Highlighted Therapeutic Expertise

NASH/NAFLD

Medpace specializes in the design and conduct of global trials in gastroenterology and hepatology, including nonalcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Central Lab Services

A2 Macroglobulin C Peptide Free Glycerol NAS Calculation
Adiponectin Total Chylomicrons Fructosamine NMR
Aldolase CK18 M30 G6PD P1NP
ANGPTL3 CK18 M65 Ghrelin PIIINP
ANGPTL4 Cortisol Salivary Glucose Phosphatidylethanol
Anti TPO CRP, hs GLP-1 Active Pro BNP
Apo A1 CTX Beta Crosslaps GLP-1 Total Pro C3
Apo B Cystatin C Hyaluronic Acid Proinsulin
Apo B 48 D Dimer Haptoglobin Pyruvic Acid
Apo B 100 ELF Panel IL1 beta Resistin
Apo CII Ferritin IL6 sLDL
Apo CIII FIB4 Calculation Insulin TGF Beta 1
APR Calculation Fibrinogen Lactate TIMP-1
Autotaxin Fibronectin Leptin TNF alpha
Beta Hydroxybutyrate Fibrotest Lp(a) Troponin I
Bile Acids Fraction FGF-19 Lipid Panel Vitamin D 25 OH
Bile Acids Total FGF-21 MCP-1 YKL-40
C4 (7-alpha) Free Fatty Acids NAFLD Calculation

 

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 EMEA.
  • 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, and fusion proteins, cholesterylester 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

LDL Cholesterol – (Friedewald, DeLong, Hopkins), “direct” or homogenous enzymatic method, PUC PCSK9, total and free
Cholesteryl Ester Transfer Protein (CETP) Activity, Mass Lipid Profile (Total Cholesterol, Triglyceride, HDL-C, LDL-C) Phospholipids
Free Fatty Acids Lipoprotein (a) Prebeta-1 HDL
Free Glycerol Lipoprotein-associated Phospholipase A2 (LpPLA2) Activity and Mass Preparative Ultracentrifugation (PUC) for lipoprotein fractionation
HDL Cholesterol – Precipitation with dextran sulfate (reference method), “direct” or homogenous enzymatic method, Preparative Ultracentrifugation (PUC) Oxidized LDL Retinyl Palmitate

Key Instrumentation

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.

Autoimmune and Inflammatory

Medpace’s central laboratories have an extensive selection of tests relevant to autoimmune and inflammatory diseases. There over 50 inflammatory biomarkers on a validated test menu.  Assays are validated on specialized instrumentation as well as a large menu (>100) of validated ELISA assays and multiplexed assays.

Central Lab Services

Alpha 1 Antitrypsin APS (antiphospholipid syndrome) markers Free Light Chains
Alpha 2 Macroglobulin Calprotectin Immunoglobulins
Amyloid A Complement Testing (C3, C4, C4a, C5a, Bb) Interleukins
Anti-Cardiolipins antibodies (IgA, IgG, IgM) C-Reactive Protein (high and ultra-sensitivity) Prealbumin
Anti-Double Stranded DNA (DsDNA) antibodies Direct Antiglobulin (DAT) Various cytokines, chemokines, and growth factors (see Medpace test menu)
Antinuclear Antibodies (ANA) Enhanced Liver Fibrosis

 

Key Instrumentation

Advia Centaur XPT Randox Daytona Tecan Evolyzer
Mesoscale Discovery Quickplex SQ Roche Immunoassay Analyzers Tecan INFINITE
MSD Secto 6000 Sebia Hydrasys Tecan Sunrise
Phadia Immunoassay Analyzers Siemens BNII Nephelometers
Protein Simple Ella Stago Compact