Tim Sandle

The digital transformation of biopharmaceutical manufacturing has continued at a rapid pace as companies mine the rich sources of data available. The requirement for more people to maintain ‘physical distance’ during the coronavirus pandemic has helped to further fuel interest in digital solutions as companies sought to avoid delays and disruption to development, production and distribution. Innovations that enable data capture and review include predictive analytics, big data analytics, and building upon the digital plant. These forms of digital transformation offer mechanisms to revise its business model, to improve production processes, to design new drugs faster by using artificial intelligence (such as to screen compounds), and to increase responsiveness to customers. Furthermore, the volume of data processed by pharmaceutical firms shows no sign of slowing down. This means pharmaceutical companies must continue to act quickly in terms of building core internal digital capabilities and moving beyond their traditional IT functions to all areas of the business.

New legislation requiring pharmaceutical companies to implement 'serialization' is now coming into force. This means that no counterfeit product should enter the supply chain and no legitimate product is diverted from its intended destination. To work effectively, serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. The application of track and trace principles can help to avoid counterfeit medicines from entering the supply chain. To be effective, digital technologies such as blockchain and RFID-enabled tag and trace systems need to be embraced.

There are a number of ways by which antimicrobial resistance can spread, and one that is of growing concern is the disposal of medicines by consumers down sinks and toilets. A new technique can help to assess the extent of the spread.

Scientists have put together a sensitive method to determine if bacteria carry a gene that can cause resistance to two common antibiotics. The test is rapid and has been tested against the bacterium which causes ‘strep throat’ and other respiratory illnesses.

New research, published in The Lancet Infectious Diseases, presents the first clinical results with CAL02 in patients suffering from severe pneumonia, the first cause of infectious mortality in the world.

The findings are of significance for pharmaceutical companies and the medical sector. This is in the context of a time of great struggle for antibiotic companies given the increase in instances of antibiotic resistant bacteria. What is of particular global concern is the acceleration of resistance. U.S. Centers for Disease Control and Prevention (CDC) data finds that many high-income countries are entering a “post-antibiotic era.”

Major companies on the scene include Second Genome, Enterome, and EpiBiome. In addition, several new startups have entered the field. Amongst the most active investors, Global Engage reports, are Seventure Partners, Flagship Pioneering and BioGaia. In fact there are some 120 companies investing in analyzing data relating to the human microbiome. To take one example, companies such as uBiome are developing genomic tests meant to identify and diagnose harmful microbes in the body.