Supporting Trials for Lipid Disorders, Cardiovascular, and Metabolic Diseases
Medpace’s central laboratories have unparalleled experience and expertise in the development of lipid and cardiovascular modifying therapies. Key staff involves doctors, managers, and technologists with considerable expertise in the area of central laboratory operations for the pharmaceutical industry and federally funded programs, from discovery and proof of concept through large, long term global lipid and cardiovascular trials.
- Since 1985, this core group has been part of central laboratory operations for virtually every successful New Drug Application (NDA) involving lipid modifying therapies including, but not limited to, all “statins”, apo B antisense, and omega-3 agents.
- Recently, Medpace has provided efficacy analysis for two Proprotein convertase subtilisin/kexin type 9 (PCSK9) mAb inhibitors that supported acceptance of the FDA biologics license application (BLA), European & Global filing, and subsequent approvals by the FDA and EMA.
- Medpace has been the global central laboratory for Phase I – IV trials involving numerous lipid altering mechanisms including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition involving monoclonal antibodies, RNA interference, fusion proteins, cholesteryl ester transfer protein (CETP) inhibition, Diacylglycerol Transferase (DGAT-1) inhibition, peroxisome proliferator-activated receptor (PPAR) agonism, omega-3 fatty acids, niacin analogs, and modifications of other biomarkers known to affect lipid metabolism such as Apo CIII and ANGPTL3 (angiopoietin-like 3).
Central Lab Services
- Apolipoprotein Analysis: AI, AII, AV, B (Total), B-48, B100, CII, CIII, E
- Cholesteryl Ester Transfer Protein (CETP), Mass
- Free Fatty Acids
- Free Glycerol
- HDL Cholesterol – Precipitation with dextran sulfate (reference method), “direct” or homogenous enzymatic method, Preparative Ultracentrifugation (PUC)
- LDL Cholesterol – (Friedewald, DeLong, Hopkins), “direct” or homogenous enzymatic method, PUC
- Lipid Profile (Total Cholesterol, Triglyceride, HDL-C, LDL-C)
- Lipoprotein (a)
- Lipoprotein-associated Phospholipase A2 (LpPLA2) Activity and Mass
- Oxidized LDL
- PCSK9, total and free
- Oxidized LDL
- Prebeta-1 HDL
- Preparative Ultracentrifugation (PUC) for lipoprotein fractionation
- Retinyl Palmitate
- Beckman Coulter AU Clinical Chemistry Analyzers
- Beckman Optima Ultracentrifuges
- Siemens BNII Nephelometers
- Randox Daytona
- Waters AcQuity UPLC H Class System
All four central lab locations globally participate in and are certified in the CDC (Center for Disease Control and Prevention) Lipid Standardization Part III Program for total cholesterol, triglyceride, High-Density Lipoprotein Cholesterol (HDL-C), and Low-Density Lipoprotein Cholesterol (LDL-C). Many lipid trials require LDL-C by the gold standard reference method, preparative ultracentrifugation (PUC), which is performed in high volume at Medpace with over 2,000 analyses monthly. Determination of efficacy and safety necessitates an accurate evaluation of drug effect, without the confounder of inaccurate data due to a less than optimal laboratory methodology. Medpace labs will get involved early in a drug development program, to aid in the determination of the best method for a clinical trial.