Serialization – Business Drivers, Building Blocks Riya Cao, Vertical Director of Life Sciences, QAD Guido Van Den Broeck, Senior Product Manager, QAD Rick

Serialization – Business Drivers, Building Blocks Riya Cao, Vertical Director of Life Sciences, QADGuido Van Den Broeck, Senior Product Manager, QADRick Seibert, Vice President, Sharp Corporation

QAD Explore 2012

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The following is intended to outline QAD’s 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 QAD’s products remains at the sole discretion of QAD.

Safe Harbor Statement

Serialization – Business Drivers, Building Blocks

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• Serialization Status Update• Industry drivers and requirements• Serialization building blocks• QAD solutions• Customer case study• Wrap up• Q and A

Agenda


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Riya Cao

Overview, Industry Drivers & Requirements


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Unique identification number

Serialization Overview


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• Combat counterfeit- 7% all merchandise globally- 10% pharmaceutical products globally

• Industry requirement- Customer requirements- Regulatory requirements

Industry Drivers


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• Roch cancer medicine Altuzan found in U.S.

• Counterfeit hybrid eXtreme Uniclamp(TM) Repair Kits

Counterfeit


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• Automotive- OEM- VIN- Sequencing- MMOG/LE

• Government contracts- Defense- Aerospace- Component level

Customer Requirement


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• Consumer products- Walmart- Big box retailer- New vending

• Electronics- Finished goods- Components



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• Life sciences- CA ePedigree- FDA serialization guidance- International serialization requirement

• Turkey• China• Greece• Italy• Netherlands (proposed)

Regulatory Requirements


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• Life sciences- Wholesalers- Distributors- Hospitals- OEM customers



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Guido Van den Broeck

Building Blocks and QAD Solutions


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Operations impacted

Serialization for Manufacturers


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• Packaging• Serialized data management• Warehouse – serialized inventory • Data carrier (labeling)• Communication and reporting

Serialization - Building Blocks


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Building Block #1 - Packaging


Unit Serialization (Lot 123)• Each saleable unit is assigned

a unique identifier

Case Serialization (Lot 123, 24 units per case)• 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)

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• Packaging types • Packaging structures• Default packaging

structures per item per origin/destination

• Label Formats

QAD - Packaging Master Data


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• Multiple serial ID formats (GS1, SSCC, SGTIN)

• Buyer regulated serial ID ranges• Multi-level aggregation serial ID’s• Identify inventory by serial ID’s and Lot

ID’s• Track & trace throughout life cycle serial

ID’s

Building Block #2 – Serialized Data


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QAD – Serialized Data Management


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Building Block #3 – Serialized Inventory


Warehouse / Distribution

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• Lot control segregated from serial control

• Aggregation Serialized Packs• Integrated with inventory

transactions (Native API’s)• Packaging transactions

(build, remove, repack…)

QAD - Serialized Inventory Management


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•Linear•2D Matrix•RFID

Building Block #4 – Label Printing


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• 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

QAD - Label Printing Manager


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Communications, integration and reporting

Building Block #5 – Communication, Reporting


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• Native API’s • Q-Docs (QAD

QXtend)• Serialization logic

integrated in API’s for inventory transactions

• Outbound ASN support serialized packs / items(RxASN)

• Reporting Serialization Data

Communication/Integration


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Business Flow Example – Item Serialization


Receive sales order

Receive authorized ID ranges

Work order

preparations

Work order

execution

Pack receipt by WO

Pack move to warehou

se

Pick goods

Pack goods

Load packs in

truck

Confirm shipmen

ts

RxASNSerial

reporting

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Rick Seibert

Sharp Corporation Company Overview & Case Study


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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

Sharp Capabilities

Sharp Corporation – Company Overview & Case Study

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Customer Base


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United Drugs Packaging Group


European Packaging Centre

Heerenveen, Oudehaske

The Netherlandswww.epc-pharma.com

Sharp Corporation

Allentown, PennsylvaniaConshohocken, Pennsylvania

United Stateswww.sharpcorporation.com

TD-Packaging

SwindonUK

www.tdpackaging.co.uk

Enestia

Hamont-AchelBelgium

www.enestia.be

UDPG – ‘International Reach, Local Focus, One voice to the customer’

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US Locations


3 Primary locations in the US9 Account Executives covering the US~ 500,000 sq. ft. of packaging spaceApprox. $120 million in turnoverApprox. 750 Full Time EmployeesApprox. 120 Pharmaceutical CustomersAcquired by United Drug, plc 2008

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Packaging


Packaging is becoming a strategic function within the supply chain

Packaging

Functional

Strategic

• Protect the drug

• Protect the user – child

resistant (CR), senior

friendly, braille.

• Protect the brand and user

through:

• Increased compliance

• Reduced diversion

• Reduced counterfeiting

• Reduced reimbursement

fraud

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• 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

ST&T Services Provided


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• QAD- QAD EA ™ - QAD WMS ™ , QAD TMS ™ , QAD Serialization ™

• Covectra AuthentiTrak™ Solution- 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™

Technology Partners


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Sharp Architecture Serialization


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• 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

Market Drivers for ST&T Implementation


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“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.

Regulation is driving this relationship through serialization

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

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• 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.

Customer Challenges


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• Withdrawal• Confidentiality – “stigma”• Isolation• Disease state itself• Need for information and access• Convenience• Education• Cost

Patient Challenges


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• Training• Practice Management• Technology access• Clinical support – clinical outcomes• Patient base monitoring• Certification - regulation

Clinician Challenges


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• Clinical endpoint?• Efficacy• Availability• Compliance and Adherence• Control of supply chain• Therapeutic choices

- Efficacy

• Diversion

Payer/PBM Challenges


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• Drug Diversion and Black Market• Patient Safety• Community Safety/Child Safety• Crime• Monitoring• Physician accounting• REMs

Regulatory Agency Challenges


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Integrated Multi-Channel StrategySharp Corporation – Company Overview & Case Study

16 years experience designing compliance and

persistency programs

In-Out bound support

HCPs & Patients

Multi-Channel Compliance

Technologies

Fulfillment Department for

Direct mail solutions

Tele-Services Nurse Educators

Packaging

Design

HCP/ Patient Educational Programs

Select Targets & Deciles

‘Total Office Call’

Synergy with Sales Force

COLL

ABORA

TIONCOLLABORATION

Multi-Channel Compliance Solution

COLLABORATION

Engaging Patients

Informing Patients

Guiding Patients

By Design

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Wrap-Up


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• 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

Business Values Serialization


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• 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

Business Values Serialization


QAD Serialization Summary


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Packaging

Serialized Data Management

Data Carriers/ Label Printing

Serialized Inventory (Transactions)

Communications / Integration

QAD Serialization

QAD Serialization

QAD Serialization

QAD Serialization

QAD Serialization

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Mar Apr May Jun Aug Sep Oct NovJul201

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Jul Aug Sep Oct Nov Dec Jan Feb201

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Serialization+ Solution Timeline


Early Adopter

Generally Available

• Demo Theater- Demo Session @ Demo Theater

Tuesday @ 7 PM

• Expo QAD Booth• Engage with your QAD account manager

Next Steps


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Riya CaoVertical Director of Life Sciences, QAD

[email protected]

Guido Van den BroeckSenior Product Manager, [email protected]

Rick SeibertVice President, Sharp [email protected]

Questions & Answers


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www.qad.com© QAD Inc 2012

http://www.qad.com/

Documents

Serialization – Business Drivers, Building Blocks Riya Cao, Vertical Director of Life Sciences, QAD Guido Van Den Broeck, Senior Product Manager, QAD Rick