July / August 2023

Message from the Chair: Board Elections and Our Strategic Plan

Michael L. Rutherford
Message from the Chair: Board Elections and Our Strategic Plan

It is starting to become more real that my term as Chair is winding down because the 2023–2024 International Board elections are happening.

We had our largest number of nominations yet this year, with an extremely strong group of potential Board candidates. Evaluating the candidates for the final ballot was a challenging process for the Nominations Committee.

I sincerely hope you, as the members of ISPE, took the time to cast your ballot and elect your International Board representatives. It amazes me every year that only 10%–15% of the membership votes. The independent service that manages the election process says this is very typical of organizations like ISPE, but I always wonder why.

I am curious if the significant increase in nominations will translate into increased members casting ballots this year. As a volunteer-based organization, member engagement is crucial to our success. The 2023–2024 International Board will be announced in September and will begin activities at our next major event on the ISPE International calendar, the 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada, 15–18 October. Please visit the conference website for more details and to register. It is surely going to be an event you don’t want to miss.

PE Theme: Continuous Manufacturing

In 2017, Sau “Larry” Lee, PhD, Deputy Director of the Office of Testing and Research, and Chair of the Emerging Technology Team, Office of Pharmaceutical Quality, CDER, published a spotlight on CDER science entitled, “Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing.” He discussed the differences between the traditional batch manufacturing methods, which involve multiple discrete steps and hold times, and continuous manufacturing, in which material is fed through an assembly line of fully integrated components to save time, reduce human error, improve quality, and allow for longer runs and more nimbleness, thereby reducing the likelihood of drug shortages. Lee is co-author of the article "Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing."

Dr. Lee emphasized that the transition to pharmaceutical continuous manufacturing was still in its early stages due to high startup costs, including the purchase of new technology and training staff, the revamping of industry infrastructure, and a serious commitment from a drug maker. But the economic analyses showed potential significant long-term savings. In addition, the technologies still needed to mature before being commercially viable, especially for certain types of drugs, such as biotech products. These biotech challenges were discussed in a PE article written by Robert Dream, PE, CPIP, PhD, Christoph Herwig, PhD, and Emilie Pelletier entitled “Continuous Manufacturing in Biotech Processes—Challenges for Implementation” in the November/December 2018 issue.

Jump ahead five years to 2023 and continuous manufacturing, especially in the solid dosage area, has moved forward, with numerous companies receiving product approvals from regulatory agencies. Regulatory agencies have kept pace with regulatory guidance to support these efforts as a result of great industry–regulatory collaboration. Numerous companies have been recognized in recent years for their innovation in continuous manufacturing with ISPE Facility of the Year Awards (FOYA) and the technology continues to expand to other areas of pharmaceutical manufacturing; hence, ISPE’s focus this issue.

Strategic Plan: Attract New Talent and Develop Future Leaders

As part of our 2023–2025 Strategic Plan to attract new talent, ISPE is passionately committed to investing—in partnership with the ISPE Foundation—in the future of the pharmaceutical industry through our student and Emerging Leaders programs. In March of this year, ISPE announced a unique opportunity for students and recent graduates to experience an ISPE conference in person.

For 2023, ISPE is providing grants for students and recent graduates to attend our two largest conferences: the 2023 ISPE Europe Annual Conference or the 2023 ISPE Annual Meeting & Expo. Thanks to this effort, more than 100 students and recent graduates will have the unique opportunity to experience an ISPE conference in person. Grant recipients receive in-person all-access registration to one of the conferences, a two-year ISPE membership, the option to participate in the ISPE Emerging Leaders Hackathon, and travel reimbursement per the ISPE travel reimbursement policy (which covers airfare/train and hotel).

As a result of this program, 51 students and recent graduates attended the 2023 ISPE Europe Annual Conference in Amsterdam in May. The application window for attending ISPE’s 2023 Annual Meeting & Expo in Las Vegas in October closes Thursday, 31 August 2023. More information and an application can be found at

I encourage students and recent graduates to apply today for this unique opportunity. Grant recipients for the AM23 grant will be notified on Tuesday, 12 September 2023. I also want to encourage companies, vendors, affiliates, chapters, members, and company leadership to support this program in future years. These students and recent graduates represent our future, and you can help enable them to learn and see what the pharmaceutical industry is all about.