2020 Was a Defining Year ??

20/20 represents the visual clarity benchmark. In optometry, it just means that you can clearly read the same block letters from a distance of 20 ft that a person with normal (standard) vision can read at 20 ft. The year 2020 likewise has provided us with an excellent 20/20 vision of how the next decade is shaping-up, a defining year in many ways. Listed are some great 2020 features that we will always remember:

• The Purple Book: Purple Book database containing information about all FDA-licensed biological products was expanded and digitalized on a modern platform in 2020. Just like the Orange Book, the stakeholder transparency efforts will potentially lead to lowering costs for lifesaving biologics in the longer term.
• CRISPR/Cas9: Emmanuelle Charpentier and Jennifer A. Doudna received the 2020 Nobel Price in Chemistry for their discovery of CRISPR/Cas9 genetic scissors. The tool can change the DNA of animals, plants, and microorganisms with extremely high precision and has a revolutionary long term impact on therapies.
• Novel Drugs: FDA CDER approved 53 new drugs in 2020. The 2019 new drug approval numbers were only 48!

2020 Novel Drug Approvals = 53

2019 Novel Drug Approvals = 48

2018 Novel Drug Approvals = 59

2017 Novel Drug Approvals = 46

2016 Novel Drug Approvals = 22

2015 Novel Drug Approvals = 45

• mRNA: WHO African Region was declared poliovirus-free in 2020; the cases of wild poliovirus have been reduced by 99.9%. Traditional vaccines use inactivated or weakened virus protein to develop immunity, however, it takes >4 years to develop. The new idea is to easily make mRNA that creates the critical piece of a virus protein that bolts up the immune cells and generates immunity. The new vaccines can be developed in less than a year! mRNA technology may also allow for one vaccine for multiple diseases and for targeting specific cancer cells. 2020 is a defining year for mRNA technology (COVID vaccines).
• Manufacturing Technology: The bio-pharmaceutical manufacturing sector has finally started delegating tasks to technology for improving compliance and operations efficiency. Advanced manufacturing technologies such as continuous manufacturing and 3D printing are becoming a new trend to increase manufacturing self-sufficiency, accelerating product development, reducing cycle times, improving quality, and solving drug shortages. 2020 saw the creation of focused funding opportunities for such futureproof technology innovations.

Virtual meets and audits are our new norms; let's stay home and share a virtual New Year’s eve with our nearest and dearest. Happy New Year