Product Lifecycle Management - Lab-to-Launch value proposition

Product Lifecycle Management Images: Oracle EMEA Life Sciences From Start to Finish Product lifecycle management is integral for shortening the ‘lab to launch’ process, and has valuable implications for the clinical supply chain especially as the pharmaceutical industry silos. These silos, containing departments Timothy Hughes at Oracle product development pipeline is under such as design, supply chain, and R&D, EMEA Life Sciences increasing pressure; companies are often fail to effectively communicate striving to conduct more clinical trials across different business functions as than ever before in order to boost a means to achieve a more cohesive growth as patents for many blockbuster and holistic picture of the product What was considered best practice in the drugs expire. development process. past is no longer applicable in today’s pharmaceutical industry, due to the need As we’re all aware, the drug As a result, it is increasingly difficult for to survive in an increasingly challenging development and production process pharmaceutical companies to maintain market landscape. Companies need to is a complex affair that requires the a 360-degree view of their business to start addressing the way they conduct involvement of many functions, ensure compliance and deliver products business, while adjusting their strategy, including manufacturing, quality to market on time and with little or no tactics and processes to ensure they assurance, regulatory affairs and errors involved in the process. This is remain competitive. marketing. On top of this, there is illustrated by the fact that more than another layer of complexity resulting 80 per cent of new products launched Ultimately, the goal of any from pharmaceutical companies fail to meet their stated financial goals pharmaceutical company is to increase evolving to a more project-centric – approximately 86 per cent of new commercial potential, while reducing model, where key activities such as product ideas never make it to market costs and shortening cycle times from clinical trials, production, packaging and and, of those that do, 50 to 70 per cent lab-to-launch – otherwise known as the labelling are increasingly outsourced fail, as DMA’s research on new product initial R&D stages until a drug hits the to contract research organisations development practices found (1). What’s market. However, the global nature of the (CROs) and contract manufacturing more, 69 per cent of companies stated industry presents significant challenges organisations (CMOs). that their product introduction processes for companies seeking to manage their are not under financial or strategic control. clinical supply chain effectively. The Added to this is the highly decentralised rising costs, complexity and need for nature of the pharma industry, a factor This demonstrates the need for regulatory compliance are challenging, that has contributed to the emergence of companies to streamline product 112 November 2011 development processes and retain financial control, as well as showing that there is a demand to connect the various business constituencies into a single, secure drug design and delivery ecosystem. Synchronisation and collaboration hold the key to strengthening a pharmaceutical company’s ability to manage the process of bringing new drugs into the marketplace. It ensures that all stakeholders work together in the most effective way possible by enabling all parties to maintain a single and unified view of the product from lab to launch. To achieve this, the standardisation – as well as automation – of key drug development processes is vital. Additionally, orchestrated change management, synchronised with development cost, companies should competitive advantage by overcoming both programme management adopt strategies to automate the entire some of the most critical challenges the and quality, is fundamental to this lab-to-launch process using product industry faces today (2). transformation process. Synchronisation lifecycle management (PLM) tools. and harmonisation is also crucial for One of the associated challenges of this achieving both improved performance PLM Tools is the R&D pipeline, due to its complex and regulatory compliance in the drug development process that requires development pipeline. But despite this, While PLM originated in the electronics global regulatory compliance and most pharmaceutical companies today and high-tech manufacturing industries, cross-functional collaboration at each do not have the necessary level of these tools are increasingly being phase of the development process. automation required to manage these adapted by medical device and Historically, these requirements have core activities effectively. pharmaceutical manufacturers as these been managed across separate business industries are now undergoing similar functions and processes, compromising Automation will ultimately lead to changes to their business models, such effective communication. But with only greater levels of adherence to standards as globalisation and decreasing profit a very low number of products ever in that are based on best practice. margins, just to name a few. development for final market approval, Furthermore, it can consolidate content investment in existing R&D practices throughout the development pipeline. Furthermore, industry experts are must be examined and analysed in Both capabilities help to reduce errors acknowledging the importance of PLM more detail. As a result, the importance and cycle times by forming a compliant to optimised product value. Research of PLM tools within the pharmaceutical data set based on Quality by Design conducted in 2010 by Capgemini, industry has grown due to their ability (QbD)-based submissions. Therefore, the consulting, technology and to effectively manage drug pipelines, in order to improve R&D pipeline outsourcing company, found that with as well as improve collaboration and performance and reduce new product PLM, companies can gain a significant regulatory compliance. www.samedanltd.com 113 Indeed, as increased collaboration is case to support it. It is important that the realise improved clinical trials supply resulting in more complex product process is viewed as a complete business management which has resulted in a development and clinical production realignment over time and not just as a significant increase to their active processes, PLM is becoming one of the top single departmental project. drug pipeline. technology imperatives within the industry. With executive buy-in ensured and a This shows a clear case for the approach PLM can address the pain-points cross-functional team supporting the that companies need to take to associated with managing the PLM process, specific objectives can be address the challenges today’s drug development process in three critical areas: set across key functional areas. ROI can be development process presents. R&D routinely analysed, enabling companies and clinical supply managers must ●● Drug pipeline execution: accelerating to focus on the most important project respond to these challenges with a more product innovation by synchronising goals – both in the short and long term cost effective and flexible approach project and global clinical supplies – as PLM offers a sound approach that that takes into account the complexity management transforms existing business structures associated with the global distribution ●● Outsourcing coordination: fully and supports processes to improve drug and management of the equipment incorporating change management development execution. needed for their clinical trials.