To keep pace with the technological and scientific advancements that continue to shake up the pharmaceutical industry, companies are increasingly finding it necessary to adapt their strategies, procedures and business practices. As leading pharma and biotech companies make advancements in the hypercompetitive and constantly changing landscape, more and more of their competitors are discovering the secret to their successes: integrated platforms that connect quality intelligence and pave the path to innovation.
The following four key business trends are changing the game in the evolving pharma industry and necessitating adjustments to companies’ approach to data and process management. Not only are sophisticated technology platforms delivering the data connectivity and management capabilities pharma companies require to keep up with each of these trends, they are also transforming the quality function from a guardrail to a business accelerator that provides quantifiable advantages over competitors.
Just as we daily find new ways for the speed and convenience afforded by digitization to enhance our everyday lives, different aspects of the pharma industry are continually enhanced in new ways by innovative digital technologies. Sweeping digitization endures as the industry’s most impactful overarching trend, which presents challenges to companies that struggle to adopt groundbreaking technologies and opportunities to those that leverage innovative tools to drive success.
While under constant pressure to reimagine and redesign their quality management practices to better align people, processes and policies to digital business requirements, leading companies are consistently restructuring around transformative digital technologies and data experts with the talent to maximize their use.
The Platform Solution
Effectively linking each phase of the product life cycle together within a common platform enables pharma companies to comprehensively map and converge data and quality processes. Organizations that have harnessed the consolidative power of integrated, flexible platforms as a digital springboard are better positioned for growth and future successes. Deloitte’s 2020 Global life sciences outlook posits that a company may be able to streamline the number of days it takes to release a drug product from approximately 100 days to just seven by maintaining a digitized core that incorporates intelligent automation.
Specialization and new market opportunities are among the many factors increasing the velocity of and raising the competitive stakes in the pharma world. What’s more, it’s become the industry standard that approximately 80% of profits are won by the first one or two companies that enter a market, according to the recently released MasterControl e-book “Connecting and Leveraging Quality-Driven Data Throughout the Pharmaceutical Product Life Cycle.” These and other related circumstances have combined to create an unprecedented urgency for pharma and biotech companies to introduce new product pipelines and accelerate time to market, all of which must be accomplished without sacrificing quality or jeopardizing regulatory compliance.
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Connecting and Leveraging Quality-Driven Data Throughout the Pharmaceutical Product Life Cycle
The Platform Solution
Decision-makers who can see what’s happening in real time are well informed and better able to take prudent actions quickly. By enabling pharma companies to achieve real-time quality intelligence, platforms have proven to be the ideal means of establishing quality as a speed-to-market accelerator. Perhaps more importantly for pharma companies positioning themselves for growth, platforms facilitate adaptability and expansion when the need to pivot or evolve is warranted.
As business processes change or new processes need to be added, a platform equips a pharma company for the future by providing a baseline technical framework that can be expanded upon and leveraged as a catalyst for development.
Timelines will always accelerate, and business demands will always change. It’s unavoidable. Out of necessity, pharma companies across the board are increasing their operational agility. Asset-light strategies are becoming more prevalent throughout the industry. The subsequent increased reliance on outsourcing partners means that organizations must be more flexible, but they must do so without increasing risk or sacrificing product quality.
Despite the changing dynamics, many companies are still clinging to conventional and rigid — and often mainly paper-based — quality management techniques. As a result, too many organizations frequently experience product launch delays that are caused by inflexible processes.
The Platform Solution
Quality and compliance aren’t the domain of a single department — they touch every function and therefore must be ingrained in every facet of the enterprise. Platforms extend quality and compliance processes and connect quality data throughout an organization’s entire ecosystem. By design, platforms foster a life cycle approach to product development and amplify a company’s ability to connect data, processes and insights across functional teams, sites and suppliers. A robust platform can dramatically improve a company’s ability to assess supplier and partner implications on product quality and make necessary adjustments in a timely manner across dispersed sites and outsourcing partners.
Employees in every department of every pharmaceutical company — from the CEO to a worker on the production line — can benefit from getting more value out of the data they handle while performing their daily activities. However, converting product quality data into real-time intelligence and insights that can be used for prevention and prediction is an elusive feat for most organizations.
In the highly competitive pharma industry, the ability to leverage data for predictive — and not merely proactive — purposes is becoming a must-have competency for quality leaders. As a result, drug manufacturers are actively seeking solutions that are geared toward proactive and predictive activities as opposed to containment and reactive responses.
The Platform Solution
A platform-enabled, data-driven approach to product life cycle management empowers companies to leverage real-time quality intelligence and predictive insights. Unlocking knowledge that would otherwise remain trapped in disconnected and unstructured data and inaccessible or locked documents can catalyze the transition from reactive to proactive and predictive operations.
Platforms that connect data across the product life cycle — both upstream into early stage discovery and downstream through production and commercialization — promote greater predictive capabilities. Industry frontrunners are finding an increasing number of high-value uses for platforms that incorporate emerging technologies like machine learning (ML) and natural language processing (NLP) to advance their quality goals. Pioneering companies that implement platforms to leverage these types of advanced technologies are finding it’s possible to extract text from unstructured documents via automation and identify and contextualize relevant data, among other breakthroughs.
Enhanced data connectivity and expanded access to quality intelligence will bring innumerable advantages to any pharma and biotech organization, and platforms are the ideal mechanism for achieving both goals. A proven software platform can help a company overcome the ongoing challenges the industry has always faced and put it in a better position to cope with the new obstacles that will inevitably arise in the evolving competitive landscape.
In addition to providing the previously discussed benefits of seamlessly connected data, platforms offer a host of additional advantages to pharma and biotech organizations, such as:
To learn about more about the adoption of a data-driven and technology-supported approach to product life cycle management and how it enables pharma companies to thrive by converting quality from a responsibility to a business-accelerating differentiator, download the exclusive MasterControl e-book, “Connecting and Leveraging Quality-Driven Data Throughout the Pharmaceutical Product Life Cycle.”
“2020 Global life sciences outlook,” Deloitte. https://www2.deloitte.com/global/en/pages/life-sciences-and-healthcare/articles/global-life-sciences-sector-outlook.html
James Jardine is a marketing content writer at MasterControl, a leading provider of cloud-based quality and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.