Insights Into How Sponsors Search Today For CDMOs
By Louis Garguilo, Chief Editor, Outsourced Pharma
An AI-driven CDMO search tool is returning interesting insights into how today’s sponsors select for their external supply-chain partners.
Aptly dubbed CDMO Signal, the application aggregates FDA inspection data, clinical trial records, SEC filings and other attributes across over 150 CDMOs.
CDMO Signal was engineered by Samir Panjwani, Associate Director, Supplier Relationship Management – Cell Therapy at Astra Zeneca, as a "side hobby."
He's noticed three main search threads originating from his creation.
The first demonstrates that “regulatory quality” has become the primary filter for evaluating CDMOs.
The second thread is that outsourcing practitioners are sourcing most for “modalities that do not match the conference-hype cycle,” according to Panjwani
“This signal is early, but it is already meaningful,” he says. “The conference-hype cycle, and the outsourcing-search cycle, don't match up.” For example, mAbs and biologics are number one as far as what people are searching for specifically in CDMO Signal, with cell therapy and AAV following behind.
Panjwani says the third indicated thread is that the selection process is "multi-jurisdictional."
“It’s now a puzzle in ways people aren’t talking about enough,” he says.
Modality Play
Regarding trend two – program-specific searches – that services for mAbs and biologics are the most searched is "an unexpected outcome," says Panjwani. Cell therapy and AAV services following in popularity is less surprising given the activity in those spaces.
“What I see after these first months post-launch of CDMO Signal is what seems big on the conference circuit is only moderately popular in the tool,” he says.
“MAbs and biologics don’t set the conference scene on fire anymore, perhaps because these areas have reached a certain level of maturity, but these are still number one as far as what people are searching for.”
After cell therapy and AAV work, plasmid DNA comes next from a modality perspective. “Plasmids have been around scientifically for a while, but they are still highly searched for.”
Following those are searches for mRNA and lentiviral services. Of course, post-COVID, there’s been much talk about and expanding mRNA-based programs, but in the CDMO Signal data, mRNA is middle of the search pack.
Notable searches for specific services include "fill-finish" and "microbial."
As for ADCs, Panjwani says, despite being one of the hottest modalities in M&A activity, they "sit near the bottom in actual outsourcing search frequency."
What about nucleotides, a topic recently ringing in our ears. He replies, “LNP nucleotides are an interesting one; they show up at relatively the same level as the mRNA searches – middle of the pack.”
Overall, Panjwani is most impressed from learning "the news or hype cycle on programs may not be equal to the actual biotech or pharma outsourcing-search cycle.”
Regulatory Coverage As Geography
As we'd all expect, geography matters, and real estate in Europe is hot.
Panjwani believes the BIOSECURE Act and other outside influences are still driving that. CDMO Signal searches indicate CMC and other professionals are thinking, ‘We can't just be focused on the US. We need European partners to mitigate risks.’
“You are seeing a global kind of search,” says Panjwani. “People are sourcing for specific geography-use cases," such as:
We are selecting a CDMO for autologous CAR-T commercial manufacturers for supply in APAC [Asia Pacific region]; we a need clean PMDA [Japan regulatory agency] inspection history; GMP certification for APAC filing; and capacity available in 12 months.
Can this CDMO support my filing in three different jurisdictions simultaneously? is the manner of thinking revealed in his tool, says Panjwani. “That's fundamentally different than ‘Do they have a GMP facility?’”
Interestingly, he notes, CDMOs still market themselves mostly by site: ‘We have a facility in Houston, and one in Veenendaal in the Netherlands.’ Sponsors aren't thinking in that narrow type of geography anymore. It's much more strategic in intent.
Comparison Behavior
A final search thread Panjwani describes is comparison behavior.
Examples could be:
WuXi, Lonza, Samsung, Abzena, compared for antibody manufacturing prowess; comparing Oxford Biomedica with others for lentiviral phase two; AGC measured against others for 2,000-liter commercial biologics manufacturing; Catalent versus Charles River for AAV gene therapy.
“Users spend time running comparisons — multiple CDMOs for antibody manufacturing, or head-to-head for lentiviral phase two, or for commercial-scale biologics manufacturing,” he says. “There's a whole group of people who just go through these exercises.”
There is also a user progression.
“The searches evolve — from discovery to shortlist to validation,” says Panjwani. “A user might start with a broad modality search, then layer on geography and regulatory requirements, then run a head-to-head comparison on their finalists.”
“They treat this as a diligence workflow. If you’re a CDMO, sponsors are pre-screening you on regulatory data before you know you’re in the running. Sponsors are not evaluating CDMOs in isolation.
"CDMOs should assume you're being compared on every RFI.”
CDMO Signal went live – promoted solely by some LinkedIn posts – the end of March.
“I saw all these static directories in the marketplace, and thought, ‘Man, this should just exist,’” says Panjwani. “I kept looking for a tool that did this. It didn’t exist, so I built it.”
That building took hundreds of hours. Panjwani’s foundation for the tool is a “fully AI-driven” operation – “anything but static,” he emphasis. He pulls from a variety of name-brand AI platforms, “whichever is most effective for each search.”
“So when you search next week, you might get different results,” says Panjwani.
And they may be just the results you are looking for.