This document discusses how track and trace technologies can transform pharmaceutical business performance by enabling supply chain as a strategic asset. It provides an overview of trends driving increased focus on supply chains, describes implications of track and trace on supply chain operations and security. The document also presents two case studies, one on a global pharmaceutical manufacturer and one on a leading drug store chain, analyzing potential benefits of track and trace technologies across various operational areas like inventory management, out-of-stock reduction, returns management, and more. It concludes by suggesting pharmaceutical companies need to address compliance responsibilities globally and prioritize an implementation plan to leverage investments in track and trace.
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
4.
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
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
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
19.
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
22.
23.
24.
25.
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
27.
28.
29.
30.
31.
32.
33.
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
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
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.
BRIC countries offer greater growth, infrastructure challenges, product security challenges
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)