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) …
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 …
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 …
PK/PD Modeling and Simulation – A Brief Overview and Upcoming Blog Series
The year I graduated from college was the same year an old family friend was retiring. He had spent the majority of his career designing and deploying farm equipment across the United States. When I asked for advice as I entered the workforce he told me a story. Three months …
Charting a Regulatory Course for Diabetic Kidney Disease Treatment
As the diabetic epidemic grows, so does the prevalence of diabetic kidney disease (DKD), a frequent complication of both type 1 and 2 diabetes. Diabetic nephropathy is the leading cause of end-stage renal disease, and despite its global health burden and increased prevalence, no specific regulatory guidelines exist for developing …
Investing in the Future of Precision Medicine
In previous posts on this blog, our scientists have described the current state of precision medicine, particularly how it relates to companion diagnostics (CDx) and immuno-oncology. As an enterprise, we have been focused on this area of medicine essentially from the beginning, more than 20 years ago. LabCorp Diagnostics developed …
Finding the Other 90%: Attracting Naïve Patients to RA Studies
A recent study by Tufts Center for the Study of Drug Development, based on a survey of 2,000 physicians and nurses primarily in the United States and Europe, found that 91% of physicians feel ‘somewhat’ or ‘very’ comfortable discussing the opportunity to participate in a clinical trial with patients, but …
Bios的整体视图imilars Landscape: Key Factors for Clinical and Commercial Success
生物仿制药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 …
Phase I cGMP Drug Manufacture at the CRU: 3 BIG Benefits
使用cGMP药房CRU第一阶段药物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 …
The Biosimilars Landscape: What All Developers Need to Know
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, …