November / December 2020

Message from the Chair: That Was the Year That Was

Frances M. Zipp
Frances M. Zipp - Board Chair

Given the events that have transpired over the last 12 months, I have penned the title of my final column as ISPE Chair to reflect the temperament of our times. Coincidentally, and please pardon my digression, the title also happens to be the name of a hit album of topical songs by Tom Lehrer, recorded live in July of 1965 at the “Hungry I” nightclub in San Francisco, California.

As the album title implies, the songs were commentaries on events that transpired during that particular year. There were many. And they had profound impact. For the record (no pun intended), “That Was the Year That Was” peaked at number 18 on the Billboard Top 200 Albums list on January 8, 1966, and stayed on the charts for almost a year—51 weeks to be precise. Ironically, 55 years later, it often seems like, as many of Tom Lehrer’s songs acknowledge, the more things change, the more some things tend to stay the same. Our world has continued to see its share of dramatic changes over that time span, most notably in the last 12 months. And during my year as ISPE Chair, change has certainly impacted our organization.

About This Year 

As I prepare my last column as Chair of the Board of Directors of ISPE, I reflect on our activities as well as some of the things at ISPE that have changed during my time as Chair, and some that remain the same.

As one of my first initiatives, I achieved a personal objective to spend “quality time” with our Chapters and Affiliates. In all, I participated in 10 of their meetings, from the end of 2019 and up to March 2020. I greatly appreciate the vision of the international group and to have learned of the good work of these many Chapters and Affiliates. I had the opportunity to get to know their teams and to gain perspective from their thoughts and comments on the life sciences in general and, more specifically, about ISPE and the role we all can play in keeping it vibrant and relevant. These visits, our interactions, and the information they provided helped me gain a greater understanding of how ISPE can continue to add value and, most importantly, thrive during these most challenging times and in the years ahead.

I am pleased to report that one thing that has not changed is our members’ outstanding dedication and ongoing contributions to the future success and growth of our organization. We remain as strong today as when I first assumed my responsibilities. In many ways, even stronger.

The New Normal

Then, in early 2020 our world changed… and virtually all travel stopped. Our ability to deliver against our plans was challenged, but our commitment remained steadfast.

We regrouped and learned that reaching out to each other and to our community was of paramount importance. In offering support to our colleagues, we learned how to connect remotely, and although our skills were put to the test, we learned how to be part of a broader community and grew stronger as a result. We continued to advance our efforts on the Workforce of the Future and our Strategic Plan and realized, now more than ever, the vital need for robust programs to address the rapidly changing way we work.

Additionally, many of us relied on some of our basics—those we learned over the years as ISPE guidance document contributors and recipients of the insights they contain. We worked on adjusting our manufacturing processes to meet the needs of accelerated availability of key product to the market. We applied our knowledge of quality systems and risk mitigation, and systems configurations and controls, to assure that speed to market was much more than a business imperative—it was a matter of quality of life.

With ISPE acting as our unifying “family,” we joined together to support each other in addressing the issues our industry faces. Via webinars, we have shared ways to develop work plans remotely and focused on innovative technologies, turning our attention to vaccine development and commercialization in order to combat the current pandemic. We worked within our regulated network and reviewed the many recently published guidance documents issued by our local regulators to assist industry and healthcare providers during this time. The efforts and ingenuity of our pharmaceutical sector came together to provide diagnostics, vaccine candidates, and therapeutics to help the many healthcare systems combat and control the spread of the SARS-CoV-2 virus.

Over the last 12 months, we have also experienced a number of changes to our team—the appointment of an interim President and CEO, a new President and CEO leaving a reduced Executive Committee of ISPE, and the need to elect both a Secretary and Treasurer to the Executive Committee of the Board of Directors. Our members supported this challenge and we again have a complete and dedicated Executive Committee and Board of Directors, representing our diverse and dynamic membership.

Finally, a most heartfelt “THANK YOU” to everyone who I have had the opportunity to work with during my tenure, to those who have generously supported my efforts, and to the many who have helped advance our organization through these most challenging of times. It has been a testament to both our strength as a team and our commitment to our industry. This pandemic has brought us together, reenergized our mission, and proved to be influential to each of us in a most personal way. Everything about business is personal—2020 reinforced this in so many ways. My, what a year it has been.