Articles

Monday, March 03, 2008

The New Recipe for Pharma Success

By Paul Wlodarczyk, JustSystems

One look at the numbers reveals the high stakes game that pharmaceutical companies play in their efforts to bring new drugs to market. In the United States, the numbers include:

• $800 million to $1 billion—the average cost of moving a new drug through the development process
• 12 to 15 years—the average time it takes to move a new drug through the development process
• Five to eight years—the average time a new drug enjoys patent protection once it reaches marketplace
• One in 10,000—the odds that a new compound will survive the development process, receive new drug approval, and ultimately reach the marketplace

In contrast to the high stakes, the tools pharmaceutical companies use to move drugs through their lifecycles are decidedly low tech. Spreadsheets, flow charts, and other unstructured documents are used to create and maintain the process definitions that effectively serve as drug recipes. These documents are also used to transfer the process definitions from research and development to manufacturing operations.

Given the recipes’ complex, iterative natures—a single spreadsheet might grow to hold tens of thousands of rows’ worth of information about equipment, materials, procedures and parameters (e.g., when and how to agitate, chill, and/or heat a mixture), etc.—the reliance on manually managed, unstructured documents is remarkable.

After all, these documents—by their very nature—cannot ensure the information they contain is accurate, authoritative, complete, and consistent as the drug moves through its lifecycle and across the supply chain. This is a critical concern, considering the documents’ multi-year lifespans as well as the multiple internal and external organizations accessing and/or updating the documents, including contract research and manufacturing organizations, marketing firms, regulatory bodies, etc.

Moreover, unstructured documents interfere with a company’s ability to identify, track, and report on the critical-to-quality process parameters. Likewise, the documents can interfere with the transfer of recipe information into the Manufacturing Execution Systems (MES) and batch control systems that drive operations on the plant floor. Typically, recipe information must be manually re-entered into these systems, a time consuming and error prone process.

Bottom line, unstructured documents needlessly increase expenses and prolong time to market. Bad data may be introduced—or good data may be overlooked—at any stage of the product lifecycle, requiring companies to repeat one or more stages. Or progress may simply slow to a crawl at stages involving manual re-entry. Regardless, pharmaceutical companies stand to lose over $2 million for each day of missed opportunity in the market.

Pharma’s New Recipe

Clearly, profitability increases as a drug’s expenses and time to market shrink. In turn, pharmaceutical companies can shrink both expenses and times to market by sharing accurate, consistent, and complete information across all the steps of the drug discovery and development process. This is exactly what JustSystems is enabling with xfy for Batch Process Definition, its batch manufacturing process definition solution for life sciences companies.

Built on the company’s xfy (pronounced “x-fie") framework, the process definition solution adheres to the JustSystems “document as the application” vision. Drug recipes are created and maintained as dynamic documents, which provide users a rich, interactive context for diverse and distributed information sources that are always up-to-date. As a result, pharmaceutical companies can standardize and automate information transfer between research, manufacturing operations, regulatory affairs, and suppliers; reduce waste from failed batches; and comply with regulatory submissions.

xfy for Batch Process Definition features an intuitive graphical user interface that requires no special training. The GUI complies with charting standards established by the ANSI/ISA-S88 industry standard for batch process definition, making it familiar to process engineers.

Researchers will find the GUI gives them a dramatic usability improvement over spreadsheets. These users can rapidly assemble recipes by dragging-and-dropping recipe “building blocks,” which let pharmaceutical companies normalize recipes on a common set of reusable manufacturing actions. This dramatically accelerates the process of creating new recipes and standardizes the representation of a firm’s manufacturing process intellectual property.

Under the covers, xfy for Batch Process Definition supports Quality by Design (QbD), ANSI/ISA-S88, and BatchML, the XML standard for representing S88 data. Recipes can save as BatchML, so recipes can be read by other BatchML-enabled applications, e.g., MES, Product Lifecycle Management, batch control, and compliance solutions.

Pharmaceutical companies are spending vast sums of money to bring drugs to market, and even incremental improvements can make a huge difference to their bottom line. Yet costs can’t be cut at the expense of quality. Fortunately, companies can improve productivity, reduce costs, mitigate risks and ease regulatory review by adopting a new system for managing their process definitions, moving from an unstructured document approach to a system that employs dynamic documents. By integrating disconnected business processes formerly housed in flowcharts and spreadsheets, companies will not only improve internal operations, but external operations as well with contract manufacturers, partners, and regulatory officials.

About Paul Wlodarczyk
Paul Wlodarczyk is vice president of solutions consulting for JustSystems, the largest ISV in Japan and a worldwide leader in XML and information management technologies. Contact Paul at .

Filed under: Content Management : Life Sciences : Structured Content : Technological Innovation : XML

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