Track & Trace

Core Services

ROI

Trac

eabi

lity

Syste

ms

Technology

Integration

Quality Management

Systems

What We Do

“PharmTech turns costs into investments.”

About Us• Established in 1995• Emphasis on FDA compliance and regulated industries

Pharmaceutical, Medical Device and Biotech• Headquartered in Libertyville, Illinois• Employee Owned ESOP• In 2007 we focused our activities to address concerns

of pharmaceutical clients on U.S. & Ex-US regulatory guidelines surrounding Track & Trace.

Our People• Management/PMs average 10 years experience• Associates average 6 years experience• Permanent staff is comprised of

• ASQ Certified Quality Auditors• Certified Supply Chain Professionals (CSCP)• Quality Engineers and Managers• IT personnel• 4-year technical degreed professionals

Our Clients

• Primarily Fortune 100 clients• 100,000 + hrs compliance services in 2008-2010• >75% repeat business• Approximately 50% projects > 5,000 hrs• Current projects in California, Georgia, Illinois and

Texas

Global Mandates

Turkey Item Level Serialization June 2009Serbia August 2009Turkey Aggregation June 2010France CIP13 , 2D Bar Code January 2011Columbia January 2012Brazil GS1, 2D Bar Code, Labels January 2012Spain 2D Bar Code 2012Italy 2D Bar Code 2012EU Package Serialization January 2014US- CA Serialization & E-Pedigree January 2015

Traceability: What’s behind it?

Traceability assists in;• Recall Management• Diversion• Counterfeit• Reimbursement• Theft

Patient Safety

Identifying Business Value

“Pharmaceutical Focus 2011: Supply Chain” Eyefortransport

“Life Science leaders are looking at these regulatory requirements as an

opportunity to improve business process and operations, enhance

patient safety and protect the brand.”-Hussain Mooraj, AMR Research

ROI

Reducing Days on Hand Inventory

Real Time Tracking

Good Distribution Practices

Planning, Production & Logistics

Import Process MonitoringLot Restriction Application

Diversion

Process Standardization

Cold Chain MonitoringShelf Life

Recall Management

Anti CounterfeitingCycle Time Balancing

Process Modeling & Simulations

ROI is Everywhere

Chargeback Management

Trade Promotion Optimization

Cash Flow Management

Improved Asset Utilization

Demand Planning

Vendor Managed Inventory (VMI)

End to End

Perfect Order

Immediate ROI OpportunitiesAsset Visibility, Tracking & Utilization

Issue Resolution and Opportunities

Real Time Response

Pedigree & Authentication Capture

Leverage Captured Data for Improvements in;Sales & MarketingInventory ControlLogisticsWorkflow ProcessesCash-to-CashPerfect Order

Recall Management

Identification of Diversion & Counterfeiting

Planning for Business ValueStrategy

• Process Mapping• Business Process Analysis• Gap Analysis• Current State/Future State Evaluation• Time and Motion Studies• Commercial Relationships• Manufacturing Standards

Planning

• Impact Analysis• Business Value Propositions• Traceability Architecture Development• Strategic Solutions• Systems Recommendations• User Requirements• Long Term Planning & Forecasting• Solutions Provider Analysis

Implementation

• Project Management• GS1 Conversion• Internal Test & Validation• Trading Partner Connection• Piloting

Phase 1: Strategy

•Process Mapping•Business Process Analysis•Gap Analysis•Current State/Future State Evaluation•Time and Motion Studies•Commercial Relationships•Manufacturing Standards

Strategy

Phase 2: Planning

•Impact Analysis•Business Value Propositions•Traceability Architecture Development•Strategic Solutions•Systems Recommendations•User Requirements•Long Term Planning & Forecasting•Solutions Provider Analysis

Planning

Phase 3: Implementation

•Project Management•GS1 Conversion•Internal Test & Validation•Trading Partner Connection•Piloting

Implementation

End to End Visibility

Scope of Work:•Pilot serialization program to understand;

• Data usage • implementation timeline & costs• line impact and required inventory build

Challenge: •Pharmaceutical manufacturer had near zero visibility into their supply chain. •Concerned with forthcoming regulatory requirements.

End to End Visibility

Results:•Dashboards, Metrics •Trading Partner data share•Visibility of Actual Demand•Budget clarity•Compliance architecture in place•Reduction in inventory and ingredient costs•End to End integration

Real World : Real ValueWith increasing costs of drug development, finding ways to boost market share of existing branded drugs which have gone off patent was of prime concern, as branded drugs have higher premium than competing generics.

Challenge: •Flat sales and generic equivalents •Current system too costly. •Need serialization compatibility

Real World: Real Value

Results:•Serialization mitigated future regulatory concerns

•Authentication achieved

•Automated software for dispenser,• Direct billing• Inventory fulfillment• Scheduling

•3% increase in overall market share

•Extensible to other products and divisions

Going Beyond a Traditional Serialization Pilot

Pharmaceutical manufacturer wanted to know what manufacturing technology solution, standards and process changes would be needed to deal with serialization of a product.

Challenge:New technology assessmentStandards ConversionUncertain regulationsLimited budget

Scope of Work:Proof of concept Advised client to incorporate additional

Going Beyond a Traditional Serialization Pilot

Business Value Highlights:Original purpose successful

In addition, without additional piloting costs:•Proved viability of authentication •Answered process questions•Provided operational improvement•Forward compatible•Influence industry direction

Reduce Days on Hand Inventory

Challenge: Need to reduce Days on Hand (DOH) costs associated with excessive inventory in the wrong locations.

Business Value:Near real time supply chain view of product in progress and historical data.

Monitoring of key process changes as they occur, expediting the confirmation of the enacted improvements

Reduction in site specific inventory to match production level demand

Decrease in manufacturing times

Strategy

• Process Mapping• Business Process Analysis• Gap Analysis• Current State/Future State

Evaluation• Time and Motion Studies• Commercial Relationships• Manufacturing Standards

Planning

• Impact Analysis• Business Value

Propositions• Traceability Architecture

Development• Strategic Solutions• Systems

Recommendations• User Requirements• Long Term Planning &

Forecasting• Solutions Provider Analysis

Implementation

• Project Management• GS1 Conversion• Internal Test & Validation• Trading Partner Connection• Piloting PharmTech

Traceability ReadinessAnalysis

Customized Traceability

Solution

Traceability Planning

Customized Traceability

Solution

ERP Business Processes

Customized Traceability

Solution

Cultural Features

Ex-US Ops

Third Party Relations

Client

Traceability PlanningMaking Sure That The Solution Is Interoperable With Existing Systems

INFRASTRUCTURE Built on a standardized and secure foundation enabling delivery of event data for tracking forward and tracing backward the flow of product.

TRACEABILITY APPLICATION Integrates event information derived from desired data sources in the distributed supply chain, displaying business activity and intelligence in a dashboard format.

BUSINESS PROCESSES Enable new and accurate sources of information from the extended supply chain for improvement of productivity and performance.

BUSINESS VISION Provide “Real Time” internal and external visibility, meeting Global Supply Chain objectives through integration of global traceability standards and technology.

The Traceability Solution

Why PharmTech?

Credentialed: 16 year track record in PharmaceuticalsFounded Traceability Solutions Group

Cost Effective: Lump Sum ProposalBudget and project clarity from day 1

We Live in Your Space with an emphasis on;Facilities, compliance, equipment and process

History of delivering ROI We don’t talk about value, we find it!

Project Leadership & Innovation

Michael StewartTraceability & Supply Chain Visibility

Direct (847) 281-8924Cell (815) 403-8425mstewart@PharmTechInc.com

Next Steps…