The Key To Outsourcing Is Timing-lines, Not Timelines

By Louis Garguilo, Chief Editor, Outsourced Pharma

Brent Powell received his Ph.D. at the University of Connecticut and then made a decision that turns out to be a prime example of a growing segment of our development and manufacturing industry.

Powell purposely decided to start out at a CDMO (namely, Nitto Avecia).

While his tenure there was not long, that initial choice, he says, continues to shape how he thinks about outsourcing. 

“Coming out of a Ph.D. program, you’re encouraged to chase new ideas, new reactions,” Powell says. “At a CDMO, it was the opposite.”

“It was more about execution and efficiency. I had to learn quickly; this wasn’t about me generating new hypotheses. It was about following SOPs, maximizing throughput, and hitting client timelines.”

He is not suggesting the innovator’s passion or sense of ownership were missing. In fact, we’ll visit that topic subsequently.

But he did move from his CDMO launching pad to the world of biotech, starting at Verve Therapeutics, which focuses on cardiovascular care. As we'd expect, his role there had him involved with Chemistry, Manufacturing, and Controls (CMC), and CDMO Management.

It almost felt like grad school again, Powell says, "but with a serious, real-world focus."

“We were a small company, passionate, creative, and constantly looking for new approaches, and because of that efficiencies in our external partnerships.”

Today Powell has moved on to other biotechs. What does his CDMO experience bring to those roles?

For one thing, he says, “I know how sponsor requests can land at the CDMO, and what it could feel like when a customer treated us as ‘two hands and a quantity of vials.’”

“I really began to shift the tone in all my roles starting at Verve, and I try to convey that to my colleagues. Instead of dictating, we should ask ourselves: ‘Have we thought enough about what the CDMO is suggesting? Could we try it that way?’

“Small changes in attitude build mutual sponsor-provider commitment.”

And that can be ultimately important at small sponsors ... with small-batch needs. Powell avers the attitude adjustment has worked well for him through the dozen years he’s now been outsourcing development and manufacturing from biotech platforms.

Time Of Our Life Cycles

The Rolling Stones sang, “Time is on my side.” Nary a biotech would agree.

In fact, there’s always the sneaky suspicion at a biotech that the CDMO could be moving faster, and even that they could get tasks done much quicker internally (had they the labs and facilities).

“I remember thinking, ‘I could run this experiment in a few days – why is our CDMO taking weeks?’” Powell recalls.

He’d fight through that inclination, and reorient to past experiences. At such times, he recalls those dozens of clients CDMOs have to juggle; how in fact external providers have to prioritize larger Pharma organizations providing them bigger contracts.

“When you’re a smaller biotech, you are not first in line. That’s just reality,” he says.

And that “reality” shouldn’t cause agita. It should, though, be built into your timelines.

No, time is not on a biotech’s side, but managing expectations can put you in line with the appropriate timing to be successful.

In fact, we might better think more about timing-lines rather than timelines when it comes to working with external partners.

“If you have chosen outsourcing as your model, you must accept you have also  given up speed in some areas to receive benefits in others. Getting upset doesn’t change how CDMOs operate.”

Speak To Me Like An Adult

Along with attitude, communication of (those realistic demands) is vital. “I’ve learned to over-communicate — but with empathy,” Powell explains.

“I acknowledge the pressure we are putting on our CDMOs, and I try to frame my questions in a way that shows respect for their expertise.”

At times, Powell has been in situations where it appears a CDMO is holding back on some information/data, or from definitively answering some questions.

“I’ve been able to tell, for example, when the challenge is they don’t fully understand what is happening with a batch, and don’t want to express that.”

They simply need a bit more time to analyze causes for anomalies.

“Having been there myself, I get that,” he says. “They didn’t want to look incompetent, and it isn’t that they are. It isn’t a type of  intentional obfuscation.”

He believes giving a CDMO a bit more space – the benefit of the doubt – can help get to the bottom of issues, and maintain a positive working relationship.

“You don’t want to demand answers that aren’t ready,” Powell sums up. "Rather, you should try to work with partners to solve arising problems."

The caveat here, of course, is along with limits on patience, let’s recall the all-important timing we discussed above. Flexibility and an open attitude are fine, but delays at a CDMO are costly.

Humanity Speaks Up

Through successes, trials and tribulations. Powell insists his strongest sentiment is that outsourcing is ultimately about humans dealing with humans.

“The data and equipment matter; the relationship can matter more," he says. "Sponsors who treat CDMOs with empathy, respect, and curiosity, get better results.”

And from the CDMO side?

Powell believes they should strive to understand the real urgency behind every customer’s needs (and at times their demands).

“It’s not that sponsors enjoy being difficult,” he says, taking both sides of the equation into consideration.

“It’s because they’ve got investors and regulators breathing down their necks, and patients waiting for help. A little acknowledgment of that goes a long way. They should keep that timing aspect of all activities in mind.”

Powell offers a simple diagnosis if you are wondering why a sponsor-CDMO relationship feels strained:

Ensure you base your projections on realistic timing-lines of the components needed to complete tasks and projects; focus on communication; and stay empathetic to the position your partner is in.

It's about time sponsor-provider relationships improve appreciably.