Michael Rutherford is a retired pharmaceutical industry quality professional with almost 36 years of experience. In November 2023, he retired from Syneos Health as Executive...
It is hard to believe that by the time this column is published, my term as Chair will be half over. We’ve accomplished much, and I’m left wondering, “Where has the year gone?”
When this column is published, we will have completed two very successful international conferences—the Facilities of the Future Conference and the Aseptic Conference—and the European Annual Meeting in Amsterdam will likely be concluded. Several regional Affiliate and Chapter conferences and vendor shows will also have occurred.
The overwhelming majority of the Affiliates and Chapters will have signed the new 2023 Charter, and the nomination process and the ballot for the Board is almost finalized. Planning for the 2023 ISPE Annual Meeting & Expo in Las Vegas in October will be well along and is beginning to be finalized.
The pharmaceutical industry is truly a global one, but it’s facing many challenges, including financial and ethical challenges, geopolitical considerations, supply chain pressures, talent shortages linked to wider labor market trends, and a swiftly changing product landscape. Inflation has risen to the highest levels in decades, leading to increasing costs for labor, raw materials, and transportation. This is on top of the price pressures the industry is already facing and the new and increasing government and protectionist trade policies on manufacturing networks that could drive increased regionalization.
North America and Europe remain the top global markets in pharmaceuticals, but the flattening of growth in pharma sales in developed countries have pharma companies increasingly looking to emerging markets—including Brazil, India, Russia, Colombia, and Egypt—for new sources of growth and revenue. These emerging markets, especially Latin America and the India subcontinent, are the ones that can see the most significant increase in pharmaceutical sales over the next three to five years. Hence the importance and focus on regional facilities in this edition of PE magazine.
ISPE is advancing our vision to shape the future of the global pharmaceutical industry.
As stated, one of the challenges facing our industry is talent shortages. This challenge is not limited to a specific region, but it is more prevalent in emerging market regions that are becoming increasingly important to the pharma industry as they aim to grow and expand. An ISPE 2023–2025 Strategic Plan objective—foster partnerships and collaboration that advance ISPE’s mission—is addressing this need through partnerships with the ISPE Foundation and industry supporters.
ISPE’s Technology Without Borders program underpins the Foundation’s Global Knowledge Exchange philanthropic pillar and supports our shared missions to provide global access to knowledge where needed. The Technology Without Borders program was created to expedite the process for availability of essential industry guidance documents and associated training to emerging economies, regulatory bodies, and organizations that would otherwise have limited or no access to the pharmaceutical industry’s best practices and standards. Aided by significant funding, the program is currently being piloted in Brazil, as there is no single greater opportunity for ISPE and the Foundation to accomplish this goal than providing training that is translated into the local language of Portuguese.
As the pharmaceutical industry is leveraging new technologies and innovation—including advancement of digital and analytics tools—to grow the business, the need for qualified and knowledgeable talent increases, especially in emerging regions. Supporting initiatives and programs such as Technology Without Borders are synergistic and beneficial to both ISPE and the ISPE Foundation and will expand our footprint globally. ISPE, through the Foundation and this program, is advancing our vision to shape the future of the global pharmaceutical industry by providing solutions to complex challenges through manufacturing and supply chain innovation; member and workforce development; and technical, regulatory, and quality leadership.
I encourage all ISPE members to support the ISPE Foundation by making a contribution. If you have questions or would like more information about the ISPE Foundation or the Technology Without Borders program, contact Tori Johnson, Director of Development and Foundation Operations.
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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...