This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising performance expectations from patients, stakeholders, pressure from government bodies for cost reduction, and regulators necessitate rapid change in execution. Fortunately for the biopharmaceutical industry, other segments of industry have pioneered advanced manufacturing technologies whose fundamental principles are readily adapted to biopharmaceuticals. Numerous service providers are eager to work with and learn from biopharmaceutical companies to develop advanced technology solutions to achieve digital transformation with the spirit of Pharma 4.0
For evidence of excitement in this space, one need only look at the plethora of terms frequently used today which were previously seldom mentioned in reference to biopharmaceutical manufacturing: Advanced Manufacturing Technology, Artificial Intelligence, Augmented Reality, Continuous Processing, Cloud-based Data Services, Digital Twin, Industry/Pharma 4.0, Intelligence based Manufacturing, Internet of Things (IoT), Manufacturing Intelligence, Model Predictive Control, Process Condition Monitoring, Real-time data analytics, Single Use Systems, and Smart Manufacturing to name several. Much has been published and spoken about the transformative power of these concepts and how they can be leveraged to deliver a step change in performance, making operations more competitive, profitable, and effective.
But how do people across industry view these technologies? Will technology make their work lives more effective, efficient and rewarding or will technology just add one more set of tasks to their already overstretched capacity, or worse, replace their roles altogether? Why should people embrace change if benefits to them are not obvious? Clearly a strategy to manage change and engage people with digital transformation will be essential to capitalize on the potential for these technologies. Digital transformation technology, if designed and implemented effectively, leverages the strengths of people and technology, and combines them to create new capabilities delivering greater value more effectively, more rapidly, and with greater fulfilment for people doing the work. If people are unclear on what digital transformation means, if they feel unprepared to be successful, and do not understand what is in it for them, then rate of uptake will lag.
To facilitate uptake and delivery of value, it is critical to create a framework to engage people across various functions, mindsets, and organizational levels. As Craig McKee, Coach and Consultant at McKee Solutions enlightened me many years ago, solutions to conflict are often readily available within an organization if the mindset and perspective of all involved are understood, considered and built into the change plan. McKee noted that participants in conflict discussions regarding a proposed change typically align into three focus areas: the Vision, the Ideas, or the Practice of a proposed change, his branded VIP model. All three perspectives with their associated mindsets are essential; however, the power is in leveraging these strengths collectively. Successful organizations have or engage people who can integrate these three mindsets, communicate effectively across distinct perspectives, and plot a course to achieve buy-in, and lead the organization successfully through change. Trust is another critical value for change. Trust grows when our ideas and concerns are heard and considered. By engaging people, listening to their vision/ideas/practice, and understanding their pain points, one can gain insights into how to continuously improve work processes and address many opportunities as part of the change process.
How and where does an organization start? It is important to lay out a vision of how digital transformation should manifest, problems to be solved and benefits to be delivered. Collecting, and building on, innovative ideas for how to accomplish transformation are also essential. Then it is important to identify a compelling solution which upon implementation would result in a step change in performance. Ultimately, and perhaps most importantly, practitioners doing the work must be engaged and be provided the solutions that allow them to deliver their best. Digital transformation can provide the right information, in the right format, at the right time to facilitate their work.
The next step an organization must do is to identify a few key challenges where digital solutions, if proved successful, can deliver significant value for effort required. From these challenges, case studies can be developed to demonstrate the concept and its associated value. Engage people to capture lessons learned from the pilot. Revisit the vision and adjust pilot or vision as necessary to maintain alignment and to ensure pilots build toward realizing the vision. Modify processes and technology according to the pilot, then invest and replicate rapidly. This approach, sometimes referred to “fail fast or scale fast”, focuses effort on projects and approaches that deliver value.
Throughout a digital transformation journey, highly skilled integrators, or change leaders, are key to project management of case studies and program management for digital transformation. These leaders serve as communication specialists, translating and connecting perspectives across the organization. They capture metrics, monitor progress, solve problems, escalate major issues for early resolution, and ensure delivery of value. They manage communication not only to those engaged with pilots, but also to the broader organizational community to ensure all are informed of the goals, progress, and value being developed. As a result the broader organization becomes familiar with challenges overcome and value delivered, increasing probability that those not involved directly will become advocates for Pharma 4.0.
This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising performance expectations from patients, stakeholders, pressure from government bodies for cost reduction, and regulators necessitate rapid change in execution.
Dr. Johnson has a distinguished pharmaceutical leadership career of over 30 years in new product and process development, technical services, innovation and technology, and advanced manufacturing solutions with Pfizer Inc. As Vice President, Technology and Business Solutions at Pfizer, he led the development and implementation of digital transformation, advanced process control, process analytical technologies, continuous processing, knowledge management, technology transfer, and systems design for rapid development paradigms for accelerated new products. After retiring from Pfizer, he continues to learn and contribute as a consultant. Dr. Johnson served as Chair of the Steering Committee for an Engineering Research Center focused on continuous manufacturing and was a Board Member of the Smart Manufacturing Leadership Coalition. Dr. Johnson earned his Ph.D. degree from Purdue University with research in controlled release, and holds a BS degree in Pharmacy from the University of North Carolina, Chapel Hill.