Drug developers are increasingly incorporating a CDx development (companion diagnostic) strategy into their programs to deliver safer, more effective and appropriate therapies to the right patients. While the end result can be significantly beneficial for patients, and development partners, the path from analytical and clinical validation to demonstrating clinical utility and obtaining regulatory approval is often challenging. It requires a comprehensive understanding of clinical trial design, regulatory submission strategies both for the therapy and the diagnostic assay, and also a line of sight for successful commercialization. Continue reading
The development of anti-infective treatments to combat illnesses caused by viral and microbial agents has witnessed many unique advances, most notably in the
fights against bacterial infections, hepatitis and HIV. The momentum in this exciting area continues with new tools and methods to better support the development journey. From improved microbial identification to quantitative technological platforms, let’s explore emerging opportunities to develop assays, interpret results and improve clinical trials.
Learn how novel technologies and analytical techniques are accelerating discoveries and transforming results in infectious disease drug development. Download our new infectious disease eBook today.