“We talk about external manufacturing and managing CDMOs, but 90% of your time is managing the internal team,” says Tamika Drummond.
Dr. Tamika Drummond, CEO and Founder of 3Kinnect Solutions, holds a master’s in pharmacology and a PhD in chemistry. She built her career at a prominent Canadian biotech, where she led CDMO selection, onboarding, and partnership management across biologics, monoclonal antibodies, bispecifics, and ADC programs. Before that, she worked in teaching, project management, and GMP quality assurance.
In the latest PharmaSource podcast episode, Tamika explains why CDMO selection is one of the most consequential decisions an early-stage biotech will make. She also explains why the choices that shape a program’s manufacturing future are usually made much earlier than most teams realize.
Build Internal Alignment Before You Contact a Single CDMO
When Tamika’s former company moved from discovery into development, every program had to be outsourced. Before the team could speak to a CDMO, it had to build the systems for doing so. That meant mapping the biologics CDMO landscape, creating RFI and RFP templates, and deciding who had a say in the final decision.
“It’s not just one person who decides that we’re going to go with this CDMO. There are so many different players here. We’re talking finance in terms of the budgeting. We’re talking who within our discovery or development team is going to be responsible for the scientific and technical components. Legal has to have a seat at the table as well. The quality and regulatory team: what are their requirements? The clinical team, what are their timelines?”
Tamika argues that this is where the external manufacturing manager earns their keep, by “leading without full authority.” The job is to collect competing priorities from across the business and reduce them to a short list of must-haves.
“You have to make sure that you take all the noise that is coming in, development saying this, quality saying that, and you synthesize that into: ultimately, what is the priority? And if we’re having a lot of disagreements, who is the ultimate decision-maker?”
Chase Fit, Not Big Names or Low Bids
Tamika sees small biotechs waste time in two ways. Some chase the best-known CDMOs, partly as a form of validation. Others chase the lowest quote. Neither, she says, starts from what the program actually needs.
An early-stage company needs flexibility and access to technical experts, and she says a large CDMO may not offer either:
“I need a CDMO that’s quite flexible because I’m new to the scene. My timelines might be wrong. I might need a bit more development. I don’t understand the process that well. I might need access to your technical team within your CDMO, and you might not be able to find that at a big CDMO.”
The cheapest proposal has its own trap:
“Cheap in the beginning ends up being expensive because every single thing requires a change order. You want to add one additional study, and then they’re like, ‘Oh, we have to do a change order. You have to spend some more money.’ So you end up, in the long term, spending more.”
Her conclusion is simple: “It’s all about fit. It might be a big CDMO in the end. It might be a small CDMO.”
The Capacity Crunch Is About Specialization, Not Space
Tamika disputes the claim that there is an industry-wide shortage of capacity. She is clear that this is her view from experience, not from data. In standard biologics, she says, “so many of those CDMOs have bioreactors that are sitting empty.”
Where she does see a real squeeze is in complex modalities. The clearest example is ADCs:
“ADC is not just a biologic. There is the monoclonal antibody component, but there’s also small molecules that might be involved. You’re making the antibody, you’re making linkers, you’re making payloads. And so the chemistry is extremely complex, and the expertise that is needed to make a single ADC, you need a lot of experience in that field.”
Complex fill-finish is the second pinch point. Plenty of CDMOs can fill vials, but fewer can handle prefilled syringes, cartridges, or autoinjector assembly. “If a biotech is thinking of their final drug product being in the form of an autoinjector, I would really advise them to start looking for a CDMO quite early,” she says. For a deeper look at ADC sourcing, see PharmaSource’s piece on ADC CDMO selection for small biotech.
For Lean Teams, Multi-Vendor ADC Programs Are a Liability
When no single CDMO can make the whole ADC, the work gets split across several vendors. Tamika explains what that means for a small company: “As a small biotech company with a lean team, having multiple vendors for an ADC is never an advantage.”
“I’m going to need a vendor for my biologics. I’m going to need a vendor who can do the linker and the payload. Sometimes that’s one or two vendors. Then I’m going to need another vendor who has experience in conjugation. So right there, I’m at four vendors. Then I might need a vendor who’s going to do my drug product manufacturing. So that’s five so far. Maybe they can’t do the testing, the analytics. So I can end up with even six vendors. That’s six different outreaches.”
Each of those vendors needs its own evaluation and its own internal expert to oversee it. A larger biotech with a full external manufacturing team can turn that into an advantage by choosing the best vendor for each step. For a small team, Tamika’s advice is to start talking to CDMOs “way before you’re ready” so you don’t end up managing five or six partners.
Never Skip the In-Person Site Visit
Capability decks are sales documents. Tamika’s rule is to visit the site in person at least once, bring your technical team, and talk to the people who actually do the work.
“Make sure that if they say they have an isolator, that you go and you see where that isolator is. Try to see someone in action using it. Check that against their SOP to make sure that they’re doing what they’re supposed to be doing. Ask questions like, ‘What if something goes wrong?’ Because I’ve worked in manufacturing. Things go wrong every single day.”
The visit also shows you the company’s culture. She has seen final shortlists decided by it:
“I’ve seen CDMOs where their facility is clean, they’re so organized, their personnel are so knowledgeable, they’re transparent. They reveal mistakes they have made in the past and how they have dealt with them. And then other CDMOs, they don’t share information. You realize that the culture just doesn’t fit.”
Plan for BioSecure Uncertainty with a Backup CDMO
Few small biotechs have a dedicated legal team. Tamika says they should still get legal advice early and make sure at least one person on the team keeps up with how the rules are changing. If a sponsor chooses a Chinese CDMO, she recommends running a full selection process that ends with a ready-to-go second option.
“Have your number one, this is my main CDMO, and this is my second option. Sometimes even having that second option, what it might look like is you start some of the contracting process with them. Your MSA and quality agreement templates are already reviewed, and they’re set to go in case anything happens. You don’t have to go through a full CDMO selection process again.”
She also recommends a contract clause that commits the Chinese CDMO to supporting a tech transfer if it becomes restricted. Sponsors should think about where commercial manufacturing will eventually take place, not just clinical supply.
Start at Least a Year Early and Push for Transparency
The most common mistake Tamika sees across her clients is starting too late, often only when a clinical batch is needed next month. “You’re just going to end up with whatever CDMO is available rather than the CDMO that is best for your program,” she warns.
“I would say at minimum, at least a year before you need your drug product. There should be someone on your team who’s thinking long-term: best case scenario, we’re going to be in the clinic by this time, we’re going to file an IND by this time, and working backwards to say at least a year before you need that, start looking into which CDMO you’re going to work with.”
Looking at the industry as a whole, Tamika would like CDMOs to be more open about the capacity they actually have available. Today, she says, finding that out often takes CDAs, NDAs, and a long legal process. She would also like to see industry-wide RFP templates:
“Most biotechs are asking the same question. When you’re comparing six different proposals, it’s difficult to standardize that, because when one CDMO quotes you for drug substance manufacturing, they factor in so many different things in their cost compared to another CDMO. I would like to see those processes standardized a bit more so that the CDMO selection process doesn’t have to take this long.”
