Progress in treating chronic Kidney Disease patients with Cardiovascular Disease: Kidney Health Initiative develops clinical research recommendations

Throughout the world, kidney disease is far more common than most people realize. It’s not a stretch to call it a “hidden epidemic,” as the number of people living with kidney disease (850 million) is roughly twice that of those living with diabetes.(1) The health issue presented by chronic kidney disease (CKD) …

Opportunities for Biomarkers in Immuno-Oncology

Exploring new opportunities for biomarkers in immuno-oncology

Pharmaceutical companies are increasingly relying on biomarkers to deliver precision medicine in immuno-oncology. Biomarkers can accelerate drug development and reduce the overall cost; they also allow sponsors to identify failed treatments sooner so that resources are not wasted on expensive, late-stage trials with unsafe or inactive compounds. Finally, these tests …

data

Target-Mediated Drug Disposition

“Affinity” is defined as, “a spontaneous or natural liking or sympathy for someone or or something.” This concept applies also to the biologics (large molecules) we help to develop. Drugs like monoclonal antibodies (mAb) or bispecific antibodies are ideal drug candidates since they have very high affinity to bind to their target …

Covance Contract Research Org Biosimilars Webinar 2

A Holistic View of the Biosimilars Landscape: Key Factors for Clinical and Commercial Success

Biosimilars have dominated the headlines in the U.S. with several FDA approvals, legal battles and questions around reimbursement, placing an increased focus on how to successfully navigate this relatively new pathway from end to end. Starting with the regulatory environment to CMC bioanalytics and pharmacodynamics, learn how drug developers can …

cGMP pharmacy Covance Blog

Phase I cGMP Drug Manufacture at the CRU: 3 BIG Benefits

Using a cGMP pharmacy at your CRU for Phase I drug manufacturing yields benefits in quality and safety, timeline reduction and cost efficiency. The regulatory environment continues to move toward requiring drug manufacturing at current good manufacturing practice (cGMP)-compliant pharmacies. This trend and other factors make it increasingly attractive to …