Outsourcing Nirvana At Eli Lilly

By Louis Garguilo, Chief Editor, Outsourced Pharma

Mark Butchko has been at Eli Lilly for 24 years, currently serving as Associate Vice President - Global Quality Laboratories. He’s also a long-term Outsourced Pharma Board member.

During a recent discussion, I indelicately suggested Butchko is “a dinosaur of sorts” for spending decades and an entire career at a single biopharma organization, even one as large as Lilly.

After all, a challenge that industry executives habitually mention as a challenge is the rapid movement of workers from one organization to another.

“I am getting older,” Butchko replies good-naturedly, “but I’m not an anomaly. One of my former supervisors has been at Lilly for 34 years!”

Below, Butchko draws from that Lilly longevity to describe what he’s currently experiencing, and what the future of outsourcing might look like from his vantage point.

Among his activities, most vital to Butchko is the utilization of external partners for batch-release testing, analytical method developments and validations, and the like.

Current State

Lilly’s Global Quality Laboratories is a central group of analytical scientists and experts that work both upstream with development, and help transfer and install methods downstream to internal QC labs – and when needed to “external strategic analytical partners.”

“We've been vocal about our reliance on both internal and external innovation,” Butchko says. “That's core to our strategy, and has been for years.”

And with the growth of Lilly’s news-making products, the company is now building a number of facilities, with the most recent announcement a $2.5 billion facility in Germany for parenteral drug-product manufacturing.

Those recently approved products include Trulicity (dulaglutide), and tirzepatide, which was approved initially for type two diabetes as Mounjaro, and now obesity as Zepbound.

“We had four substantial new product approvals in 2023,” says Butchko. “While we are building additional internal capacity to keep up with the projections, we are leveraging external partners to supplement our internal footprint.”

Which brings us to the search for an enlightened external partnering strategy.

Close To Nirvana

Something Butchko has been reflecting on the last couple of years comes in the form of an answer to a large question.

“If you were to ask me about an outsourcing Nirvana,” he says, “I’d answer ‘bundle it all together – if you can find a reliable partner with the capability and professionals, capacity, speed, and of course quality compliance and safety aspects.”

Then with a wry smile, “So I want it all.”

“In my world of analytical and methods, and wanting to generate data on material made at a CDMO’s facility, there are certainly good reasons to transfer those methods into that site of manufacturing.

“Unfortunately, it doesn't always work as advertised.”

He mentions a lack of capacity for analytical and related services, or certain capabilities. Or “the manufacturing transfer experience doesn't necessarily go hand-in-hand or as seamlessly as the analytical transfer, or vice versa.”

So now there’s another question for Butchko and Lilly as they head into 2024 and beyond.

“We’re asking ourselves from a strategic perspective, is that bundled view an achievable Nirvana?”

Logistically from a supply-chain standpoint, especially with Lilly’s recent high-volume products, minimizing sample shipments from facility A to facility B mitigates risks and challenges, if indeed you can do it reliably.

However, should there be a method transfer failure at an external CDMO, it can cause a company to ask if now it has to repeat all those methods and transfers to understand why it failed.

“Science happens,” says Butchko, “and maybe in fact there's some new learning there, and we can reflect, for example, on instrument differences or comparability, whatever it may be.”

But that scenario competes with the value of what Butchko considers “reliable standalone analytical partners specialized and focused, and agnostic of the site of manufacturer.”

“These independent facilities and partners thus play a significant role in our world.”

Nirvana, it appears, has a backup plan.

Locating Peace Of Mind

Perhaps our main point, then, is that not all CDMOs have the same capabilities and competencies relative to QC labs where methods are already installed.

Should challenges at a CDMO arise, says Butchko, “I've got that ACE up my sleeve if I already have methods installed at independent partners A, B or C, where all they do is analytical. I’m effectively taking analytical off the critical path.”

Yet even this seemingly safe strategy has some challenges.

“Where that strategy can break down,” says Butchko, “is geography.”

Even if he has methods installed at a trusted standalone partner with “an excellent inspection history and all those attributes we talked about earlier,” but they're in the U.S. and it turns out the manufacturing CDMO selected is in the EU, “nobody wins when it comes to releasing those batches.”

The time, effort, and increased complexity of shipping samples for release testing “across the pond” is much less than desirable.

“Meanwhile,” Butchko adds, “I have a patient waiting for that medicine I can't release without confirmed results and a COA.”

Therefore, he says, Lilly is again thinking through the challenges of geography in great detail, as well as looking at their existing network of reliable CDMOs that can manufacture and test their products.

In other words, back to the outsourcing Garden of Eden?

“It is nice to have the insurance policy of a standalone analytical partner,” replies Butchko, “but if that partner and my site of manufacturing are an ocean apart, and our quantities are so large, it just brings its own layer of complexity.”

Thus, while the strategic preference is bundle where we can, since experience still teaches it’s hard to put that into practice, “continue to pursue in parallel both multi-service CDMOs and the value propositions offered by standalone analytical service providers.”

Still, we are compelled to end here with a final obstacle for Butchko and Lilly.  

“Those reliable, standalone analytical partners that excel in the industry, and can handle our capacity, you can count on one hand today.”

It’s certain Butchko and Lilly will sort it out. But  entering an outsourcing Nirvana, sure has its layers of attainment.