Cell-Therapy Outsourcing And The Flip Of A Coin
By Louis Garguilo, Chief Editor, Outsourced Pharma
His has been an “all-in on outsourcing” organization from the get-go. But now his company – initially focused on an autologous cell-therapy program – is changing direction, and heading into a broader set of clinical trials in the coming years.
“We are definitely going to open up lab and GMP facilities ourselves somewhere in the U.S,” Triumvira CEO Paul Lammers tells me.
“Why the change of heart?” I ask, suspecting the reply we’ve heard from other biopharma professionals throughout 2021.
“Because the biggest bottleneck in the cell-and-gene space is access – getting into the queue at the GMP manufacturers,” he replies, as if on cue. Even today, it remains difficult to find a sufficient number of service providers with the “specialty experience” Lammers seeks.
“And nothing is worse than being in that situation,” he adds.
Not Quite A Coin Flip
But each of these, says Lammers, is being bombarded with clients.
“I've been doing drug development for over 30 years,” he says. “Nothing is worse than depending on somebody else to deliver your products in this environment. For clinical trials, you need to have control over your supply.”
The dilemma presents as two sides of the outsourcing coin.
- “Heads” and external partners are extraordinary enablers, allowing drug/therapy sponsors to advance programs, access expertise, technologies and facilities, while staying lean and nimble.
- “Tails” and you may find your development programs on-ramping a clogged freeway for services and expertise, or driving down a road with few service stops offering the specific assistance you need to complete your journey.
Perhaps this is not news to Outsourced Pharma readers; it is the de facto milieu of our times – and despite the challenges, most times it (somehow) works remarkably well.
Still, outsourcing introduces a set of risks, and those are heightened for organizations getting started on novel development programs and technologies – particularly in many cases for cell- or gene-therapy developers.
Lammers says clinical trials are key right now for so many emerging organizations. “If we can provide that whole supply chain ourselves – and have control over that aspect – it’s much better than relying on a process of getting into the queue with everybody else.”
“We use Lentigen as the manufacturer of our lentiviral vector,” he says of a key component of his supply-chain needs. “They are an awesome GMP manufacturer of these vectors, but they are also bombarded with requests; people are lined up outside the door to try to get in.”
One strategy, then, “is to jump into that queue as soon as possible – and make sure it is the right queue for your programs – and plan very carefully once in line.”
“You need to make sure you obtain your slots, but then also that you use those slots wisely. Think how many clinical studies in cell-and-gene are ongoing in the U.S. right now – more than a thousand? It’s massive, and we need to get control over that whole supply chain.”
I’ll interject there’s also the great unknown: How many development programs are shelved because start-ups can’t get development services or trial materials? That, alas, is an immeasurable at this point.
Paths Of Least Resistance
Besides changing the business model to building out and growing internal capabilities, are there still applicable “best practices” to mitigate encounters with service-provider bottlenecks? After all, Outsourced Pharma is in the business of providing you such advice.
Among the rinse-and-repeat (but effective) practices:
- build relationships with your service providers; understand optimal mutual outcomes (for provider and sponsor)
- manage your internal dynamics (e.g., program timelines; personnel) to ensure optimal productivity when working with external provider
- communicate constantly and effectively about a program’s scientific history and data, the exacting needs of the present, and future planning
- perform the upfront R&D (or allow your service provider to), so you can select the materials and technologies allowing for smoother development and less expensive production
There are others. But particularly when it comes to the unique needs of the cell-and-gene space, don’t take lightly the option for internal build-out as an advancing solution.
Can You DIY?
It’s not our intention here to paint outsourcing success as a flip of the coin, or advocate for or against building internal resources.
Nor is this the space to suggest how to accomplish a build out if that appears as the best path. Our aim is more elemental and questioning of individual companies and situations: Is this really an option for more companies to select?
Lammers says regarding considerations of square feet, instrumentation and equipment, funding and capital expenditures, setting up GMP facilities for development or clinical material in this space is in fact a viable option.
He does, though, draw distinctions between autologous and allogeneic programs, with the latter most often requiring larger amounts of space and resources. He also makes clear for either cell therapy, post-approval, full commercial “is a different story.”
“The good thing here is you can make it efficient to gain internal control early on,” Lammers explains, using Triumvira’s autologous program as an example. In his case, it started with internal resources for guidance: he hired in a chief technology officer with vast experiences building facilities (even commercial) for cell therapies.
But these resources can also be in the form of consultants; in the best of circumstances, even some CDMOs looking for future relationships can step in with support.
“If you're readers are looking at a 5,000 to10,000 square-foot space, with that alone they can build up a substantial opportunity for themselves.”
“And the nice thing about new equipment and automation – like the Cocoons – is you can easily scale them up when necessary. There’s no need for growing your footprint, or sucking up large investment dollars and adding financial risk.”
Ah, back to the Cocoons – and the new models emerging to best serve the needs of biopharma. This, then, is a good place to wrap up our four-part series. For those who haven’t read the earlier editorials, here you go:
1. No Joke: A Cell-Therapy Start-Up Meets A Super-Sized CDMO
2. CDMOs Can Serve CGT Companies, Make Money, And Support A Nation
3. "Nick And the Cocoons": Automation for Autologous Therapies