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Coverage of COVID-19 vaccines was surprisingly displaced by this year’s astounding oncology and iconoclastic gene therapy “cures.”
It’s easy to get excited about flamboyant paradigm breaking inventions. As editors, we don’t hesitate. Coverage of COVID-19 vaccines, alongside the business and regulatory innovations that allowed their warp speed passage, was surprisingly displaced by this year’s astounding oncology and iconoclastic gene therapy “cures.” Without taking shine off these mercurial performances, the background workhorse approaches and tools to these atypical advances have generated consistent growth, performance, and adaption to increasingly complex demands.
By sheer readership percentages, the most absorbing content in 2022 was ALCOA+ (attributable, legible, contemporaneous, original, and accurate—with complete, consistent, enduring, and available components added). As Industry 4.0 demands spread, there is increasing need for more layers of deeper equipment integration and coordination as digital data acquisition and transfer ramps up; hence, the need for aligning processes to ALCOA+. In close second place came perspective and context on various international pharmacopoeias and regulatory requirements, monographs, reference standards, and protocols. This is no surprise, and we’ve allocated many spots for these topics on the 2023 editorial calendars.
A fair way behind, but well ahead of all others, we see topics such as chewable tablet formulation, chromatography development and validation, tablet disintegration, dissolution testing, statistical understanding, and updating supply chains. Next are perennial primers like assessing shelf life through stability tests, establishing acceptance criteria for analytical methods, and closure design and test controls. If I were an advertiser seeking to speak directly to any of our 2 million annual website users, I would circle any of the above that my clients were active in or in some fashion, supported.
But I would also target staff recruitment and training. For ordinary roles, but also for advanced therapy medicinal products, one of the most pedestrian needs you can conjure is the experienced staff to execute these activities. Alongside digital transformation, I see trained staff (even pedestrian team members) as being a requirement no winning pharmaceutical company can avoid placing at the top of the priority list.
Chris Spivey is editorial director for BioPharm International.
Vol. 36, No. 1
When referring to this article, please cite it as C. Spivey. Pedestrians as Priority. BioPharm International 2023, 36 (1)