(Photo Credit: NextCure)

Quality Culture Runs Deep at NextCure

For many companies, Quality is only addressed out in the open after something goes wrong. By then, it’s often too late and the damage is done. 

At NextCure, a rapidly growing and exciting clinical-stage biotechnology company located in Maryland, Quality is done just a bit differently. 

For CEO Michael Richman, “Quality starts at the beginning. Quality science that’s reproducible, robust, and relevant lays the groundwork for quality manufacturing, quality control, and quality assurance and that will ultimately lead to improving the quality of people’s lives. That’s why it’s so important for us that Quality is top-of-mind in everything we do. When you’re building an organization, Quality starts on day one and it starts at the top. Leadership has to be fully committed to Quality and compliance both upstream and downstream and beyond.”

“Quality is critically important at any biotech, but particularly at NextCure, where our mission is developing novel, first-in class therapies to meet unmet patient needs. A lot of what we’re doing has never been done before,” he added.   

NextCure (Nasdaq: NXTC), located in Beltsville, Maryland, is a biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases. NextCure’s FIND-IO platform is the discovery engine that fuels the company’s pipeline by identifying proteins that can be targeted to repair and maintain anti-tumor immunity. 

Richman, who previously led Amplimmune to an acquisition by AstraZeneca in 2013, founded the company in 2015. In the last handful of years, NextCure has made substantial progress, including a successful $90M IPO that closed in mid-2019. The company is currently advancing one therapeutic candidate through Phase 2 clinical trials (NC318 given mono and NC318 in combination with an anti-PD-1 antibody) and two candidates through Phase 1 trials (NC410 and NC762).

The Four P’s

NextCure is adapting quickly and intelligently in support of its advancing pipeline. The team has grown to over 100 employees and the company’s technological and facilities footprint is continually expanding and improving. 

NextCure’s Quality program is based on four key pillars: Patients, Process, Products, and People. Everything from Standard Operating Procedures (SOPs), document controls and Master Product Records (MPRs) to equipment and process validation, batch records, assay testing, and employee onboarding and training is underpinned by NextCure’s “Four P’s.” 

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This growth is exciting for NextCure but, like with any evolving organization, change tests all aspects of a company’s culture, including its Quality ecosystem. Just as new team members need to be onboarded and integrated into NextCure’s vibrant culture, new R&D assets need to be tested, refined, and seamlessly blended into existing Good Manufacturing Practice (GMP) and Chemistry, Manufacturing and Controls (CMC) processes. The successful integration of people and technology into GMP and CMC processes is a testament to the Quality culture’s deep and strong foundation created and protected by its executive team, Quality Control (QC), and Quality Assurance (QA) leaders.

Collaboration Drives and Maintains NextCure’s Strong Quality Culture

Cross-functional collaboration is also a hallmark of NextCure as is an “open door” policy that foments communication among departments, leaders, and individual contributors. This open, collaborative environment is a key mechanism for QA and QC leaders and team members to ensure Quality processes are understood and followed by every function at the company.

NextCure’s Yvon Joseph, Senior Director, Quality Assurance, and Dr. Ron Copeland, Senior Director, Analytical Development/Quality Control, drive Quality adherence across the organization, using their deep industry work experiences to drive QA and QC best practice(s) adherence across teams, technologies, and equipment.

Yvon Joseph

Joseph has had a long and successful career in Quality leadership positions, including time at Johnson & Johnson, Pfizer, Merck, and Sanofi Aventis. Copeland came over to NextCure with Richman shortly after Amplimmune was acquired and has had a successful career as a protein chemistry scientist and Quality control leader. Joseph and Copeland have built and work every day to maintain a collaborative, trust-driven relationship with one another, executive leadership, function heads, and the QA/QC team. 

Joseph and Copeland’s keys to success in driving NextCure’s Quality culture have been strong communication and understanding the balance between automation/tech with the human element. 

“I came to NextCure for the opportunity to teach, mentor and coach people into a Quality process. I wear many hats; I’m a teacher, a mentor, and an inspector. When you engage with people genuinely, they embrace Quality,” shared Joseph. “Teaching is really natural to me, and I try to connect the importance of Quality to the bigger picture—our clients, who are the patients—for my colleagues and new team members.” 

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“We always meet in the middle. I want our team to learn, and I want to hear what they learned. You can have all this great technology in place, but success is dependent on people and trust,” he added. 

Copeland added, “With the new technology and automation we use at NextCure, it’s important for us to take great pride in bringing these assets into our system. Everything we do has a Quality aspect to it. We do Quality risk assessments on equipment, then we test and qualify assays. We then develop SOPs for equipment and our assays and then our analysts, the human component, are the check at the end of the assay qualification process.”

Ron Copeland, PhD

“We marry our tech and our people with ongoing, continual training in QA/QC and cross training with other functions,” he added.

Despite rapid growth, NextCure is very intentional in its efforts to maintain a flat startup culture where open communication thrives and functional silos don’t have the opportunity to spawn and spread. 

“I work very closely with Ron; we are great partners and internal customers to one another. We train each other on QA and QC so we understand the expectations and rules from each side. This collaboration speeds up the process and we’re good neighbors to each other. We overlap and always give a heads up to each other—this is about working together to get things done,” stated Joseph.

“I’ve worked in Big Pharma. It’s very bureaucratic. At NextCure it’s different. We have something that needs to get done, we go and get it done while being process-consistent and committed to cross-training, and Quality” he added. 

“We just don’t have silos here,” reaffirmed Copeland. “At some big companies, the QA team is seen like the police. People are scared to talk to QA or are scared to report a deviation. Here, we are all colleagues and solution providers; we are all in the trenches together.”

By the time Joseph gets to the quarterly Quality System Management review meeting with NextCure’s executive leadership team, any Quality successes or challenges, according to Copeland, have usually already been discussed. 

“We don’t wait for the quarterly meeting to solve any challenges or get questions answered. We have weekly check-in meetings with our teams and our QA and QC team can really just walk up to our CEO’s office and talk through things. By the time the formal FDA-mandated quarterly Quality System Management review meeting happens, everyone in that meeting is aware of what’s going on in QA and QC,” shared Copeland.

“Our Quality team is driven by high quality people. We have a phenomenal team of experts that have spent their careers developing the knowledge and expertise in developing products. They understand systems and training in the context of evolving Quality processes, including automation,” stated Richman.   

“When you’re developing novel therapies, you operate in a very challenging Quality environment. Every NextCure team member has to understand Quality. This is not just a QA and QC department focus. We have integrated Quality into our corporate culture. We bring it to the forefront and give Quality a voice and a platform to talk about why QA and QC matters,” shared Richman.

“You build a much stronger organization if everyone understands the link between Quality and our mission, which is to develop safe and effective products that help people,” he shared.

“When our team understands that link, they can then respect and embrace it. That’s why as a young organization, everything we do from day one is about Quality. New team members are exposed to our Quality vision and commitment from their interview through onboarding through ongoing training. Quality is more than a regulatory issue. A strong Quality culture is about building a business the right way, doing your job well and ultimately helping patients,” Richman added.