January / February 2024

Message from the Chair: Opportunities for Growth and Expansion

Scott W. Billman
Message from the Chair: Scott W. Billman

Next year promises to be a busy one for ISPE. The year starts with the 2024 ISPE Facilities of the Future Conference in San Francisco and is quickly followed by the 2024 ISPE Aseptic Conference in Vienna. Both conferences bring together key technical talent from across the industry to engage in critical discussions about the future of delivering safe and effective products to patients around the world.

ISPE Conferences and Community Collaboration

A common theme across the ISPE conferences is the digitization of everything we do. From basic GMP automation and systems to artificial intelligence use in the industry, our conference attendees are presenting on and discussing how we will continue to automate and digitize our work.

This issue of Pharmaceutical Engineering® magazine includes many articles about GAMP® and its importance to this digital transformation journey. In 2022, the FDA issued their draft guidance “Computer Software Assurance for Production and Quality System Software.” Our GAMP community continues to stay current on these topics to ensure we have the most up-to-date and relevant information to discuss and collaborate on.

More than 30 years ago, a group of dedicated and passionate volunteers developed a special interest group to bring together the various thoughts and efforts around computerized system compliance. Through the years, this group has grown in size and popularity. As one of the leading ISPE Communities of Practice (CoPs), the GAMP CoP drives industry-wide standards and practices that are referenced globally with the GAMP Guides.

Opportunities to become involved with GAMP continue to grow around the world. In 2023, new local GAMP CoPs were created in New Jersey and Boston in the US, as well as GAMP South Asia, which includes Australia, Indonesia, Malaysia, Philippines, Singapore, Thailand, and New Zealand collectively. These local CoPs each need new volunteers to lead them and to create events that are tailored to their location and members’ interests. If you are interested in volunteering, please reach out to one of the local or international CoPs for more information.

Volunteer Engagement and CoP Growth

Volunteer engagement and the growth of CoPs is a key element of the 2023–2025 ISPE Strategic Plan. ISPE was founded on, and grew through, volunteer engagement and activities. I personally engaged in various local ISPE Chapter events, committee positions, and local Chapter leadership for many years. Local Chapters and Affiliates provide you with easily accessible events and programs, along with the opportunity to network and engage with local and regional industry stakeholders. Many CoPs have local, regional, or international groups as well.

There are more than 20 active CoPs with enthusiastic volunteers and contributors around the world that engage in relevant topics, guide development, and create conference material. Reach out to any staff member or ISPE leader to see how you can get more involved today.

Global Expansion

Another key strategic pillar is global expansion to reach areas previously underserved by ISPE. International leadership continues to support geographic expansion to areas such as South America, China, and Southeast Asia. One example of that expanded reach of ISPE technical knowledge is a program that was coordinated through the ISPE Foundation and made possible by a generous corporate donation. An ISPE guidance document and training course materials in biotechnology manufacturing topics were translated to Portuguese for use in Brazil. This was done in collaboration with the ISPE Brazil Affiliate, the Brazilian Academy of Pharmaceutical Sciences, the University of São Paulo, and Agência Nacional de Vigilância Sanitária, Brazil’s National Health Regulatory Agency.

The training was rolled out to approximately 130 participants comprised mainly of regulatory authorities, industry members, students, and emerging leaders. The paired guidance document, the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs)—Autologous Cell Therapy, will soon be available to local targeted audiences. Throughout 2024, the International Board of Directors and ISPE leadership will continue to look for impactful areas to further engage and bring the vast technical advice and knowledge, developed by our dedicated volunteers, to more areas of the globe.

Moving Forward as One ISPE

I want to take this opportunity to thank all the dedicated volunteers who have taken on leadership roles across the various efforts and regions. This includes Chapter and Affiliate leaders, the International Board of Directors, the ISPE Foundation Board of Directors, CoP leaders, conference planning teams, guide and document writers and reviewers, and our various regulatory committees.

It is only when we work together, as One ISPE, that we can continue to bring high-quality, technical, and relevant topics to our membership across the globe. It is through the continued collaboration and partnerships we have developed that we will continue to share this knowledge globally to ensure we are bringing cutting-edge technology and solutions into the industry and driving toward life-saving therapies available globally to patients.