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<\/p>\n\n\n\nOne of the most important industries in the world that our lives have revolved around is healthcare. Without drugs and medicine, it is not possible to cure ailments no matter how well the doctors diagnose the patient. From ancient times a physician used herbs and bandages to cure injuries and diseases, which is all medicine in one form or the other.<\/p>\n\n\n\n
Today, the pharmaceutical industry is very big and worth almost 1. 2 trillion dollars worldwide. Giants like Pfizer, Roche, Novartis are alone worth almost 50 billion each. Though this industry has a lot of income per drug created, the expenditure in R and D is very large. Each drug requires almost 4 billion dollars and sometimes can exceed 10 billion dollars. In order to profit from each discovery, the company needs to buy expensive patents and need to come up with innovative methods of selling the drug in order to make up for the losses. The drug patent expires in 20 years after which it becomes public domain and other companies can \u201ccopy\u201d it without exactly copying it. For example, an anti-allergy medicine called Montek lc has a number of competitors like monovalent lc and Montemac lc, even the naming is similar!<\/p>\n\n\n\n
The way the process starts is by finding the underlying cause of a certain disease. Find the targeted organ and the method of attack. The bacteria\/virus bind with certain proteins to block or produce important chemicals that would cause inflammation, allergy, fever, etc. The drug is a compound that is found after virtually screening thousands of compounds in order to find which one binds to the protein better than the bacteria\/virus. There are also different methods for this. One would be competitive binding, the other would be attaching to a different site close by and change the shape of the binding site of the bacteria\/virus so as to prevent it from being able to recognise the binding site. The binding sites are found using software like Schrodinger or Autodock which give the hypothetical free energy that would be released if the substrate bound to the protein. Finding the most negative free energy would give the most suitable binding site out of the many available. This process is used to screen thousands of compounds and finally reduced a hand few to conduct further research in the labs. The further tests would be based on side effects, bi-reactions, etc.<\/p>\n\n\n\n
This is just the R and D where all research is done using computational methods in order to find out the mechanism of interaction. Next is the synthesizing part. This is very complex as it needs to take into account how long the drug would take to bind with the target area as many factors like how the drug reacts with different environmental conditions in the body all come into consideration. How the drug diffuses in and out of membranes, any bi-reactions that may take place, and any other similar areas it may target instead of the one required. Pharmacokinetics places huge importance. Another major importance is how long the outer covering of the drug will take to dissolve without harm due to the HCl or many other acids and enzymes present in the stomach and intestines before reaching the target area. All this needs to be taken into account while manufacturing this.<\/p>\n\n\n\n
After painstaking efforts and almost 5-6 years of continuous research, the drug can be started on trial. For this permission from the FDA(Food and drug administration) is necessary. First animals with similar genetic characteristics are chosen. Once these trials are cleared and permission to start human trials is obtained, three main phases of human trials begin. Phase 1 is a small group of patients about 10-15 healthy individuals to check for side effects. Phase 2 checks for efficiency of the drug in about 150-200 patients. Many drugs fail here as they wouldn’t be as effective as they expected. If the drug clears Phase 2 then it goes to Phase 3 which is around 1000 people. It is to check for its efficacy in a given population and other rare side effects. A few drugs try something called a Phase 4 trial which is trying the same drug on different populations for different side effects based on different gene types. For example, a drug developed in Africa may not work in the population of the USA as they are different environments and people can be allergic to different things.<\/p>\n\n\n\n
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Finally, once these phases are cleared, the FDA approves the drug to be moved into the market. This is where the commercialization part comes into the picture. As I already stated, a lot of money is spent on just the preparation of each drug. In order to make up for all the expenditures, an expensive patent needs to be filed citing intellectual property rights. Also whoever files the patent first gets the rights over the monopoly of the drug, not who first discovered it. If a company achieves its results much later than another company but files for the patent first, then the rights would go to the company that discovered it late. So a lot of strategy and investing goes into when patents are filed and when they expire. What follows is good marketing, finance, and investment in order to bring out the best in a given market. Where to set up the market also matters. The drug market in France isn’t as profitable to these companies as they have health laws that are based on free healthcare. Similarly, certain places have a booming market where everything is sold. Everything depends on where and when the drug becomes available. Pricing the drug also has laws that prevent these companies from overpricing drugs that are in demand.
Thus the journey of how a pill that you pop in your mouth and cures you over a small period of time like weeks has 10 years of history behind it.<\/p>\n\n\n\n
-Article by Atideepth Bharadwaj, 3rd year, Department of Chemical Engineering<\/em><\/p>\n","protected":false},"excerpt":{"rendered":" One of the most important industries in the world that our lives have revolved around is healthcare. Without drugs and medicine, it is not possible to cure ailments no matter how well the doctors diagnose the patient. From ancient times a physician used herbs and bandages to cure injuries and diseases, which is all medicine…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[27],"tags":[314,313,315],"class_list":["post-948","post","type-post","status-publish","format-standard","hentry","category-yantrika","tag-drug-commercialization","tag-drug-developoment","tag-pharmaceutical-development"],"_links":{"self":[{"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/posts\/948","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/comments?post=948"}],"version-history":[{"count":1,"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/posts\/948\/revisions"}],"predecessor-version":[{"id":949,"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/posts\/948\/revisions\/949"}],"wp:attachment":[{"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/media?parent=948"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/categories?post=948"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nitk.acm.org\/blog\/wp-json\/wp\/v2\/tags?post=948"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}