From The Editor | July 1, 2024

Select Your CDMO Based On How You Operate


By Louis Garguilo, Chief Editor, Outsourced Pharma

Outsourcing, human resources, recruitment-GettyImages-1419225776

Pittsburgh-based BlueSphere Bio CEO Keir Loiacono thinks highly of his external relationships and the general state of our outsourcing industry, but he never sheds his tenacity for execution, attention to detail, and continual improvement.

“I'm a lawyer by training,” he told us in part one of our discussion. “I worked as a general counsel, and have managed multiple law firms in complex litigations at public companies.”

“I learned early in my career the only way you're successful is if you manage your people and nurture your relationships with your partners,” he says.

Keir Loiacono
He applies that today to BlueSphere, founded to enable each patient’s immune system the ability to create a personal adoptive cell therapy (ACT) to treat their cancer, and to variouis service providers assisting him with that lofty mission.

“That’s not because our partners aren’t good,” he says. “In fact, overall they are excellent.”

“But you as senior executive at a biotech are in charge of priorities and timelines.”

And the pursuit of productivity and excellence throughout the entire development and manufacturing cycle.

Time To Perform

“No one watches the clock like the CEO of a biotech, where your investors think in terms of burn rates, inflection points triggering further investments, and timeframes for ultimate return on those investments.”

A multi-month delay at your CDMO may sound like a standard predicament in today’s outsourcing world, but Loiacono knows “a delay of that kind can bankrupt an emerging biotech.”

The even bigger concern to Loiacono, who is a cancer survivor himself, are the patients.

“While success and building shareholder value are critical to our survival, the real ticking clock is for our patients. We have a moral and ethical obligation to execute with unfettered intensity. That is our mandate,” says Loiacono.

And that should be the mandate of external partners.

To better ensure it is, Loiacono says BlueSphere employees are “inside” their CDMOs, managing every step of the way.

“We tell them up front that we will be hands on. I think that's a good way to pick the right partners.

“In other words, we select and view our CDMOs based on the way we operate.”

While he considers CDMOs as true partners, those partners need to understand that BlueSphere also has its own skilled professionals, PhD-level product development, operations staff, and project managers.

“You are going to have challenges in manufacturing. That's important for your readers to hear,” he says.

“This is drug development, and that’s the way it is. There's no such thing as a perfect manufacturing run.”

Because of that, Loiacono likes to “set the stage with the heads of the CDMOs he may or is working with.”

He immediately gets on the phone with the CEOs or other senior executives at the CDMOs when there are critical issues not being adequately addressed or handled the way he wants them to be.

“These are patients' lives we are ultimately talking about; we're not making lifestyle drugs,” he says presenting his case with rising emotions.

“Our patients are sick. They have poor prognosis. Often times, they are out of options.”

The intensity Loiacono and team brings lends to a fundamental questioning at every step of the outsourcing process. For example:

  • Do we judge the CDMOs’ cleanrooms and GMP facilities as exceptional? Have they covered all the bases; for example, are their backup generators adequate?
  • Is the staff experienced and well trained? Who are their day-to-day contact people, and are they highly responsive?
  • How have our audits with them gone?
  • Are they experienced in particulars such as clinical-trial material shipment?

“Without knowing and living in every aspect, you can’t be sure of your execution,” he says.

“Once you get to the clinic, you are in the courtroom and on stage. That's your performance. So strive for perfection.”

Driven To Excellence

Finally, I should point out that Loiacono does not subscribe to the fact because he is a lawyer by training that makes him so driven. It's his “fundamental makeup” that brings the drive to whatever profession or position he’s occupied.

Some people are simply born with a certain energy. Executives, we often say, need to be driven – and that sense of drive comes from something inside each individual.

Loiacono began his career working in emergency management services (EMS), as an EMT.

“I did that through college,” he says with visible pride. “You and your partner are taking care of a patient 40 minutes from a hospital. It's attention to detail, it's time oriented.”

He adds, “It's about understanding what the objectives are and being focused, but also staying fluent in a situation.”

Years after that experience, Loiacono launched a sales force in pharma, where he worked in med-device sales, and helped build a company that was sold to J&J. Only then he became a lawyer … and now the CEO of BlueSphere.

“Look, if you're in sales,” he says of that experience, “your number is your number.”

“I probably shouldn’t say it this way, but ‘you eat what you can kill.’

“Yes, I think I was always programmed this way. People don't care about excuses. There's a bottom line, and that's what drives revenue. It's just my mentality of being in these situations.”

Today, he makes clear that unequivocally, it's the patients for whom he devotes himself.

Second are the employees and investors who enable the delivery of new medicines to those patients.

Then there is the enabling activity of outsourcing. If CDMOs want to be a part of the BlueSphere team, they need a similar mentality upon which sponsor and provider can forge close relationships.

“A win for me as a CEO is putting a new, safe medication into a patient who didn't have that option before.”