Embracing Pharma 5.0 for a patient-centered future

Tom Wilson, Global Contract Manufacturing Lead at Pfizer CentreOne, shares his unique insight into the need for the pharma industry to truly embrace the Pharma 5.0 revolution to continue improving patients’ lives.

In the next five years, global spending on drugs is anticipated to increase by 3-6% to a staggering $1.9 trillion [1]. This surge is primarily attributed to the growing demand for biologics. The global biologics market is predicted to surpass $600 billion by 2032, driven by the increasing incidence and prevalence of chronic diseases like arthritis, cancer, and autoimmune disorders [2].

To enhance production volume and optimize operational efficiency effectively, pharmaceutical companies are prioritizing significant investments in generative artificial intelligence (AI) solutions. Industry analysts estimate the pharmaceutical industry may be spending $50 billion per year on AI within the next decade to speed up drug development [3].

As a result, the pharmaceutical industry is witnessing a significant leap, marked by the transition from Pharma 4.0 to Pharma 5.0. While Pharma 4.0 focused on leveraging technology to enhance connectivity and streamline production, Pharma 5.0 takes a more holistic approach by centering around the collaboration between humans and AI. It represents another tool that enables the pharma industry to meet the needs of patients better.

The pharma 5.0 journey begins

At the forefront of the pharmaceutical industry, leading life science organizations are already embracing digital technologies like AI, machine learning (ML), and digital twin models in drug manufacturing, transforming their processes and enhancing their capabilities.

In recent years, the U.S. Food and Drug Administration (FDA) has observed a substantial surge in the number of drug and biologic applications that incorporate AI and ML components. This is, in part, attributed to the growth of the global AI in the drug discovery market, which is projected to grow from $3.54 billion in 2023 to $7.94 billion by 2030, at a compound annual growth rate of 12.2% [4].

Pfizer, for instance, employs AI/ML technologies throughout its manufacturing operations. These processes encompass automated visual inspection through image analysis, real-time anomaly detection, and AI-driven rapid root analysis in diverse operations. Pfizer’s Manufacturing Intelligence Platform underpins all these processes. In fact, Pfizer’s overall approach to global manufacturing is leveraged through its Manufacturing Excellence (IMEx) program. This program leverages Pfizer’s real-time manufacturing digital systems and its employees’ expertise to drive continuous productivity and operational improvements.

Changing lives by embracing Pharma 5.0

No matter the process, the science, the disease state, or the condition, patients are waiting. Improving the pharmaceutical production process can only benefit the patient. This is the true outcome measure of success in the pharma industry. We are already seeing how embracing Pharma 5.0 and the adoption of digital technologies are demonstrating the potential to help deliver medicines to waiting patients in many ways:

Enabling precision medicines

Pharma 5.0 seeks to revolutionize drug manufacturing and provide tailored healthcare solutions by prioritizing the development of customized and personalized medications, redefining the traditional approach to drug production. The production of individualized medicines and the development of smaller, targeted therapies require digital tools to provide customization and flexibility during manufacturing processes.

As the pharmaceutical industry strives to advance toward precision therapies and ultimately personalized medicine, it can anticipate a substantial transformation focusing on total patient centricity.

In the field of rare diseases, remarkable progress has been achieved through research and development programs, resulting in groundbreaking advancements. By combining these breakthroughs with similar ones in the digitization of manufacturing, the pharma industry can accelerate the delivery of medicines to these patients, reducing the time it takes to bring therapies to market.

Leveraging robotics

Embracing robotics in Pharma 5.0 has the potential to revolutionize the pharmaceutical industry and improve patient outcomes. Robots can be used to automate various tasks in drug manufacturing, such as loading and unloading materials, assembling and packaging products, and inspecting and testing finished products.

By automating these tasks, robotics can help to improve efficiency, accuracy, and consistency, which can lead to reduced production costs and faster time to market for new drugs. Pfizer’s global development and manufacturing network is using robotics across various processes, IoT sensors to track processes, and drones to travel through a glass line to identify breakage. All these technologies are continuously helping with process reliability, cycle time reduction, and yield increase.

Responding to threats at speed

A critical aspect for pharmaceutical manufacturers is ensuring the rapid development and commercialization of drugs. This entails optimizing the time taken from drug discovery to commercial manufacturing and scaling up production efficiently. During the COVID-19 pandemic, this need was put in the spotlight, highlighting the importance of the pharmaceutical industry to respond quickly and effectively to pandemic threats. Amid the COVID-19 pandemic, IMEx facilitated Pfizer CentreOne’s rapid response, enabling swifter and more efficient operations.

With a focus on enhancing efficiency, responsiveness, quality, and customer service through standardized tools, data-driven decision-making, and a culture of continuous improvement, IMEx conceptualizes an operational excellence system fit for pharma’s future.

Remember the human element

In the pharmaceutical industry, implementing digital innovations offers numerous advantages, providing a substantial competitive edge for pharmaceutical companies embracing digitalization, ultimately leading to improved patient outcomes. However, deploying technology will only be part of Pharma 5.0’s journey. Successfully implementing Pharma 5.0 will require a harmonious blend of technology, people, and processes.

Although leveraging digital technologies such as optimizing processes, managing replenishment cycles, and shortening lead times can significantly enhance cycle time, titers, and yields, human expertise plays a crucial role in Pharma 5.0. It will be important to remember that the success of this transformation hinges on the knowledge and skills of frontline workers at the manufacturing plants.

Find out more about how Pfizer CentreOne is embracing Pharma 5.0 to support you in the development and manufacture of your drug product: