2025 ISPE Annual Report
Executive Summary
In 2025, ISPE marked a defining moment in its 45-year history. Founded in 1980 to bring life sciences professionals together to share knowledge and advance industry practices, ISPE has grown into a global community committed to elevating standards, accelerating innovation, and strengthening professional excellence across the pharmaceutical and biopharmaceutical landscape. This year’s milestone anniversary underscored ISPE’s enduring role as a leader and convener for the industry.
Advancing Industry Knowledge and Practice
Throughout 2025, ISPE continued to deliver trusted guidance, regulatory insights, technical training, and world‑class conferences that support the evolving needs of the life sciences sector. ISPE’s authoritative Guidance Documents, collaborative forums, and global events served as instrumental platforms for shaping industry frameworks and fostering innovation. The Society’s ability to convene experts and drive knowledge exchange continues to raise expectations for quality, safety, and operational excellence worldwide.
A Community at the Center of Every Achievement
ISPE’s progress is rooted in the strength of its members and volunteers. The global ISPE community—united by a shared commitment to science, integrity, and advancing patient well‑being—has fueled the Society’s growth year after year. In 2025, this collective dedication was reflected in both the depth of member engagement and the diversity of professional expertise contributing to ISPE’s mission.
Unveiling ISPE’s Strategic Vision for the Future
Looking ahead, ISPE is poised to guide the industry through a new era of technological advancement, regulatory complexity, and global opportunity. At the 2025 ISPE Annual Meeting & Expo, the Society introduced a refreshed strategic vision.
Shaping the Future, Together
As ISPE looks to the future, its community remains its greatest strength. With new technologies emerging, new challenges ahead, and new opportunities on the horizon, ISPE is committed to leading with purpose and empowering professionals across the life sciences. Guided by its strategic vision and united by its global membership, ISPE will continue transforming possibility into progress—and improving lives worldwide.
ISPE International Board of Directors
2024-2025 ISPE International Board of Directors
Officers
Directors
Ex-Officio
2025 ISPE Accomplishments
ISPE continued to deliver best-in-class experiences and resources in 2025, carrying forth its reputation as the go-to organization for professional development and knowledge-sharing. The global ISPE community continued to thrive, dedicating countless volunteer hours to meet with regulators, develop Guidance Documents, provide training courses and webinars, contribute to conference programming, and more.
ISPE Membership Highlights
Celebrating Major Membership Milestones
At the 2025 ISPE Annual Meeting & Expo, Mike Martin, President and CEO of ISPE, revealed that ISPE had surpassed 25,000 members worldwide. Several weeks after the conference, we exceeded 100,000 LinkedIn followers. These achievements reflect not only the expanding global reach of the Society but also the trust and value that professionals place in ISPE as a hub for connection, learning, and leadership. ISPE acknowledges these milestones as shared successes made possible by every member across every region.
25,000+ Members Worldwide
- • 120 Countries Represented
- • 40+ Affiliates and Chapters
- • With the continued growth of the following petitioning Affiliates: ISPE Greece and Cyprus, Middle East, Pakistan, and Ukraine
Community and Connectivity
Community and connectivity are fundamental values underpinning ISPE’s mission as a global association for pharmaceutical professionals. ISPE Communities of Practice (CoPs) are the technical engines uniting professionals worldwide to generate meaningful content in our gold-standard documents, training programs, and conference programs. ISPE CoPs cover 23 unique technical areas in the pharmaceutical industry. Professional communities include Affiliates and Chapters, Women in Pharma®, and Emerging Leaders. ISPE’s networking platform, ISPE Engage, continues to facilitate an open forum for all members and each CoP to connect and collaborate virtually.
ISPE CoPs:
- • Expanded to include 23 active technical communities and additional communities with the introduction of the Radiopharmaceuticals CoP
- • 1,000+ engaged volunteers originating ISPE content
- • ISPE members generated 1,700+ discussion posts, with 500+ new discussion threads on ISPE Engage
In 2025, ISPE recognized the critical contributions of ISPE member volunteers. ISPE hosted appreciation events at the 2025 ISPE Europe Annual Conference and the 2025 ISPE Annual Meeting & Expo. Additionally, ISPE published 12 CoP leader profiles in Pharmaceutical Engineering® magazine.
ISPE Conferences and Digital Engagements Highlights
6 International Conferences
- • 275+ Presentations
- • 500+ Speakers
- • 6 Facility Tours
- • 47 Webinars
- • 9 Podcast Episodes
The Debut of the ISPE Podcast
In 2025, ISPE successfully launched the ISPE Podcast: Shaping the Future of Pharma, a new industry-critical digital initiative designed to extend ISPE’s global educational reach and thought leadership beyond conferences and webinars. The podcast provides an accessible, on-demand platform for timely conversations with pharmaceutical industry leaders, subject matter experts, and regulatory voices on topics shaping the future of pharmaceutical engineering and manufacturing. By delivering expert insights in an easily consumable format, the ISPE podcast supports continuous learning, knowledge sharing, and industry alignment across geographies, roles, and experience levels.
As a complement to ISPE’s conferences and webinars, the podcast strengthens year-round engagement with the global ISPE community, enabling professionals to stay connected to emerging trends, regulatory considerations, and best practices anytime, anywhere. This initiative reinforces ISPE’s mission to educate and connect the industry while helping professionals translate expert insights into real-world impact that ultimately benefits patients.
ISPE Publications Highlights
10 Guidance Documents were published, involving 145 authoring team members and nearly 300 reviewers:
Standard Operating Procedure (SOP) Templates
In 2025, ISPE launched a new offering, SOP Templates, which are designed to help organizations document, implement, and maintain quality procedures that meet global regulatory standards.
Pharmaceutical Engineering® Magazine
- • 6 Issues
- • 175 Authors
- • 128 Articles, including 49 Technical Articles
ISPE Professional Development Highlights
The Launch of ISPE Academy
2025 marked a transformative period for ISPE’s Professional Development team. ISPE successfully launched the new ISPE Academy, introducing six specialized certificate programs:
Since its debut in April 2025, the Academy has attracted more than 100 enrollees, underscoring strong industry demand for structured learning pathways.
The Establishment of the ISPE–Biomanufacturing Training and Education Center (BTEC) Partnership
ISPE pioneered a hands-on training initiative in partnership with BTEC at North Carolina State University, establishing its first experiential learning site in the United States and setting the stage for future global expansion. These milestones reflect ISPE’s commitment to advancing workforce development and delivering innovative, high-impact training solutions for the pharmaceutical industry.
Training Courses Conducted
- • 496 Registrants for On-Demand Courses (Including ISPE Academy Courses)
- • 54 Online Live Courses
- • 25 Custom Courses (Including Training for Regulatory Agencies)
- • 12 In-Person Courses
ISPE Regulatory Operations Highlights
ISPE’s regulatory initiatives and programs focus on solving problems of importance to industry and supporting convergence of global regulatory and quality expectations for the benefit of patients.
Regulatory Engagement and Professional Development Highlights
- • More than 200 inspectors and assessors from 7 health authorities trained on ICH guidances
- • Engaged with 52 regulators across 6 ISPE international conferences, fostering dialogue on key industry topics
- • Hosted approximately 200 regulatory attendees at ISPE events, enhancing global regulatory collaboration*
- • ISPE members provided regulatory comments on 13 draft documents during public health authority consultation
- • Delivered training to 200+ regulators representing 10 health authorities, supporting regulatory knowledge and consistency
*Data reflects partial-year webinar participation; final numbers may vary.
ISPE Regulatory Volunteer Leadership and Impact
- • Successfully led 17 regulatory volunteer groups, driving collaboration and knowledge-sharing across the global regulatory community
- • These groups comprise over 250 dedicated ISPE members, representing diverse expertise and commitment to advancing regulatory excellence
- • Collectively, our volunteers delivered more than 40 impactful contributions, including conference sessions, technical articles, and thought-leadership blog posts
- • ISPE membership contains more than 3,700 regulator members representing more than 85 countries
- • Provided substantive regulatory input by submitting comments on 13 public consultation documents to health authorities worldwide, reinforcing ISPE’s role as a trusted industry voice
Driving Global Regulatory Collaboration
In 2025, ISPE’s committees, working groups, and initiatives strengthened international partnerships and advanced regulatory knowledge through mutually beneficial engagements:
- • Delivered specialized training with Health Canada, featuring participation from the Medicines and Healthcare products Regulatory Agency (MHRA), focused on ICH Q13 principles (April 2025)
- • Conducted a multi-agency training with the Jordan FDA, joined by INVIMA (Colombia), TGA (Australia), and NPRA (Malaysia), covering critical guidelines including ICH Q8(R2), Q9(R1), Q10, Q11, Q12, and Q14 (August 2025)
- • Partnered with Brazil’s National Health Surveillance Agency (ANVISA) to host a workshop focused on innovation and regulatory harmonization in Latin America. More than 50 inspectors and assessors from ANVISA, Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT), Paraguay’s Dirección Nacional de Vigilancia Sanitaria (DINAVISA), and Colombia’s Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) attended the live virtual sessions
- • Led discussions on key topics at the annual meeting of the EMA’s GMP Inspectors Working Group with Interested Parties (March 2025)
- • Provided input to the EMA Quality Innovation Group (QIG) Listen and Learn Focus Group on Platform Technologies (November 2025)
- • Participated in the EMA Heads of Medicines Agency (HMA) Multi-stakeholder Workshop on Artificial Intelligence (November 2025)
- • Contributed to the Duke-Margolis ReVAMP Drug Supply Chain Consortium, providing input to consortium 2025 work products
- • Participated in the planning and delivery of a National Academies of Sciences, Engineering, and Medicine (NASEM) work on Improving Resiliency in the U.S. Pharmaceutical Supply Chain Through Make-Buy-Invest Strategic Actions (October 2025)
ISPE Foundation Highlights
The ISPE Foundation awarded 112 professional development grants to students and recent graduates in 2025, including:
- • 14 grants awarded to students and recent graduates from 10 countries to attend the 2025 ISPE Europe Annual Conference
- • 98 grants awarded to students and recent graduates from 10 countries to attend the 2025 ISPE Annual Meeting & Expo
ISPE Facility of the Year Awards (FOYA) Highlights
The 20th Anniversary of the FOYA Program
The FOYA program recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. FOYA provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches.
FOYA celebrated its 20th anniversary in 2025, commemorating two decades of recognizing the most innovative, high‑impact pharmaceutical manufacturing facilities around the world. As one of ISPE’s most influential and industry‑critical initiatives, FOYA continues to spotlight the breakthroughs that are shaping the future of life sciences, from advanced therapeutics and digital transformation to sustainability, automation, and next‑generation facility design.
This anniversary year underscores FOYA’s enduring role in elevating global best practices, inspiring operational excellence, and showcasing the technologies and approaches that are redefining pharmaceutical manufacturing. By honoring organizations that push boundaries and set new standards, FOYA reinforces ISPE’s leadership in driving progress and strengthening the global community of pharmaceutical professionals.
2025 FOYA Category Winners
Overall Winner and Pharma 4.0™ Category Winner
CSL Behring
Location: Broadmeadows, Victoria, Australia
Project: Project Aurora – Facility F Base Fractionation
2025 FOYA Category Winners
Johnson & Johnson Innovative Medicine
Location: Latina, Italy
Project: Flexible Bottle Packaging Line
Johnson & Johnson Innovative Medicine
Location: Ringaskiddy, Cork, Ireland
Project: BioCork 3.2 Expansion Project
Bayer Healthcare LLC
Location: Berkeley, California, USA
Project: Cell Therapy Launch and Manufacturing Facility
Sanofi
Location: Toronto, Ontario, Canada
Project: WWTRP: Wastewater Treatment and Recovery Plant
Touchlight
Location: Hampton, London, UK
Project: Development and Manufacture of Novel Synthetic DNA to Enable the Future of Genetic Medicines
Erbe Elektromedizin GmbH
Location: Rangendingen, Germany
Project: Erbe 4.i
United Therapeutics
Location: Christiansburg, Virginia, USA
Project: Clinical Xenotransplantation DPF Facility
Additional Updates from ISPE
The ISPE Digital Transformation Initiative
In 2025, ISPE initiated a multi-year digital transformation initiative aimed at elevating how members discover, access, and benefit from ISPE’s authoritative technical knowledge. As part of this effort, ISPE launched a phased implementation of an AI-enabled natural language query tool designed to provide intuitive access to the ISPE Body of Knowledge using accurate, expert validated content. In parallel, the Body of Knowledge Content Strategy project mobilized ISPE’s global volunteer community to strengthen content integration, enhance curation processes, and identify gaps across ISPE’s diverse knowledge modalities. Together, these projects lay the groundwork for a more connected, accessible, and future ready Body of Knowledge that will support the pharmaceutical industry’s ongoing advancement.
ISPE Corporate Partnership Program
The ISPE Corporate Partnership program is a strategic, annual partnership designed for companies wanting to enhance their industry leadership and exposure to a global network of pharmaceutical manufacturers and service providers. Corporate Partners benefit from exclusive opportunities, including expanded brand visibility through the ISPE Corporate Partnership logo, recognition across ISPE’s communication channels, discounted ISPE memberships, and dedicated content marketing opportunities.
We would like to thank our 2025 ISPE Corporate Partners for their continued engagement and support of ISPE’s mission.
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