Pharmaceutical Technologist - September/October 2008 - (Page 25)

Product life cycle management discovery through commercialization. PLM tools can harmonize product portfolios and enhance visibility across the entire pipeline. A principal benefit of PLM, which many executives still do not fully comprehend, is its ability to address the challenges of managing a portfolio of tens or hundreds of drug candidates — from disparate R&D facilities to manufacturing plants across the globe. The daunting challenge Unlike products in other industries, bringing a drug to market is a more complicated and difficult process, and only one out of thousands of screened molecules makes it to market. Throughout each phase of the life cycle, from discovery through to commercialization, the data collected are instrumental to decision making; for example, pharmaceutical companies must decide on how and when to leverage previous research on a certain drug, how to collaborate on clinical trial results, and how to ‘scale-up’ drug production from Phase III clinical trials to large-scale manufacturing. Without centralized product information systems and automated business processes, companies lack the single point of truth necessary to make those decisions. As a result, many organizations struggle with making appropriate decisions about a product’s life cycle, and their actions have often been untimely, faulty and inefficient. Managing product records and assembling elements from several sources is daunting. This task becomes even more challenging given the complex nature of scientific information, the silo mentality for data and knowledge management, and the constant merger and acquisition activities of pharma and biotech companies. As market pressures increase, the industry as a whole is finally beginning to focus on PLM as it helps leverage the full potential of the drugs in the pipeline and take them to market as fast as possible. The pharma industry must also manage the life cycles of marketed drugs. As the industry faces a weaker R&D pipeline and generic competition, lower returns from new products are more likely and it is imperative that greater value is extracted from existing portfolios by implementing PLM solutions. Adding to the business drivers for investing in PLM is the increasing emphasis on compliance and drug safety by regulatory bodies. As a result, the industry needs sophisticated tools that automate research processes and create electronic trails that help reduce noncompliance errors. PLM supports regulatory compliance by including applications that track adherence to regulation codes and identify risks of noncompliance. level. This offers all stakeholders additional visibility and flexibility across otherwise isolated functional departments. Recognizing the value of an enterprise PLM solution indicates that the pharma organization has a strategic view of PLM, rather than a tactical or technical view, and has the potential to lure additional investors. Knowledge is power In the data-rich pharma industry, knowledge is diluted quickly unless organizations adopt effective methodologies for transferring it, and ensuring visibility and access to critical information at all times. The drug development process is characterized by heterogeneity and fluidity, in which scientists, compliance staff and engineers work with multiple protocols, materials, and internal and external partners to constantly adapt their workflows according to experimental results. Although the degree of variability tends to decrease as the drug’s life cycle progresses, a flexible PLM system that can keep up with this iterative process is crucial in supporting the developmental needs of the drug life cycle. To maximize the full benefits of a PLM solution, it must be adopted on an enterprise-wide As the industry faces a weaker R&D pipeline and generic competition, lower returns from new products are more likely and it is imperative that greater value is extracted from existing portfolios by implementing PLM solutions. To date, PLM software adoption has been slow, primarily because the technology is in its nascent stages for the pharma industry, which is often reluctant to implement technology solutions, mainly because of the belief that IT vendors do not fully comprehend the unique needs of the pharma world. In addition, first-generation PLM solutions have taken anywhere between 6 months to 2 years to implement because the systems required extensive customization. Thus far, PLM solutions, along with many other IT solutions, have been viewed as an option rather than a necessity. Fortunately, companies are finally realizing that technology, such as PLM software, is essential to sustain growth. As PLM On the go ● ● ● ● Companies are implementing new technology and IT solutions to increase efficiency and streamline operations. A PLM system links product data to people and processes, and offers upper management increased visibility into the research process. To date, PLM software adoption has been slow in the pharmaceutical industry as technology is often seen as an option rather than a necessity. If pharmaceutical companies work with PLM solution providers, they can ensure the technology fits their specific needs. www.ptemagazine.com 25 http://www.ptemagazine.com

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Pharmaceutical Technologist - September/October 2008 Contents Industry Highlights Morpheus Market Watch Smoke and Mirrors Reducing Data Burdens Keeping it Simple Bringing Pharma Up to Date

Pharmaceutical Technologist - September/October 2008

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