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. After all, 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 our Scientific Operations team, which ensures all programs are running as seamlessly and efficiently as possible, while also in full compliance with the increasingly rigorous regulations that govern preclinical testing.
As a department that closely interfaces with the FDA, the USDA, the CDC, and other regulatory agencies, the Scientific Operations team anticipates new or changing requirements, and ensures Lovelace’s programs are designed to generate the evidence of documentation that evolving requirements call for. This is especially important for complex studies, where documentation is not a simple task.
The Scientific Operations team examines quality on many fronts, looking at ways to refine processes and improve performance in the areas of compliance, training, equipment calibration and validation, compliance documents management, corrective and preventative action programs (CAPA), environmental safety and health, and radiation safety.
Given the size of the Lovelace facility, and the diversity of the IND-enabling programs we handle, it’s safe to say the Scientific Operations team is never bored. The team is always in motion, seeking out opportunities for progress. But any of its proposed changes are always backed by metrics: Just as strong data is needed for the success of a preclinical program, it’s also needed to support decisions to change a process.
As it seeks to mitigate all sorts of risks — risks to study integrity, risks to safety, risks to budget or timeline — the Scientific Operations team literally measures every step of the program to see what could be done differently or better. When the team presents a decision to make change, it also present the compelling reason, and then works towards measuring the success of this change.
Best Part: Playing Host
Adding to the daily variety of duties handled by the Scientific Operations team, its members also serve as host to biotechnology and pharmaceutical companies who visit the Lovelace Biomedical facilities in Albuquerque to explore our capabilities. Sponsors who visit are often surprised about the vast amount of physical space, often remarking that they had no idea we had this much capacity, this diversity of species or this much technical knowledge among our staff. But the most valuable aspect of these visits is being able to introduce sponsors to our scientific and technical teams.
Every site visit is an opportunity to show off Lovelace Biomedical’s capabilities and showcase our facility, 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 or to schedule a site visit.