“CDMO selection isn’t just a technical decision. It’s also a counterparty risk decision.”
Ahead of CDMO Live Americas, Samir Panjwani sums up one of the biggest blind spots in biopharma outsourcing today. Sponsors spend months vetting a contract development and manufacturing organization on capability alone, he says, only to discover the real risk was sitting somewhere else entirely: in the manufacturing partner’s balance sheet.
Samir’s interest in CDMO selection is not purely academic. He was diagnosed with ulcerative colitis and, at one point, seriously questioned what his future would look like. A biologic medicine gave him his quality of life back, and that experience changed how he sees the industry.
“What ultimately gave me my quality of life back was a biologic medicine, and that changed how I look at the industry,” Samir says. “Suddenly the manufacturing, the quality, the supply chain weren’t abstract anymore. I was personally experiencing what it meant to be the patient on the other side of the system that we’re all working in.”
That dual perspective, as both an industry operator and a patient who depends on the medicines this industry produces, sits behind everything CDMO Signal is trying to solve.
Why CDMO Selection Turns Into a “Sourcing Echo Chamber”
Samir built CDMO Signal after watching the same pattern play out again and again inside sourcing meetings.
“You get smart, experienced individuals in a room and someone says, well, I’ve worked with this CDMO five years ago, or someone else knows the supplier you’re talking about,” he explains. “There are spreadsheets and Google searches and consultants that you bring into the mix, conference relationships, and then you can very easily end up recycling the same familiar names over and over again.”
He describes this as a sourcing echo chamber: a small set of familiar names that keeps resurfacing regardless of whether they’re actually the best technical fit for a given program.
His answer was to flip the process around. “I kept coming back to a really simple question,” Samir says. “Why not start from a first principles approach? Think about what the program actually needs, modality, scale, geography, even the regulatory requirements, and then ask which suppliers actually fit that problem statement. That’s really where CDMO Signal started.”
For sponsors, the practical takeaway is to define a program’s technical and regulatory requirements before a single supplier name enters the conversation. Let those requirements generate the consideration set, instead of starting with a handful of familiar CDMOs and working backward to justify them.
The Three Shifts Reshaping CDMO Sourcing Behavior
Samir points to three simultaneous shifts changing how outsourcing leaders approach CDMO sourcing.
First, the questions being asked have become far more sophisticated. “Sponsors aren’t just asking who does biologics anymore,” he says. “They’re asking specific questions about modality, scale, geography, technology, regulatory history, timelines, and increasingly even business risks.”
Second, discovery has become far more digital, and increasingly AI-driven. “Historically your network, the people you know, and your consultants could heavily influence the universe of suppliers that would be considered,” Samir notes. “Now with technology you can interrogate a market from a much broader scope, much faster.”
Third, sourcing is becoming more evidence-backed. Rather than starting with five familiar names and working backward to see which one fits, outsourcing leaders can now start with an actual requirement and use technical, regulatory, operational, and financial evidence to build the initial consideration set.
Importantly, Samir doesn’t see relationships disappearing from the process. “I don’t think relationships are disappearing at all,” he says. “I think technology changes where those relationships become most valuable.”
The practical implication is a division of labor. Digital tools and evidence do the work of widening and validating the initial consideration set, while relationship-driven judgment gets reserved for the later, higher-stakes stages of due diligence and partnership building.
GMP Certificate Density: A New Lens, Not a Ranking
One of CDMO Signal’s most talked-about outputs is a top 10 list of CDMOs based on a metric Samir calls GMP certificate density. It’s built on data pulled from public regulatory databases, including the FDA, EMA, and MHRA, which CDMO Signal continues to expand as it grows.
“I would say it’s not necessarily a ranking of the best CDMOs,” Samir clarifies. “But it’s a very interesting filter.” Looking across EMA and MHRA GMP certificates in CDMO Signal’s tracked data set, the top 10 CDMOs held roughly half of the certificates being tracked, around 250 of approximately 500 to 530 total.
Each GMP certificate is tied to a specific site and manufacturing activity that has gone through regulatory oversight, which is why Samir sees certificate density as a useful lens into an organization’s regulatory breadth and operating footprint. But he’s clear that it shouldn’t stand alone.
“You still need to understand the specific site, the modality, the scope, the inspection history, and whether any of it is actually relevant to your program,” he says. “More GMP certificates doesn’t actually mean anything. It doesn’t mean that it’s better. It just means there’s another point of view of regulatory evidence that’s worth understanding about the program you might be looking at.”
Samir has also noticed sponsors moving this kind of regulatory and quality diligence earlier in the process, often before a shortlist is finalized or an RFP is issued, rather than treating it as a late-stage checkpoint. The lesson for outsourcing teams is to treat certificate density and other public regulatory data as an early screening signal rather than a final scorecard, and to pair it with site-specific, modality-specific diligence before drawing any conclusions about fit.
Financial Health: The Risk Most Sponsors Don’t Ask About
Perhaps Samir’s strongest message is about CDMO financial health, a factor he believes is consistently underweighted in outsourcing decisions.
“CDMO selection isn’t just a technical decision. It’s also a counterparty risk decision,” he says. “Imagine spending months selecting a manufacturer. You transfer the process in, you validate the methods, you establish the quality relationship. You may even have regulatory commitments built around the facility you’ve chosen. And then the company starts to have financial problems. Maybe the site closes. Maybe there’s a restructuring. Maybe the capability your program relies on gets sold or spun off.”
For drug developers, the cost of that kind of disruption isn’t only financial. “The scarier thing with drug development is that the issue sometimes is not even the financial part. It’s the time,” Samir says. “A development program could lose months, or potentially much longer, if one of these catastrophic financial events happen.”
He argues sponsors need to evaluate three things together when choosing a manufacturing partner: technical fit, regulatory and quality fit, and business durability. “The technically perfect CDMO can still be the wrong partner if the business underneath it is not durable,” he says.
Because private CDMOs don’t open their books to prospective clients, Samir recommends watching for patterns rather than any single red flag: restructuring, facility closures, capacity reductions, repeated layoffs, leadership turnover, financing pressures, customer concentration, or a company quietly backing away from a specific modality.
“None of those alone means don’t use the supplier,” he says. “But together they start to tell a really interesting story that maybe encourages the drug developer to ask some harder questions.”
The takeaway for sponsors is to build a lightweight business durability check into every CDMO evaluation, alongside the technical and quality assessments that already exist. The value is in the pattern, so it pays to look for clusters of warning signs rather than dismissing or fixating on any single metric.
What’s Next for CDMO Signal
Samir will be sharing his insights at CDMO Live Americas, Boston, 20-21 October 2026, where he plans to walk through some of the early behavioral data CDMO Signal has gathered from sponsors and CDMOs actively using the platform.
“When I created CDMO Signal, I thought it would just be lookups, CDMO lookups,” he says. “But surprisingly, it has really turned into a decision intelligence platform.” He expects to share more of what that evolution looks like with the audience in Boston.
Samir also welcomes input from both sides of the market. “I genuinely welcome any feedback from both sponsors and CDMOs,” he says. “We’re still early, and a lot of what we’re building is coming directly from learning how people are actually making these decisions.”
CDMO Signal is available at cdmosignal.com
