Guest Column | December 30, 2019

How "Two People With A Molecule" Can Build A Quality Culture

By Judy Carmody, Ph.D., Carmody Quality Solutions, LLC


Last holiday season, my piece “The 12 Months Of Quality” looked at tips on how to build a voluntary QA (VQA) culture. This year, let’s focus on how people take steps to institutionalize a VQA culture in their organization.

The impetus came from a blog post by the FDA’s Janet Woodcock, which explores developing a new quality rating system to bring transparency to life sciences. Her focus is on selling quality along with medicine, and she notes the importance of manufacturers needing to “establish mature quality management capabilities.”

More often than not, I hear from potential clients considering quality systems that they are “… just two people and a molecule. We don’t have the money to spend on quality or dedicate resources to training. We’ll worry about it once we are close to going into the clinic or later.”

This thought process puts a company at risk — and unnecessarily so.

To build mature capabilities, you must start with nascent ones. I encourage leaders to go boldly and commit early to building a strong foundation from the beginning. Quality is as important as everything else. It’s all important. And it’s all achievable.

Today, we examine one company that understands the importance of this approach.

Quality At The Leadership Table From Day One

Robert Lutz, Ph.D., is chief science officer of Iksuda Therapeutics, a 20-person start-up developing new antibody drug conjugates (ADCs) to target difficult-to-treat cancers. With an extensive background in ADC development, he believes that building mature quality capabilities is what your company must do every day from day one.

“Once we formed Iksuda, we gathered the newly appointed functional leaders around a table. All are people well-established in their areas of expertise — clinical development; regulatory; chemistry, manufacturing, and controls (CMC); and research & development (R&D). We asked what resources, if any, are we missing? We looked around and found we lacked a quality lead to help us begin to put the right systems and infrastructure in place.”

Lutz and his colleagues know what happens when quality is an afterthought. “Retrofitting quality into a biotech firm is the worst thing you can do for your people and your investors,” he says. “Thinking you can do quality later is the biggest lie people tell themselves.”

He’s observed that medical doctors or researchers, who find themselves as CEOs of biotech firms, can lack experience bringing a drug to market. “Drug development is not research. When assessing what needs to be done first, they focus on the molecule, and decide you can deal with quality later. That fallacy is only made worse as they kick the can down the road because it only makes the issues and problems larger.”

Lutz believes focusing on quality early helps the organization gain solid footing. “If you are going to develop drugs, having quality systems in place gives people clarity. And, more importantly, when there is an issue (because there are always issues), you will have procedures to help navigate internal and regulatory requirements. When quality is part of your initial beginnings, it is not a significant expense and, if structured properly, it scales with your organization, preventing non-compliances or errors, and results in cost savings.”

A Little Pain Now … Or A Lot Later

When start-up companies begin without quality systems in place, there is immense pain when they finally realize they need them. When people who have worked without a system for a long time finally get introduced to one, adoption can be painful. “I don’t blame people for finding it painful — of course it’s painful, and it’s painful for no reason,” says Lutz.


Putting the appropriate systems in place from the beginning has its advantages. “When systems are in place, the learning curve is not steep. People are free from the burden of ‘unlearning’ anything. When introducing any new technology, it is easier for people to grasp when it is not replacing anything. You hire people and introduce them to your specific structure during training, where they learn what is expected and how they will be held accountable. Everyone starts from the same place with the same understanding.Early implementation of quality systems can also minimize the impact on an organization when you introduce change later because you have foundation. And you built up trust and confidence.”

A key part of the success of this approach is training, as it is during this step that expectations are established, and people begin to feel empowered and understand they have ownership. “We train our people to know what the right thing is. They learn they are part of a safe, collaborative environment where they can speak up, ask questions, and provide feedback about what works and what needs improvement.”

When organizations lack formal systems, Lutz notes, “you have a tendency to lose people. Without a contiguous system that has proper communication and touch points, you can isolate people and create siloed departments. People then come up with their own disparate procedures, separated from a company-wide approach. This can create an ‘us-vs.-them’ mentality and lead to a lack of transparency about how things are getting done. Such lack of transparency can increase the risk of non-compliance, with the potential for significant negative repercussions.”

Senior Leadership Offers Support, Models Accountability

As a small company, Iksuda is successfully developing its VQA culture in part because the senior leadership team holds each functional head accountable for their role in quality. “We support our quality lead just as we support each person that heads up R&D, clinical development, CMC, and regulatory. Quality discussions take place regularly at senior levels of the company, which is one method the leadership uses to show its commitment to quality. We talk about it as part of what we must do to successfully bring our ADCs to market. It is integral to our mission — not just a box to check off,” says Lutz.

He also notes Iksuda wants everyone from functional leads to those in the trenches engaged in this process. “We are in the building stage, but expectations are set. We are going to build systems with the team’s involvement — and not do it in a bubble. We expect people to show up, participate, provide feedback, and offer their perspectives.”  It is through this collective process that a VQA culture can be realized.

Lutz believes quality is an important foundational piece for any successful biotech company, large or small. “It starts with a commitment from the top — from the leadership — to make it part of the company philosophy, approach, and culture that carries on every day. When it’s a strategic initiative, perceived biases drop away. Frankly, manufacturing an ADC is way more challenging than implementing a quality system. Quality is just another important piece of what you need to do to develop drugs successfully.”

The bottom line for Lutz? “It’s all important, and it’s all achievable when you think about it — and commit to it — early enough.”

About The Author:

Judy Carmody, Ph.D., is the founder and principal consultant of Carmody Quality Solutions, LLC (CQS). She has 20+ years of expertise in applied technology, bench chemistry, analytical development, validation, quality management, and senior leadership. She has built quality management systems for both startup and Fortune 500 companies. Carmody founded Avatar Pharmaceutical Services, an FDA-registered contract research organization that provided quality, submission-ready, customized analytical services in compliance with cGMP. She grew Avatar to 25+ employees and more than 75 clients before it was purchased by a Boston-based pharmaceutical company in 2010. She holds a Ph.D. in analytical chemistry from Clark University in Worcester, Massachusetts. Please connect with her on LinkedIn.