Will 2024 Unlock Options Enabling Our Technologies
By Louis Garguilo, Chief Editor, Outsourced Pharma
“I can speak from our experience with CDMOs throughout 2023 that the biggest challenge we face is still capacity, particularly for a number of technologies,” says Outsourced Pharma Advisory Board member Doug Bakan, EVP, Technical Operations and Quality Assurance, Ventyx Biosciences, Inc.
Along with Bakan (who just left Ventyx as we were publishing this), a number of our Board members offered me with what they saw as the speed bumps of 2023, and provided a few provocative questions on how to flatten them in 2024.
Start With Capacity
The past 12 months, Bakan says Ventyx has often been informed the “next available slot” at CDMOs for development or manufacturing needs remains from 9-12 months out.
“For smaller companies on limited budgets, locking up capital to reserve slots so far in advance is challenging. Clinical development plans can change well ahead of the originally planned manufacturing date,” Bakan says.
That in turn can lead to “steep cancellation penalties or – worse yet – huge delays to get the next slot, which can be yet another matter of months in some cases.”
What should 2024 ring in?
In an ideal world, says Bakan, and one that should be manageable to both sponsors and service providers, “CDMOs would have capacity to slot in manufacturing campaigns with 3-4 months lead time at most. Anything our industry can do to make this a reality would be exceedingly helpful for innovator companies.”
But for now, a suffocating challenge Bakan faced in 2023 is severely limited access to certain technologies at CDMOs.
An example is the manufacture of high-potent compounds, where there is at least some good news heading into 2024. “I think it is improving as more CDMOs upgrade facilities and personnel to handle those compounds,” Bakan says.
On the other hand, spray drying is an example where the industry is still “woefully under-resourced,” and Bakan fears there’s some unfortunate market influences exacerbating the challenges.
“There are a couple companies that have dominated that service sector for years,” he says, “and in some cases they’ve implemented aggressive business practices to ensure competition doesn’t impact their own business plans.”
“I understand that can be good for their bottom line, but it’s not so good for the many biopharma companies that need contract spray-drying services in an environment with limited options to begin with.”
Here, too, there may be bright spots developing for 2024, as a number of service providers are in the process of adding new or additional spray-drying capabilities. Still, it appears those services coming on line are already booked through the first 6-9 months from the startup of operations.
So while 2023 was a good year for Ventyx’s pipeline and future overall, Bakan says it has proven frustrating navigating the CDMO space.
“Unless something changes in the industry to provide increased capacity and timely access to services,” he says, “I’m not confident 2024 will be any easier for smaller companies needing to access specialized technologies at external partners.”
Tech For Tech
Here are some of the questions I asked of our Board members that elicited the discussion above:
“Considering science/technologies/platforms in 2024, will the focus be on oglionucleotides, vaccines, specific advancing cell/gene platforms, the integration/utilization of AI/ML or other digital intelligences? Will it be RNA broadly considered – or has RNA, as they say, sucked the air out of the room, and now be put back among the other trending platforms?
- Regarding technology platforms, should we consider looking at what the common elements are, and how they can be used to help us develop facilities, equipment, and workforce that can support several different modalities?
- Can we improve our utilization of AI to better predict and control the end-to-end supply chain by working together?
“Artificial Intelligence is a great opportunity for our industry to reduce human errors,” she says.
“I’d assign AI to work for us like a ‘quality cop,’ ensuring first that none of the repetitive, routine tasks still performed in our labs and factories contain errors.
“Then there are opportunities to automate review of batch records, calibration, maintenance, other quality tasks, and auto-generate repetitive document templates.”
“I certainly could be wrong,” he says, “but I think mRNA had it’s moment as a COVID vaccine platform. Now there are a lot of questions around mRNA’s application for therapeutics,” which is exactly where the financial backers and developers of that technology are rushing towards.
More generally, Graskemper adds “advanced therapies had an enormous amount of growth in a short period of time.”
That pace, he feels, is slowing down, “and normalizing against the current economic environment.”
“Understanding that raising capital is currently difficult, it puts the advanced-therapies industry in a bit of a conundrum. There’s tremendous pressure on moving forward, patient accessibility, and the overall cost of these new therapies.”
For 2024, Graskemper wonders:
“How can we expect innovators and CDMOs to improve R&D and manufacturing processes without the investment needed for process intensification and integration/utilization of technologies such as AI/ML? And can we learn to do better with less resources?
“Digitalization is now critical,” he adds.
“This moves us to manufacturing profiles more like semiconductor fabs, or even EV-battery assembly operations, and helps us prepare for the lower number of STEM employees emanating from colleges.”
Unfortunately, we still have not established general models for cost- or risk-sharing for the implementation of new technologies in our CDMOs that will enable the new technologies in our pipelines.
Perhaps 2024 will bring more of that.