SEND [Standard for Exchange of Nonclinical Data] is more than just a tool to facilitate nonclinical data submissions to the FDA. SEND datasets are rich in information, albeit in a form that’s time-consuming for non-experts to parse. With the right visualization tools, SEND data sets can inform nonclinical programs and yield important insights.
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 lead to better outcomes for patients, which help companies make a stronger case for reimbursement.
However, biomarker discovery requires substantial time and resources. While expenses will likely be outweighed by increased development efficiency, companies must ensure that drug and diagnostic timelines are closely aligned so that the treatment and test can launch simultaneously. Technical, workflow and commercial factors are critical to the successful use of immuno-oncology biomarkers. Continue reading
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 tumor’s genetic makeup. This has led to significantly improved outcomes for many patients.
But can we leverage the knowledge of the biology of other disease states along with the appropriate technical progress into successful CDx expansion beyond oncology? Given that nearly 50% of all compounds in clinical development are dropped for lack of efficacy, CDx may represent a viable approach to improve this statistic and boost the efficiency of drug development efforts. Promising clinical areas where CDx may play an important role include immunology, rare and orphan diseases, and neurodegenerative diseases such as Alzheimer’s disease. Continue reading
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 the clinical trials assay and served as the central lab for the testing of HER2-positive breast cancer during the development of trastuzumab. The company provided analytical testing data for the associated immunohistochemistry laboratory test resulting in the first companion diagnostic approved by the FDA. More recently, Covance was instrumental in supporting the drug development efforts for pembrolizumab, the therapy used successfully to treat former President Jimmy Carter’s melanoma, and its associated companion diagnostic. Continue reading
The NIH defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person1.” In cancer patients, we can rephrase the definition to “through detailed understanding of a cancer’s biology, providing the right drug, for the right patient, at the right time.”
In order to identify the correct drug, biomarkers are used to identify patients that can be treated with the appropriate therapy for their cancer. The FDA defines biomarkers as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions2.” Great strides have been made in the discovery and validation of biomarkers in drug development. Continue reading