About Maria Teresa Lee, M.D., FCAP

Dr. Lee is the Director of Medical Affairs for Central Laboratory Services at Covance Inc.

Reducing the Variability in Multiple Myeloma Testing

IFE-PEP-2_blogMultiple myeloma is a blood cancer that typically affects those aged 70 years and older. Although considered an uncommon disease, the American Cancer Society estimates that in 2015, 26,850 new cases will be diagnosed in the United States this year. Global studies show a worldwide incidence of 86,000 cases per year.

The high five-year patient survival rate makes this type of cancer an ideal target for research and treatment studies. Pharmaceutical companies have also embraced the search for treatment of multiple myeloma, since the availability of a successful therapy would enable patients to live significantly improved and productive lives. Continue reading

Delivering Globally Consistent Data from In-House ANA-IFA Assays

Fluorescent micrograph of an ANA-IFA slide.

Image used with permission – Bio-Rad Laboratories and the University of Washington

Simply meeting regulatory standards is not enough for you to remain competitive in today’s evolving immune-mediated inflammatory disease (IMID) drug market. When it comes to FDA approval and successful commercialization of IMID drugs, the consistency of your data is critical. In addition, biopharmaceutical companies such as yours need the ability to detect and quantify small effects, secondary results, potential additional indications, and other insights that can enhance the value of your products.

Covance Central Laboratory Services (Covance CLS) offers extensive in-house capabilities and dedicated support for a variety of key assays used in IMID trials to ensure you obtain unmatched data consistency. One such assay that we perform in-house is the Anti-Nuclear Antibody Indirect Fluorescence Assay, or ANA-IFA – a sensitive screening test used to detect autoimmune diseases. Continue reading