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Transforming Pharmaceutical Business Performance:  The Supply Chain as a Strategic Enabler Robin Koh and Yun Kang SupplyScape, Inc.
Leveraging technology with supply chain domain expertise… …  to deliver industry’s most relevant Track & Trace based Supply Chain Solutions SupplyScape  Driving Product Integrity and Additional Business Value Turning Data Into Actionable Knowledge Pedigree, Serialization & Authentication Business Collaboration & Traceability
A Safe & Secure Chain  The Evolution Continues Improving Accountability & Control Product Security Transaction Security Physical Auth. Features Serialization Trace Track Authentication Pedigree Pharmaceutical Co Wholesaler Pharmacy Chain of Custody Security Individual Product Security
Agenda ,[object Object],[object Object],[object Object],[object Object]
Patent Expiry and Generic Substitution An Increased Emphasis on Efficiency & Cost US Patent Sales at Risk Number of Generic Filings Impacts on price per dose
Global Growth Strategies Emerging Markets Offer Growth, Challenges Source: IMS Market Data, 2007 Year over Year Growth
Product Security Incidents The need for better control on Supply Chains ,[object Object],[object Object],[object Object],[object Object],(Prescription only, not including Biologics) Worldwide Commercial Impact 65 09 56 08 49 07 44 06 39 05 75 10 04 35 ( Counterfeit drugs — $ billions ) Sources: Center for Medicines in the Public Interest Global Pharma Safety Incidents Sources: Organisation for Economic Co-operation and Development 964 04 196 02 484 03 1,123 05 1,412 06 1,759 07 US Drug Recalls Sources: FDA (CDER) Drug Counterfeit Incidents Investigated Sources: FDA 58 04 27 02 21 01 6 00 11 99 30 03 32 05 54 06 31 07 (# Investigation cases opened)
Select Strategic Transformation Programs
Supply Chain Traceability Increasing Global Requirements & Complexity   (1)  Hemophilia products only Est. 2013 Yes TBD Batch # Linear Barcode - TBD Batch Level Korea In effect Batch # Data Matrix / QR Code Biologics Only – Unit Japan In effect Yes SGTIN -96 Serial # - TBD Data matrix Sales Pack Ireland 1 TBD Yes TBD Product Code, Batch #, Date of Mfg, Expiration Date Data Carrier – TBD Sales Pack Brazil Oct 31, 2008 Yes 6  digits  - Numeric 9  digits  - Numeric Serial #  4 digit – Numeric check digit  manufacturer code +  serial number +  check digits Code 128c  Sales Pack China  16 digits  - Numeric  Including 8 digit sequence #  Product License # +  Random Sequence # Product code, Serial # Reimbursement data CIP code 13, Lot #, Expiry date Product Code, Batch #, Unit #, Expiry date National Reg. Number , Sequential # Sequential # Product License # Data Required AI(01) + AI(21) 14 digit – Product code  20 Digit – Serial number  13 digits - Numeric TBD 13 digits  - Numeric 12 digits  - Numeric 9 digits - Numeric 1 letter for Drug Class + 9 digit Numeric Data Format Turkey France Spain Greece Belgium Italy Country Start – 01/08 End – 12/10 Yes Data matrix Lot  In effect Yes Code 39  Sales Pack Jan 1, 09 Yes GS1 standard  (Data Matrix ECC 200 or GS1 128) Sales pack, transport unit  In effect Yes EAN 13 Sales Pack Data matrix on vignette TBD Yes Data Carrier TBD –  PDF 417 / Data matrix  Sales Pack In effect Yes EAN 128  Sales Pack  I2/5 Timeline Mandatory Data Carrier Tracking Level
Agenda ,[object Object],[object Object],[object Object],[object Object]
Supply Network Design Impact of Track & Trace Technologies PharmaCo Distributor Pharmacy Customs CMO/CPO Globalization Acquisitions & Divestitures Outsourcing Capability Constraints Reliability Flexibility
Inventory Management The Systematic Reduction of Uncertainty ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Cost Service Time Inventory Min Max
Other Supply Chain Initiatives Supply Chain  Rationalization KPIs Reverse Logistics Pricing Programs Description Opportunity for Track & Trace ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Agenda ,[object Object],[object Object],[object Object],[object Object]
Case Study #1 Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Study #1 Operational Areas Investigated Product Security Trade Financials Supply Chain Efficiency Out-of-Stock Reduction (Direct Channel) Anti-Counterfeit & Diversion Returns Management Theft & Shrinkage Reduction Clinical Trials Supply Chain Product Complaints  Management & Resolution Shelf-life Management Chargeback Management New Product Launch Management Demand Forecasting & Planning Rebates Management Government Pricing Consignment Inventory / VMI
Case Study #1   Three Different Approaches Used To Estimate Counterfeit Revenue Loss Online Pharmacy Model ,[object Object],[object Object],Overall Market Size Model ,[object Object],[object Object],Global Seizures Model ,[object Object],[object Object],Revenue Loss Estimate 1 2 3
Case Study #1   Returns Problem Decomposed Returned Products Direct Returns Indirect Returns Sold on Contract Not Sold on Contract Sold on Contract Not Sold on Contract
Case Study #1  Returns Reconciliation – Issues and Opportunities   ,[object Object],[object Object],[object Object],[object Object],Business Issues/Challenges Opportunities ,[object Object],[object Object],[object Object]
Case Study #1  Hard Savings Identification Yearly Benefits (unit: $ Thousand)  Supply Chain & Trade Financials – I Supply Chain & Trade Financials – II  Total Product Security Realizable unilaterally by Client Requires data sharing with TP Benefit A Benefit B Benefit C Benefit D Benefit E
Case Study #1  Key Success Factor: Getting Downstream Partners to Participate
Case Study #1   Key Takeaways ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Study #2: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Frequency of manual checking of aging Monthly Typical man-hours spent each time X hours Average hourly wage $ Y # of stores Z Today’s practice ~ $  XX M Business benefit ,[object Object],[object Object],Man-hour reduction due to T&T ~ X   % (incl manual searching & checking, creating and managing current tags, etc.) ePedigree process How T&T can help Stores Case Study #2  Shelf Life Management and Control Made Easier at Store-level
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Root causes of inaccuracy % accountable for inaccuracy How ePedigree can help X  % Y  % Z  % V  % ~  XX  % PI Improvement % ,[object Object],[object Object],[object Object],% improvement by T&T 50  % 0  % 0  % 50  % Stores Case Study #2   Perpetual Inventory Accuracy Improvement Identified
Cycle count frequency Daily Typical man-hours spent each time ~X min Average hourly wage $ Y # of stores Z Today’s practice ~ $  XX M Business benefit PI accuracy improvement  ~ XX % % reduction in cycle count efforts ~ X   % (excluding controlled drugs) ePedigree process Stores Case Study #2  Inventory Accuracy Leads to Potential Reduction in Cycle Count Effort
% of scripts with OOS X % # of scripts/week/store Y Avg retail value of script $ Z Avg markup % V % Out-of-stock (OOS) relevant status Leave for a competitor nearby ~ 5 % Leave for another ABS store ~ 15 % Accept partial fill and/or ~ 80 % return some other time Patient reaction to OOS Ordering ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Supplier delivery failure Inaccurate perpetual inventory Root causes of OOS % accountable for OOS % improvement by Track & Trace ~ X  % ~ Y  % ~ Z  % ~ 0  % ~ 0 % ~ 30 % ~ $  XX M Business benefit Stores Case Study #2  Inventory Accuracy Also Leads to Out-of-Stock Reduction at Stores
Sample on-hand qty of an item at DC A  ,[object Object],[object Object],Rationale for inventory reduction ~ $  XX M Business benefit ,[object Object],[object Object],[object Object],[object Object],DC Case Study #2  Inventory Accuracy Leads to Similar Operational Savings at DC Level Productivity Increase in Receiving Leads to Potential Inventory Reduction Order point = 2880
Key Takeaways ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Agenda ,[object Object],[object Object],[object Object],[object Object]
What Top Pharmaceutical Companies Need To Be Able To Address Today ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Business Opportunities in Supply Chain Traceability ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Experience  Nexus  and our  Global Traceability and Serialization  Solutions  Today ! ,[object Object],[object Object],[object Object],[object Object],[object Object],Country Information Manager Serialized Product Authentication Trade Event Monitor Trading Partner Directory Trade Event Exchange The information on products, technology or customers contained in this presentation is  proprietary  to SupplyScape and is offered  in confidence . SupplyScape makes  no warranty  regarding this information. SupplyScape, in its sole discretion and with no notice, may revise, eliminate or otherwise alter any functionality or product plan to which the information disclosed is related. This information is presented solely for  discussion purposes . This information should not be used as the basis for any current purchase decision from SupplyScape. Contact Mary Hall  today  to schedule a demonstration! 781.503.7462, mhall@supplyscape.com

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Transforming Pharmaceutical Operational Performance with Supply Chain Traceability

  • 1. Transforming Pharmaceutical Business Performance: The Supply Chain as a Strategic Enabler Robin Koh and Yun Kang SupplyScape, Inc.
  • 2. Leveraging technology with supply chain domain expertise… … to deliver industry’s most relevant Track & Trace based Supply Chain Solutions SupplyScape Driving Product Integrity and Additional Business Value Turning Data Into Actionable Knowledge Pedigree, Serialization & Authentication Business Collaboration & Traceability
  • 3. A Safe & Secure Chain The Evolution Continues Improving Accountability & Control Product Security Transaction Security Physical Auth. Features Serialization Trace Track Authentication Pedigree Pharmaceutical Co Wholesaler Pharmacy Chain of Custody Security Individual Product Security
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  • 5. Patent Expiry and Generic Substitution An Increased Emphasis on Efficiency & Cost US Patent Sales at Risk Number of Generic Filings Impacts on price per dose
  • 6. Global Growth Strategies Emerging Markets Offer Growth, Challenges Source: IMS Market Data, 2007 Year over Year Growth
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  • 9. Supply Chain Traceability Increasing Global Requirements & Complexity (1) Hemophilia products only Est. 2013 Yes TBD Batch # Linear Barcode - TBD Batch Level Korea In effect Batch # Data Matrix / QR Code Biologics Only – Unit Japan In effect Yes SGTIN -96 Serial # - TBD Data matrix Sales Pack Ireland 1 TBD Yes TBD Product Code, Batch #, Date of Mfg, Expiration Date Data Carrier – TBD Sales Pack Brazil Oct 31, 2008 Yes 6 digits - Numeric 9 digits - Numeric Serial # 4 digit – Numeric check digit manufacturer code + serial number + check digits Code 128c Sales Pack China 16 digits - Numeric Including 8 digit sequence # Product License # + Random Sequence # Product code, Serial # Reimbursement data CIP code 13, Lot #, Expiry date Product Code, Batch #, Unit #, Expiry date National Reg. Number , Sequential # Sequential # Product License # Data Required AI(01) + AI(21) 14 digit – Product code 20 Digit – Serial number 13 digits - Numeric TBD 13 digits - Numeric 12 digits - Numeric 9 digits - Numeric 1 letter for Drug Class + 9 digit Numeric Data Format Turkey France Spain Greece Belgium Italy Country Start – 01/08 End – 12/10 Yes Data matrix Lot In effect Yes Code 39 Sales Pack Jan 1, 09 Yes GS1 standard (Data Matrix ECC 200 or GS1 128) Sales pack, transport unit In effect Yes EAN 13 Sales Pack Data matrix on vignette TBD Yes Data Carrier TBD – PDF 417 / Data matrix Sales Pack In effect Yes EAN 128 Sales Pack I2/5 Timeline Mandatory Data Carrier Tracking Level
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  • 11. Supply Network Design Impact of Track & Trace Technologies PharmaCo Distributor Pharmacy Customs CMO/CPO Globalization Acquisitions & Divestitures Outsourcing Capability Constraints Reliability Flexibility
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  • 16. Case Study #1 Operational Areas Investigated Product Security Trade Financials Supply Chain Efficiency Out-of-Stock Reduction (Direct Channel) Anti-Counterfeit & Diversion Returns Management Theft & Shrinkage Reduction Clinical Trials Supply Chain Product Complaints Management & Resolution Shelf-life Management Chargeback Management New Product Launch Management Demand Forecasting & Planning Rebates Management Government Pricing Consignment Inventory / VMI
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  • 18. Case Study #1 Returns Problem Decomposed Returned Products Direct Returns Indirect Returns Sold on Contract Not Sold on Contract Sold on Contract Not Sold on Contract
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  • 20. Case Study #1 Hard Savings Identification Yearly Benefits (unit: $ Thousand) Supply Chain & Trade Financials – I Supply Chain & Trade Financials – II Total Product Security Realizable unilaterally by Client Requires data sharing with TP Benefit A Benefit B Benefit C Benefit D Benefit E
  • 21. Case Study #1 Key Success Factor: Getting Downstream Partners to Participate
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  • 26. Cycle count frequency Daily Typical man-hours spent each time ~X min Average hourly wage $ Y # of stores Z Today’s practice ~ $ XX M Business benefit PI accuracy improvement ~ XX % % reduction in cycle count efforts ~ X % (excluding controlled drugs) ePedigree process Stores Case Study #2 Inventory Accuracy Leads to Potential Reduction in Cycle Count Effort
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  • 34. Next Steps Get Started on Improving Supply Chain Performance Contact Mary Hall today to schedule a consultation! 781.503.7462, mhall@supplyscape.com Visit SupplyScape.com to learn more www.supplyscape.com

Editor's Notes

  1. The focus has always on the solution - & folding the appropriate technology into the desired end state…. Solving for different kinds of product problems – counterfeit, up-label, adulteration Diversion SC Efficiency
  2. A delay in launch can cost a company an average of $15 milllion dollars per drug, per day for a potential blockbuster. (based on IMS sales) Earnings of 10 to 30% at risk Increasing pressure for line extensions Driving up number of unique products the channel must handle The average cost of new drug development for a successful New Molecular Entity ranges from $800M to $900B according to several industry studies and Purdue University. A drug with peak annual sales of $1 Billion generates extra $600million (NPV) over its lifetime if peak sales attained 2 years earlier.
  3. BRIC countries offer greater growth, infrastructure challenges, product security challenges
  4. A&D – constant changing grid strategically – serial mgt headache operationally Outsourcing 3PL, CPOs Capability – if the mandates are to be taken seriously, our client base will have to move at a rate of 14 lines per month to make the 2015 deadline Reliability and Flexibility to meet cycle stock and safety stock requirements (lead time variation)