DIGI-TECH PHARMA & AI 2022

The management of the United States’ massive prescription drug spend is plagued by inefficient, manual processes and errors which exact enormous human and financial tolls on society.

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.

There are approximately 7,000 distinct rare diseases affecting 350 million people worldwide, approximately 80 percent of which are caused by faulty genes. Scientific advances such as the CRISPR/Cas9 genome-engineering system have simplified the pharmaceutical and biotech industry’s ability to develop gene therapies, especially for single gene mutation disorders. The US Food and Drug Administration (FDA) has more than 700 active Investigational New Drug Applications (INDs) for gene and cell therapies and in 2017, the FDA approved two cell-based gene therapies and it is anticipated that gene therapy will become a mainstay treatment for many rare diseases.

Microbial risk in pharmaceutical process is not limited to living microorganisms and intact microbial cells. Subcellular components from microorganisms remaining from the production process can be source of pyrogens, compromising product quality and patient safety as these substances are not eliminated by classical filtration or sterilization steps.