On September 7, Michael Decker came to discuss Richard Mohs and Nigel Greig’s paper surrounding the lengthy drug development and discovery process. It is shown that the process of finding a new drug and evolving it is arduous, complex, and very expensive. Decker discussed that being presently aware of these processes with eventually lead to measures being put in place that improve efficiency and inevitably increase the opportunity for success surrounding the discovery and development of any new drug. Mohs and Greig outlined six parts of this process and what each part entails. Beginning with “the process” itself, drug discovery originates with a biological target. Taking the time to test this target in ways outside of what is already known can take up to 12 years or longer. Before even reaching the FDA, there has to be basic research, preclinical development, and clinical trials, which take all that time and money. Since it takes so long to do the research into one target, the costs are consistently rising. Developing a new biological or molecular target can cost on average $2.6 billion. The research is this expensive because there are a lot of mistakes made and trials and error which add up. Once reaching the Food and Drug Administration, there are more trials and tests that need to be done to even reach final review.
For research that needs a shorter timetable, there have steadily been new laws put in place that could alleviate a lot of the empty time taken for the drug approval process. More specifically these laws have been categorized as “the breakthrough approval process” which only take research that qualifies as being outside the “standard” measures of research needs like a change in the size of a tumor or blood test over a trial period. In 2015, the legislation titled “the 21st Century Cures Act” was introduced. This is “a wide-reaching bill aimed at improving medical innovation and reforming the F.D.A.’s approval process for drugs and medical devices” (Margot Sanger-Katz NYT). Having laws like this implemented, make it so that the pathways to combatting and curing life-threatening diseases can be made a priority in order to lessen the length to discovery and saving lives. The clinical trials wouldn’t be rushed to a point that things will be missed, but as Mohs and Greig have stated, with awareness comes efficiency for what is trying to be accomplished. Researchers will be able to garner more precise diagnosis of the molecules that are intended to provide information that will make biological history. Determining how intellectual property and subsequent research is regulated gives rise to a better ability for researchers and the FDA to get medicines to those that need it urgently.
For research that needs a shorter timetable, there have steadily been new laws put in place that could alleviate a lot of the empty time taken for the drug approval process. More specifically these laws have been categorized as “the breakthrough approval process” which only take research that qualifies as being outside the “standard” measures of research needs like a change in the size of a tumor or blood test over a trial period. In 2015, the legislation titled “the 21st Century Cures Act” was introduced. This is “a wide-reaching bill aimed at improving medical innovation and reforming the F.D.A.’s approval process for drugs and medical devices” (Margot Sanger-Katz NYT). Having laws like this implemented, make it so that the pathways to combatting and curing life-threatening diseases can be made a priority in order to lessen the length to discovery and saving lives. The clinical trials wouldn’t be rushed to a point that things will be missed, but as Mohs and Greig have stated, with awareness comes efficiency for what is trying to be accomplished. Researchers will be able to garner more precise diagnosis of the molecules that are intended to provide information that will make biological history. Determining how intellectual property and subsequent research is regulated gives rise to a better ability for researchers and the FDA to get medicines to those that need it urgently.
Works Cited:
Sanger-Katz, M. (2015, May 1). Speedy Drug Approvals Have Become the Rule, Not the Exception . Retrieved from https://www.nytimes.com/2015/05/02/upshot/speedy-drug-approvals-have-become-the-rule-not-the-exception.html?searchResultPosition=3.
Mohs, R. C., & Greig, N. H. (2017). Drug discovery and development: Role of basic biological research. Alzheimer’s & Dementia: Translational Research & Clinical Interventions
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