Message from the Chair: ISPE’s Regulatory, Technical, and Quality Leadership

Supporting Leadership and Workforce Development

ISPE is working to bridge the talent gap and support workforce development—helping the future workforce prepare to drive the industry forward. Workforce development is a critical need: A 2017 study by ISPE and McKinsey & Company found disruptors in pharmaceutical operations, including digitization, advanced analytics, and new product modalities (such as cell and gene therapy), were creating a skills mismatch in more than 80% of pharmaceutical manufacturing companies. In the seven years since that report, additional research has confirmed those gaps persist across the pharmaceutical value chain.

ISPE offers a wealth of resources and opportunities to support leadership development. We recently launched a new column focused on leadership. This topic is at the forefront of our conferences as well. Leadership development opportunities are available through many avenues, including ISPE’s Women in Pharma^®, the Mentor ISPE program, and the ISPE Emerging Leaders program.

ISPE is expanding its scope of professional development opportunities. This year, we plan to launch a new professional development certificate program; more details will be unveiled later this year. We are also seeing momentum around professional development offerings specifically tailored for ISPE Affiliates and Chapters, thanks to One ISPE.

Enabling Regulatory, Technical, and Quality Leadership

ISPE steadfastly supports enabling regulatory leadership; this is part of our vision statement and a top priority for me as the ISPE International Board Chair. ISPE is uniquely positioned to bring together regulators, manufacturers, and other key stakeholders from across the industry and around the world.

We operate around this mindset: If we knew what regulators were thinking, what they wanted or needed, it would help us do our job better in serving them. We come together so we can understand the challenges and opportunities surrounding regulatory compliance collectively, enabling us to engage in complex problem-solving to make improvements together.

We are actively engaging with regulators. By the third quarter of 2024, our conferences had featured more than 27 speakers from 10 regulatory agencies around the world. Collectively and individually, ISPE has built relationships that drive remarkable benefits to the pharmaceutical industry. Regulators, pharmaceutical manufacturers, service providers, and equipment vendors have all contributed significantly to the industry and ISPE. Many professionals have benefited from ISPE trainings and in many cases, they were the trainer or were involved in developing the training program.

ISPE has delivered 45 years of technical leadership to the industry and continues to make strides in providing novel insights and approaches as the industry grows and evolves. Our technical leadership is apparent in everything we do—starting with our 22 technical Communities of Practices, who inform content from ISPE Guidance Documents to professional development courses to conferences. We are expanding the ISPE community to engage all aspects of the pharmaceutical industry—appealing to and looking beyond our dedicated audience of engineers.

We are also providing quality leadership, which closely ties with our regulatory leadership initiatives. Our regulatory volunteer groups actively submit commentary to regulators, engage in meetings with health authorities, and provide valuable content and insights to inform ISPE Guidance Documents, conference sessions, webinars, articles, blog posts, and more.

As we broaden our scope, we are exploring a wider array of topics, including a focus on biotechnology, with our 2024 ISPE Biotechnology Conference in June and early-stage plans for ISPE Guides focusing on topics like oligonucleotides and mRNA. ISPE also has guides on pharmaceutical compounding and continuous manufacturing. Together, we can advance the workforce of the future and support industry growth with our leadership initiatives, a wealth of resources, and collaborative support.