Biosimilars Covance

A Creative Solution to Address the Biosimilar Boom

Identifying viable study sites presents a challenge in many clinical trials. Biosimilar development is especially challenging as the number of sponsors preparing to broaden access to today’s blockbuster biologics, by providing lower-cost biosimilar alternative, continues to grow. While this flood of research activity will make a significant improvement for patient …

Purple DNA Strand

Immuno-Oncology Studies: Optimizing Design, Recruitment and Execution

The rise of immunotherapy has been meteoric — there are now well more than 1,000 immuno-oncology (IO) trials ongoing according to clinicaltrials.gov. Finding and enrolling the appropriate patients for these potentially revolutionary treatments has presented a profound challenge, one that was recently covered in the aptly titled New York Times …

ELISPOT Addresses the Complex Questions Arising From Vaccine and Novel Therapies

The accelerated arrival of novel vaccines and immunotherapies into the clinical space spurred the emergence of fields like personalized medicine, immuno-profiling and immuno-monitoring built around increasingly sophisticated testing platforms. Among them, immunoassays in the ELISpot (Enzyme-Linked ImmunoSpot) family are the most frequently used functional assays for single-cell analysis.1 

Can We Expand Companion Diagnostics Beyond Oncology?

The majority of today’s approved companion (and complementary) diagnostics (CDx) support personalized medicine efforts in oncology, a testament to researchers’ growing knowledge regarding the genetic pathways impacted in various cancers. That understanding increases our ability to convert such knowledge of biology into treatments that specifically target disease based on a …

Antihyperglycemic Agents and Heart Failure (HF): An Examination of Recent Studies

In the last 10 years, the study of medications for type 2 diabetes (T2D) has rapidly expanded its investigational footprint to evaluate cardiovascular (CV) effects, a shift driven largely by regulatory guidance that requires at least a demonstration of CV safety. Clinical investigators are also concerned with the effect diabetes …