Message from the Chair: ISPE Resilience in a Challenging Year

I wanted to visit with as many of you as possible in person at Chapter and Affiliate events and conferences, but this was not possible. ISPE has been resilient, pivoting to virtual platforms faster than most other not for profits for conferences, webinars, and training. We have continued to deliver the pharma industry gold standard guidance documents and magazine. We are leading collaboration in interpretation and addressing several new pharma regulatory expectations, and are facilitating innovative technical solutions to manufacturing challenges. The lessons learned position us to be even more impactful in the future.

Thank you to the ISPE Board of Directors Executive Committee, the ISPE Board, Tom Hartman, ISPE’s President and CEO, and all ISPE staff for your unwavering and dedicated efforts and support throughout the year. I look forward to serving on the Executive Committee for one more year as Immediate Past Chair.

A Changing World

There have been so many significant events over the past 18 months: more than 4.7 million COVID-19 deaths, more than 6.1 billion vaccine doses administered, antibody treatments authorized, passenger travel into space, massively destructive forest fires in the United States, mudslides in Germany, and tsunamis in Japan. Achieving equality and embracing diversity and inclusion continue to be significant challenges in society.

In the pharma industry, we saw unprecedented collaboration and have achieved speed and agility never thought possible, but also exposed vulnerabilities in supply chain that must be resolved to assure a reliable supply of high-quality medicines for patients we serve throughout the globe. Our industry continues to rise to the challenges, not only developing vaccines and treatments for COVID-19, but manufacturing and delivering unprecedented numbers of doses in a short time. Additionally, the pharma industry continued to manufacture many other drugs and treatments for numerous other illnesses while the pandemic raged with very few disruptions in supply. I have never been prouder to be part of the pharma industry. As we move forward, efforts to harmonize regulatory expectations will be paramount in assuring agility to meet the world’s upcoming needs, with many yet to be identified.

Lessons Learned

As ISPE moves forward, we will need to evaluate the parts of the lessons learned over the past two years that we will keep and continue and those we can discard. We have learned the value of 90-minute webinars: short enough for attendees to carve out the time, but long enough to deliver sufficient detail on important regulatory and technical topics. We have learned that virtual town halls can have numerous regulatory authorities represented and be very effective. Chapters and Affiliates have learned that virtual events enable regional sharing and participation.

The One ISPE initiative to refresh the Chapter/Affiliate operating model will progress, with the objective of enhancing ISPE’s position as a global organization and will support growth in underserved and pharma-emerging areas of the globe. Biotechnology continues to be a more significant portion of the pharmaceutical industry and ISPE’s portfolio of offerings is quickly evolving to reflect the change. New Communities of Practice and Special Interest Groups on ATMPs and Virology and future courses on ATMP manufacturing support the changing environment and the need to reskill some of our existing workforce. And finally, we have learned that both virtual and face-to-face conferences and networking have advantages. I will never again take the opportunity for in-person networking for granted!

I urge you to take full advantage of the benefits of being a member of the ISPE family. Most Board members choose to run for election and serve on the Board because we are grateful to the ISPE organization and the role it has played in our careers. This is a way to give back, but there are so many other ways. Please consider sharing ISPE with others. As included in our newly revised value proposition, ISPE gives us a platform and a chance to advance and shape the pharma industry—and who won’t want to be part of that?!

No one could have imaged the devastation COVID-19 has caused in 2020–2021. It has transformed our world in ways we are still processing, but also illuminated the courage, resilience, and innovative spirit of ISPE and the broader pharmaceutical industry. There are still many unaddressed opportunities and patients around the globe are relying on us to deliver medicines to improve their lives.

ISPE creates a network where members can synergistically thrive, foster hope, and enhance pharma excellence for the patients we serve. We are emerging stronger than ever as individuals and as the ISPE organization. Thank you for being a member of the ISPE community. As your Chair, farewell and thank you again for this honor.