Covid 19 Drug Development

 

The research process for creating therapeutic prescription medications that will lessen the severity of coronavirus sickness in 2019 is known as COVID-19 drug development (COVID-19). As of April 2021, 419 potential COVID-19 drugs were in clinical trials, with hundreds of pharmaceutical companies, biotechnology companies, academic research centers, and healthcare organizations developing therapeutic candidates for COVID-19 disease at various stages of preclinical or clinical research (506 total candidates).

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The World Health Organization (WHO), European Medicines Agency (EMA), US Food and Drug Administration (FDA), Chinese government and drug manufacturers, as well as academic and commercial researchers, were working together as early as March 2020 to hasten the development of vaccines, antiviral medications, and post-infection therapies. The WHO’s International Clinical Trials Registry Platform listed 536 clinical investigations to create post-infection medicines for COVID-19 infections, as well as other established antiviral drugs being repurposed for use in treating other illnesses.

The WHO launched the “SOLIDARITY Trial” in March 2020, recruiting hundreds of COVID-19 infected individuals in order to evaluate the effects of four currently available antiviral medicines that show the greatest promise for efficacy. To monitor the development of registered clinical studies for COVID-19 vaccination and therapeutic medication candidates, a dynamic, systematic review was developed in April 2020.

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Drug development is a multi-step process that normally takes more than five years to complete in order to ensure the new compound’s safety and effectiveness. Procedures to hasten clinical testing have received approval from a number of national regulatory organisations, including the FDA and EMA. Numerous putative post-infection treatments were in their final phase of human testing by June 2021, known as Phase III-IV clinical studies. A recent Jefferies & Co estimate suggests that the yearly sales of a practical, efficient COVID-19 treatment could exceed $10 billion.

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Background

Diagram of the drug discovery cycle

Once a lead molecule has been found through the process of drug discovery, drug development is the process of bringing a new anti-infective vaccination or therapeutic medicine to market. It entails animal and microbe laboratory studies, requesting regulatory status — for example, through the FDA — for an experimental new medicine to start human clinical trials, and it could also include the step of securing regulatory approval through a new drug application to commercialise the drug. It typically takes more than ten years to produce a vaccine or medication from concept to approval, including preclinical research in the lab, clinical trial development, and Phase I to III trials.

Before a candidate compound is advanced for safety and efficacy evaluation in humans, “preclinical research” refers to laboratory studies in vitro and in vivo that indicate an early stage for the development of a preventative vaccine, antiviral, or other post-infection therapies, such as experiments to determine effective doses and toxicity in animals. According to multiple estimates in early 2020, it will likely take 1–2 years for COVID-19 medicines to complete the preclinical stage of drug development and then be tested for safety and efficacy in an adequate number of persons infected with COVID-19 (hundreds to thousands in different countries). Despite these efforts, only 19 percent of drug candidates for the treatment of infectious diseases are successful in receiving regulatory approval at some point in the drug development process.

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Following Phase I success, Phase II trials evaluate therapeutic efficacy against the COVID-19 disease at ascending dose levels (efficacy based on biomarkers), while carefully evaluating any potential side effects of the candidate therapy (or combined therapies), typically in hundreds of patients. Phase I trials test primarily for safety and preliminary dosing in a few dozen healthy subjects. Randomized, placebo-controlled, blinded, multi-site trials are frequently used in Phase II investigations of potential COVID-19 medicines to establish more accurate, efficient doses and track any negative effects.

For all diseases, the success rate for Phase II trials to move on to Phase III is around 31%, and for infectious diseases particularly, it is around 43%. An average-length Phase II trial costs US$57 million and can last from several months to two years (the longer the experiment, the more expensive it is) (2013 dollars, including preclinical and Phase I costs). A prospective drug’s performance in a Phase II study does not necessarily indicate that it will be effective in Phase III research.

As with the international Solidarity and Discovery trials, phase III COVID-19 trials involve hundreds to thousands of hospitalised participants and examine the efficacy of the medication to lessen the disease’s effects while monitoring for side effects at the recommended dose.

Important Information:

Conference Name: 11th Global Pharma Conference and Expo
Short Name: PPNUCG2022
Dates: December 21–22, 2022
Venue: Dubai, UAE
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