As I reflect on my time at Mesa last week, three main topics jump out. First, the AAV space is still in need of “competent capacity.” Sure, there is an abundance of CDMOs with plenty of large-scale bioreactors, facility space, and people available for AAV manufacturing. But as we all know, the product is the process and if your CDMO has an inconsistent process, or rapid employee turnover, or immature support systems, or just lacks experience, the process is not going to perform, and your product is going to suffer. We met with a number of potential partners that echoed this sentiment. The industry is still starving for competent capacity that can deliver the full experience for partners and patients.
This leads into my second key takeaway. As an industry, we need to continue to “raise the bar” on our expectations for both product quality and CDMO performance. Our CEO Andrew Knudten, spoke about this during his presentation last Tuesday and as I looked around the meeting room, I saw a number of heads nodding along. We cannot be complacent with the quality of products; 70% full capsids is just not good enough. The technology is there to consistently manufacture >90% functional, full capsids, so why would we ever settle for less? Our job as service providers and as drug developers is to completely remove CMC from the regulatory equation. It should be the neutral element that allows regulatory agencies to focus all their time on evaluating clinical outcomes for safety and efficacy.
Both of these items, “competent capacity” and “raising the bar,” highlight my third and final key takeaway: People + Culture is still a winning formula. The equipment you have, the facility you build, the systems you implement, they’re all dependent upon the people who utilize them. You can’t have “competent capacity” if you don’t have the right people executing. You can’t “raise the bar” on product quality and performance if you don’t have the right leaders demanding it. Even then, if you’ve been able to find the right people, you can’t sustain excellence unless you foster a culture that diffuses throughout the company. Culture is the foundation that will support the company through the lifecycle of ups and downs and sustain dedicated employees. It’s the one true asset that cannot be duplicated. Throughout Mesa, we had people stopping by our booth complementing our team, informing us that they heard about us, that they wanted to work with a team like us. It’s probably overused but understated: People + Culture = Hard to beat.
In closing, I’d like to comment on my experience as a whole while out in Phoenix this week. ARM does an outstanding job hosting this event. Everything from the venue to the catering, the stage presentation, the speakers, the networking events; it is all top notch. I attend a number of these large industry conferences, and this one is at the top of the list. So, thank you to the ARM team and to everyone else who came out to make Mesa another successful meeting. Here’s to seeing everyone again next year – and sweating it out together in the desert heat!
Will Jones
Senior Vice President, Analytical Development and QC