The right prescription: Pharma manufacturers use PLM to swallow bitter regulatory pill

William Atkinson, contributing editor -- Manufacturing Business Technology, 1/18/2008 12:13:00 PM

Pharmaceutical manufacturers are focusing much more attention and resources on product life-cycle management (PLM) adoption, according to a report out of London-based Datamonitor, Streamlining Information in the Pharmaceutical Industry with PLM.

"Similar to other industries that have not traditionally had a focus on PLM, there have been above-average growth rates in PLM for pharmaceuticals and biotechnology," states Roy Wildeman, a senior analyst with Forrester Research GmbH, Frankfurt, Germany.

In addition to regulatory compliance pressures and increased competition, heightened interest in PLM is driven by the need to accelerate drug development processes. Datamonitor says PLM addresses the challenges of managing a portfolio of tens or hundreds of drug candidates from a number of R&D facilities and manufacturing plants around the globe. PLM also supports regulatory compliance by including applications that track adherence to regulation codes and identify noncompliance risk.

"Pharma manufacturers face a dual challenge of increased product compliance and regulatory scrutiny, along with downward pressure on revenues from patent expirations on blockbuster products," adds Wildeman. "Other reasons are insufficient R&D pipelines and government pricing controls."

Focusing on PLM product and process knowledge is one lever pharma companies can use to offset these pressures, Wildeman adds. "Many PLM vendors are seeking ways to grow market share in new verticals, including specializing their offerings to serve the unique product and process requirements that pharma and other nontraditional sectors have," says Wildeman.

So it seems the potential benefits of PLM to pharma manufacturers abound.

"In terms of quality and compliance, PLM software can capture, monitor, and manage the impact that material selection and process parameters can have on product quality," states Wildeman. This allows users to consistently achieve target quality profiles and comply with regulatory requirements. In terms of efficiency, centralizing product and process data into a core PLM repository helps promote better, more accurate design information, so that non-value tasks such as copying data between data sources or searching for missing information are reduced or eliminated. "At the end of the design process, assembling scattered product data for tech transfer and commercial ramp-up also can be a chaotic and time-consuming endeavor," he explains. "A centralized PLM system can help ease this transition of data to manufacturing."

One key to success in PLM adoption is a strategic mind-set, according to Markella Kordoyanni, pharmaceutical technology analyst for Datamonitor, and author of the report. "Although the industry is starting to recognize the potential benefits of PLM in drug development, unless pharmaceutical companies adopt a strategic mind-set about PLM—with all of the process management changes and cultural adaptations it requires—PLM will remain a tactical solution whose potential is not maximized," she suggests.

The report also suggests that an enterprise wide PLM system is required to maximize the value of PLM. A second key is to partner with a PLM vendor, reasoning that while PLM at its core aligns closely with pharmaceutical industry business processes, most current PLM solutions lack configurability attributes and other essential features. Working with a vendor allows the user to address these challenges.