BPR is the legislation governing the use of biocidal products in the European Union. Read on to find out how to navigate the authorization process and manage the information required. Biocidal products are used to control unwanted organisms (e.g., pests, such as rats, or micro-organisms, like bacteria) that are harmful …
Impact to the bioanalytical community of the FDA issuance of the draft guidance on biomarker qualification: evidentiary framework
FDA于12月(2018年)发布了一项指导草案,就实现合格生物标志物所需的证据框架和标准。它旨在涵盖与特定药物计划之外的使用生物标志物相关的监管差距。因此,该指南草案支持药物开发工具的资格......
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 …
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 …
Can We Expand Companion Diagnostics Beyond Oncology?
大多数今天的批准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 …
Applying Preclinical Biomarkers to Identify Renal Injuries
Identification of new medicines for kidney disease remains an ongoing challenge in drug development. This challenge includes establishing new biochemical measurements (biomarkers) which can sensitively and accurately reflect the status of renal health and any associated changes in renal function. Sponsors are exploring many options to improve the application of …
The Current Status of Clinical Biomarkers for Diabetic Kidney Disease Progression
Of the 422 million people in the world with type 1 and 2 diabetes, 20-30% will develop diabetic nephropathy, also called diabetic kidney disease (DKD) – the leading cause of renal failure in the western world1. From the perspective of drug developers, testing new therapies to prevent, treat or reverse this …
纳什的新兴的非侵入性生物标志物是什么?
Novel biomarkers represent a promising means to improve diagnosis of nonalcoholic steatohepatitis (NASH). Currently, a definitive diagnosis requires a liver biopsy, a surgical procedure with many limitations. There are a variety of biomarkers that can assess liver status, but they do not always distinguish between patients with NASH and those …
在中国的更加个性化药物转变
Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China’s drug development and translational medicine landscape. An emerging focus on biomarkers …
Accelerating Rare Disease and Orphan Drug Development: Opportunities for Biomarkers, Diagnostics & Patient Engagement
Rare diseases affect more than 350 million people worldwide but patients often face limited options for approved therapies. As a result, many patients have joined advocacy groups first and foremost to connect with others struggling with their rare disease, but also to promote research, unite multiple stakeholders and stimulate new possibilities …