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At the Oracle OpenWorld show in San Francisco, the enterprise software giant unveiled a new version of its Agile Product Lifecycle Management application that it says will “help pharmaceutical companies streamline drug development processes … and enable Quality by Design practices.”
Oracle Agile PLM 9.3.1 will allow pharmaceutical companies to better manage a drug portfolio’s value chain by ensuring that regulatory requirements are met and essential elements of the drug program are carried out, Oracle said.
The software provides analysis tools for the entire “drug value chain, including suppliers, materials, equipment and processes,” the company said in a news release Sept 20, and allows companies to integrate QbD practices into the early phases of the product’s life.
“We are committed to helping organizations across all industries manage product value chain processes so that they can accelerate product innovation and maximize product profitability,” Hardeep Gulati, Oracle vice president of PLM and PIM (product information management) product strategy, said in a statement. “With this release, Oracle has added new differentiated capabilities that enable pharmaceutical drug development while also enhancing the deep cross-industry capabilities delivered in Agile Enterprise PLM.”
The software enables a company to reduce costs when taking an application to a new development phase, and it reduces the amount of time it takes for a product to reach market, according to Oracle. It will also help pharmaceutical companies manage label printing and packaging and keep track of clinical supply, and allows companies to track reservations for pharmaceutical manufacturing machinery and variations in medication recipes during clinical trials. In addition, analytics features built into Agile PLM 9.3.1 let companies keep track of and prioritize costs and limit risks.
The software also generates drug development records to allow companies to reuse CTD (Common Technical Documents) “by capturing complex multidimensional data from material, equipment, process/recipes and analytical methods in one system.” CTD is a set of specifications governing the registration of medications.
And with Agile PLM 9.3.1’s Next Generation CAD Connectors feature, pharmaceutical companies can manage multidisciplinary engineering environments, the company said, while Agile PLM 9.3.1’s Agile Design Variant Management integrates with Oracle Product Hub and Oracle Configurator “to provide an end-to-end mass customization environment.”
Oracle’s recent health care releases have focused on end-to-end health care applications.
Two product announcements at the HIMSS (Healthcare Information and Management Systems Society) Conference & Exhibition on March 1 also focused on centralized end-to-end management: Oracle Healthcare Transaction Base 6.1 and the combination of Oracle Healthcare Data Warehouse Foundation and Oracle Operating Room Analytics.
“Agile PLM 9.3.1 is highly complementary to our other significant investments and capabilities within Life Sciences,” Neil de Crescenzo, Oracle senior vice president and the general manager of its Health Sciences global business unit, said in a statement. “With the new Agile PLM capabilities and our recent acquisition of Phase Forward, we have a comprehensive solution for clinical trials and clinical supply management.”
Oracle announced the acquisition of Phase Forward on April 16. Phase Forward’s software is “designed to enable life science companies to automate and integrate the management of their entire clinical development process” from end to end, the company says on its Website.
Agile Product Lifecycle Management 9.3 was introduced in June 2009; the PLM software was originally developed by Agile Software, which Oracle acquired in May 2007.
With the complicated value chains and highly regulated environment of the pharmaceutical industry, a product such as Agile PLM could help streamline processes, according to IDC Health Insights analyst Eric Newmark.
“These companies require solutions like Oracle’s Agile PLM, which helps address the shifting landscape they face by streamlining complex processes, reducing waste, improving collaboration and supporting compliance with incredibly strict regulations,” Newmark wrote in a statement.