2021 has been a wild year for the world, and the pharmaceutical industry as well. There have been significant developments in the past few months that have changed the state of the industry and have showed many advances that promise a lot of success for the future of pharmaceuticals.
The first and most publicized update is the current state of vaccines for COVID-19. The vaccines were developed in an unprecedentedly quick fashion and today are being distributed and used across the world. Around two dozen vaccines, including the ones made by Pfizer and BioNTech, Astra Zeneca, Moderna, and Sinopharm, are being used across the world.
52.3% of the world population has received at least one dose of a COVID-19 vaccine. 7.56 billion doses have been administered globally, and 29.92 million are now administered each day as of November 17, 2021. (1) Over two billion people, a growing number, are fully vaccinated at the time, and six billion doses have been administered by the fall of 2021, a little over a year since the pandemic started. Countries like Singapore, the United Arab Emirates, and Portugal have had significant success vaccinating a majority of their populations, while in other countries, only smaller parts of the population, 4.7% of people in low-income countries have received vaccines at least one dose due to access issues and other problems. (1,2)
Vaccine development, production, and approval have significantly accelerated. From a normal 2-4 years, some parts of the process were sped up to 6 months to a year or even less. The development of new vaccines is tied to advancements in the pharmaceutical industries and a show of the capabilities when the necessary funds and opportunities for research are created. (2)
Therefore, vaccines are a clear success of the pharmaceutical industry. As of now, many people are vaccinated and more are being vaccinated still. While issues of anti-vaccination ideas and voices and unequal access to the vaccine are significant, there is a lot of consideration from what has been achieved with the current solutions.
Gene Therapies for Rare Diseases
People with rare diseases often struggle to gain access to treatment and even find research that is focused on their condition. Fall of 2021 saw a new partnership between the National Institutes of Health, the FDA, 10 pharmaceutical companies, and five non-profits to accelerate the development of gene therapies for 25 to 30 million individuals in the United States who suffer from one of the 7000 rare diseases that have currently been recognized. FDA has received more than 900 applications to investigate gene therapy in clinical trials. (3, 4) Among all these, only two have gene therapies that were approved by the FDA as of June 2021. (5)
Specifically, the partnership is titled the Bespoke Gene Therapy Consortium or BGTC. The focus is on rare diseases and gene therapies because most of these conditions are caused by a single gene defect that could be corrected to help patients. The process is also expected to improve the overall understanding and development of gene therapy, as it could allow to create a standardized model that could make it faster and more efficient. Rare diseases tend to get less attention, as developing a cure for a condition that affects only a few patients offers less of a profit. However, an effective understanding of the gene and vector manufacturing and production processes and standardization could allow companies to work on specific therapies at a much lower cost. (5)
Advancements in Artificial Intelligence (AI)
Artificial Intelligence (AI) is becoming increasingly widely used in the pharmaceutical industry. Currently, the AI in the pharmaceutical market is growing at 39% per year and is expected to surpass $1 billion. The current trends involve improved clinical trial recruitment, lower drug development costs, optimized manufacturing, better diagnostics, and an overall shift towards personalized medicine. AI can help reduce costs and timelines, which allows more people to create therapies with lower demand and that are needed but are too expensive to develop traditionally. (6)
At the same time, as AI grows, there is a significant shortage in AI job skills, even though the demand is there. This is true for AI applications overall, but particularly in the field of pharmacology that has specific demands and adds additional skills that professionals need to have. In addition to this, there have been concerns about biased data, such as harmful or inaccurate treatment recommendations or bias in how the data from AI is employed. (6)
However, the COVID-19 pandemic has opened the way for new applications of AI and has been successfully applied in searching for solutions to COVID, such as the recognition of baricitinib (a janus kinase inhibitor) as a potential treatment for the disease in just a few days thanks to Benevolent AI. Current different pharmaceutical companies are partnering up with AI companies to use this technology for advancing drug development and other processes. (6)
Another example, an AI called EVE was used to assess disease-associated genes. (7) The results show that previously unknown gene variants can be reclassified as benign or associated with disease, which provides a lot more information for gene therapies and other interventions. (8)
Advances in Regards to Cancer
The last months have also seen some exciting advances in cancer research. One such finding by Duke University Medical Center and colleagues at the University of California (UC) was the discovery of a new solution to treat chronic pain associated with nerve injury and metastatic cancer through a “junkyard of cancer drugs” to identify a compound, called Kenpaullone (KP), which might be used to treat this pain, as it seems to be able to reset a genetic switch that is involved in the chronic condition. (9)
Another promising finding published in Nature Chemistry was the development of a molecular agent based on glutathione that can target lung and other cancer cells for detection and treatment. This is done in a photoacoustic imaging-based device that can detect elevated glutathione which is abundant in most cells and can be a good target for treatments such as chemotherapy. (10)
A significant finding by scientists at the University of California (UC) has been associated with the discovery of the mechanisms behind aneuploidy that promotes tumor development. Their data indicated that around 90% of solid tumors are associated with this problem, which leads to tumor progression and is also associated with poor prognoses. Aneuploidy is an aberration in the number of chromosomes that triggers a stress response in tumor cells. This finding can help assess tumor progression more efficiently and offer new options for evaluating the patient’s condition. (11)
So anyhow, 2021 was a year that, so far, has led to important advancements in the pharmaceutical industry and has several promising findings that bring the market closer to more successful and fulfilling management of different needs, in particular, unmet needs like rare disease and chronic pain.
2. Felter, C. (2021). A Guide to Global COVID-19 Vaccine Efforts. https://www.cfr.org/backgrounder/guide-global-covid-19-vaccine-efforts
The current acute shortage of syringes for administering COVID-19 vaccine in Africa and other emerging nations, is yet another indication of how disruptive the SAR-CoV-2 virus driven disease has been on the global supply chain.