Advising The Biotech C-Suite To Reconsider Quality
By Louis Garguilo, Chief Editor, Outsourced Pharma
“I assist C-suite executives and private equity firms to transfer quality from a painful cost center to a competitive asset.”
That’s the type of statement that piques interest.
I ask David Grote, VP of Strategy at GrayMatter Partners, and an authority in pharmaceutical quality systems (PQS), what this assertion means materially – and how that’s applied to working with CDMOs.
He replies this transformation begins by moving executives away from regarding quality as ‘overhead’ or something the FDA monitors, and instead recognizing quality as “an operational element pursued because its maintenance is a business advantage.”
“You should have the right controls in place,” he says, and even when outsourcing, you can affect more than you might think.
Look At Other Industries
Grote has previously worked at such organizations as Amgen, Immunocore, and Teva. However, he likes to reference industries other than biopharma when talking with senior biopharma executives.
“I ask biotech executives to consider the semiconductor industry, or a Toyota in the automotive industry. It's ironic that these were the industries that raised the bar on quality assurance – not our drug industry.”
They introduced lean production and Six Sigma black belts. They pursue quality because it prevents costly problems, and is a competitive – and measurable – business advantage.
“Comparatively, in semiconductors a microscopic flaw kills the chip instantly. In pharma, a compliance-only mindset lets flaws linger until they kill a clinical trial.”
“A well implemented quality system should not be viewed as a costly line item or potential bottleneck," he says. "It’s a tool for continuous improvement, for learning, and applying those learnings across the organization."
He then adds, “As one whose career has been devoted to quality assurance, I take some responsibility for the current mindset.
“It really has been quality professionals’ fault for getting so stuck in the compliance aspect, and simply following SOPs."
I'm sure that won't sit well with a number of readers. Nonetheless, "That’s what needs to be changed," says Grote.
And to accomplish that change, “it has to start at the top of the biopharma organization – in the C-suite.”
Reassessing Quality Costs
What if you are a biotech relying on investors who see larger layouts on the balance sheet for process or product development, including hiring additional quality support at CDMOs?
If you are in the C-suite, you have a hard time justifying those amounts.
I ask Grote if this is simply the age-old struggle over spending money now to (theoretically) save money later?
“I wouldn't say it's necessarily about money,” replies Grote. “It's about being smarter about your business, and your product.” And explaining why that is to others.
Grote says there are helpful software tools (he mentions Veeva or Doc Compliance) that offer a relatively small upfront cost and provide the CEO with “a modern quality management system.”
“This is about prioritizing the building of a culture of quality, where everyone understands the value.
"At its core, a QMS isn’t about any software—it’s about how quality is intentionally designed and managed to drive success and protect patient safety."
Grote has always championed the idea that quality systems are not simply compliance tools; they are “engines for continuous improvement and organizational learning.”
“Leadership needs to instill this into the entire organization, so nobody rolls their eyes when you intone ‘quality.’
"Make it clear: This is not just a word painted on a wall.”
Much of his comes down to helping leadership “prioritize teaching ‘the why’ behind an organization's decisions dealing with product day-to-day."
It’s not just about protocols and SOPs. Real issues arise when individuals don't understand why they're doing what they're doing:
Why is this process step necessary?
Why is there a time limit there?
Why do we filter at this stage?
Why do we investigate failed results this way?
Grote points to the recent example of ‘The FDA 483 Heard Round The World’ – the Catalent/Novo warning letter for their Bloomington, Indiana site. “The issue wasn’t just the presence of foreign matter,” says Grote. “It was the decision-making process that allowed batches to be released despite clear warning signs."
This again emphasis the value in investing in ways to target this type of flawed analysis. There are certain things you can do with software systems, but also, says Grote, physical systems.
For example, the design of your bioreactors and chromatography systems – or those at your CDMO – to minimize the risk of quality issues occurring.
Grote notes how challenging the status quo led to recent industry discussions on sanitary valve technology and microbial monitoring.
Those improvements don’t necessarily show up as line items in the budget, but they help instill a mindset in workers, avoid unexpected costs, and reduce risk.
That shows up on the bottom line of drug development and manufacturing.
More People, More Quality?
Again, considering the money-conserving emerging biotech, this emphasis on quality seems to necessitate either hiring more quality professionals, or spending more at the CDMO.
Grote does not entirely disagree. Every sponsor, he says, requires "something tangible established in-house to oversee quality.”
He advises as much, but says this doesn't have to mean full-time hires. It could be a ‘fractional chief quality officer,’ consultant, or a member of the team who has a solid background in quality.
Grote reminds CEOs that ultimately, you are responsible for your product, and business. The proverbial buck stops in the C-Suite should quality issues arise.
Here’s the requisite mindset: investments in modern QMS and building a culture of quality are essential for long-term success.
You outsource much of your development and manufacturing. You will not outsource the responsibility for quality.
“The FDA will come in and say it's your name on this label. It's not going to be your CDMO’s,” says Grote.
However, the FDA won’t come calling in the first place if you carefully select a CDMO with “proven high-quality operations and systems.“
In the biopharma C-suite, quality should be the opening premise in discussions on selecting the most appropriate CDMOs.
Nonetheless, Grote refuses to take responsibility away from the sponsor for maintaining quality standards, no matter where actual operations take place.
The correct questions for C-suite executives to ask:
"Have we established the understanding of quality as a strategic asset, and are we configuring a method to continuously monitor? And what of our CDMO?"