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STRATEGIC INSIGHTS 

Pharma manufacturers can learn from their industrial counterparts: Integrating systems can accelerate product delivery

BY BILL FERNANDEZ

January 15, 2008 | Pharmaceutical manufacturers must navigate a daunting logistical and regulatory maze — one that requires a significant investment in time and money in clinical trials. As a result, even a minor glitch in the trial process can wreak havoc on a pharmaceutical manufacturer's bottom line and its ability to market a product in a timely fashion.

The logistical web of interconnected research and testing silos surrounding a clinical trial is matched in complexity by a diverse group of representatives — pharmaceutical and biostatistics personnel, trial investigators, regulatory representatives, manufacturing personnel. The complex design of most clinical trial settings naturally makes the production, distribution, patient analysis, and storing of clinical data inherently difficult.

To succeed in such a competitive environment, drug companies must integrate a viable IT system so they can better manage the clinical trials process. Many leading drug companies are learning from their counterparts in industrial manufacturing, using automated IT systems to blend processes into a cohesive system.

To successfully develop, test, and market a new drug, pharmaceutical manufacturers must handle a disparate amount of research data and regulatory issues, while also managing million-dollar budgets and pushing the time-to-market envelope. Because pharmaceutical R&D is such a time-consuming process, with relatively low production levels, the integration of cutting-edge technology is often slow. As a result, many R&D departments have created their own "homegrown" IT systems using an array of applications and systems. While these systems provide specific functionalities, they emulate the disconnected individual parts of the overall clinical supply chain.

R&D departments are often measured by the number of blockbuster drugs released, but manufacturers regularly neglect to add efficiencies into the R&D process. Functional subsets are made up of separate silos: biostatisticians handle the randomization of patient lists, clinical research operations outsource packaging, and investigators manage events out in the field. Communication among groups remains primarily manual and paper-based, because R&D divisions are graded mostly on how well they remain within their allotted budgets, versus integrating efficient processes and removing costs from infrastructures.

But today's competitive climate is changing the way R&D works in the clinical trials process. As the cost of drug development climbs and the number of successful drugs coming to market decreases, drug companies are placing a greater emphasis on integrating efficient processes and reducing these costs by as much as $1 million a day. Efficient acquisition and use of clinical trial data can optimize an entire research process. Along with ensuring data accountability, successful IT system solutions also allow companies to become more efficient, ensure compliance and ultimately perform more studies.

Regulation Here and Abroad 
A successful clinical trial management (CTM) process depends on a precisely timed, monitored, coordinated, and cataloged flow of information and materials. The FDA reviews the execution of each step in the process, from packaging of patient kits to labeling compliance. In the event that a study patient in the field has an adverse reaction to a particular drug, for instance, the clinical labeling assigned to that specific patient and packaged kit must be traceable from the field all the way back to the manufacture of the drug's raw materials.

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The drug application process follows a similar path when submitting clinical study data to international regulatory scrutiny. Because most clinical trials are conducted worldwide, the trial management process must also deal with unique packaging and distributing issues associated with international compliance review. Language translation, for example, can become a significant barrier to compliance of patient kits. Terminology that is improperly translated from one language to another can potentially fault an entire study.

Maximum Impact: An End-to-End IT Solution
Current point IT solutions making headway into the trial management process generally only address individual processes in the clinical supply chain and are highly fragmented, failing to provide a seamless dialogue between study segments. Weigh-and-dispense solutions, for example, continue to endorse the fragmented system because their functions aren't fully automated by linking the activity data to a central repository.

Implementing electronic batch recordings of study design, population randomization, inventory management, weigh and dispense, label design, printing, and packaging of patient kits, can enable pharmaceutical companies to save significant costs associated with documentation, manufacturing, and distribution. A fully integrated IT solution can, for example, quickly trace a single patient assigned to a specific package or product, as well as the date, time, and location of the patient's kit materials' manufacture — adding wide-ranging efficiencies and advantages compared to existing systems.

By integrating into one system a set of solutions that share a common platform, an effective CTM system can enable pharmaceutical companies to manage different stages of the clinical trial process more effectively and efficiently, ultimately freeing up personnel. To meet these new capabilities, software solutions need to offer tools at every stage, from study design to enterprise resource planning.

A comprehensive solution package might include:

  • Weigh and dispense
  • Inventory and material management
  • Performance without paper
  • Electronic planning board
  • Master batch record/production recipe management
  • Labeling
  • Study management
  • Clinical supplies planning
  • Worldwide connections

For maximum impact, the entire CTM system solution should offer complete, end-to-end automation, batch records, and audit trails. Effective process workflow software in a manufacturing environment enables communication of pure manufacturing data from the machine layer to top levels of an organization. To support all levels of the manufacturing process, a solid system must also include necessary compliance criteria, accumulating data electronically and storing it in one repository. An investigator should need to review only an exception report — any process that was performed in exception to the way it was supposed to be performed — to cut down the review cycle from weeks to hours.

Strategic Insights:
Efficiencies can be quickly multiplied by assigning specific tasks to several remote users who can review and access the same information from a single global database, thereby compounding savings for all of the processes involved in a clinical trial.

On the Horizon 
Five years from now, effective IT systems will grow on the re-supply side. Interactive voice response systems, for example, have already begun making headway into the process. Eventually, distribution systems will evolve further, and study participants will have access to automatic dispensing systems to receive their patient kits. As a result, pharmaceutical manufacturers will be able to reduce inventory investments and decrease expired drug rates. Electronic study management, online documentation, and user-friendly design will all combine to help manufacturers accelerate delivery of their products to market.

Bill Fernandez is the North American director of professional services for Propack Data, a Rockwell Automation company. 








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