How To Approach Build vs. Buy Like A Boss
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
There’s seemingly more pain than pleasure in the advanced therapies outsourcing paradigm today, thanks in part to talent, capacity, and supply crunches. As much as I hate to say it, this is likely to be the reality we continue to face in the near-term. In a recent report, “U.S. Pharma Market 2022 and Beyond,” CPhI Insights predicts that we can expect capacity demand —especially for viral vectors — will keep growing over the next two to three years. (Thanks, COVID.) In turn, there will be a greater push on the CDMO side, particularly amongst the bigger CDMOs, to keep building, acquiring, or snapping up pre-existing facilities.
I’ve previously discussed the consolidation we’re seeing on the CDMO front, which those of you on the innovator side know can pose some added challenges in the competitive partnering process. It’s these challenges that I’d argue give rise to the bold, seemingly black-and-white equation of build vs. buy that has captured so much industry discussion today — as if every company under the sun will find peace, happiness, and unbridled success by only picking one and sticking with it. The reality is inevitably going to be finding comfort in a hybrid model for the long-term.
I recently read an article by my colleague Louis Garguilo at Outsourced Pharma that was a fantastic reminder that your build-buy strategy can (and probably will) change in one of two ways: it can be a gradual, purposeful, data-driven decision, or it can occur, as this article outlines, when you’re suddenly dropped by your CMO. Ouch.
Though such an article should probably come with a trigger warning, this is a critical experience to showcase today because it epitomizes the fluid nature of building-and-buying. In recent weeks, I wrote a post about “staying the course” and what this means for those of you chipping away at advancing the C&G manufacturing paradigm. This story is a great example of staying that course; not only does money abound for companies to invest earlier and earlier in their in-house manufacturing capabilities, but as GenVivo’s COO Robert Johnson shared, the decision to build — albeit an important step for knowledge development/management — must also be accompanied with a level head about your capabilities to progress through scale-up on your own. As he emphasized within the article, GMP development is resource-intensive, and partnering to expand capacity and right-angle check certain processes is likely in the company’s future.
I’d also argue that we can’t talk about staying the course without keeping a realistic eye on the long-term outsourcing landscape. It’s worth the reminder that the pains of today’s constricted outsourcing landscape will not be the forever story; in fact, the more I read and listen to folks, the common opinion is that we’re looking at a future ripe with additional — if not excessive — capacity for C&G therapies. For companies investing early (and maybe earlier than they’d like) in manufacturing capacity today, this predicted abundance of future capacity promotes the possibility and/or probability that smaller companies will have support in shouldering the immense GMP management challenges that come with broadening pipelines and earlier/greater patient access.