By Anna Rose Welch, Director, Cell & Gene Collaborative
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In recent months, I watched an Endpoints News webinar entitled, “Strategies For Building A Cell Therapy Manufacturing Facility.” The webinar, which included executives from Tenaya Therapeutics, Iovance, Kite Pharma, and Instil Bio, provided some great considerations and best practices for those of you who have chosen to take the plunge into building your own capacity.
Because the C&G space is a wild adventure, to say the least, I wanted to share these experts’ insights in a less traditional way: via a (very simple) “choose your own adventure” series of articles. This “adventure” addresses the following scenario:
You have had a whirlwind of an afternoon learning about facility design, the operational implications of the make-to-order cell therapy model, and how to know the time is right to expand a facility.
Following your last discussion over ice cream with Alexis Melendez, senior director, facilities and engineering, Kite Pharma, and Faraz Siddiqui, VP, process development & manufacturing operations for Instil Bio, you asked if they’d like to cleanse their palates with a coffee. As a member of a small but swiftly growing company, you know that how that company is structured will play a critical role in the efficient execution of ideas and strategies. Alexis agrees to accompany you for a coffee and share his experiences on how a burgeoning cell therapy company should prepare to manage its workflow.
“In this business, we’re often thinking about expansions, especially as it relates to our capital and our facility capacity,” he begins. “But we don’t put enough consideration into how our business process will be impacted by increasing headcounts. How our workforce is designed to support our business processes is just as important a consideration as our facilities; we need to make sure that our employees can work on and in the wonderful facility we’re building so we can get these products to patients.”
For many a young company just starting out on its journey to develop a cell therapy and/or a new facility, resources — especially talent — can be hard to come by. Teams will likely be small and co-located, which allows big ideas and cross-team collaboration to flourish. However, as Alexis politely reminds you, “Ideas don’t execute themselves.” This is where the “communication path principle” comes in. There is obviously going to be a big difference in communication between two people and 10 people or 30 people — and so on. Two people can communicate back and forth and provide immediate feedback to each other. However, as soon as you add a handful of other people into the mix, that communication path is going to increase exponentially.
“You’re not going to be able to control that, no matter how good you are as a project manager or a director,” he warns.
A company will likely have five to six work streams that encompass the most important functional areas, including manufacturing, IT, QA/QC, supply chain, and utilities. As each of these workstreams grow in headcount, a company will be challenged to establish a system of governance: one that both promotes the independence and accountability of each individual workstream and reinforces cross-functional unity.
“It’s not as easy as it looks,” Alexis admits.
As you two turn from the counter with your to-go cups, you almost run head-first into a familiar face: Scott Bertch, executive director, clinical site head of Tenaya Therapeutics. After your previous conversation, he’d stopped into the café to send some emails before heading back on site. Fortuitously, when you tell him that you and Alexis were just discussing talent management, his eyes light up and he’s quick to offer some additional food-for-thought.
No one says that the innovation needs to be restricted to scientific and engineering advances; as Scott emphasizes, there are a lot of ways companies can apply flexibility and creativity to managing their staff, as well.
For example, one best practice may be to move employees across departments within the organization as development and manufacturing demands wax and wane. MSAT, PD, and manufacturing and engineering experts at Tenaya may often find themselves moved into different departments depending on where the greatest need may be at the time. So, a PD expert may be shifted into manufacturing for a manufacturing run requiring more manpower; in cases where the company has to hit the ground running with development, more staff may be allocated to the PD department. In turn, because each employee has the capabilities to serve in multiple departments, the employee base itself can remain small.
Scott is careful to note, however, that quality operations are a different story. “You must build quality into everything that you do, but to maintain transparency and compliance, quality operations must remain standalone from the rest of the technical operations organization,” he clarified. “They are at the table; their opinion is important, and their voice is heard. They get to vote with the rest of the team on the best directions to take. But from a compliance standpoint, they must stand alone.”
You, Scott, and Alexis exit the café. Alexis shakes your hand and tells you he has to head back to the office. You look toward your own office across the street and see your boss standing in one of the windows. As you look at your phone to make sure he isn’t on the lookout for you, a familiar voice greets Scott. It’s Instil Bio’s Faraz Siddiqui again who is on his way to his car. Apparently, he and Scott know each other. (It seems like everyone in the C&G manufacturing world knows each other — did you miss a party or something?)
You’re once again faced with a choice: you can head back to the office and face a potentially annoyed boss who has been looking for you. (But think about all you can share with him!)
Or, you can stay on the sidewalk and talk for a few minutes longer with Scott and Faraz, both of whom have fallen back into easy discussion about a question they received while participating together on a recent panel. (So, there wasn’t a party. Your FOMO disappears immediately.)
You hear the phrase, COGS — and suddenly, you’re off again…