We're A Virtual Biotech. CDMOs Should Treat Us As A Priority
By Louis Garguilo, Chief Editor, Outsourced Pharma
Some readers may be smirking a bit at our headline. I get it.
CDMOs are running a business. They may attempt to treat all customers equally, but they must focus where the most financial gain awaits. That is usually with bigger clients.
Scott Jeffers, Chief Technology Officer at gene-therapy developer GenSight Biologics, also acknowledges this outsourcing equation. But he doesn't necessarily buy into it.
He started at a smallish CDMO called Florida Biologix. It merged with Brammer Biopharmaceuticals in March 2016 to form Brammer Bio, which was subsequently acquired by Thermo Fisher Scientific in 2019. For the past few years, Jeffers has been a leader at GenSight, a virtual biotech with just 10 employees.
All those vantage points – added to his inherent personality – combine to provide him a certain philosophy regarding sponsor-provider relationships.
That philosophy arrives with specific, practical application. He outsources, if you will, with mind and body. He thinks you should, too.
Of his current position in the industry he says, “I work for a French company, and I live in Boston. We’re globally distributed. We actually get more hours out of the day that way.”
It doesn't normally matter where you work today – or where your CDMO is located. “It’s how outsourcing operates,” he says.
He does, though, admit to a preference for smaller CDMOs. “They usually have a little more hunger to please the customer.” Which returns us to our opening thoughts on the lot of smaller customers at larger external providers.
Evaluate Like An Acquirer
When Jeffers began working at Florida Biologix, he was one of about 100 employees. He enjoyed that atmosphere and customer-service spirit.
Without a hint of criticism, he says that certain appeal changed as the company merged, and then was acquired.
His first takeaway? Sponsors should be aware of the potential for such dynamics unfolding at any CDMO. In some regards, this can make you our as an even smaller customer.
On the other hand, some sponsors welcome the idea of their programs becoming associated with a bigger organization that offers more locations, capacity and equipment, and skilled workers.
“Yes, if a company can maintain the attitude of a smaller organization – responsive, flexible, hungry – that works for me," Jeffers says.
But scale isn’t the real issue. Culture is.
The challenge is uncovering which growing CDMOs will continue to suit your own culture, and your own advancing needs.
"Test the prospective CDMO with a small project," Jeffers says. “See how they treat you now." If they already appear somewhat disinterested, that's an immediate, telltale sign. Things probably won't improve.
When selecting a CDMO, he tries to discern whether, should that organization grow, "Can we grow together?”
"Evaluate CDMOs with the rigor of an acquirer," he says
Jeffers wants to see hiring plans and turnover statistics, training programs, and if a CDMO says it will have certain upgrades or new capabilities in the future, he wants to see blueprints and projected completion dates, not brochures.
As we heard in part one, he asks management directly about future mergers and acquisitions. “Those will change culture,” he says. “The CDMO you sign with today may not be the same organization in five years.”
Complicating matters? Your organization may not be the same, either. Can your futures integrate?
Demanding Equal Treatment
GenSight will never be a CDMO’s largest client. For example, with batch sizes as low as 50 liters of AAV, Jeffers knows his programs won’t keep a CDMO's reactors humming.
Nonetheless, he fully expects smaller biotechs to be treated like any other “priority customer." That's where his personal philosophy kicks in.
That type of expectation has to be set upfront with the CDMO. It should be reinforced "with the way you show up to weekly meetings," how empowered project managers are to act and how accessible management is on both sides.
These all signal the seriousness to which you and a CDMO juggling dozens of clients prioritize each other's situations and needs.
Jeffers also emphasizes what outsourcing professionals often say: People make the difference.
Partly, this means to him that “operator X’s hands don’t work the same as operator Y’s hands. Some people just have a green thumb.”
Thus, the emphasis on maintaining skilled workers, training programs, mentorship, and the culture at your CDMO.
A partner with high turnover and weak training will never deliver consistency, no matter how polished the SOPs look on paper. Or whether they remain their current size or get acquired.
From CDMO to Sponsor: Lessons Learned
Jeffers says he often reflects on his career to date.
“When I was at Brammer, I saw 20 or 30 very different processes. That gave me an early perspective most sponsors never get.”
Now as a biotech leader, he applies those lessons in reverse. “Sponsors, including me, have to listen to our CDMOs. They have seen and identify landmines before you even know they exist.”
Past experience also dissuades him of thinking, as too many sponsors do, that CDMOs push extra work onto projects partly to run up the tab.
“In my experience, the CDMO’s suggestions are reasonable," Jeffers counters. "Sometimes I can’t act on them because of regulatory constraints or economics, but everyone including the CDMO wants to see better science more reliably delivered.”
That desire to optimize outcomes arrives initially via contracting – an area where many sponsors trip up, according to Jeffers.
At the least, some agreements need to be updated as projects and relationships progress. Many may end up incurring dozens of amendments. However, few leaders contemplate, and these agreements don't clearly address, what happens when a CDMO takes on new ownership and moves a program across its growing network.
That has to change. Jeffers believes the sponsor-CDMO relationship will only grow more complex. Consolidations and growth will continue. Talent turnover will persist. Supply-chain strains will continue to test even the best-laid plans.
No matter your respective size, today your defense of all this is to make clear your expectations, and select your CDMOs with an eye on the horizon.
Again, CDMOs have an obligation to run a profitable business. We aren't talking about being unrealistic (or unreasonable).
But you might be surprised the level of service attained when maintaining Jeffer's outsourcing philosophy based on your self-respect and assertion you are a priority customer.