A Glimpse Into The Post-Implementation Future of Serialization

(Cases from Europe and the U.S.)

Evren Ozkaya, Ph.D., Founder and CEO at Supply Chain Wizard, LLC

Lawrence Hotz, Marketing Manager at WDSrx – Woodfield Distribution, LLC

Serialization for 3PLs

Agenda

2

DIGITAL SUPPLY CHAIN TRENDS

USA – SERIALIZATOIN FOR 3PLs

INTRODUCTIONS: SCW & WDSrx

Quick introduction of presenters & their companies

Technology and Business Trends in Life Sciences

EUROPE – 3PL SERIALIZATION CASE STUDY

VALUE BEYOND COMPLIANCE

Experience from the largest Pharma 3PL in Turkey – Ekol Logistics

WDSrx compliance journey

What comes after the deadlines? How to manage operational efficiency.

Introductions

• WDSrx Provides Third Party Logistics Services And Value Added Solutions Empowering The Life Sciences Industry

• DSCSA Compliant Warehousing, Fulfillment, Packaging and Labeling

• U.S. And International Clients

• Primarily Mid-Size Generics Manufacturers

• Client Base Includes Rx, OTC, Veterinary, Supplements And Nutraceuticals

• On A Typical Day Our Headquarters Facility In Boca Raton, FL Packs 14 Million Dosages Into 800 Orders Reaching 530 Zip Codes And Traveling Over 1.6 Million Kilometers

Woodfield Distribution, LLC – Overview

5

Serialization

(Track & Trace)

Consulting

Supply Chain

Management

Software & Solutions

IoT & Digital

Supply Chain

Transformation

6

• Track operational activities live w/ IoT

• Enhance serialization data for ROI

• Facilitate Trade Partner Collaboration

• Build a “learning” digital supply chain

• Increase the speed of digital transformation

Digital Supply Chain Trends

=

Track and Trace /

Digital Infrastructure

Industry 4.0 &

Internet of Things (IoT)

• Serialization regulations

• Serialization systems

• IT connectivity

• Unit level traceability

• IoT Sensors

• Connectivity of Things (equip., people, products)

• Real-Time Tracking

Business Intelligence & Advanced Analytics

• Big Data Solutions

• Analytics-as-a-Service

• Machine Learning

• Automated Controls

Te

ch

no

log

y

=

End-to-End Collaboration

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Granular Supply Chain Visibility

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Data Driven Decision Making

• Intercompany visibility

• End-to-end SC visibility

• Unit-level Asset / Product / Labor Monitor & Planning

• Supplier Collaboration

• Customer Collaboration

• End-to-End Supply Chain Collaboration

• Patient/Consumer Insights

• Advanced Planning

• Pricing / Commercial / Operations Strategy

Bu

sin

es

s

Right Product Right Quantity Right Time Right Quality Right Price

SC Mission

Supply Chain

Pharma / CMO

Supply Chain

• Make-to-order • Order size 1 • 3-7 minutes

• Transparency

• Feedback

• Reviews / KPIs

• Half-price vs. Taxi

• Variable cost structure

• Abundant Supply that is outsourced

• Make-to-order • Order size = Batch size

• ~90-120 days • High % QA holds

• Low Service Level

• No Customer Feedback KPI

• Limited outsourcing

• High fixed cost

• High prices

• Low Efficiency

Europe – 3PL Serialization Case Study

Ekol Logistics - Overview

Ekol Healthcare in Turkey

30%

Turkish Track & Trace Journey – Early Days

Track & Trace Journey – System & Data

Track & Trace Journey – Integration

Track & Trace Journey – Process Improvements

Track & Trace Journey – 5 years after go-live

2017:

Partnered with Supply Chain Wizard to bring

Serialization-as-a-Service Hub service in EU

Track & Trace Journey – Key Challenges for 3PLs

Track & Trace Journey – Key Benefits for 3PLs

USA – Serialization for 3PLs

Serialization Viewpoints

• The DSCSA Was Passed Into Law By President Obama In 2013

• At That Time, WDSrx Made The Decision To Invest Significant Resources For Early Compliance Implementation Despite Vague Requirements

• Strategic Benefits Of That Decision: Early Industry Influencer, Client Guidance, Streamlined Onboarding, Multiple Entry Points

Jumping In The Deep End

• Partners: TraceLink, ROC IT Solutions, Optel Vision

• Implementation in Q3 2017

• Receiving Serialized Product

• Reaching Out To Clients And Potential Customers And Advocating For A Comprehensive Serialization Program

• Vague Language; Wholesaler Requirements; CMO/Brand Owner Labeling

• Major Wholesalers Are Working With Big Pharma Because They Have Leverage

• Our Smaller Clients Are Vulnerable Because They Lack Volume

Current Outreach and Feedback

We spoke with a client who is a virtual manufacturer

• According to their CMO, their product was serialized because they were adding unique serial numbers to each package

• We explained serial numbers are only one component of serialization

• Brand owner forfeits some ownership control if serial numbers generated from another party repository

• We are battling the ambiguity in the Act and the confusion it is causing

• Product flow and information flow follow different pathways

• Our client dialogue is in two phases: 1. Understanding, leading to 2. Appreciation

Case Study

We Offer Solutions For Manufacturers That Don’t Plan To Serialize And For Others That Have Item Serialization

• Establish Level 4 Repository On Behalf Of Client And Under Their Control

• Packaging And Labeling With DSCSA-Compliant Labels And Barcodes On Each Unit And Package And Pallet

• Store And Fulfill

• Ability To Transmit Aggregated Serialized Data Back To Client To Send Downstream – Information Flow Different From Product Flow

• For Distribution, Managing Data Transmission Of Serialized Data Between Customer And Trading Partner

Serialization Solutions Today

Serialization Solutions For European Manufacturers

• European Manufacturers With Multiple U.S. CMOs

• WDSrx Can Serialize Products From Their Non-Compliant CMOs

• We Are Capable Of Adhering To EU Requirements Through TraceLink To Ship Compliant Products To Europe For Their Market

• Serialization Implementation And Services Affect Warehouse Performance Metrics –Supply Chain Wizard

For European Brand Owners

Value Beyond Compliance – Digital Warehouse

Joint Value Creation in 3PL Operations

• Achieve transformational

impact in the way 3PLs operate

• Inter-Organizational Insights and Best Practices sharing

• Proactive approach to addressing

serialization efficiency impact

• Advanced analytics platform leveraging data & optimizationabilities

Operational Efficiency

Industry Leadership

ImpactCollaboration

Technology is modular, flexible and easy to integrate into all known IoT Platforms. Designed for Industry 4.0 to transform Supply Chains.

SensorsMore than 60 sensors

• Temperature

• Humidity

• Accelerometer

• GPS Location

• Pressure

• Light

GatewaysDifferent connection types

• GSM GW

• WiFi GW

• Ethernet GW

• InCar GW

• Smart Phone App GW

• Lora GW

• SigFox GW

TriggersMechanical needs

• Button

• Touch

• Contact Switch

• Read Switch

• Mechanic Switch

PlatformsCompatible IoT Platforms

• Microsoft Azure IoT Suite

• SAP Hana

• ThingWorx

• Axeda

• IBM BlueMix

• AWS IoT

R&D

Consultancy

Electronic Device

Manufacturing

Mobile

Applications

Software

Development

Big Data Analytics

Payment Systems

Vertical IoT Platforms

Industrial IoT

Tailor Made

Projects

Smart City

Solutions

Vehicle Telematics

Smart Grid

Data CenterWhite Label

Manufacturing

LIVE & Historical Dashboards

SCW DIGITAL WAREHOUSE DASHBOARDS REPORTS SETTINGS ozkayae

OVERVIEW: Track Labor in real time to see current status of workers; monitor actual labor cost in operations

Live Staff Locations Spaghetti Diagrams Heatmaps

(Illustrative only)

Read more at:

http://www.pharmamanufacturing.com/articles/2017/pharmas-digital-supply-chain-transformation/

DASHBOARD

Focus: Turning data into insights, visualizing what’s not visible before (patterns, trends…etc.)

Technology: Data visualization tools, charts, statistics

Example Applications:

• OEE Tracker

• Management Dashboard

• Labor Tracker

DECISIONS

Focus: Turning insights into strategic, tactical and operational decisions to improve performance

Technology: Operations Research, Smart Algorithms, Heuristics, Machine Learning

Example Applications:

• Serialization Wizard

• [Line & Staff] Scheduler

DATA

Focus: Collecting, organizing data on supply chain components at unit level (products, people, processes)

Technology: T&T systems, IoTsensors, Surveys, HMIs, Databases

Example Applications:

• Supply Chain Portal

• Serialization Survey

• Regulations Database

• Digital Logbook

Track & Trace Compliance