As lipid-focused therapies continue to evolve, Sponsors require a central lab partner with deep scientific expertise, validated high-complexity assays, and the ability to translate complex biomarker data into reliable, actionable study results.
As part of our ongoing Q&A series highlighting the experts behind Medpace’s central labs, we spoke with Santica Marcovina, PhD, ScD, FAHA, Senior Director of Clinical Laboratory Sciences, about her work advancing lipid biomarker science and how Medpace supports Sponsors running sophisticated lipid-focused clinical trials.
Sr. Director, Clinical Laboratory Sciences
Career Journey: From Academic Leadership to Central Lab Innovation
What initially drew you to Medpace and your current role?
Before joining Medpace, I was a faculty member in the Department of Medicine and the Director of the Northwest Lipid Metabolism and Diabetes Research Laboratory (NWRL) at the University of Washington. For more than 30 years, NWRL served as a central laboratory for large, multi-site clinical trials and was internationally recognized for its work in lipid and cardiovascular research.
In 2020, during the COVID-19 pandemic, the University of Washington made the decision to close the laboratory, leaving many investigator-initiated and privately funded clinical trials without a central laboratory. While the NIH coordinated alternative solutions for some studies, this created a significant challenge for many Sponsors. I had known Medpace’s central laboratories for many years and was familiar with their reputation for quality. With the support of Dr. Evan Stein, we successfully transferred multiple ongoing studies from the University of Washington to Medpace. When Medpace offered me the opportunity to join the organization, I retired from academia and was very pleased to become part of the Medpace central lab team.
Innovation and Impact in Lipid Biomarker Science
How do you stay on top of new developments or trends in your field?
My primary research focus has long been lipoprotein(a) [Lp(a)], where I contributed to understanding the structure–function relationships of apo(a), the protein component unique to Lp(a). Using monoclonal antibodies developed in my laboratory, I established a reference ELISA method for Lp(a) quantification and a sensitive agarose gel method for separating apo(a) isoforms. I also developed extensive collaborations with leading Lp(a) experts, many of which continue today.
In my role at Medpace, I am actively involved in reviewing and interpreting Lp(a) results across a large number of clinical trials and interacting directly with Sponsors. This ongoing scientific engagement keeps me closely aligned with emerging developments in the field.
What innovation are you particularly excited about right now?
Following several years of collaboration with Dr. Sotirios Tsimikas at the University of California San Diego, we have recently implemented, fully validated, and optimized three novel ELISA methods at Medpace.
The first two assays measure oxidized phospholipids – one in apoB-containing particles and one specifically in Lp(a), which is the primary carrier of oxidized phospholipids in circulation. These assays are already being used at Medpace in multiple Lp(a)-lowering clinical trials, and the resulting data are expected to significantly advance our understanding of the atherogenicity of Lp(a).
The third assay is a homogeneous ELISA method for directly measuring cholesterol within Lp(a) particles. This innovative approach allows, for the first time, separate evaluation of the atherogenicity of Lp(a)-cholesterol versus LDL-cholesterol – an important distinction in both Lp(a)-lowering and LDL-lowering intervention studies.
Collaboration, Culture, and Leadership
How does cross-functional collaboration contribute to success at Medpace’s central labs?
Cross-functional collaboration between laboratory operations, data management, and project management is at the basis of Medpace management philosophy and essential for the successful conduct of clinical trials. This close interaction between the leaders of each section at any stage of a clinical trial allows for rapid problem solving and innovative solutions.
What sets the Medpace central lab culture apart from others in the industry?
Medpace’s central labs is truly science-driven, with a large number of experienced scientists overseeing laboratory sections, advising Sponsors, and actively participating in the development, validation, and standardization of complex biomarker assays. In addition, results from sophisticated analyses and primary endpoint biomarkers are reviewed daily and assessed against each participant’s longitudinal data prior to release. This depth of scientific oversight is, in my view, a defining trademark of Medpace’s central labs.
About Medpace’s Central Laboratories
Strategically located in the US, Belgium, China, and Singapore, Medpace’s central laboratories have the global reach and capability to conduct studies, assist with regulatory requirements, and deliver custom solutions specific to our Sponsor’s needs. Our four wholly owned laboratories offer full-service support to six continents for phase I-IV studies, enhanced by our extensive experience running small to complex, global studies. Our standardized testing platforms, comprehensive test menu, and expert project management teams ensure seamless execution of customized projects.
