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18 Pharmaceutical Technology ® The Real Message Behind Commercial mRNA Products April eBook 2023 PharmTech.com M.RODE-FOTO - STOCK.ADOBE.COM R NA-based therapeutics have been in de- velopment for decades. The RNA drug development trend was on the rise in ear- ly 2000s; however, its popularity went down due to unique challenges. The COVID-19 pan- demic helped to bring a spotlight on RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufac- turing, logistics and storage. This is the silver lining of the pandemic, where necessity and emergency need for vaccine and therapy highlighted potential solutions. Hopefully, it also opens the door for novel RNA therapeutics. Who: winners and losers Historically, RNA research began from discovery of nucleic acids by Watson and Crick and later studies on messenger RNA (mRNA) molecule in the 1960s. However, it took decades for RNA biolog y to "ex- plode" in the 1990s and early 2000s leading to dis- covery of variety of novel RNA molecules for therapy: antisense oligonucleotides, small interfering RNAs, aptamers, and more (1). RNA drug development, how- ever, proved to be a challenging pathway for commer- cialization. Currently, only a dozen of RNA-based medicine are approved and available in the market. The first RNA drug on the market was fomivirsen (Vitravene). It is an antisense antiviral that was used for treatment of cytomegalovirus retinitis (CMV) in immunocompromised patients. It was approved by FDA in 1998; however, by 2006 Novartis withdrew it from the European Union and the United States mar- kets due to lower cases of CMV and consequently no further need for such medication (2). It took another decade for another antisense drug, Kynamro, to be approved in 2013. Overall, in addition to antisense platform, small interfering RNAs and mRNA drugs were approved in the past five to seven years (3). This is not surprising because RNA research is known to be challenging and costly. COVID-19's Impact on RNA Drug Development Marina Necdina is a business development manager, former pharma analyst, and research scientist. The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.