March / April 2024

Message from the Chair: A Regional Focus for 2024

Scott W. Billman
International Board Chair - Scott W. Billman

ISPE has started 2024 with great momentum, having two technical conferences in the first quarter, the 2024 ISPE Facilities of the Future Conference in San Francisco, California and the 2024 ISPE Aseptic Conference in Vienna, Austria.

We will continue that momentum with the 2024 ISPE Europe Annual Conference in Lisbon, Portugal, 16–18 April. This conference will bring together regional ISPE membership and industry leaders to continue discussions on topics like digital transformation and GAMP® 5, while also discussing learnings and case studies in the regulatory and GMP inspections space. I look forward to meeting and speaking with many of you at that conference.

Regional Focus

ISPE membership is a global ecosystem of industry professionals and students. Our membership engages at local, regional, and international levels through attendance at conferences, trainings, and networking events. In this issue of Pharmaceutical Engineering®, we focus on the regional aspect of this global organization and industry.

Like many of our members, I began my involvement and volunteer engagement with ISPE at the local Chapter level. The Chapters and Affiliates offer a vast array of opportunities for local and regional members and companies to engage in dialogue and learn about global topics and then apply these to their local needs and their network. Building a strong local community of industry contacts who can learn from each other and support the industry is a key value to members and the broader industry.

ISPE membership is a global ecosystem of industry professionals and students.

Part of the ISPE 2023–2025 Strategic Plan—and a focus area for the current International Board of Directors—is to grow engagement and increase offerings in the emerging market areas. With more than 50% of the world’s population living in the Asia Pacific (APAC) region, the industry and ISPE will also continue to focus on building technical knowledge and workforce capabilities in this region of the world.

We have strong Affiliates in the APAC region that are doing great work at expanding industry engagement and knowledge sharing. Geopolitical pres-sures, inflation, and supply chain challenges drive the need for our industry to continue to innovate and to clear the hurdles that prevent us from get-ting lifesaving therapies to patients.

Affiliate/Chapter Growth Fund

A critical component of the One ISPE framework is the Affiliate/Chapter Growth Fund. This central fund is established through financial contributions from the various Affiliates and Chapters, then matched by ISPE International each year. These funds are held separately and are designated for the strict purpose of supporting ISPE’s global mission and vision at the local level. The disbursement of funds is administered by a committee composed of ISPE members from the International Board of Directors and the Chairs of each Regional Affiliate Council.

Affiliates and Chapters can submit proposals for projects to use these funds to further membership outreach and engagement. Some examples of how the funds are being used in the first year of the program are in-person Women in Pharma® workshops and events, educational sessions to increase membership recruiting, new local student chapters, specific training for members in response to FDA industry feedback, and sponsorship of ISPE educational sessions for operating companies.

With the submissions, applicants are asked to do something different, be specific on what the funding would go toward, and set goals for how it will grow and retain members at the local level. If you have an idea, we encourage you to reach out to your local ISPE Affiliate or Chapter board.

Biotech in the Northeast Us

As we enter the second quarter of 2024, we will look to engage

in another impactful region as we meet for the 2024 ISPE Biotechnology Conference in Boston, Massachusetts, 17–18 June. The Northeast region of the US has been a concentrated center for the biotechnology industry for decades and biotechnology continues to be a strong growth area for patient ther-apies.

Bringing industry experts together to discuss the interaction of the various topics and their impact on the biotechnology industry is critical for us to meet the increasing demands on supply, quality of medicines, and sustainability goals. ISPE continues to expand the Communities of Practice (CoPs) around these areas to ensure we provide forums for learning, debate, and knowledge sharing.

This issue of PE has articles spanning topics like regional regulations, systems validation, digital display labeling for clinical trials, and sustainability. The breadth of topics covered by the article contributors, CoP members, and staff—all in one publication—shows the complex network that is the pharmaceutical industry. I hope you continue to see value in the content and topics. Happy reading!