The best-run preclinical research programs are just as devoted to strong science and achieving experimental objectives as they are to adhering to Good Laboratory Practice standards and other essential regulations that govern the industry.
Without meeting the strict protocols of the FDA, USDA and numerous other oversight organizations, a drug’s preclinical development program is in jeopardy.
At Lovelace Biomedical, the essential functions of compliance and quality assurance are spearheaded by the passionate Jennifer Cleerdin, Senior Director of Scientific Operations. Since joining Lovelace in 2003, Ms. Cleerdin has developed and implemented a quality process that’s unparalleled in the contract research field. Here, she takes us behind the scenes to explain Lovelace Biomedical’s quality program, and why quality needs to be at the top of the priority list for any biotech or pharma company on track for an IND.
Q. First, tell us a bit more about what your day-to-day job entails.
Essentially, I oversee the many operational support departments at Lovelace to ensure our programs are running as seamlessly and efficiently as possible, while also in full compliance with the increasingly rigorous regulations that govern preclinical testing. My purview includes project management, compliance, training, equipment calibration and validation, compliance documents management, corrective and preventative action programs (CAPA), environmental safety and health, and radiation safety departments. It’s nice to have that diversity.
Q. Given the size of the Lovelace facility, and the diversity of the IND-enabling programs you handle, this must make for busy days.
Certainly. As you can imagine, the quality assurance team is dealing with many moving parts, which means we are never, ever bored. Our role requires that we work across the organization to continuously refine our processes; we’re always looking for new efficiencies and proposing quality enhancements when we see an opportunity. It’s extremely rewarding to be able to implement changes and see an immediate payoff. Lovelace is unique in this industry as it is so open to making changes and improving processes. It’s part of our culture here; we’re always in motion, always ready for progress.
Q. You’re a big proponent of metrics. Talk about what this means for you and for quality assurance in general.
Yes, metrics is one of my favorite topics. We all know that good data is needed for the success of a preclinical program, but we also need strong data to support decisions to change a process. One essential purpose of a thriving quality assurance department is the ability to mitigate all sorts of risks . . . risks to study integrity, risks to safety, risks to budget or timeline. We literally measure every step of the program to see where we need to be focusing our attention and what we need to be doing differently. When we present a decision to make change, we also present the compelling reason — and then work towards measuring the success of this change.
Q. As a department that closely interfaces with the FDA, the USDA, the CDC, and other regulatory agencies, are there any key trends you’re are seeing?
Across the agencies, we are seeing a lot more rigor and oversight of compliance in preclinical testing. This dovetails well with our focus on quality assurance. We anticipate new or changing requirements, and we’re able to show the evidence of documentation that requirements call for. This is especially important for complex studies, where documentation is not a simple task.
Q. Part of your job is playing host to biotechnology and pharmaceutical companies who visit the Lovelace Biomedical facilities. What do the visiting companies tend to think when they make the trip to Albuquerque?
Sponsors who visit us are most surprised about the vast amount of physical space and breadth of capabilities. They often will tell us they had no idea we had this much capacity, this diversity of species or this much technical knowledge in all of our different staff. But the most valuable aspect of these visits is being able to introduce sponsors to our scientific and technical teams. We enjoy any opportunity to show off our capabilities and take a lot of pride in our facility, our processes, and the work we’ve done with sponsors to advance their drugs into clinical development and ultimately approval.
Contact us to learn more about Lovelace’s approach to quality assurance.
Jennnifer Cleerdin, Senior Director of Scientific Operations at Lovelace, holds a Bachelor of Science in Physical Science and Chemistry from York College of Pennsylvania and a Juris Doctorate from Concord School of Law. She joined Lovelace in 2003.