QAD Explore 2012 Serialization Business Drivers, Building Blocks

QAD Explore 2012 Serialization  Business Drivers, Building Blocks

QAD Explore 2012 Serialization Business Drivers, Building Blocks Riya Cao, Vertical Director of Life Sciences, QAD Guido Van Den Broeck, Senior Product Manager, QAD Rick Seibert, Vice President, Sharp Corporation Serialization Business Drivers, Building Blocks Safe Harbor Statement The following is intended to outline QADs general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, functional capabilities, and should not be relied upon in making purchasing decisions. The development, release, and timing of any

features or functional capabilities described for QADs products remains at the sole discretion of QAD. 2 Serialization Business Drivers, Building Blocks Agenda Serialization Status Update Industry drivers and requirements

Serialization building blocks QAD solutions Customer case study Wrap up Q and A 3 Serialization Business Drivers, Building Blocks Overview, Industry Drivers & Requirements Riya Cao 4 Serialization Business Drivers, Building Blocks Serialization Overview Unique identification number

5 Serialization Business Drivers, Building Blocks Industry Drivers Combat counterfeit - 7% all merchandise globally - 10% pharmaceutical products globally Industry requirement - Customer requirements - Regulatory requirements 6 Serialization Business Drivers, Building Blocks Counterfeit

Roch cancer medicine Altuzan found in U.S. Counterfeit hybrid eXtreme Uniclamp(TM) Repair Kits 7 Serialization Business Drivers, Building Blocks Customer Requirement Automotive - OEM VIN

Sequencing MMOG/LE Government contracts - Defense - Aerospace - Component level 8 Serialization Business Drivers, Building Blocks Customer Requirement Consumer products - Walmart - Big box retailer - New vending

Electronics - Finished goods - Components 9 Serialization Business Drivers, Building Blocks Regulatory Requirements Life sciences - CA ePedigree - FDA serialization guidance - International serialization requirement

Turkey China Greece Italy Netherlands (proposed) 10 Serialization Business Drivers, Building Blocks Customer Requirement Life sciences - Wholesalers Distributors Hospitals OEM customers

11 Serialization Business Drivers, Building Blocks Building Blocks and QAD Solutions Guido Van den Broeck 12 Serialization Business Drivers, Building Blocks Serialization for Manufacturers Operations impacted 13 Serialization Business Drivers, Building Blocks Serialization - Building Blocks

Packaging Serialized data management Warehouse serialized inventory Data carrier (labeling) Communication and reporting 14 Serialization Business Drivers, Building Blocks Building Block #1 - Packaging Unit Serialization (Lot

123) Case Serialization (Lot 123, 24 units per case) Each saleable unit is assigned a unique identifier Units packed into cases. Each case is assigned a unique identifier and each unit (child) is associated with the case (parent) Pallet Serialization (Lot # 123, 128 cases per pallet) Cases packed onto pallets. Each pallet is assigned a

unique identifier and each case (child) is associated with the pallet (parent) 15 Serialization Business Drivers, Building Blocks QAD - Packaging Master Data Packaging types Packaging structures Default packaging structures per item per origin/destination Label Formats 16 Serialization Business Drivers, Building Blocks

Building Block #2 Serialized Data Multiple serial ID formats (GS1, SSCC, SGTIN) Buyer regulated serial ID ranges Multi-level aggregation serial IDs Identify inventory by serial IDs and Lot IDs Track & trace throughout life cycle serial IDs 17 Serialization Business Drivers, Building Blocks QAD Serialized Data Management 18

Serialization Business Drivers, Building Blocks Building Block #3 Serialized Inventory Warehouse / Distribution 19 Serialization Business Drivers, Building Blocks QAD - Serialized Inventory Management Lot control segregated from serial control

Aggregation Serialized Packs Integrated with inventory transactions (Native APIs) Packaging transactions (build, remove, repack) 20 Serialization Business Drivers, Building Blocks Building Block #4 Label Printing RFID 2D Matrix Linear 21

Serialization Business Drivers, Building Blocks QAD - Label Printing Manager Setup printers for label printing Print barcode labels directly from key transactions Label design using 3rd party software (label template)

Label format definitions Generate file with fixed and variable data according to label format Connect to hardware via different communication protocols 22 Serialization Business Drivers, Building Blocks Building Block #5 Communication, Reporting

Communications, integration and reporting 23 Serialization Business Drivers, Building Blocks Communication/Integration Native APIs Q-Docs (QAD QXtend)

Serialization logic integrated in APIs for inventory transactions Outbound ASN support serialized packs / items(RxASN) Reporting Serialization Data 24 Serialization Business Drivers, Building Blocks Business Flow Example Item Serialization 25

Serialization Business Drivers, Building Blocks Sharp Corporation Company Overview & Case Study Rick Seibert 26 Sharp Corporation Company Overview & Case Study Sharp Capabilities Package specialized products Oral Solid dose Specialized drug delivery systems - OTF/TD Liquids Creams Powders

Ointments Contract Services / Programs Standard Packaging - Blisters - Bottles - Pouches Compliance Packages Vial Labeling/Kit Design Serialization & Track & Trace Clinical Trial Materials Packaging Specialty Distribution

- Physician Samples - Cold Chain 27 Sharp Corporation Company Overview & Case Study Customer Base 28 Sharp Corporation Company Overview & Case Study United Drugs Packaging Group UDPG International Reach, Local Focus, One voice to the customer Sharp Corporation TD-Packaging

Enestia European Packaging Centre Allentown, Pennsylvania Conshohocken, Pennsylvania United States www.sharpcorporation.com Swindon UK www.tdpackaging.co.uk Hamont-Achel Belgium www.enestia.be Heerenveen,

Oudehaske The Netherlands www.epc-pharma.com 29 Sharp Corporation Company Overview & Case Study US Locations 3 Primary locations in the US 9 Account Executives covering the US ~ 500,000 sq. ft. of packaging space Approx. $120 million in turnover Approx. 750 Full Time Employees Approx. 120 Pharmaceutical Customers Acquired by United Drug, plc 2008 30

Sharp Corporation Company Overview & Case Study Packaging Packaging is becoming a strategic function within the supply chain Functional Protect the drug Protect the user child resistant (CR), senior friendly, braille.

Packaging Protect the brand and user through: Strategic Increased compliance Reduced diversion

Reduced counterfeiting Reduced reimbursement fraud 31 Sharp Corporation Company Overview & Case Study ST&T Services Provided Project Consulting and Project Management - Package and process definition

Serial number management services Data Carrier selection and line integration - 2D barcodes, RFID Tags - Pre-serialized carton/tag aggregation services ERP integration services Flexible solutions custom fit into value added programs - REMs solutions - Physician, patient and care giver training and counseling programs - Patient registries - Event based reporting - Data management and customer interface

Specialty distribution, cold chain distribution 32 Sharp Corporation Company Overview & Case Study Technology Partners QAD - Covectra AuthentiTrak Solution -

QAD EA QAD WMS , QAD TMS , QAD Serialization Saas and on-site system configuration/integration ERP interface Serial number management services Solution development and integration services Systech International Serialized Product Tracking (SPT) - Systech Guardian, Systech Advisor, Systech Sentri 33 Sharp Corporation Company Overview & Case Study Sharp Architecture Serialization 34

Sharp Corporation Company Overview & Case Study Market Drivers for ST&T Implementation Regulatory Compliance - Federal, State, and International requirements - PDMA requirements Product diversion REMs Programs Product counterfeiting, safety Supply Chain Efficiency

- Returns processing - Charge-Back authentication, verification Compliance and Adherence programs Patient, Physician and Care Taker education/counseling 35 Regulation is driving this relationship through serialization Use of mass serialization to uniquely identify all drug products intended for use in the United States is the single most powerful tool available to secure the US drug supply FDA Counterfeit Drug Task Force 2004

Pfizer have ear marked 150 million for investment in serialization in 2012 AstraZeneca has implemented serialization on 25 packaging lines in the UK, Sweden and China. 36 Sharp Corporation Company Overview & Case Study Substance Addiction A Case for Integrated Solutions The Key Stakeholders - PharmaCo Our Customer - The Patient - The Clinician - The Payer/PBM

(Pharmacy Benefits Managers) - Regulatory Agencies The FDA The DEA Sharp Corporation Company Overview & Case Study Customer Challenges Losing patent protection/exclusivity on the existing formulation - Pending generic entry Launching a new formulation which changes prescribing habits Different product requirements for US and ROW Limited physician demographics (training

and monitoring) Regulatory approval risks REMs, delays, etc. 38 Sharp Corporation Company Overview & Case Study Patient Challenges Withdrawal Confidentiality stigma

Isolation Disease state itself Need for information and access Convenience Education Cost 39 Sharp Corporation Company Overview & Case Study Clinician Challenges

Training Practice Management Technology access Clinical support clinical outcomes Patient base monitoring Certification - regulation 40 Sharp Corporation Company Overview & Case Study Payer/PBM Challenges

Clinical endpoint? Efficacy Availability Compliance and Adherence Control of supply chain Therapeutic choices - Efficacy Diversion 41 Sharp Corporation Company Overview & Case Study Regulatory Agency Challenges

Drug Diversion and Black Market Patient Safety Community Safety/Child Safety Crime Monitoring Physician accounting REMs 42 Sharp Corporation Company Overview & Case Study Integrated Multi-Channel Strategy Multi-Channel Compliance Solution 16 years experience

designing compliance and persistency programs In-Out bound support HCP/ Patient Educational Programs Nurse Educators COLLABORATION Tele-Services Select Targets & Deciles HCPs & Patients N Total Office Call

LA BO RA TI O R BO LA Technologies L CO Multi-Channel Compliance CO L

IO AT Synergy with Sales Force N Fulfillment Department for Direct mail solutions Packaging Engaging Patients Design Informing Patients Guiding Patients By Design

43 Serialization Business Drivers, Building Blocks Wrap-Up 44 Serialization Business Drivers, Building Blocks Business Values Serialization Meeting Regulatory Requirements - Compliancy California ePedigree Act (2015) Similar requirements other countries Enhanced product Safety and Integrity

- Increased granularity in tracking and tracing inventory Speed Up and reduced cost of product recall process Detect and eliminate counterfeiting 45 Serialization Business Drivers, Building Blocks Business Values Serialization Opportunity for Business Value - Compliancy Customer Requirements Branding & customer Loyalty Explore New Markets

Improving Business Operations - Accuracy Inventory / Order Fullfilment / Shipping Performance Increased Inventory Visibility accross Supply Chain 46 Serialization Business Drivers, Building Blocks QAD Serialization Summary Packaging QAD Serialization

Serialized Data Management QAD Serialization Data Carriers/ Label Printing QAD Serialization QAD Serialized Inventory (Transactions) Serialization Communications / Integration QAD Serialization 47

Serialization Business Drivers, Building Blocks Serialization+ Solution Timeline Generally Available Early Adopter Jul Aug 201 2 Sep Oct Nov

Dec Jan 201 3 Feb Mar Apr May Jun Jul

Aug Sep Oct Nov 48 Serialization Business Drivers, Building Blocks Next Steps Demo Theater - Demo Session @ Demo Theater Tuesday @ 7 PM Expo QAD Booth Engage with your QAD account manager

49 Serialization Business Drivers, Building Blocks Questions & Answers Riya Cao Vertical Director of Life Sciences, QAD [email protected] Guido Van den Broeck Senior Product Manager, QAD [email protected] Rick Seibert Vice President, Sharp Corporation [email protected] 50 www.qad.com QAD Inc 2012

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