Driving CDMO Performance And Customer Service
By Louis Garguilo, Chief Editor, Outsourced Pharma
Decades after founding and leading a contract research, development and manufacturing organization that helped usher in the ubiquitous model for outsourcing we rely on today, Thomas D’Ambra finds himself on the other end of the equation: heading a drug sponsor that needs to utilize CDMOs.
After a sabbatical of a few years, he’s returned to the industry as CEO of Pharmapotheca A, Inc., a pharmaceutical-development company working to manufacture amphetamine products free from the presence of a trace potentially genotoxic impurity created in current manufacturing processes starting with norephedrine.
That has him revisiting with me – a former employee – the core values we once created and instilled into our service organization.
In part one we set the background, and covered one of the eight core values (Commitment To Purpose). Here we’ll get to three more.
2. High Performance – Achieving excellence by embodying the highest quality, productivity, innovation and commitment to purpose.
“We wanted to be known as one of the best among the many competitors that had cropped up around the world,” recalls D’Ambra. “We can’t control what our competition does, but we can control what we are known for in the industry.”
Accordingly, I ask, is “performance” predominantly benchmarked against established internal metrics, and then the competition?
“It goes well beyond that,” he replies.
“High performance leads to customer service where you want to be performing at a level as good as or better than what the best people in your customer’s organization could perform at, and always at the level of the best people in your organization.”
D’Ambra says high performance is putting all the other values into practice, both on individual and companywide levels.
“It’s sort of like karate,” he suddenly says, knowing of my background with the martial art.
“When you reach a high-level blackbelt, you are one of the best at what you do. It's not just about physical conditioning, it's also your mental attitude, and spiritual respect as well.”
With that, I pivot to a concern I’ve had with “productivity” in our industry. I recently wrote in an editorial:
"The argument can be made that development and manufacturing outsourcing professionals do not focus enough on productivity, or at least not enough directly and by name. It's talked around and embedded in capacity considerations. And at times non-constructive timelines."
In our industry, how is performance related to productivity? I ask D’Ambra.
“Good question,” is his initial reply, “because it is complex.”
“In the outsourcing world, you go from lab research to manufacturing, and for example, face challenges such as scaling up a complex process.
“At a CDMO, when your reactors are full and being used, that's when you can realize productivity. You can maximize the spread of your cost over as many projects as you can, which gives your customers the best price, for example, but also gives your company the best margins.
“However, when you are at lab level and consider productivity, that's a tougher metric.
“You can work for a couple years on a med-chem research project, but come out empty-handed because the science itself led to a dead end, or there was a problem with side effects or the specificity of the compounds.
“Productivity really is a function of where you are in the discovery-development life cycle. It's looked at in different ways, but overall productivity can always by measured in the quality and efficiency of the work you're doing, your work ethic, and your ability to solve problems.”
3. Quality – Uncompromising and consistent performance with an attention to detail, excellence, and professionalism.
“Quality is not all about good manufacturing practices and FDA regulations,” says D’Ambra, echoing what we’ve heard from many industry professionals over the years.
“It’s a critical component of any of your efforts – whether you are cleaning the restrooms, answering a customer’s phone call, or working in the lab.
“You can consider the other values as meaningless without high quality behind them.”
D’Ambra reminds me the FDA requires a quality department within any drug-related organization be situated outside the chain of command of another department. This avoids conflicts or compromise (for example, arising from project management or manufacturing).
“Therefore,” he says, “Quality in most companies reports to the CEO, which is what the FDA does want.”
Since many CEOs don’t have quality-related backgrounds, there’s then a great responsibility to “hire and learn from the right professionals, and build those quality organizations correctly.”
“But again,” D’Ambra adds, “the ‘quality department’ doesn’t really have anything to do with the quality of an organization in a broader sense. All department heads must ensure the quality of the work going on under them is of high standards.”
And that includes business development.
4. Customer Satisfaction and Service – A resolve and commitment to the customer to assure that the best service, performance, and results are delivered.
“We only have our jobs and salaries because customers choose to place their projects with us. They have other choices,” D’Ambra says.
He believes today this value presents the biggest challenge to CDMOs – and drug sponsors should be aware of this.
And the challenge has been amplified by the M&A taking place at CDMOs.
“In efforts to integrate organizations and take out cost, it’s important not to forget the customer,” he says. “The truth is, even a momentary loss of customer focus hurts a company, and a damaged reputation can take forever to repair.”
I ask D’Ambra about the role of business development. He smiles at the questioner, who once served as a senior BD professional for him.
“BD performs an important role,” he says. “The BD person may feel he or she has done their job once a deal is closed. Some may think and act as if once you are a client, the relationship and customer service is up to project management. That’s wrong. In fact, all parts of the company need to be on – and stay on – the customer-service bandwagon.”
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Next up: Our final four core values.