R&D Logistics: Clinical Trial Supply Management for the Life Sciences Industry. SAP Online Conference October 7, 2003

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1 R&D Logistics: Trial Supply for the Life Sciences Industry SAP Online Conference October, 00

2 Agenda Introduction & Challenges Meeting the Challenges with SAP Solution Demonstration Summary and Q & A SAP AG 00, Trial Supply Webinar October, 00

3 Pharmaceuticals Enterprise Strategic Enterprise Business Business Intelligence & Decision Support Accounting Employee Relationship & Workforce Research & Development R & D Administration Drug Discovery Chemical & Pharmaceutical Development Trial Regulatory Submission Commercialization Product Marketing Service Sales Commercial Transactions Enterprise Quality Supplier Quality Laboratory Information Corrective Action and Preventive Action Quality Assurance Logistics Production Planning Regulated Facilities and Equipment Facilities Equipment Maintenance Execution Business Support Employee Life-Cycle & Transaction Procurement Financial Supply Chain Fixed Asset SAP AG 00, Trial Supply Webinar October, 00

4 Increased Time Total Drug Development Time From Synthesis to Approval Development Time (Years),, Approval Phase,, Phase, Preclinical Phase, 0,,,,,,,,9,, 0 90s 90s 90s 990s Source: DiMasi, J.A., New Drug Development in U.S Pharmacology & Therapeutics 00. May. 9(s). Source: PhRma Outlook 00 SAP AG 00, Trial Supply Webinar October, 00

5 Total Spending on Development Total in 999: $. billion $0.9 billion $. billion $. billion $. billion Phase I Phase II Phase III Phase IV Source: PhRMA, Tufts Center for the Study of Drug Development, CenterWatch analysis 000 SAP AG 00, Trial Supply Webinar October, 00

6 Wide Gap in Cycle Times for Supply 0 00 Ship and arrive at domestic site Wait to ship Calendar Days Package and release Wait to package Manufacture and release dose form Wait to manufacture dose 0 Best-in-class Average Develop and enter order Best-in-class is the average of the top 0% responses Average is the average of all responses Source: Life science today: Making clinical trial supply operations pay off; Harald Geimer/ Frank Schulz SAP AG 00, Trial Supply Webinar October, 00

7 Agenda Introduction & Challenges Meeting the Challenges with SAP Solution Demonstration Summary and Q & A SAP AG 00, Trial Supply Webinar October, 00

8 Platform for Growth Chemical & Pharmaceutical Development Specification & Formulation Development Trial Supply Full scale manufacturing Execution System SAP AG 00, Trial Supply Webinar October, 00 Compliant Reduce supply chain cycle time Improve time to value

9 Trial Supply Lifecycle SAP AG 00, Trial Supply Webinar October, 00 9

10 CTSM Lifecycle: Adding Value Sufficient supply planning horizon (- yrs.) Reduced inventory costs (-0%) Reduced inventory overage SAP AG 00, Trial Supply Webinar October, 00 0

11 CTSM Lifecycle: Adding Value Regulatory & GMP Compliance Increased manufacturing utilization Reduced operational costs Continuous quality control and mgmt. SAP AG 00, Trial Supply Webinar October, 00

12 CTSM Lifecycle: Adding Value Reduced inventory carrying costs Real-time visibility/ trace-ability Continuous quality control and mgmt. Shelf-life monitoring and retesting SAP AG 00, Trial Supply Webinar October, 00

13 CTSM Lifecycle: Adding Value Reduced time from order to delivery (- weeks) SAP AG 00, Trial Supply Webinar October, 00

14 CTSM Lifecycle: Adding Value On-time delivery (90-9%) Regulatory compliance labeling SAP AG 00, Trial Supply Webinar October, 00

15 CTSM Lifecycle: Adding Value Visibility and trace-ability of patient kits down to patient level SAP AG 00, Trial Supply Webinar October, 00

16 CTSM Lifecycle: Adding Value Optimized reporting throughout the supply lifecycle Decision support SAP AG 00, Trial Supply Webinar October, 00

17 CTSM Lifecycle: Adding Value Regulatory Compliance Optimized reporting based on real-time data SAP AG 00, Trial Supply Webinar October, 00

18 Complete CTSM Lifecycle: Adding Value Regulatory Compliance Optimized reporting throughout the supply lifecycle Decision support On-time delivery (90-9%) Regulatory compliance labelling Optimized reporting based on real-time data Visibility and trace-ability of patient kits down to patient level SAP AG 00, Trial Supply Webinar October, 00 Sufficient supply planning horizon (- yrs.) Reduced inventory costs (-0%) Reduced inventory overage Regulatory & GMP Compliance Increased manufacturing utilization Reduced operational costs Continuous quality control and mgmt. Reduced inventory carrying costs Real-time visibility/ trace-ability Continuous quality control and mgmt. Shelf-life monitoring and retesting Reduced time from order to delivery (- weeks)

19 Agenda Introduction & Challenges Meeting the Challenges with SAP Solution Demonstration Summary and Q & A SAP AG 00, Trial Supply Webinar October, 00 9

20 Trial Supply Lifecycle SAP AG 00, Trial Supply Webinar October, 00 0

21 Planning and SAP AG 00, Trial Supply Webinar October, 00

22 SAP AG 00, Trial Supply Webinar October, 00

23 SAP AG 00, Trial Supply Webinar October, 00

24 Labeling SAP AG 00, Trial Supply Webinar October, 00

25 Reporting, & Reconciliation SAP AG 00, Trial Supply Webinar October, 00

26 Agenda Introduction & Challenges Meeting the Challenges with SAP Solution Demonstration Summary and Q & A SAP AG 00, Trial Supply Webinar October, 00

27 SAP Customer Case Study Global ethical pharmaceutical Net sales: ~$ billion CTSM in Global Supplies Operations: Supply Planning Packaging Internal & external execution SAP AG 00, Trial Supply Webinar October, 00

28 Summary Reduction of clinical supply cycle time Reduction in cycle time 0-0% Complete control of drug supply chain Optimization of drug inventory Reduce inventory -% SAP AG 00, Trial Supply Webinar October, 00

29 Learn more about SAP SAP Business Forum SAP is Scalable to Your Business October, 00 Chicago Hyatt Regency O Hare Keynote Speakers: Bill McDermott, CEO, SAP America Dr. Philip Kotler, Northwestern University Kellogg Graduate School of Mgmt Endo Pharmaceuticals Takeda Pharmaceuticals Dade Behring Serologicals TriVirix There is no cost to attend. To Register call -9- or visit ASUG (Americas SAP Users Group) SCM Forum: October, 00 Phoenix, AZ PLM Forum: November -, 00 Phoenix, AZ To Register visit www. asug.com/00forums Solutions Industry Solutions SAP for Pharmaceuticals SAP AG 00, Trial Supply Webinar October, 00 9

30 Copyright 00 SAP AG. 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. The information contained herein may be changed without prior notice. Some software products marketed by SAP AG and its distributors contain proprietary software components of other software vendors. Microsoft, WINDOWS, NT, EXCEL, Word, PowerPoint and SQL Server are registered trademarks of Microsoft Corporation. IBM, DB, DB Universal Database, OS/, Parallel Sysplex, MVS/ESA, AIX, S/90, AS/00, OS/90, OS/00, iseries, pseries, xseries, zseries, z/os, AFP, Intelligent Miner, WebSphere, Netfinity, Tivoli, Informix and Informix Dynamic ServerTM are trademarks of IBM Corporation in USA and/or other countries. ORACLE is a registered trademark of ORACLE Corporation. UNIX, X/Open, OSF/, and Motif are registered trademarks of the Open Group. Citrix, the Citrix logo, ICA, Program Neighborhood, MetaFrame, WinFrame, VideoFrame, MultiWin and other Citrix product names referenced herein are trademarks of Citrix Systems, Inc. HTML, DHTML, XML, XHTML are trademarks or registered trademarks of WC, World Wide Web Consortium, Massachusetts Institute of Technology. JAVA is a registered trademark of Sun Microsystems, Inc. JAVASCRIPT is a registered trademark of Sun Microsystems, Inc., used under license for technology invented and implemented by Netscape. MarketSet and Enterprise Buyer are jointly owned trademarks of SAP AG and Commerce One. SAP, SAP Logo, R/, R/, mysap, mysap.com and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP AG in Germany and in several other countries all over the world. All other product and service names mentioned are trademarks of their respective companies. SAP AG 00, Trial Supply Webinar October, 00 0

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