Applying Technology to New Science: Biopharma’s New Growth Engine

Leachable risk management continues to be of regulatory interest. However, we continue to rely on experimental extractable studies as predictors of leachable risk. These are complex to design and implement and do not always offer the answer to what is the leachable risk for a drug product or medical device.

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.

This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development and how to save time and money while maximizing the value of their drug development program.

Using electronics today is a part of our daily lives. It is almost impossible to imagine how the world would be without electronics. The healthcare industry is not an exception to this. The drive towards having connected healthcare has become a well-established facet of current drug delivery device development, the overwhelming potential benefits has led to an explosion of development projects aiming to create connected device.