Outsourcing: You Own It, They Earn It

By Louis Garguilo, Chief Editor, Outsourced Pharma

“Well, of course they’ll charge you, one way or another,” says Scott Jeffers, Chief Technology Officer of GenSight Biologics, describing what happens when your CDMO decides to move your program from one site to another – even if they initiate the move.

Jeffers, a pragmatic but positive biopharma professional whose career has traversed both the CDMO and innovator-outsourcing sides, believes too many virtual and small biotechs underestimate these types of complexities and risks that can arise when relying on external partners.

Here’s his advice for anticipating and thus avoiding some of them, and tackling the challenges when they arise.

Owning Your Assays (and Everything Else)

Jeffers decides to start here: As the sponsor, you need to “own” your assays.

The CDMO will run the tests, but you hold the IP and ensure transferability across labs and geographies. Without that ownership, you’ll risk delays, disputes, and costly dependence.

Ditto for process knowledge. He’s seen that virtual companies often cede too much responsibility to their CDMOs. Afterall, the regulators, your investors – and ultimately patients – hold you, the sponsor, accountable for having a firm, internal grasp of how and why a drug was developed and progressed as it was. Without this, it is extremely difficult to address issues with manufacturing challenges, safety or effectiveness.

Think in terms of life cycles of your process, Jeffers advises. How will you validate? How will you scale up and move production? How will you protect the integrity of your process and final product ?

And back to our beginning: “You have to understand you most likely will have to move – or be moved. Even changing buildings is a tech transfer,” Jeffers says.

Own your assays, own your process, own the decisions during your drug’s entire life cycle.

The FDA, EMA and all regulators actually outline for us what tech transfer should look like: detailed, documented procedures; clear comparability data; qualification runs; quality provisions; etc.

But Jeffers insists the “soft” factors are also important, and too often totally overlooked.

“Successful tech transfer requires strong leadership, collaboration, and mutual communication,” he says.

“For example, the CDMO you’re leaving may not cooperate to the level you had wished.

"Therefore, you need to make sure both sides – the partner you are leaving and the one you are joining – can and do in fact work through you, or better yet, work with each other to help you.”

That, says Jeffers, also requires a good dose of trust, echoing a recent editorial on the subject (Tech Transfer 2025 – A High-Stakes Game Of Trust).

“Trust,” by the way, is not a word you’ll find in a quality agreement, but it’s created day by day, and should extend through the finalizing of a relationship.

And why shouldn’t it? More projects may follow, and reputations (on both sides) are built on it.

Tamp Down The Turnover Turnstile

Jeffers brings attention to a question perhaps as important as ever: What’s your CDMO’s turnover rate?

“I’ve seen turnover as high as 33%,” he says, with a slight shaking of his head. “That basically means a new team every year. Once you’ve replaced three people out of nine, that’s not the same team anymore.”

Even within GMP systems, “Operator X’s hands don’t work the same as Operator Y’s,” he explains.

Skill, experience, even intuition, matter. When that talent walks out the door, what ensures consistency?

That's the issue; what can a sponsor do about it?

For Jeffers, the acceptable answer is not “carefully read and understand the SOPs.”

It’s ensuring – and in some cases sponsors helping out with – training, mentoring, and fostering a culture of continuous improvement.

In fact, those factors – along with improved overall relationships with sponsors – help tamp down employee departures from CDMOs in the first place.

And Jeffers has seen both sides. At Florida Biologics, later turned into Brammer Bio, he saw firsthand how some people built careers inside CDMOs, only to leave after a few years for innovator companies.

“I started out at CDMOs,” he says. “That gave me my understanding of GMP manufacturing, but also showed me the challenge: people don’t stay long."

"I understand that dynamic. Nonetheless, if you’re not trying to solve high turnover with culture and training, you’re starting over every few years.”

So ‘What’s your turnover look like?’ is in fact a loaded question of sorts. It is one that should be followed up with questions on training, culture, relationship management, and overall attitudes towards the challenges of outsourcing.

Small Batches, Bathrooms, Hoses, and Culture

Jeffers has now been at GenSight for going on four years. Diseases of the eye are the therapeutic targets. For him, that means very small batches of AAV—sometimes just a few runs per year.

“I’ll never be the big client,” he says. “So the question to the CDMO becomes: ‘Will you still treat me like one?’”

He notes the stark difference between CDMOs where he can pick up the phone and talk to senior management, and those where he’s lucky to reach a director. A willingness to engage at the highest levels regardless of batch size, separates his preferred partners from those he considers transactional vendors.

Jeffers recalls advice he received from a  mentor during his days at Brammer: “Walk into the bathroom. If it’s clean, the rest of the facility probably is, too.” He chuckles when he says this, but he’s serious.

I chimed in with my own story from my days working at a CDMO:

A Japanese pharma customer always started inspecting our pilot plant by checking whether a certain hose, which once hadn’t, was neatly wrapped and not left touching the plant floor.

Culture shows up in all the details. Bathrooms and hoses: small things, big tells.

Some Final Long-Term Thoughts

Finally for this initial conversation (part two follows), Jeffers urges biotechs to think long-term.

Although we talked about transfers above, a current CDMO relationship might turn out to be for the lifetime of your product.

That requires evaluating CDMOs not just on present capabilities but on their future plans for capacity, the earlier stated susceptibility to turnover, even questions on potential acquisitions and corporate goals.

“I once directly asked a CDMO when — not if — they planned on merging with another organization,” he says.

“How they answer those questions matters, because a currently nimble, responsive partner today may become an unrecognizable division of a multinational tomorrow.”

Which brings us around to his opening thoughts on owning the details of your project, understanding tech transfer requirements, and preparing for the unexpected.

Assays, processes, and contracts matter. They get completed through training, human relationships, ownership, and building trust.