ASSISTIVE MEDICAL TECHNOLOGIES

I like to view the year 2020 as a “buffer” in an exothermic chemical reaction: a buffer, that is, that has allowed us to accelerate processes, protocols, and technologies as never before in the history of mankind.

Several diagnostic technologies emerged from multi-sector partnerships formed to develop prototypes, to validate them, to comply with critical records, and to have them released, in less than three months, into the global market, with standards of quality, accessibility, scalability, and accuracy. A clear example is the recent study conducted by the University of Vermont and Cedars-Sinai ―and published in the Journal of Medical Internet Research―, which demonstrates the high accuracy of the AI-COVID™ software for predicting COVID-19 by using routine blood samples. This will help hospitals reduce the number of patients that need to be referred to scarce PCR tests.

The Fast Track approval of the Pfizer and Moderna vaccines is an unprecedented development in the face of the new century’s first major public health emergency. The Fast Track process is designed to facilitate the development and accelerate the review of new drugs and vaccines used to treat serious conditions that have the potential to address an unmet medical need. Just over a decade ago, in my undergraduate thesis, I described the impact of gene therapy as an alternative to the treatment of infectious diseases that were not amenable to standard clinical treatments. And 2020 turned out to be the year when mRNA-based vaccines, based on preliminary data from Phase I and II studies, were approved by the U.S. Food and Drug Administration as well as by the European Medicines Agency for use in humans bringing, Phase III directly to the world’s population. I am confident that, at the international level, we will have the infrastructure and pharmacovigilance necessary to document this unprecedented event.

The World Economic Forum has established the era of digitalization as one of the links in the distribution, service, and transportation chain from the standpoint of globalization and competitiveness. I would add that, in the short term, we can expect new technologies in the distribution and labeling of medicines, such as radio-frequency identification (RFID) tags, a technology I became aware of a little over a decade ago, but which has gained ground in the health sector as a standardized method of tracking medicines, devices, and consumables. One of these is DoseID™, which aims to ensure the interoperability, quality, and performance of RFID-tagged pharmaceutical products all along the pharmaceutical supply chain.

We also face new challenges in the distribution and storage chain. One example is the storage conditions of Pfizer vaccines: from -60°C to -80°C for up to fifteen days in the thermal container, or from 2°C to 8°C for up to five days; while the Moderna vaccine can be frozen from -25°C to 15°C for up to six months and refrigerated from 2°C to 8°C for up to thirty days, with a second dose twenty days later, according to the hospital guidelines of the Massachusetts COVID Vaccine Program. The logistics and preparatory steps in hospitals for the administration of the vaccines will be a task for the next few months.

The development of advanced therapy medicinal products (ATMPs) is a rapidly growing field in modern medicine. Cell and gene therapies are a hot topic in the pharmaceutical and manufacturing industry, where innovative and flexible solutions are required. These can be customized to perform both the upstream and downstream processes of cell and gene therapy, through containment technologies such as “ATMP isolators,” which I will discuss in future articles.

And toward the end of this most extraordinary year ―a year marked by COVID-19 and an economic crisis that has caused havoc in the economies of OECD countries―, we have seen millions of professionals contributing their experience, knowledge, talents, and enthusiasm to take advantage of this long-term opportunity and working to lay the foundations and infrastructure to “achieve wonderful things together,” as expressed in a message from Juliemarie Vander Burg, Senior Director, Global Health Policy, of the Partnership for Quality Medical Donations (PQMD). For my part, the buffer that has enhanced my taste for technology and science!

Liliana Mora

is the CEO of Síoltalife and a pharmaceutical chemist with more than fifteen years’ experience as a business developer in the life sciences market. Passionate about continuing education, she has created forums for bringing together international talent, know-how, and experience. She currently lives in Belgium, where she remains up-to-date with to the innovation and technology hubs in her sector.