional Incentives

Paper-Based Sample DocumentationSample Fulfillment

Calibration

Weigh and Dispense, MESData Historian

Lab Scheduling, Methods Validation

Regulatory Submissions

Clinical Data Management

eLN, eDC

IP & Alliance Mgmt

Warehouse Automation

© SAP 2008 /

Developing the Life Sciences portfolio

Partner

SAP Portfolio Ind. ValueNetwork

Sho

rt T

erm

Industry Best Practices

Make/Buy

White Space Analysis

Long

Ter

m

SAP Strategy

Business &Technology

Vision

SAP Industry Strategy

Business Process Roadmap

Mid

Ter

mIndustry Vision

Partner Edge and ISV Partner CooperationModels

© SAP 2008 /

“Open Ecosystem”

POWERED BY NETWEAVER

Partner applications are certified to run on SAPNetWeaver

ISV products published via the Partner SolutionCatalog

Invitation to SAP events, and other promotionalactivities

Associate LevelProgram Entry Point

Standard RequirementsBusiness Benefits

Silver-LevelHigher

CommitmentElevated Benefits

GoldLevelHighest

CommitmentMost Benefits

Endorsed BusinessSolutions (EBS)

Collaboratively marketcomplementary productsSolution QualificationPartner product inclusion inSAP Solution MapsJoint sharing of productroadmapsOpportunity to join IndustryValue NetworkHighly selective

SAP SolutionExtensions

(OEM/Reselling)

Joint businessplanningPartner on SAP pricelistSolution ValidationHighly selective, byinvitation only

ISV Cooperation Models

SAP : 10 +

SAP : 20 +

LS : 30 +

SAP : 300-400

Goal for our Customers :End-to-End Solutions plugging white spaces

© SAP 2008 /

Cooperation Models

Additional revenue streams

Leverage common customerbase, SAP brand, sales &marketing

Benefit from global supportstructures

Insights into SAP productroadmap

Broad solution exposure throughinclusion in SAP Solution Maps

Leverage SAP brand and SAPNetWeaver platform

Listed in SAP Partner Directory

Value to Partner

Customers can choose from awide array of products

Lowering integration and TCOby leveraging SAP NetWeavercomponents

Guidance by SAP forcomplementary and qualifiedpartner products

Most complete solution protfolioaligned wirth SAP roadmap

High degree of solution fit andquality throgh solutionqualification and validation

Reduced TCO through existingintegration

Value to Customer

EndorsedBusinessSolutions

SAPSolution

Extensions

OpenEcosystem

© SAP 2008 /

SAP for Life Sciences IVN - Industry ValueNetwork (To be released later in 2008)

SAP User Groups, Industry Forums

Business ConsultingValidation Services

New joint & partner xApps

Endorsed BusinessSolutions & Resellers

Technology infrastructureSecurity / Compliance

SAP for Life Sciences(Best Practices)

© SAP 2008 /

From LS Ecosystem For Partners Today ToIndustry Value Network (IVN) Program Tomorrow

Goal of LS Ecosystem for Partners:SAP for Life Sciences would like to publish the set of partners that SAPcollaborates with in the existing SAP customer baseSAP wants to have a suitable filtering mechanism to identify right strategicpartners for an intensified collaboration so as to reinforce SAP's IndustryThought Leadership (ITL)

Pre-requisite for IVN partner member: Members of the LS Ecosystem for Partnersinterested in IVN group for life sciences need to bring one reference customerExample: SI implementing an ISV solution (based on SAP platform) at a customer

Goal of IVN program:Based on the momentum built from the LS Ecosystem for Partners deploy theIVN group for life sciences

Trigger projects / work-streams from focus areas (ITL) leveraging the SAPplatform (e.g. enterprise SOA)

Deliver "end-to-end solutions" for Life Sciences customers by filling whitespaces with partners

© SAP 2008 /

Focus Areas in Life Sciences Ecosystem ForPartners and IVN Program For Life Sciences

Contract Management

Sales & Marketing Excellence

Clinical Trial ManagementRegulatory Submission

Pharmacovigilance & Product SafetyPharmaceutical Development

Innovation Productivity

Compliant ManufacturingLaboratory Scheduling

Supply Chain ExecutionRFID

Operational Excellence

Mid Market for Life Sciences

Mid Market

GRC Operational Compliance for LSValidation for Life Sciences

Governance, Risk & Compliance

© SAP 2008 /

SAP

Proposal - Life Sciences (LS) Ecosystem ForPartners - Pre-cursor to LS IVN : Planned Members

LS Eco-system ofPartners lead & enabler

System Integrators&Support Services

Industry Services & Solutions

Independent Software Vendors

Complementary Solutions

Customers

Industry Customer Needs

Technology Vendors

Supporting Technology & Solutions

© SAP 2008 /

SAP

Outlook - Prospective candidates to enhance theexisting LS Ecosystem For Partners

System Integrators &Support Services

Industry Services & Solutions

Independent Software Vendors

Complementary Solutions

Customers

Industry Customer Needs

Pharmaceuticals companiesBiotechnology corporationsMedical Products & Instruments firms

Technology Vendors

Supporting Technology & Solutions

Technology Titans that operate inregulated environment

Entegreat Geometrics CreatechCamelot Taratec Cormeta AGGAP Intelligroup Ki SolutionsClarkston OBT Global NNITCognizant Groom SystechInfosys Wipro Cohesion

NRX LabVantageCamstar GE FanucBlueMountain CallidusSystech Performix

LS Eco-system ofPartners lead & enabler

© SAP 2007 /

1. Overview of Life Sciences partners2. Examples of Partner Collaboration

2.1. Manufacturing2.2. Serialization (RFID)2.3. R&D

3. Summary

Agenda

© SAP 2008 /

The Perfect Plant aligns roles, measures andgoals within and across manufacturing

VP Operations

Plant Managers

ProductionManager

MaintenanceManager

Yield

Cycle Times

Manufacturing Process

OptimizedManufacturing

Processes

Changeovers

Compliance to Plan

Within Supply Chain

Efficient Fulfillment

Asset Availability

Efficiency

Within Assets

Reliable Assets

Manufacturing Costs

Within Plant and AcrossProcesses

Operational Excellence

Return on Assets

Across Plants

Profitability

RoleRoleMeasures

Focus

Goal

Perfect Plant provides a cohesive solution to address the need for completealignment and efficient execution from shop floor to top floor

Measures

Focus

Goal

Measures

Focus

Goal

Business

Plant

Planner /Scheduler

© SAP 2008 /

Overview of the End-to-End Process…

VP of Operations

Production Planner

Plant Manager

Production Supervisor

Production Operator

Quality Manager/Inspector

ForecastDemand

Net ForecastAgainst Orders

Develop Supply NetworkPlan for Manufacturing

Role

Out of Scope of this Compliant Manufacturing Process

Develop Detailed MonthlyProduction Plan

Test Samples forQuality Control

Approve and ReleaseProduced Batch / Lot

Approve ProductionPlan and Targets

Create detailed ProductionPlan and Schedule

Outsource PartialProduction to Contract

Manufacturer

Release ProductionOrders

View Work list &Select Order Sequence

Move Goods to Bulk Production Line, Weigh andDispense and Manufacture Product

Monitor, Compare, Analyze and Benchmark and Improve PerformanceGlobally across Multiple Plants, Assets and Personnel

Update ProductionPlans and Report Up

© SAP 2008 /

Manufacturing Process Scenario Showcases

VP of Operations

Production Planner

Plant Manager

Production Supervisor

Production Operator

Quality Manager/Inspector

ForecastDemand

Net ForecastAgainst Orders

Develop Supply NetworkPlan for Manufacturing

Role

Out of Scope of this Compliant Manufacturing Process

Develop Detailed MonthlyProduction Plan

Test Samples forQuality Control

Approve and ReleaseProduced Batch / Lot

Approve ProductionPlan and Targets

Create detailed ProductionPlan and Schedule

Outsource PartialProduction to Contract

Manufacturer

Release ProductionOrders

View Work list &Select Order Sequence

Move Goods to Bulk Production Line, Weigh andDispense and Manufacture Product

Monitor, Compare, Analyze and Benchmark and Improve PerformanceGlobally across Multiple Plants, Assets and Personnel

Update ProductionPlans and Report Up

1 Manage Performance Globally acrossMultiple Plants thru Actionable Insights

2 Planning viaRhythm Wheel

Detailed Scheduling andReleasing Production Orders3

4 Weigh, Dispense andExecute Production Order

Lot Disposition, ExceptionManagement and Reporting5

6 Manage In- sourced and Outsourced Manufacturingand Improve Performance

© SAP 2008 /

EBS: PAS-X (Weigh-Dispense, MBR & EBR) by Werum

Industry Pain PointsConnecting Factory to Enterprise, enablingProduction Personnel are critical to cost-effectively deliver on customer expectations

Global competitiveness placing tremendouspressure on Cost - Savings for profitability,Quality - Drive standardization andResponsiveness - Common execution platform

PAS-ECMI

SolutionEnd-to-End Solution :- Integrated solution to reduce integrationchallenges- Provides complete functional coverageManufacturing platform :

- Single platform for common execution strategy- Integrates with shop-floor automation layer

Open architecture :- Supports industry standards- Adheres to compliance and validation

PAS-X extends the compliant manufacturing capabilities of SAP ERP. With thehelp of PAS-X solution integrated with ERP leveraging MII , offices can beconnected to the factories, weigh-dispense can be managed with bettervisibility to SAP Manufacturing for global sites.

Business BenefitsBetter manage the business growth by gainingcontrol and visibility over global mfg to optimizeperformance.

Reduce overall manufacturing cost bylowering cost of ownership and improveproduct quality.

Ensure Compliance by adhering to regulations.

Interface MES / DCS, SCADA

Interface ERP / MES

Enterprise level

Plantlevel

Fieldlevel

MES

ERP

PLS

SAP Manufacturing M

I

I

Industry Pain PointsSlow decision-making while rescheduling

Infeasible lab scheduling plansManaging expiration dates ofCapacity overloads for a single or group oflabs with different hierarchyIntegration of quality sample data from labswith manufacturing data from ERP orders

LabScheduling

SolutionDetailed lab scheduling for raw material,inprocess and finished goodsSimplified handling of SAP ERP Quality OrderDataSimultaneous Material and Capacity PlanningSimulation versions for decision making

LabScheduling by ORSoft

Lab Planning integrates all relevant logistical data of SAP ERP our additionalsystems - Dynamic Data and Master Data on a single or multi-plant level.

Showing data in browsers allows to gain rapid overview about both planningand master data situation with easy to use interface involving gant charts.

Business BenefitsCreate feasible lab planningReduce time for planning and reaction tounexpected changes for the involved staffQuick response to customer requestsHigher efficiency of lab through put

Industry Pain PointsCustomer service KPIs including order lead timeperformance and order fill rates are below best-in-classand a key factor for customer satisfactionHigh inventory levels tie up working capital and reduceReturn on Capital EmployedIncreasing supply and demand uncertainty causesplanners to spend time expediting and “firefighting”Product proliferation and globalization means plannershave less time to manage more products, supply chains

The SAP-SmartOps solution provides a enterprise-scale process fordynamically positioning and optimizing inventory in multi-tier distribution andmanufacturing supply chains

Enterprise Inventory Optimization is a key component of Dynamic S&OP andSense and Respond business processes

Solution CapabilitesMulti-echelon inventory optimizationAdvanced demand, production, and supply analyticsleverage SAP ERP, SCM and BIIndustry data model and data validation processFlexible workflows, content, and reporting through SAPPortal or SmartOps user interfacesPreconfigured Standard Data Interface with SAP

EBS : SAP Enterprise Inventory Optimization by SmartOps

xAPP MIPO

Business BenefitsStabilize and Improve Product AvailabilityReduce working capitalImprove planner and analyst productivityFast time to value with very large ROI

© SAP 2007 /



3. Summary

Agenda

Typical Life Sciences SerializationDeployment

© SAP 2008 /

Electronic Pedigree

PartnerE-Pedigree

PartnerE-Pedigree Rx ASNs

Product / BatchData

Delivery Data

Collect Tag Reads(Commission ifwriting)

CertifiedInterface

Object EventRepository

[EPCIS]

Build Item/Case/PalletHierarchy **

Build Item/Case/PalletHierarchy **

SAP AII Enterprise - Object Event Repository

© SAP 2008 /

DATA EXCHANGE

TRADINGPARTNERS

e-Proofof

Delivery

PromotionManagement

RecallManagement …

ProductTracking

&Authentication

SAP OER

AUTO-ID RepositoryEvent Management

AnalyticsSecurity Services

AUTO-ID RepositoryEvent Management

AnalyticsSecurity Services

QUERY INTERFACEQUERY INTERFACE

CAPTURE INTERFACECAPTURE INTERFACE

Non-SAPERP

Non-SAPERP

EnterpriseDataSources

© SAP 2008 /

Serialization (RFID/ePedigree) Consortium ofSAP Partners -> California (CA) Express

http://www.getepedigreeready.com/press/CEST_NewsRelease_Oct07.pdf

http://www.getepedigreeready.com/press/CEST_NewsRelease_Oct07.pdf

© SAP 2008 /

SAP ERP “integration” touch-pointswith CA Express solution

© SAP 2008 /

Co-InnovateEvolve vertically integratedBlockbuster development

into virtually integrateddevelopment and

commercialization modelbased on M&A, partnering,

co-development

1

SAP for Life Sciences Solution Areas

InstitutionalizeCompliance

Reinforce public trust bymanaging compliance andrisk in all aspects of your

business in a collaborativeapproach

2Scale Operational

ExcellenceEnsure operational excellenceon a global scale to manage

proliferation in products, pricetags, channels, partners,

reporting etc.

3

Enterprise Management and Platform

• Financial• Operational• Global trade

• Environmental

• e-Sourcing and Procurement• Supply Chain Planning

• Compliant Mfg Operations

• Project & Portfolio Mgmt• Clinical Trial Supply Mgmt

RegulatorySafety

ClinicalDevelopment

© SAP 2008 /

SAP & Partner Solutions in Life Science R&D

R&D AdministationProject, program & portfolio managementResource and capacity managementProfitability analysisRisk management

BenefitsVisibility and Transparency:

Real-time information for decision supportOptimized investment and resource utilizationStandardization across global organization

Clinical Trial Supply ManagementPlanning & forecastingManufacturing, packaging and labelingPatient kit replenishmentDrug accountability

BenefitsOptimized clinical supply chain cycle timeVisibility and traceability down to patient levelReduced inventory overageContinuous quality control

Regulatory SubmissionDocument and Knowledge ManagementInternal and external collaborationSubmission compilation (paper or electronic)Agency communication

BenefitsEnterprise-wide 21 CFR part 11 compliant

document and collaboration platformHigher productivity and efficiencySubmission process acceleration & cost reduction

Bio/Pharmaceutical DevelopmentSpecification & formulation managementPotency / purity assaysAnalytical development and stability testingQuality control

BenefitsCost-effective, safe and compliant developmentEffective monitoring of product qualityEnd-to-end solution with integration / info transfer

from Dev. Operations Commercial Manufacturing

Industry Pain PointsIncreasingly complex R&DLong Cycle time from innovation to

commercial productEscalating Development CostsIncreasing Inefficiency / Capacity

Problems in R&DInability to harmonize information to facilitate

submissions to the FDAInability to rapidly transfer technology from

development to commercial manufacturing

SAP - Conformia deliver a comprehensive solution to accelerate developmentfrom candidate to commercial product, improve pipeline productivity and builda bridge between development and manufacturing.

SolutionEnables to plan, execute, analyze and monitordevelopment from candidate to commercial on asingle platform, to improve your pipelineproductivityProvides comprehensive electronicdevelopment records (EDRs) to enabletraceability, compliance, auditability andaccelerate technology transfer

Product andProcess

Development

Product & Process Development Operation from Conformia

Business BenefitsBetter productivity for business by faster time to Clinic,increased efficiency, improved throughputImproved visibility for science by better developmentlifecycle, reduced data silos / redundancy andinnovationIncreased focus on compliance due to pressure tojustify development history, Quality by Design (QbD)

SAP NetWeaver as common platform

SAP Web Application Server

SAP Enterprise Portal

PCM DevelopmentPlatform Services

CompliantManufacturing & RFID

Clinical TrialSupply Management

SUMS DevelopmentApps Module

eDR – Electronic Development Record

Chemical DrugSubstance

SUMS

Biological DrugSubstance

SUMS

Pharma DrugProductSUMS

SAP xMII (Intelligence & Integration)

SAPNon-SAP

= SAP = Conformia

© SAP 2008 /

Multi-Purpose Document Access &Regulatory Submission (Partner: Lorenz)

Finance / HR R&D & Regulatory Affairs Manufacturing Sales&Mktg

Submissions,Product Dossiers

SOPs,Designs,Specifications

InvoicesEmployee Records,

Training

Product dossiers,Invoices

ResearchPapers,

StudyReports

Business ProcessObject:-Project/Study-Formula-Equipment-Product-Employee-Customer

External/Internal:- Web or Windows Environment- In front of or behind firewall- SAP, non-SAP, legacy

Collaborative WorkEnvironment:-Team Folders-Portal Access-News Distribution-Subscription

Direct/Indirect:-Workflow-Search via Classification or Taxonomy-Access via Business Process Object

Access Mode:

Business Content

Business Benefits21 CFR part 11 compliantMinimal training effort throughportal and windows based accessImproved collaborationOptimization of regulatorysubmission

SAP’s R&D Approach

© SAP 2008 /

Time

Deal

R&D Administration

Clinical Trial Supply Management

Document Management Regulatory Submission

Document Management

Development Operations

Pharmacovigil-ence & Safety

Clinical TrialManagement

RegulatoryRegistration

Tracking

© SAP 2008 /

Community Process Creates Opportunities toDeliver end-to-end solutions to Customers

SAP

PUBLIC

TechnologyPartners

Customers

ISVs

SystemsIntegrators

DefinitionGroups

DefinitionGroups

4. PRODUCTIZE

Customer& Partner

Companies

2. PARTICIPATE 3. CREATE

EnterpriseServices

EnterpriseServiceDefinitions

ESC

1. JOIN

5. SAP CERTIFICATION

Maintain a ES InventoryList & ES Repository –visibility to what’savailable & what’s beenrequested by community

© SAP 2008 /

ES COMMUNITY

SAP

ENTERPRISESERVICES

REPOSITORY

IVN(PBNW)

ASUG/DSUG BPX / Other

ENTERPRISESERVICES

PROPOSAL

TechnologyPartners

ISVs

Customers

SAP

SIs

Definition Groups

Summary - Allows the partner ecosystem to influence &define enterprise services critical to our long term success

Customer and Partner Groups

© SAP 2007 /

For additional information and to get a copy of these slides please visitthe Life Sciences Business Process Expert (BPx) web page at

https://www.sdn.sap.com/irj/sdn/bpx-lifesciences

or to the BPx general web page: http://bpx.sap.com/and go under the "Industries" sectionand then to the "Life Sciences" page

Thank you!

https://www.sdn.sap.com/irj/sdn/bpx-lifesciences

http://bpx.sap.com/

© SAP 2008 /

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