As part of the Axway Healthcare Platform, Axway brings best-in-class Serialized Business Applications to the GTT Solution, including solutions for Counterfeit Detection, Diversion Detection, Cold Chain Tracking, Track & Trace, Returns & Recalls and Trade Activity Management. To learn more about the components of the GTT Serialized Business Applications Layer, click on the colored boxes below.
It is commonly estimated by drug analysts that nearly 10% of all drugs worldwide are counterfeit. In addition, the World Health Organization (WHO) estimates that legitimate manufacturers of drug product lose over $32 billion annually with that number expected to increase to over $75 billion by 2010. Tough economic times and the increased demand for high cost specialty drugs contribute to the continued spread of counterfeit drug product.
While the economic impact is bad enough, the even more concerning aspect is that counterfeit product has a high probability of causing harm to the unsuspecting patient. Counterfeit product often contains no active ingredient, or it might contain the wrong active ingredient or packaging. In some cases, the counterfeit product might even contain too much of the active ingredient. All of these scenarios have a high probability to present severe risk to the patient’s health and well-being. In addition, as we know, anything that has a potential to harm the patient can also impact the business negatively through damage to the brand and lost revenue.
Axway’s Track & Trace Counterfeit Detection solution capitalizes on your investment in serialization to enhance your ability to authenticate and identify suspected counterfeit product. Axway’s solution allows for enhanced visibility of the entire supply chain with tools in place to allow for rapid detection and documentation of suspect events. In addition these tools provide for the rapid notification and investigative support which are crucial to effectively deal with the threat posed by counterfeiters.
Axway Track & Trace performs five main functions:
- Associates serial numbers, product master and distribution channel information and events in a GS1 compliant EPCIS
- Supports a "Book-end" approach through remote authentication service to validate serial number
- Blocks serial number ranges for targeted recall notification
- Enables further analysis and investigation initiation through alerting, dashboards and reports
For more information about the Axway Counterfeit Detection Solution, please visit www.axway.com.
Original manufacturers of branded product have been combating diversion or ’gray market’ activity for a long time. The ’gray market’ consists of unauthorized resellers who have moved branded product from one channel to another channel without the direct knowledge of the manufacturer. Few supply chains are immune to the ’gray market.’ Some of the most common diverted products include medical devices, high-tech equipment and even shampoo. Although most supply agreements prohibit the unauthorized reselling of products, it is often difficult for channel managers to gather enough evidence which allows them to take action against unauthorized sales of their product. As a result, original manufactures and their authorized channel partners are exposed to several risks, including:
- Margin erosion up to 25%
- Brand damage
- Consumer or patient risk from mislabeled or tampered product
- Higher customer service costs
- Demand volatility
- Exposure to counterfeits
Axway’s Track & Trace capitalizes on your investment in serialization to enhance your channel management. It collects and organizes product lifecycle events from multiple sources, including disparate internal systems and channel partner sales data, providing the single source of knowledge your channel managers need. Through integration to order and customer management systems, Track & Trace enhances that knowledge for greater understanding about channel performance against supply policies and helps detect anomalies so channel managers can take appropriate action.
Axway Track & Trace performs five main functions:
- Aggregates event visibility across enterprise systems
- Associates product serial numbers with product master and sales channel events
- Maintains a permanent link between product (bulk or individual) and initial purchaser in the channel
- Provides a remote authentication service for field investigators to validate serial number and sales channel
- Through alerting, dashboards and reporting, enables further analysis and investigation initiation
For more information about the Axway Diversion Detection Solution, please visit www.axway.com.
Simply put, a cold chain is a temperature controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities within a given temperature range, typically 2-8° C. A cold chain is necessary to extend the shelf life of most biotech products.
As biotech products continue to play a more important and prevalent role in a broader range of patient therapies, distributing cold chain products safely requires additional visibility throughout the pharmaceutical supply chain. Even though growth has slowed a bit in the past year, the global biotech market continues to grow at a rate double that of the pharmaceutical industry with annual sales of over $75 billion. Sales of biotech products in the US account for over 59% of the overall global sales of biotech products. In addition over 25% of the pharmaceutical pipeline is classified as biotech products. The FDA has noticed this trend as well and has formed a group called Team Biologics, which is a partnership between CBER and ORA. This group was formed to provide additional focus on the inspection and compliance issues in the biologics areas. The formation of this team has led to longer inspections times and additional scrutiny of GMPs (Good Manufacturing Practice) associated with cold chain.
In addition to providing the shipment accuracy (or shipment management) tools that enable Diversion and Counterfeit Detection, a track and trace solution must also provide visibility into the environmental storage conditions of the cold chain in order to be considered completely successful. Axway’s Track & Trace capitalizes on your investment in serialization to enhance the management of your cold chain. Axway’s solution tracks data at any level and integrates with any temperature tracking device allowing you to track events and receive alerts via a web based portal.
Axway Track & Trace for cold chain performs five main functions:
- Collects events from multiple sources (internal, carrier, customers)
- Provides single life-cycle views for product
- Provides mechanism for alerts (out of range point, out of range aggregate, time duration)
- Detects and alerts when the dwell time of an item exceeds expectations or when products stalled in-transit cannot sustain their target temperature
- Reports and dashboards (track upcoming expirations, by product/customer)
For more information about the Axway Cold Chain Tracking Solution, please visit www.axway.com.
The increased complexity of modern supply chains has driven a number of changes over the last ten years, including increasing the number of intermediaries needed to manage the requirements of a vast network of distribution points in the marketplace. The net result is decreased transparency of the end-to-end supply chain and increased opportunity for fraud and decreased quality of service. To combat this, industry leaders throughout the supply chain and numerous regulatory bodies have put processes, mandates and laws in place to resolve spot issues by enhancing visibility. What once was viewed by many supply chain participants as either a cost of doing business or cost of compliance is now being viewed as a valuable weapon in their performance management and risk mitigation arsenal.
Supply chain visibility is recognized by most forward thinking organizations as critical to sustainability and innovation, and especially in these economic times, both of these factors are critical to survival. Organizations of all sizes are investing in track & trace technology to help them improve their performance and secure their supply chains. However, they are not taking a ’boil the ocean’ approach to implementing track & trace solutions. The investment to apply unique serialized identifiers at the pallet, case and/or unit level can be significant. Therefore, most companies take a risk-based approach to their efforts targeting specific business issues, vulnerable products and/or channels to ensure return-on-investment (ROI). These efforts tend to be focused in three key areas:
- Promote product safety
- Protect Brand Equity
- Supply Chain Optimization
Axway’s Synchrony™ Track & Trace manages serialized events and product lifecycle in an open GS1 standards-based solution. Synchrony™ Track & Trace components integrate with existing enterprise resource planning (ERP) systems to help you improve efficiency and visibility into product life cycle tracking, achieve global regulatory compliance, and assure the integrity of your data.
It performs three main functions:
- Securely captures, retrieves, transfers and manages key product and serialized event data
- Centrally manages serial number generation and allocation
- Easily integrates to 3rd party systems
It is fully integrated with the Synchrony™ platform to enable advanced collaboration with supply chain trading partners including shared execution.
For more information about the Axway Track & Trace Solution, please visit www.axway.com.
The healthcare industry faces an unprecedented number of challenges as it continues to strive towards providing the highest level of quality services and products to the end patient. While it is clear that opportunities for efficiencies and overall cost reduction exist throughout the healthcare industry, companies often overlook the area of pharmaceutical returns. Pharmaceutical returns are difficult to deal with and cause multiple financial and process headaches for companies due to the confusing and inefficient processes that are often used. Companies face many challenges in dealing with returns:
- Reconciling financial transactions with the major trading partners in the supply chain
- Product related count and identification errors
- Inconsistent and different interpretations of returns policies
- Return of product through incorrect or duplicate channels
Axway understands the returns process and works collaboratively with companies to implement a strong solution resulting in increased efficiencies and reduced losses. These improvements result in significant savings to the company. Axway’s systems can use shipment and invoice level data to correlate to customers returned product. When serialization is in place, Axway’s Returns Module will track product flow and always be able to provide the associated original pricing of that product.
Axway simplifies the reconciliation process by accepting data feeds from all parts of the supply chain. The data can be correlated to allow invoice information to be matched automatically to the returns packing slip or ASN. The technology incorporates unique validation functionality to ensure the highest quality data. Additionally, online reporting and analytics will allow the pharmacy, wholesaler and manufacturers to understand and more efficiently manage inventories and profitability throughout the supply chain. The payment reconciliation process uses the real pricing for the products and the actual payments received versus the implied price or WAC. ROI is realized through an improved, more efficient, more accurate reconciliation process.
For more information about the Axway Returns & Recalls Solution, please visit www.axway.com.
Today’s global supply chains involve a complex network of distribution channels and models where buyers and sellers face an increasing number of economic and compliance challenges. Incorrect shipments, charge back/rebate disputes, poor sales force planning, counterfeiting, and diversion—all can result in revenue leakage, lost market share, and higher costs. While commercial distribution and sourcing agreements are increasingly common, many organizations struggle to enforce these agreements due to complex data management issues.
Best practices in global commercial operations are fact-based and performance centric. These new operating models require a solid data management foundation to provide:
- Accurate and timely revenue information
- Trusted sales and distribution data for planning and financial reporting
- Timely demand details for more effective new product launches
- Increased revenues and improved service levels with pay for performance program support
- Proactive management of charge backs, adjustments and returns
- Improved sales force planning to ensure maximum effectiveness
Axway’s Trade Activity Manager provides reliable, secure capture, transfer, and management of disparate channel data files as they flow between wholesalers, retailers, and manufacturers. Best practice scorecards, packaged approval processes, standard reports, exception-based analytics and complete audit trails help you to trigger automated payments and adjustments from your ERP system based on actual operational performance. The net result is that your organization can grow revenues and increase service levels by increasing the accuracy and effectiveness of:
- Revenue management by matching inventory to demand and proactively monitoring charge backs, adjustments and returns
- Replenishment by comparing brand, financial, sales and operations forecasts to actual demand
- New product introductions by tracking pre-launch inventories, push programs, and return trends
- Performance scorecard generation, adjustments, approvals and archival processes
- Charge backs, adjustments and rebate management by reconciling related logistics transactions
- Sales force planning by helping sales target regional inventory and demand issues
For more information about the Axway Trade Activity Management Solution, please visit www.axway.com.