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Thursday, January 31st, 2008 1:00 – 3:00pm EST
Best Practices for Serialized Distribution in Support of ePedigree Compliance
  • Ann Grackin, Mangaging Director, Supply Chain Risk (RISC) Consulting, Marsh Advisors  Learn More
  • John DiPalo, Senior Vice President, Product Development, Acsis  Learn More
  • Mike Lipton, Director of Strategy for RIFD/Supply Chain Management, SAP Labs  Learn More
  • James Dowden, Director, Distribution Services, Hoffman La-Roche  Learn More
  • Best Practices for Serialized Distribution
    in Support of ePedigree Compliance

    The pharmaceutical supply chain is undergoing dramatic changes as companies accelerate initiatives to comply with new pedigree regulations in support of improving patient safety, product integrity, supply chain security and at the same time protect product revenue streams, company image and brand.

    As every participant in the pharmaceutical supply chain looks to serialize their warehousing  and distribution operations, they find themselves facing several key challenges including:

    • Incorporating serialized product into existing processes
    • Supporting the additional data and complexities of serialization
    • Establishing and maintaining serialization relationships through the distribution process
    • Generating and maintaining ePedigree’s for  compliance

    Acsis is working with leading pharmaceutical firms and industry partners to develop innovative approaches to helping solve this critical issue and at the same time demonstrate how these technology investments can provide significant return on investment. Working with the largest and most important companies in the pharmaceutical industry, Acsis is not only solving the technology challenges of serialization but also demonstrating a sustainable ROI.  

    Acsis addresses the challenges of enabling an efficient, safe and secure pharmaceutical supply chain by providing both unparalleled expertise and leading-edge software technology for streamlining the serialization process in distribution that enhances patient safety and business value.

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    The Problem:

    • Increased theft, counterfeiting & diversion
    • Ability to comply with retail mandates
    • Ability to comply with federal and state pedigree regulations
    • Adding serialized products to warehousing and distribution processes
    • Integrating with ePedigree and ERP systems
    • Accelerating time-to-compliance


    • Drug Manufacturers
    • Distributors/Wholesalers
    • Retail/Pharmacies


    • Automate serialization of distribution processes for drug product susceptible to theft and counterfeiting
    • Generation of a pedigree document and RxASN for every drug shipment
    • Manage parent/child relationships throughout distribution processes including repack and exceptions
    • Integrate distribution with ePedigree and ERP systems
    • Integrate mobile and fixed devices
    • Facilitate tracking & authentication of drug product ensuring trusted partners in possession of drug product at each step in the chain of custody


    Acsis PharmaTrak has been specifically developed for any participant in the pharmaceutical supply chain who is required to distribute serialized drug product including manufacturers, wholesaler/distributors and retail pharmacies.  Each drug manufacturer will be required by mandate, to serialize drug product at the item, case and pallet level to support the ability to generate a serialized pedigree document and track, trace and authenticate the product from the time it is initially sold to a distributor all the way through the supply chain to the point of dispensation. 

    Acsis PharmaTrak simplifies and accelerates the serialization of distribution processes and the tracking of drug products from receiving through shipment, ensuring compliance with government regulations for ePedigree.


    ·         The key challenge areas associated with serializing distribution processes

    ·         Best practices learned from the front line with early adopters

    ·         Technologies (RFID and Barcode)

    ·         EPC number management

    ·         ePedigree data management

    ·         ERP  integration

    ·         Device integration and management

    ·         Real world implementation examples


    Supply Chain Professionals within the Pharmaceutical Industry

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    Acsis is a global provider of track & trace solutions for supply chain safety, security and efficiency. Our enterprise-class software automates data collection, streamlines manufacturing and distribution processes and provides real-time access to supply chain information  With implementations in 28 countries, Acsis solutions are used by the leading manufacturers and distributors in pharmaceuticals, chemicals, and consumer products to safeguard the general public, protect their brands, reduce risks and increase efficiency and profitability.  Acsis is an SAP Services Partner, SAP Technology Partner and charter member of SAP’s Enterprise Services Community.

    For more information visit: http://www.acsisinc.com/


    Ann Grackin, Mangaging Director, Supply Chain Risk (RISC) Consulting, Marsh Advisors 

    Presentation:  The key challenges that ePedigree compliance places on warehousing and distribution

    Ms. Grackin leads Marsh’s Global RISC Consulting group. This organization has been formed to enable our clients to address both operational and global concerns in today’s supply chain.

    For more than two decades, Ann Grackin has been on the frontlines of the Supply Chain managing global business and technology strategy engagements around the globe in the worlds most admired companies. She comes to this position with a parallax view from seeing all angles of the supply chain problem-as an end-user implementer in a global fortune 100 firm, a technologist, a global consultant, an executive in a Supply Chain software firm, a columnist in the leading Supply Chain magazines, and one of the leading analysts in Supply Chain.

    John DiPalo, Senior Vice President, Product Development, Acsis 

    Presentation:  Meeting the serialization challenge: Modeling Best practices and lessons learned from the front line

    John DiPalo has 20 years of process and system analysis and design experience, having implemented many manufacturing and warehouse systems in SAP environments.  As the Senior Vice President of Product Development, Mr. DiPalo works directly with some of the world’s leading manufacturers and distributors to integrate their requirements, best practices and new technologies into Acsis’ product roadmap. Prior to joining Acsis, Mr. DiPalo worked for ARMS Inc. where he was responsible for the SAP consulting practice.  Mr. DiPalo's in-depth knowledge of SAP, shop floor processes, data collection, and RFID uniquely qualifies him as an expert in the field of automating supply chain processes in SAP environments.

    Mike Lipton, Director of Strategy for RIFD/Supply Chain Management, SAP Labs 

    Presentation:  The Impact of Capturing Serialization and Pedigree Information on IT Infrastructure

    Mr. Lipton has over 20 years of experience in supply chain management consulting and solutions design. Prior to SAP, he led the Supply Chain Consulting practice at Gensym Corporation, where his group delivered planning and scheduling solutions to process, consumer, and high-tech customers. Mr. Lipton was a founder and principal of the ITP Group, where he was VP of Consulting in the area of supply chain and factory automation systems. Prior to ITP, Mr. Lipton was in the high tech industry, in the areas of planning, manufacturing, and distribution. Mr. Lipton holds a Master of Science degree in Management from the MIT Sloan School of Management, and a Bachelor of Science degree in Chemistry from MIT.

    As the world’s third-largest independent software provider, SAP delivers business solutions to more than 36,200 customers in more than 120 countries around the world. We owe our success to the experience and expertise of our employees and the quality and effectiveness of our solutions. It’s no wonder the best-run businesses run SAP.


    James Dowden, Director, Distribution Services, Hoffman La-Roche

    Presentation:  Real world insights from an early adopter

    As the Director of Distribution Services, James Dowden is responsible for distribution, transportation, import/export, warehousing for Hoffman-La Roche. Mr. Dowden also serves as the Project Director for Hoffman-La Roche's domestic RFID efforts. His prior experience includes consulting services for vendor managed inventory/ electronic commerce, Director of Efficient Consumer Response and Customer Logistics Partnership Management for DowBrands,, and sales and marketing for Dow Chemical

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