Timely availability of medicines, heightened expectations around drug quality and persistent disruptions to the supply chain are, collectively, the new normal for the pharmaceutical and life science industry that highlight the continued need to improve business operations. This was sincerely, yet sternly, reinforced by Remo Colarusso, VP of Supply Chain at Johnson & Johnson (J&J), during the opening sessions this week at the IFPAC (International Forum on Process Analytical Chemistry) 2022 Annual Meeting. However, shifting to operate under the collective new normal requires the industry to see “over the horizon.”  

What is required to be able to see past the traditional “horizon?” Dr. Patricia Cavazonni, Deputy Director of Operations for the Center for Drug Evaluation and Research (CDER) and the keynote speaker for the IFPAC 2022 Annual Meeting, set the stage by summarizing the importance of adopting a Quality Management Maturity culture, an act and thought process that goes beyond “checking the boxes” to meet the minimum requirements and maintain current Good Manufacturing Practices (cGMP). Quality Management Maturity encapsulates the goals and aspirations of quality risk management and motivates companies to move beyond the “check box” mentality by adopting modern manufacturing technologies. These manufacturing technologies promote the continuous improvement of quality risk management systems which in turn, improves the quality of drugs and minimizes the risks of drug shortages. Dr. Cavazonni stated nearly half of the drug shortages are due to quality issues. 

Dr. Cavazonni set the theme of subsequent talks which discussed the implementation of advanced manufacturing tools, such as artificial intelligence and machine learning software, to become proactive, agile and resilient. Increasing transparency to drive value, profitable growth and cost competitiveness are also important, but in the end, the desired outcome is to better serve patients, and to foster improved human and animal health. 

Advanced manufacturing requires the use of digital tools that advance operational processes such as planning & scheduling and manufacturing. It is critical to remember that the point of digitalization is to improve efficiencies, mitigate risks and build quality into the operations - not necessarily to flag instances of poor quality.  

Mr. Colarusso explained that J&J began its digitalization journey in 2009 because of an impending “patent cliff;" their critical revenue-generating drugs were going off patent, resulting in a business standstill. J&J pivoted and reshaped their business by focusing on becoming a transformation medical innovator (TMI) by proactively taking risks to find solutions that address unmet medical needs. Their first Pharma 4.0 initiative was to achieve a resilient and reliable supply chain to support and uphold their promise of being a TMI for patients. They worked with the FDA’s Emerging Technology Program to implement and transform their manufacturing operations to ensure efficient drug supply by implementing digital twins for end-to-end (E2E) supply chain management, specifically for targeted medicines, continuously improving risk management systems, and using automation intelligence to build out their value chain network. Throughout their past and current digitalization journey, J&J maintains course and objectives by constantly considering the “why” and the “so what” of digitalization. 

With the resounding messages and examples underlining the importance of advanced manufacturing, the fear of changing from traditional industry and regulatory-accepted manufacturing processes, remains a huge barrier. The acceptance of, and the shift to, a digitalized culture is imperative to successfully begin the Pharma 4.0 journey, but the industry is still feeling lost in translation. However, the FDA, is happily “open for business” to become a partner that demystifies the Pharma 4.0 initiatives and available technologies, through collaboration and troubleshooting, to bring the value and benefits of digitalization to reality.  

The time to begin the Pharma 4.0 journey is now. As reinforced by Dr. Cavazzoni, the FDA has brought forth tools, white papers, pilot programs & workshops, and advisory committees to help pharmaceutical and life science companies understand and leverage digitalization and begin the journey. As alluded to by Dr Cavazzoni, delaying this journey "is starting to become a bit of an excuse." 

Learn more about digitalization for pharma at aspentech.com/pharma