The pharmaceutical and biotech companies should check out Oracle's Agile Product Lifecycle Management.
Having worked in a pharmaceutical company (Eli Lilly), I can understand the risks and pains associated with the development of a single drug. It involves million of dollars and takes 10-15 years to develop a single drug. And even then it might fail during the development stage or clinical trial stage or might fail due to non-compliance with regulations.
As per Oracle, Agile is a complete product lifecycle management solution suite built on industry best practices that enables organizations to manage-from a single interface-the product compliant dataset throughout its lifecycle, including research and development, prototype development, clinical trials, regulatory submissions, new product introduction, market acceptance, and end-of-life content.
Oracle claimed that the major benefits that the Agile PLM solutions can provide to the pharmaceutical companies are as listed below:
• Drive product innovation and introduction with one central solution for collaboration across research networks both internally and externally, and managing all product portfolio aspects such as project and resource management, thereby automating the design control process across the organization
• Lower inefficiency and compliance exposure with a secure workflow-enabled change management processes for core product record components such as development documents and records, product and process specifications, through regulatory submission information providing a compliant archive to support regulatory audits
• Support enterprise quality management by providing one central solution for aggregating, analyzing, and acting on product quality issues from customer complaints to manufacturing deviations to adverse-event information or supplier corrective actions, and "closing the loop" on these quality events by resolving the product quality problem and communicating the resolution to all parties involved, including compiling medical device reports for submission to the FDA
• Enable regulatory compliance by providing the infrastructure to meet the requirements outlined by the FDA's quality system regulations, as well as providing a platform for full compliance with FDA 21 CFR Part 11. Agile also provides solutions to help speed the validation of your Agile PLM system implementation
• Leverage outsourced research, design, manufacturing, and packaging by providing secure role-based access to product information and progress status, allowing the company to focus on its core competency while ensuring swift progress and high-quality from its networked supply chain
From my perspective, the biggest benefit seems to be:
a) The ability to collaborate. Diverse groups are involved during the development of a single group and at each development phase; and if the groups or individuals are able to collaborate or if there is a break/miscommunication/misinformation during the flow of information—the whole cycle might break; that would result in loss of millions of dollars and wastage of hundreds of manhours.
b) Enabling regulatory compliance as listed by FDA and specifically full compliance with FDA 21 CFR Part 11. Non-compliance whether willing or unwilling with the FDA guidelines can mean a complete ban of the drug. Agile PLM can help be compliant with regulations like FDA 21 CFR Part 11.
