As Lovelace Biomedical expands its footprint in toxicology service offerings, some are asking: Why general toxicology, and why now? Here, we get the answers from Dr. Matthew Reed, a board-certified toxicologist and Lovelace’s Vice President of Applied Toxicology and Nonclinical Development.
Lovelace has a well-respected reputation as an organization that performs “hard-to-do” work for the federal government, in inhalation toxicology and pulmonary drug development. What prompted Lovelace’s expansion to offer GLP general toxicology studies?
GLP and commercial-focused toxicology is something we’ve been doing for years now, but over the last decade we’ve made a concerted effort to expand this side of our business. We have found that we have an important role to play for our pharmaceutical, biotech and agricultural-chemical partners. We get a lot of satisfaction out of being able to advance these programs through the regulatory lifecycle and in appropriate cases through clinical development.
What do you mean by “general toxicology”?
Our team has wide expertise in multiple routes of dosing in nearly every species, so we’re not pinned to just one specialty area like inhalation delivery. We’re able to perform regulatory toxicology programs for U.S. and a variety of international registrations. Whether it is an acute dose oral study, a cardiovascular-respiratory safety pharmacology program, a 28-day intravenous repeat dose GLP toxicology study in a mini pig or NHP, a GLP carcinogenicity study…we can get it done. So while we’re made up of many specialists in many areas, we say “general” because we can take on just about anything.
So how is this different from what you have done to date?
In many ways, it’s not much different at all. We’re just doing a better job of telling the world about it because we realize it’s an area in which we excel, and toxicology outsourcing is in high demand. For many years we’ve supported successful GLP regulatory programs that have incorporated IV, subcutaneous and oral routes, for example. And we’ve been performing GLP studies since near the inception of GLPs, for over 30 years. But now our job is to get out and tell the toxicology and scientific communities that we can perform these studies on time, with regulatory and scientific quality, and at a fair price point.
How is Lovelace Biomedical different from the other players in this competitive world of CRO conglomerates?
Lovelace has a more personal touch, which our clients tell us they like, as well as the many conveniences that come from the fact that we’re in one centralized location. We represent a shrinking demographic of mid-sized CRO offerings in the mega-CRO world. But we have quite similar analytical, bioanalytical, pharmacokinetic, histopathology, SEND and quality compliance capabilities as compared to a Charles River or a Covance. And we have a massive 90-plus animal room multispecies vivarium with European standard housing facilities that can compete with any large CRO site across the world. We implement similar process and people efficiency metrics, study planning, space utilization and tracking, quality process and scheduling procedures. So we are very different, but also in many ways similar.
Lovelace is often seen as a company that does the out-of-the box projects. With all the talk about “general” toxicology, does that mean that you’re not doing these difficult or unusual projects anymore?
Great question! We have no intention of losing our capability to do “the complex.” We see our real reputation as being able to provide the highest level of scientific quality, whether the project is complex or straightforward. This has a lot to do with our staff, which is an area where we have an edge.
In toxicology and pathology alone we’ve retained upwards of 10 accessible study directors, four with American Board of Toxicology (ABT) certifications. Most hold doctoral degrees and their average tenure at Lovelace is over 10 years. We also have more than 50 cross-trained research technicians, another 10-plus necropsy and histopathology technical staff, 15-plus chemistry staff, multiple seasoned PMP project managers, clinical pathology personnel, telemetry personnel, and multiple support staff to ensure quality scientific performance. Not to mention, three board-certified veterinary pathologists, each with 17-30-plus years of experience. These are not new hires, either. But we are hiring strategically, building our technical staff and additional senior scientific staff to augment our capabilities and our study director pool.
Dr. Reed encourages existing or potential clients to come and visit the Lovelace site in Albuquerque to meet the technical, support, scientific and management staff and tour the facility.