November / December 2023

Message from the Chair: Thank You and Here’s to a Phenomenal Year in 2024

Michael L. Rutherford
Message from the Chair: Thank You and Here’s to a Phenomenal Year in 2024Thank You and Here’s to a Phenomenal Year in 2024

This is my last column in Pharmaceutical Engineering®. It has been my real pleasure and an honor to serve as your International Board Chair. Thank you for your support and I, like you, look forward to another phenomenal year for ISPE in 2024.

We had an awesome 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada. It was great seeing so many of you there, including our second group of 2023 ISPE Student/Recent Graduate Grant recipients. Just like all of you, these students and recent graduates had the opportunity to attend numerous keynote and education sessions, listen to global regulators during our Regulatory Round Table, interact with and learn from vendors about the latest and greatest new technologies and services in the exhibit hall, and attend numerous networking events during the conference.

I again encourage companies, vendors, affiliates, chapters, members, and company leadership to consider support for programs like the Stu-dent/Recent Graduate Grant in future years through donations to the ISPE Foundation. These students and recent graduates represent our future, and you can help influence their career decisions by enabling them to learn and see what the pharmaceutical industry is all about.

Pharmaceutical Engineering® Theme: Biotech, C&GT, and ATMPs

The pharmaceutical industry has come a long way in the 36 years since I started my career. In the late 1980s, small molecules dominated the product portfolios of pharmaceutical companies, and rDNA products were just beginning to be developed and approved by regulatory agencies around the globe. The biotech side of the industry was just beginning, and now has evolved to heavily dominate the development of new therapies for patients.

This issue is focused on biotech, cell and gene therapy C&GT, and advanced therapy medicinal products (ATMPs)—topics that, quite honestly, I am far from an expert in and I’ve truly been amazed to see the innovative therapies that have resulted from advances in these areas. These therapies are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit, determined by a specific target of interest. For ATMPs, the therapy is a cell, engineered tissues, or the manipulation of the patient’s genome.

ATMPs have been the focus of numerous Pharmaceutical Engineering®. articles, an ISPE guide (Advanced Therapy Medicinal Products—Autologous Cell Therapy), and conferences, including the 2023 ISPE Pharma 4.0™ and Annex 1 Conference 11–12 December 2023 in Barcelona, Spain, which has a dedicated track focused on Annex 1 (“ATMPs and Pharma 4.0™: How Do They Fit Together?”). I encourage you to attend and to learn more about this technology, which provides real promise for the future of patient therapies.

My Final Thoughts

This is my last “Message from the Chair” column. It has been my real pleasure and an honor to serve as your International Board Chair. During the last year, I have had an even greater chance to interact with Affiliates and Chapters, leadership teams, Communities of Practice (CoPs), task teams, individual members, ISPE staff, and regulators. ISPE has also started to implement our 2023–2025 Strategic Plan.

Some significant highlights include making great strides on implementing our One ISPE program, which has enabled ISPE to successfully operate its worldwide business, achieve the ISPE vision and mission, provide an operating framework that fosters global growth, and enable synergistic value between ISPE International and the Affiliates and Chapters. This also included the approval and establishment of our 40th Affiliate/Chapter, the Southwest Chapter.

ISPE successfully partnered with Wiley to enhance our guidance documents portal, which significantly improves the online user experience for ISPE’s full library of guidance documents, and launched a new ISPE website configuration, which improved our members’ ability to find and use their member benefits. ISPE launched several new CoPs in 2022 and 2023, including Pharma 4.0™, Pharmaceutical Compounding, and Quality Control/Analytical, and is looking to establish other CoPs, including Sustainability and Artificial Intelligence (AI).

In the regulatory area, ISPE continued efforts associated with the drug shortage crisis. We released new guidance on prevention readiness in May 2023 and the ISPE Harmonization Initiative, Enabling Global Pharmaceutical Innovation: Delivering for Patients, was launched with the objective to “catalyze consistent and harmonized interpretation and implementation of ICH guidelines.”1 In addition, three guides on Advancing Pharmaceutical Quality (APQ) were published: Change Management (CM) System, Cultural Excellence, and Process Performance and Product Quality Monitoring System (PPPQMS).

These are just some of the highlights from 2022–2023. Thank you to those who have supported efforts like this—we are very much a volunteer organization and cannot be successful without the support and efforts of our members and the staff of ISPE. I passed the gavel to Scott Billman, the 2023–2024 International Board Chair, at the Annual Meeting, and now pass the “Message from the Chair” column to him as well. I know you are in great hands with him as Chair and look forward to supporting him in my last year on the Board as the Immediate Past Chair. Thank you again for your support and I, like you, look forward to another phenomenal year for ISPE in 2024.