Getting Started with Life Sciences
This reality is leading firms to embrace new innovation in order to increase new product success rates and ensure ongoing revenue streams to fuel growth and shareholder value. With an increasing demand for affordable treatment programs comes an increase in regulations that ensure product safety. It is also forcing firms to look at ways to reduce the cost of innovation through increased efficiencies in the areas of R&D, manufacturing, compliance, and sales & marketing.
Opportunities in Transformation
Change is happening. The question for each firm in the life sciences industry is whether or not they want to capitalize on the opportunities presented as the industry undergoes its transformation.
With a focus on continuously developing business process expertise, the BPX Community for the Life Sciences Industry will play a critical role in facilitating transformation for firms willing to embrace these opportunities. While nobody can predict the future, critical areas of focus are beginning to emerge as Pharma, biotech, and medical device firms respond to market change. Broadly speaking, life sciences firms will seek to do the following:
As part of the most highly regulated industry in the world, life sciences firms must deal with compliance issues across all aspects of the business from drug discovery and new product development through manufacturing and supply chain management – while also complying with corporate initiatives like Sarbanes Oxley and Basel II. With silo-ed business applications supporting business processes, managing compliance in an end-to-end fashion is extremely costly – but not as costly as a potential mishap.
This is why companies are looking for ways to approach compliance as an integral part of each process – rather than as a layer added on after the fact. By building financial, operational, environmental, and global trade compliance into core process steps, companies can reduce costs as well as the risk of non-compliance. And as regulatory demands grow, companies will look seriously at the benefits of a robust business process platform. Requirements will include industry-specific content; automated, exception-based compliance, documentation, and risk management that doesn’t disrupt the business; process flexibility to incorporate new regulatory changes; and full transparency to support speedy audits.
Ensure Operational Excellence
The life sciences industry lags most industries in operational efficiency. For many firms, this is an easy reality to live with as long as there are numerous revenue opportunities in the offing, enabling high margins. As those opportunities become increasingly scarce, we can expect life sciences companies to take a page from consumer packaged goods or high tech and start to think more seriously about streamlining processes and reaping the benefits of improved operational efficiencies.
Many firms are now global – and this requires meticulous attention to how processes are managed in order to deal with the proliferation of products, price tags, channels, partners, reporting, and so much more. Marketplace changes also argue for greater process flexibility and manageability. Take for example, the manufacturing process that is increasingly being outsourced to contract manufacturers across the globe. Achieving alignment and real-time visibility into the operations of contract manufacturers – while ensuring they are compliant with CFR Part 11 and environmental and global trade regulations – is a significant challenge. These and other changes introduce greater process complexity – and this requires improved process expertise. Firms that execute on operational excellence initiatives are in a better position to succeed.
Many life sciences firms are vertically integrated to align with the blockbuster model of development where all aspects of the business – from research and supply to manufacturing and sales & distribution – are managed in-house. Today, there is growing understanding of the need to move toward a more virtually integrated development and commercialization model where non-value-added, labor-intensive processes are outsourced to firms with specialized expertise. Firms, in other words, are learning how to co-innovate.
This is hardly a new trend – but it’s one that will pick up pace as firms realize the efficiencies and cost savings to be had by pursuing the model more aggressively. Already, many firms are engaged in cooperative research relationships with other organizations to tackle the sheer scope and complexity of scientific research.
Clinical trial management (CTM) – which contributes 50-60% of development costs – is being increasingly outsourced to Clinical Research Organizations (CROs) across the globe, as is manufacturing and distribution.
To succeed with this model, organizations need to take a hard look at where they add the most value and keep those aspects of the business in house. Other areas where there is little or no value-add – these qualify as candidates for outsourcing. But outsourcing requires a set of capabilities itself. Firms will need greater IT openness to facilitate collaboration with partners and to closely monitor performance. Business process experts, of course, will play a critical role in helping their firms develop the process expertise they’ll need to execute on this objective.