Industry’s Best Secret

In business, understanding future key variables ahead of competitors provides a decisive advantage. In highly regulated industries, such as pharmaceuticals, this includes policy and compliance filing changes. Despite an editors’ mission being to educate and inform, I have been conflicted about sharing the following. The reason the first and second rules of fight club are famously “do not talk about fight club” is that productive events often depend on a delicate framework balancing expression, fun, and flexible social mores against a need for certainty and durable authoritative institutions. The annual PDA/FDA Joint Regulatory Conference is, in this way, the same as fight club. I concluded that sharing the fact that there are secrets is entirely different from sharing any of the secrets themselves.

Advertising for the conference says it “is designed to share approaches that facilitate sustainable compliance with CGMPs [current good manufacturing practices] by addressing emerging risks to manufacturing and supply chain reliability [and that] it will provide forums for open discussion between FDA representatives and industry experts, and offer opportunities for the application of approaches that enhance assurance of raw material quality, quality assurance management of contract manufacturing relationships, root cause analysis, and use of current technologies... [and that] key themes will include leveraging the digital and automation revolution, contamination control strategy, latest FDA CGMP trends, how to respond effectively to FDA 483s” and so on (1).

Pivotally, this description left out the secret that “open discussion” extends to a willingness to listen and take into account new information and anecdote, genuine attempts to learn about and resolve short and long-term problems, and heartfelt honest opinion and conjecture. Cumulatively, that makes this event easily the most useful time spent during the year. Details themselves are expressly “off-the-record” and not to be talked about outside of the event. That’s the engine that generates the power of this event, creating more light than heat. Attendance will provide a decisive advantage to anyone attending, and there’s clearly no reason to fight about that.

Reference

1. FDA, 2022 PDA/FDA Joint Regulatory Conference, Events, FDA.gov, accessed Sept. 27, 2022.

About the author

Chris Spivey is the editorial director of BioPharm International.

Article details

BioPharm International
Vol. 35, No. 10
October 2022
Pages: 6

Citation

When referring to this article, please cite it as C. Spivey, "Industry’s Best Secret," BioPharm International 35 (10) 8 (2022).