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
2
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
3
• Serialization Status Update• Industry drivers and requirements• Serialization building blocks• QAD solutions• Customer case study• Wrap up• Q and A
Agenda
Serialization – Business Drivers, Building Blocks
4
Riya Cao
Overview, Industry Drivers & Requirements
Serialization – Business Drivers, Building Blocks
5
Unique identification number
Serialization Overview
Serialization – Business Drivers, Building Blocks
6
• Combat counterfeit- 7% all merchandise globally- 10% pharmaceutical products globally
• Industry requirement- Customer requirements- Regulatory requirements
Industry Drivers
Serialization – Business Drivers, Building Blocks
7
• Roch cancer medicine Altuzan found in U.S.
• Counterfeit hybrid eXtreme Uniclamp(TM) Repair Kits
Counterfeit
Serialization – Business Drivers, Building Blocks
8
• Automotive- OEM- VIN- Sequencing- MMOG/LE
• Government contracts- Defense- Aerospace- Component level
Customer Requirement
Serialization – Business Drivers, Building Blocks
9
• Consumer products- Walmart- Big box retailer- New vending
• Electronics- Finished goods- Components
Customer Requirement
Serialization – Business Drivers, Building Blocks
10
• Life sciences- CA ePedigree- FDA serialization guidance- International serialization requirement
• Turkey• China• Greece• Italy• Netherlands (proposed)
Regulatory Requirements
Serialization – Business Drivers, Building Blocks
11
• Life sciences- Wholesalers- Distributors- Hospitals- OEM customers
Customer Requirement
Serialization – Business Drivers, Building Blocks
12
Guido Van den Broeck
Building Blocks and QAD Solutions
Serialization – Business Drivers, Building Blocks
13
Operations impacted
Serialization for Manufacturers
Serialization – Business Drivers, Building Blocks
14
• Packaging• Serialized data management• Warehouse – serialized inventory • Data carrier (labeling)• Communication and reporting
Serialization - Building Blocks
Serialization – Business Drivers, Building Blocks
15
Building Block #1 - Packaging
Serialization – Business Drivers, Building Blocks
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)
16
• Packaging types • Packaging structures• Default packaging
structures per item per origin/destination
• Label Formats
QAD - Packaging Master Data
Serialization – Business Drivers, Building Blocks
17
• 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
Serialization – Business Drivers, Building Blocks
18
QAD – Serialized Data Management
Serialization – Business Drivers, Building Blocks
19
Building Block #3 – Serialized Inventory
Serialization – Business Drivers, Building Blocks
Warehouse / Distribution
20
• 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
Serialization – Business Drivers, Building Blocks
21
•Linear•2D Matrix•RFID
Building Block #4 – Label Printing
Serialization – Business Drivers, Building Blocks
22
• 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
Serialization – Business Drivers, Building Blocks
23
Communications, integration and reporting
Building Block #5 – Communication, Reporting
Serialization – Business Drivers, Building Blocks
24
• 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
Serialization – Business Drivers, Building Blocks
25
Business Flow Example – Item Serialization
Serialization – Business Drivers, Building Blocks
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
26
Rick Seibert
Sharp Corporation Company Overview & Case Study
Serialization – Business Drivers, Building Blocks
27
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
28
Customer Base
Sharp Corporation – Company Overview & Case Study
29
United Drugs Packaging Group
Sharp Corporation – Company Overview & Case Study
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’
30
US Locations
Sharp Corporation – Company Overview & Case Study
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
31
Packaging
Sharp Corporation – Company Overview & Case Study
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
32
• 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
Sharp Corporation – Company Overview & Case Study
33
• 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
Sharp Corporation – Company Overview & Case Study
34
Sharp Architecture Serialization
Sharp Corporation – Company Overview & Case Study
35
• 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
Sharp Corporation – Company Overview & Case Study
36
“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”
Sharp Corporation – Company Overview & Case Study
• The Key Stakeholders- PharmaCo – Our
“Customer”- The Patient- The Clinician- The Payer/PBM
(Pharmacy Benefits Managers)
- Regulatory Agencies
• The FDA• The DEA
38
• 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
Sharp Corporation – Company Overview & Case Study
39
• Withdrawal• Confidentiality – “stigma”• Isolation• Disease state itself• Need for information and access• Convenience• Education• Cost
Patient Challenges
Sharp Corporation – Company Overview & Case Study
40
• Training• Practice Management• Technology access• Clinical support – clinical outcomes• Patient base monitoring• Certification - regulation
Clinician Challenges
Sharp Corporation – Company Overview & Case Study
41
• Clinical endpoint?• Efficacy• Availability• Compliance and Adherence• Control of supply chain• Therapeutic choices
- Efficacy
• Diversion
Payer/PBM Challenges
Sharp Corporation – Company Overview & Case Study
42
• Drug Diversion and Black Market• Patient Safety• Community Safety/Child Safety• Crime• Monitoring• Physician accounting• REMs
Regulatory Agency Challenges
Sharp Corporation – Company Overview & Case Study
43
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
44
Wrap-Up
Serialization – Business Drivers, Building Blocks
45
• 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
Serialization – Business Drivers, Building Blocks
46
• 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
Serialization – Business Drivers, Building Blocks
QAD Serialization Summary
Serialization – Business Drivers, Building Blocks
47
Packaging
Serialized Data Management
Data Carriers/ Label Printing
Serialized Inventory (Transactions)
Communications / Integration
QAD Serialization
QAD Serialization
QAD Serialization
QAD Serialization
QAD Serialization
48
Mar Apr May Jun Aug Sep Oct NovJul201
2
Jul Aug Sep Oct Nov Dec Jan Feb201
3
Serialization+ Solution Timeline
Serialization – Business Drivers, Building Blocks
Early Adopter
Generally Available
• Demo Theater- Demo Session @ Demo Theater
Tuesday @ 7 PM
• Expo QAD Booth• Engage with your QAD account manager
Next Steps
Serialization – Business Drivers, Building Blocks
49
50
Riya CaoVertical Director of Life Sciences, QAD
Guido Van den BroeckSenior Product Manager, [email protected]
Rick SeibertVice President, Sharp [email protected]
Questions & Answers
Serialization – Business Drivers, Building Blocks