May / June 2022

Message From the Chair: The Return to Live Conferences

Jörg Zimmermann
Message From the Chair: Jörg Zimmermann

The unprecedented speed in the development and global rollout of vaccines and treatments for COVID-19 over the last two years has made it possible to get back to a new normal. The 2022 ISPE Facilities of the Future Conference in February brought us together in person again and included a virtual option.

More than 300 people gathered for cutting-edge presentations and lively discussions at the conference, including featured projects from ISPE’s Facility of the Year (FOYA) program. Presentations also focused on successful projects in advanced therapy medicinal products (ATMPs) and cell and gene therapy (C&GT). It is fantastic to see how these new therapies are getting traction, and while some products are marketed now, there is no one way of doing it due to the variety of processes needed for production.

For me, highlights of the conference were the presentations by Matthew Hepburn, MD, Senior Advisor to the Director, Pandemic Prevention, US Office of Science and Technology Policy, Executive Office of the President; Arlene Joyner, Branch Chief PCI Division, BARDA; and Tom Warf, Director, Manufacturing, Facilities and Engineering, DHHS/OS/ASPR/BARDA. Having lived through the pandemic and helping shape the industry response, it was fascinating to see the activities undertaken by the US government and their determination to protect the people. Early on, the right decisions were made to combat the virus, such as using multidose vials for the vaccines and securing the supply of polymer syringes and needles for the vaccination.

It is fantastic to see how new therapies are getting traction, and there is no one way of doing it due to the variety of processes needed for production.

Viral vectors are one way to deliver the product (a gene) to cells. Produced in cell culture similar to large-scale biotech production, the virus is the product rather than the contaminant. In this issue of Pharmaceutical Engineering®, an article explores design basics for viral vector production facilities. Also in this issue, past FOYA category winners and honorable mentions share insights about what made their successful facilities projects that supported development of treatments and cures for patients.

Aseptic Conference

The 2022 ISPE Aseptic Conference was held in March, which was very well attended with over 250 people on site (and 80 more attending virtually). Speakers included Andrew Spasoff, Senior Director Quality, AstraZeneca, who discussed the final stages of their COVID-19 vaccine in a presentation called “Pre-PPQ Vaccine Lots—They Weren’t So Crazy After All,” sharing details on how commercial-scale production was made possible in such a short timeframe.

ATMPs and C&GT were also featured, with an industry panel of experts from operating companies, engineering companies, and equipment suppliers discussing challenges and solutions for these new modalities.

As always, the regulatory panel with representatives from US FDA and this time, Health Canada, was a very popular session at the Aseptic Conference. Brooke Higgins, Alonza Cruse, Rick Friedman, Bob Sausville, and Paul Gustafson responded in a live setting to previously submitted questions, including a discussion about regulatory expectations and challenges in interpreting guidelines. Everybody is eagerly waiting for the publication of the final updated version of Annex 1, and speculations about what is in it and what is not are heated. As Annex 1 with its adaptation by PIC/S and WHO is a truly global document, the differences in culture and quality maturity become apparent. We will provide coverage of the regulatory panel session soon in PE magazine’s Online Exclusives.

Building the Workforce of the Future

The future of the pharmaceutical industry is largely dependent on attracting talent to our companies. For me as a pharmacist, it has always been my intrinsic interest to participate in making the lives of patients better, but with the predicted growth in the industry and the war for talent, we need to be extra careful.

Student Chapters and the ISPE Emerging Leaders program play vital roles, but there is another aspect to building the future workforce. One area where the pharmaceutical industry is lagging is in terms of diversity. Observing the ongoing efforts in this space, we can see that progress is slow because many wrongly believe that diversity and inclusion efforts are nice to have and “look good” in marketing materials. In reality, a diverse workforce provides us with so many more viewpoints and cultural aspects, and that is what we can put to work to our advantage as a global industry. In reality, diversity is a business must-have, will drive the bottom line, and should be adopted as a key element to prepare our industry for the future.

Gilead Sciences has been a major sponsor of the ISPE Foundation’s Diversity Internship Program (IFDIP). You will find an article in this issue by Joydeep Ganguly on Gilead’s engagement with the program, which is also supported by Nephron and WuXi, and other diversity initiatives. Every year, students can apply for the IFDIP summer internship programs, and we can proudly announce that some have found their first permanent placements in industry there, right out of university!

On ISPE major projects in 2022, I can report a lot of progress: The One ISPE Charter, which regulates the relationship between ISPE International and the Chapters and Affiliates, has been signed by the vast majority of Chapters and Affiliates. They now benefit from the many incentives that were introduced, including a managed growth fund to attract new members, incentives for student members, training materials that they can use at the local level, no restrictions on content for local events, and many more. A big thank you to all the leadership in all the regions!

The refresh project on the ISPE Strategic Plan is also making good progress, and we are on track to unveil this at the 2022 ISPE Annual Meeting & Expo in Orlando, Florida, 30 October–2 November.

Before then, we hope you were able to join us at the ISPE Europe Annual Conference in Madrid, Spain, 25–27 April. Featured themes were Sustainability, Annex 1, Digital Quality, Trends in Pharmaceutical Engineering, and Project Management.