Variant Assessment for Reduced Penetrance Diseases

The clinical development marketplace continues to become more complex and competitive, with stricter regulatory standards and trial oversight—all the while demanding patient-centric drug development. These, and other factors, contribute to unsustainable costs and longer timelines before much-needed therapies reach the market.

The ability to link disparate datasets with de-identified or anonymized patient data has existed for decades but has been unrealistic to apply at scale.

Current diagnostic methods for lower respiratory specimens typically take one to two days to identify most bacterial pathogens. During that time, clinicians must rely on guideline recommendations and clinical diagnosis to guide empiric therapy, which is not optimized based on the patient’s individual pathogen. The BioFire Pneumonia Panel will provide pathogen identification in a much shorter timeframe and may allow clinicians to optimize targeted pathogen-specific therapy sooner. The BioFire Pneumonia Panel is a rapid multiplex-PCR test that identifies 33 targets, including 18 bacteria, 8 viruses and 7 antimicrobial resistance genes from lower respiratory tract specimens in about an hour. It provides semi-quantitative results (in copies/ml) for 15 of the bacterial targets. This new feature provided by multiplex-PCR testing may help clinicians and laboratorians separate colonizing from pathogenic levels of bacteria.

In this webinar, Anders Högdin, Senior Sales Director at Recipharm discusses the common challenges companies encounter during upscaling. He also outlines the key considerations during the medicinal and process chemistry planning phases, the regulatory requirements and the steps companies can take to streamline the process.