Message from the Chair: Better Days Ahead

Just at a time when the number of COVID-19 cases was skyrocketing, gathering size restrictions were being reimposed, schools were returning to virtual only, and hospitals were pushing their limits, antibody treatments and vaccines were approved. I am so proud of and inspired by my ISPE and other industry colleagues who have accomplished years of development work in a matter of months. Thank you for long hours, nights, and weekends you have devoted. Thank you for the unprecedented level of collaboration between companies, regulators, and distributors, and the sharing of manufacturing capacity, all with the common goal of conquering and overcoming this pandemic.

Improved Collaboration and More

I think we have all heard “necessity is the mother of invention.” While none of us would have chosen to go through this pandemic, we have been forced to work differently and, in many cases, much better. In addition to the improved collaboration, I am amazed by the increased productivity and creativity of many working from home. The need to work differently and much better in the pharma industry was realized several years ago, consistent with the Fourth Industrial Revolution and it has been accelerated by the pandemic.

A collaborative pharmaceutical industry version of this revolution, Pharma 4.0™ (trademarked by ISPE in the EU and trademark registration pending in the US) was started in 2016 by the ISPE Germany, Austria, and Switzerland (D/A/CH) Affiliate and quickly spread into the surrounding regions. Implementation of technologies together with the operating model developed by the ISPE Pharma 4.0™ Special Interest Group are key enablers to improving manufacturing process understanding and monitoring, and facilitate modern manufacturing techniques.

This effort provides valuable, compliant guidance for accelerated process development, improved control strategies for manufacturing consistency and reliability, and real-time utilization of process data. Pharma 4.0™ principles and models facilitate having the right information at the right time, enabling better decisions at all levels of the organization. The Pharma 4.0™ mission is to accelerate transformation, innovation, and full utilization of digitalization for the benefit of patients, and this is exactly the right time to spotlight this effort in this issue of Pharmaceutical Engineering®.

Aseptic Conference Turns 30

I want to offer my heartfelt appreciation to the Aseptic Conference program committee for their work to present the 30^th anniversary event that continues this year as a virtual event. The focus on unraveling the mysteries of Annex 1 and guiding technical modifications needed for compliance is central to this conference. It is still going strong as perhaps the industry’s finest conference on sterile manufacturing, filling, and inspection processes, with many attendees participating year after year. Congratulations to Jörg Zimmermann, Dave Doleski, and the entire program committee for their continued outstanding leadership.

I believe there are truly much better days, not only ahead but in the very near future.

Moving Forward

Early in the pandemic, I found comfort in “Better Days,” the One Republic song. The chorus reiterates “there’ll be better days,” which keeps echoing in my head. I believe there are truly much better days, not only ahead but in the very near future. However, I will go forward with a much better appreciation of things I previously would have taken for granted, like time with family, friends, and colleagues, and travel.

The “new normal,” has never become normal, and as much as we have become very effective at working remotely, there are aspects of seeing all of you face to face that cannot be replaced. I look forward to seeing many of you at our upcoming face-to-face meetings in Dublin, North Bethesda, and Boston.