CGT Manufacturing Resolution #5: Find Balance Between "The Sky Is Falling!" & "Surprise!" In Communicating Risks
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
In early December, I invited Katy Spink, COO and managing partner of Dark Horse Consulting, to sit down with me for a discussion on her expectations and predictions for CGT manufacturing paradigms in the new year. But because cross-industry collaboration, face-to-face communication, and transparency are critical in this burgeoning industry (and, let’s be honest, can be a lot of fun), Katy and I were also joined by a small group of CGT manufacturing experts from different companies across the industry.
Our conversation ultimately outlined five best practices — or, more fittingly, New Year’s Resolutions — that companies should embrace in 2022 that will (incrementally) help us define and achieve manufacturing maturity in the future.
In the fifth of this five-part article, Spink dives into resolution #5, urging companies to perfect the “what’s” “when’s” and “how’s” of communicating manufacturing risks in a “balanced manner” at the highest levels of a company.
You could have the most beautifully defined TPPs, QTPPs, the best talent on board, and a brand-new facility filled with top-of-the-line equipment. But if your processes and timelines are poorly documented and communicated, and/or your C-suite and investors are ill-versed in the importance of CMC, efficiency will be held at bay, regardless of your in-house scientific and technological innovations.
The importance of communication both across and upwards in a CGT organization was a point Spink drove home throughout our conversation.
“Senior executives and investors vary tremendously in their level of sophistication and understanding of manufacturing issues,” Spink explained. “It’s critical the executives at the highest level of the company and on the board understand that the company needs to invest in process development and process understanding early to achieve manufacturing consistency in the long-term.”
This may (and likely will) mean spending more money on CMC before an inflection point or taking more time to reach a certain milestone — a concept that, for executives with a small molecule or biologics background, will be unfamiliar and/or potentially uncomfortable to accept.
“That can be a hard pill to swallow for some executives and investors, especially if they’re used to more routine manufacturing and supply chain processes,” Spink added. “There’s a balance to be had in making sure you’ve laid the basic CMC groundwork before rushing to that inflection point or else it’s not a real inflection point; it’s just a mirage.”
In addition to achieving this balanced communication style at the executive level, learning how to plan for different development scenarios and appropriately communicate risks across the organization will be no mean feat. As Spink, who has a background in project management, admitted, each Gantt chart outlining a project’s expected timeline often feels like the “real and universal truth.”
That’s why, rather than creating just one Gantt that “bakes in” all the broad assumptions, risks, and uncertainties shaping that timeline, Spink advises companies to clearly outline several different scenarios and how they could ultimately impact that timeline. This requires identifying the ideal-, middle-ground-, and conservative-case expectations for each timeline; breaking down each scenario’s risks; evaluating the severity and likelihood of those risks occurring; and potential mitigations that could be implemented in advance to reduce future disruptions.
In doing so, a company can create a dashboard for communicating risks across and to the very top of an organization. However, manufacturing teams will also need to identify which risks must be communicated upwards and when, as well as have an information escalation plan in place, as needed.
It would be hard to find anyone arguing that communication within an organization isn’t a critical factor for success. But as someone who works with words daily, I appreciated Spink’s attention to the nuances that companies may struggle with in communicating up the chain of command.
“Communicating risks in a balanced way is a core competency for CGT companies,” she concluded. “You don’t want to sound like ‘Chicken Little,’ but should any risks manifest, you also don’t want to catch senior management by surprise.”
For a complete list of all five CGT manufacturing resolutions, click here — and don’t forget to share with all of your friends!
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