The Pharmaceutical Manufacturing Imperative: Transform Now

Used to its fullest potential, a LIMS is an enabler of business transformation

By Kim Shah, Director, Informatics, Thermo Fisher Scientific

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Transform your business before it’s transformed for you. These words convey a hard truth about modern business — external forces are rapidly conspiring to unravel even the best-laid plans. From geopolitical and economic macro trends to global threats to health and the environment, business change is now maddeningly unpredictable and capricious. Absent a proactive plan to address these new business realities, some businesses are in for challenging futures. But as always with business challenges, these pressures create opportunities.

First the good news: For decades, many businesses, including those in the pharmaceutical industry, have methodically added technology in preparation for this transformation. But all this investment could be for naught unless these businesses make a strategic commitment to align non-integrated, often disparate resources in ways that enable maximum agility. Over the next decade, the industry will see massive shifts in the way businesses approach investment, expansion, R&D spending, human resources and other critical drivers of growth.

FOUR DRIVERS
What has all this got to do with labs and laboratory management? Quite a bit, actually. To push the boundaries of innovation, companies must assiduously monitor performance and quality and be ready to capitalize on opportunities to transform and grow. For today’s elite companies, there are four drivers of constant business transformation: integration, innovation, automation and business intelligence. When all four drivers are in sync, business transformation isn’t just a strategy anymore; it’s a state of being.

Adding to the complexities of business transformation is the constant pull of technology. Gartner describes the technical changes we are now experiencing as a “Nexus of Forces.” A Gartner analyst defines this Nexus as, “the convergence and mutual reinforcement of social, mobility, cloud and information patterns that drive new business scenarios. Although these forces are innovative and disruptive on their own; together they are revolutionizing business and society, disrupting old business models and creating new leaders. The Nexus is the basis of the technology platform of the future.” Organizations that are looking at advancements in instrument technology alone are missing the benefits that can be achieved through IT technologies such as cloud and mobile computing that can not only affect business velocity, but also lower entry barriers to increasing competition. In this way, technology is an equal-opportunity catalyst that puts even more pressure on CIOs to stay ahead.

Data is the currency of business, especially in the lab, and business transformation is inexorably linked to effective data management. Even with the best laboratory instruments and information technology infrastructure in place, there is often little difference between solutions. It is how the data is managed and applied across the enterprise that becomes the unique competitive advantage.

Businesses today must have full visibility into laboratory operations and outputs and strategies to make new insights actionable. A one-day head start diagnosing an issue with raw materials in the supply chain or recalling shipments of tainted product could save millions. In other words, the benefits of agile decision-making are not trivial — bottom-line and top-line revenue hangs in the balance. This is why it’s so important for companies to regard a laboratory information management system (LIMS) as much more than just a data collection solution for the lab; when used to its fullest potential, a LIMS becomes an enabler of business transformation.

When LIMS are tightly integrated with other enterprise operation systems such as ERP, insights from the lab have the potential to be even more central to businesses seeking true enterprise-wide agility. Organizations aren’t simply capturing and collecting data; they are making data actionable across the enterprise, putting management in position to transform their businesses into agile organizations capable of responding to market trends or new regulations and flexible enough to recognize and capitalize on cost-saving or margin-growing opportunities in the future.

TOWARD AGILITY
The agile enterprise, one that is truly business transformation-ready, must rest on a platform that is supported by the four pillars identified earlier: integration, innovation, automation and business intelligence. Across the spectrum of biopharmaceutical companies, organizations are already taking advantage of the opportunities presenting themselves when any of these strategic initiatives are fully embraced. Now is the time to assess what you are doing today and what initiatives could benefit your organization.

• Integration – Integration is critical at two levels. At the laboratory level, scientists need access to the real scientific data regardless of vendor to correctly identify any product quality issues or potential environmental contamination as quickly as possible. At a high level, management needs to integrate these lab results with the overall manufacturing process. This provides true visibility to inform business decisions through executive dashboards built on comprehensive real or near-real time data. When people, processes, technology (and data) are stuck in silos, business agility is impossible.

• Innovation – Biopharma companies today are looking at big data to identify opportunities for improvement, market opportunities, optimizing costs and improving operational efficiency. Addressing challenges as diverse as accelerating drug discovery to more efficient ways to manufacture product, liberating laboratory data in dashboard form can be a new catalyst for continuous change. A LIMS, providing a centralized aggregation of all of the laboratory’s critical operational and scientific information, holds the key to solving many of these challenges and is a critical component of any big data strategy. And the ability to recognize and exploit pathways for innovation is as much cultural as it is process-oriented. By aggregating this information and centralizing it for all to see, the LIMS is allowing everyone to see the value of organizational change and commitment.


• Automation – Automating time-consuming tasks such as instrument calibration, compliance, user training and maintenance liberates more time for science, investing this perishable intellectual capital back into business transformation.

• Business Intelligence (BI) – In many enterprises, if a manager or executive wants to see laboratory progress or productivity reports, the IT department has to step in. Today, however, thanks to more mature BI approaches enabled by cloud computing, lab personnel can create real-time dashboard reports that are accessible to managers and executives 24/7 via desktop, tablet or mobile devices.

A technology roadmap now exists for building a business transformation-ready enterprise. The first step, however, is liberating insights that are stored in laboratories around the world, enabling people to proactively query and use vast stores of knowledge. When that happens, a business is truly transformed; its laboratory is a growth driver; and the C-suite is fully engaged. The real measure of success is the improved profitability and increased revenues realized by these efforts.

Published in the January 2014 edition of Pharmaceutical Manufacturing magazine

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