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Drug developers thrive on production speed. Speed that is continually accelerated by the threat to remain competitive, regardless
of pressures from generics and pressures to deliver an increasingly complex product portfolio to satisfy global demand. It
is no surprise that many pharmaceutical manufacturers are searching for new ways to keep pace.
One trend having an impact is the transformation of the IT landscape from disconnected, application-by-application efforts
to a holistic, integrated systems approach. In the clinical trials process, for instance, clinical supply units are learning
how to use valuable information derived from early development and testing to improve product quality.
In a 2008 article,1 Hussain Mooraj from AMR Research said: "AMR Research recently conducted a Web-based survey of life sciences manufacturers'
struggle to enter a new phase of innovation with technology among various manufacturing segments for business growth strategies.
The study found that life sciences manufacturers are 'looking to build the global end-to-end value chain, but current product
supply competency is weak.' It also states that 'contract manufacturing is becoming a strategic part of the emerging business
model...and companies are transforming traditional supply chains to demand-driven value networks.'"
In today's fiercely competitive market, discovering ways to leverage this information can prove crucial to winning the first-to-market
race, and ultimately, capturing valuable market share. AMR's results show that life science companies "embarking on a demand-driven
transformation are able to lower working capital costs, reduce stock-outs, improve perfect order, and have more successful
product launches." Independent systems
In recent years, drug developers have realized the benefits of applying automated technology to optimize various processes
within the clinical supply chain. Because each process step within the supply chain presents unique challenges, companies
have implemented highly specialized, stand-alone systems to best manage them.
This presents a formidable challenge for clinical supply departments that manage a multitude of systems from different suppliers.
Perhaps, more importantly, it limits the value that manufacturers are able to extract from their automated technology because
of limited information-exchanging capabilities and the time it takes to validate each system and train each employee.
One of the best ways to see how all of these disparate business and plant-floor systems impact the drug development process
is by reviewing how they fit into the manufacturing and distribution landscape. Although integration between these systems
seems easy enough, it poses one of the greatest challenges for clinical supply units because of the lack of standards or linking
mechanisms. For example, Boehringer Ingelheim International, a German-based pharmaceutical company, was challenged with reducing
the time it took to bring a product to market. All business processes and systems had to be regularly reviewed and streamlined
to help ensure global compliance. The company determined that a clinical trial supply system using software and hardware technology
with a common platform could be an effective way to meet the goal of producing clinical supplies faster, more efficiently,
and less expensively. All of which helped the company to meet the competitive pace of the industry.
Enterprise resource planning (ERP) systems are some of the most prevalent systems in the commercial production area, offering
drugmakers the ability to standardize business procedures and share information across the enterprise. In fact, many drugmakers
are seeking ways to track clinical supplies using ERP so that they extract maximum value out of the system. However, because
ERP systems typically are unable to gather plant floor information, let alone individual products, this has proven extremely
difficult.
Another key component of a drug development facility is the warehouse management system (WMS) that manages the materials inside
the warehouse and the production site. Although the WMS can track a product, batch or physical location, most commercial systems
available today are unable to track individual items because it has many of the same limitations as an ERP system.
