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).
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 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 determination of the best method for a clinical trial.
Central Lab Services include:
Apolipoprotein Analysis: AI, AII, AV, B (Total), B-48, B100, CII, CIII, E
Cholesteryl Ester Transfer Protein (CETP) Activity, Mass
Free Fatty Acids
HDL Cholesterol – Precipitation with dextran sulfate (reference method), “direct” or homogenous enzymatic method, Preparative Ultracentrifugation (PUC)
Lipoprotein associated Phospholipase A2 (LpPLA2) Activity and Mass
PCSK9, total and free
Preparative Ultracentrifugation (PUC) for lipoprotein fractionation
Remnant Lipoprotein Cholesterol (RLP-C)
Expert Therapeutic Leadership
Traci Turner MD, MT(ASCP)
Executive Director, Medpace Central Labs Operations
Global responsibility for Medpace Central Labs operations since 2011
Diplomate, American Board of Clinical Lipidology 2013
MD – Board Certification in Internal Medicine 2004
15 years clinical laboratory experience from the bench to management 1982-97
Evan Stein MD, PhD
Founded & built Medical Research Laboratories 1987
Founded Medpace Labs 2006 with the same experienced team
Has been part of the central lab for virtually all lipid lowering agents approved & marketed since 1986
Member of the NIH NCEP Lab Committee for methods and standardization of lab guidelines
Advisor to the NIH NHLBI and CDC Lipid Standardization branch
Key Instrumentation includes:
Beckman Coulter AU Clinical Chemistry Analyzers
Beckman Optima Ultracentrifuges
Siemens BNII Nephelometers
Waters AcQuity UPLC H Class System
Along with our experienced CRO and strategic anatomical pathology lab partners, Medpace’s central lab has broad experience in managing oncology clinical trials. Medpace’s central lab has a team of PhD directors overseeing the expansion of Medpace’s oncology test menu with newly validated biomarkers in support of our clients’ oncology programs.
In-house Oncology Biomarkers:
CK-18 M30 Apoptosense
CK-18 M65 EpiDeath
Fecal Occult Blood
Fibroblast Growth Factors (2, 21, 23)
Neuron Specific Enolase
Prostate Specific Antigen
Vascular Adhesion Molecule (VCAM-1)
Vascular Endothelial Growth Factor (VEGF)
Medpace’s strategic partnership provides our clients with access to board certified pathologists and state of the art histology services.
Full specimen processing capabilities
Paraffin block embedding (FFPE)
IHC Stains – over 150 validated IHC stains
Aperio whole slide imaging – web accessible, interactive
Infectious disease studies have grown in complexity with traditional microbiology methods increasingly supplemented with new molecular techniques, providing rapid and accurate data, facilitating improved understanding of disease mechanism and enhance clinical outcomes. Medpace’s central laboratories’ in house capabilities coupled with strategic laboratory partnerships with top labs in microbiology and virology provide the specific testing required for each study. This approach streamlines timelines, simplifies requirements for sites, and provides a centralized model for communication.
The Medpace Advantage
Access to top research scientists who are therapeutically focused in infectious disease, deliver regulatory-quality reports and meet the tight timelines demanded in ID trials
With Medpace central labs coordinating the shipping between sites and labs around the world, logistics are greatly simplified, resulting in higher efficiency
Medpace’s central laboratories have an extensive selection of tests relevant to autoimmune and inflammatory diseases. There over 50 inflammatory biomarkers on 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 include:
Anti-Double Stranded DNA (DsDNA) antibodies
Antinuclear Antibodies (ANA)
Anti-Cardiolipins antibodies (IgA, IgG, IgM)
APS (antiphospholipid syndrome) markers
C-Reactive Protein (high and ultra-sensitivity)
Complement Testing (C3, C4, C4a, C5a, Bb)
Various cytokines, chemokines, and growth factors (see Medpace test menu)
Whitepaper: A Central Laboratory Inter-laboratory Comparison Program to Assess the Comparability of Data of Forty-one Tests from Four Regional Laboratories Involved in Global Clinical Trials over a Twelve-Month Period
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