Before It Hits the Market

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believe at some point in your life you must have taken some kind of medication but at the time when you talked the feeling to your mouth have you ever wondered how safe it is how effective it is and what is the kind of development that comes that that comes before it hits the market so this is what i’m going to talk about this evening we’re going to talk about the clinical research development stages of the medicine we’re also going to talk about why some medications are so expensive and we’re also going to talk about copycats so maybe at this point you don’t really have an idea what copycat is but we’ll get that shortly so i’m going to start off with talking about the stages of clinical research um it basically is just five stages where you start off with testing the drop in the animal so that’s the laboratory uh laboratory setting and then it goes on to phase one the plasma human that’s the time when you try out the drug on the human for the first time and then we on phase two phase two phase for so in the next few slides i’m going to talk about i’m going i’m going to talk in detail the different phases so for preclinical face um this is the time when we tested out all the animals for the first time and usually the animal that we use is red mice and also the guinea pig that’s very well known that the term that we usually use so i want to ask you a question why is it that most of the time we use rats mice and guinea pigs anybody

yes they’re very very quickly but they break very quick oh yeah that’s one of the reasons the genetic makeup is very similar yes that’s right and see it’s meant to be unprecedented

but for some amazing reason my answer pointed out the genetic makeup the anatomy and also the physiology our behavioral traits are very close to rest that’s why they they are a good animal that we can use for testing and like what um

because they’re small they’re easy to maintain so that’s why it’s a good candidate for us to use mechanical research and if you think that the red is the only animal that we use and you’re wrong because there are many other animals that we use as well and uh in the interest of time i can only take two questions any animal logos over here no anymore

Before it hits the market
Clinical Trials

you like cats oh yeah okay i don’t think you will like what you’re going to hear spinal cords damaged and are forced to run on treadmills to show how the nerve activity might affect being movement another animal dog you have dogs something yes okay same thing i don’t think you’re the dogs have their laughing lungs or kidneys deliberately damaged or removed to study how experimental substances might affect human organ function yeah so the animal lovers if you’re interested about the other animals you can always come to me and i’ll share this list with you you can read my very neat handwriting so these are the some of the experiments that patients but not patients but the animals have put through and in case you’re wondering there’s an act there’s actually some regulations that put in place um for example the animal welfare act that’s put in place to protect these animals but sadly um the governance is not that straight so there are a lot more animals that not posted here that are being used for clinical setting which is not reported and not recorded anywhere and then once we have cleared the animal stage we will move on to phase one where we start to administer in patients in humans and the main objective is safety testing so it’s really trying to establish which is the safe dose to administer education so this is how it works for example i will recruit these four people into one group and then i’ll start them off at 10 milligrams whatever the medication will be and then i’ll observe them for a month if there’s no serious adverse event i’ll move on to a row another four over here and i’ll start you off at 15 milligrams and i’ll observe you and see if there’s any serious or severe side effects so this is how it works so in phase 1 we will recruit in badges and then we will step up the dose until we get a dose that is showing some a little bit severe adverse event but at the same time effective enough to to cause an effect in your body so that’s for phase one and different trials will recruit different kind of patients so if i have a very mild condition like if the drug is just to treat a pain or it’s just a blood pressure it’s very malt i can always recruit like someone who’s healthy but if i’m talking about a cancer drug then i have to definitely recruit someone who already has that condition so that’s a difference and then once we clear phase one we will move on to phase two and phase two the objective is really to confirm efficacy to really show that this drug is effective for the patients and the sample size is usually a few hundreds and it can last up to a few months to several years and then once we’ve proved advocacy we’ll move on to phase three and the main objective in phase three is really to compare it to a standard of care anybody knows that healthcare so when we say standoff care it means the recognized drug that is used to treat a particular condition so we call it the standoff here so for example you have a heart disease you go to a doctor the doctor will follow this standard of care for example abc this drug is supposed to treat your condition and it will administer that to you so we usually compare it with standard health care and do you know the reason why it must perform equally well yes or better yeah yes correct so it doesn’t make sense for anybody to develop something that is not as good as or even better than what is really in the market i guess it’s a lot cheaper a lot uh yeah we’ll get to that even if it’s cheaper maybe the doctor may not want to use because it’s not infected yeah so um usually the sample size is hundreds to a thousands and besides looking at efficacy we will be also looking at something like convenience of use we will be comparing this with here so our example will be cancer drugs you know sometimes we do infusion so infusion can take up to a few hours the patients can be in the hospital from morning to night but if you can administer it in a pill then that saves the patient a lot of time and effort yeah so this are the things that we compare and then this child can last up to several years

and then this is the phase where you collect all the data and then you start to submit for marketing so that’s when you have all this data and you prove that it’s effective it’s safe enough and then the companies will start to put in applications for it to market so this is the phase where the marketing takes place so if you think that this is all then there’s still a phase four so what happens in phase four is um this is a time when you really cast net and make this drug available to the whole population to the to the world and it’s during this time when you really get to meet real life circumstances and i’ll explain why from phase one to phase three usually the patients that we recruit we’re very selective we don’t want people who are too weak we don’t want people who have underlying conditions you know why we’ll fix the results yes it will affect the safety profile if i recruit someone who is too weak someone already has a underlying condition they may show some very weird side effects that may jeopardize the whole safety profile of the drug and when the authorities reveal the drug efficiency they are also reviewing the safety profile so if they see anything that’s too off they will not approve this drug so most of the time very very selective and what the kind of patients that we’re recruiting but so that is the purpose of phase four it is really just to extend the drug to a larger population and see how it works in real life situations and that’s when along the way you may see some companies updating their labels you know when you buy drugs that’s like a label so you will see that they update some of the side effects information or some information along the way so they add on another sticker yeah it can be the label the sticker yeah yeah so it can be awful okay so that’s pretty much the whole um five stages of clinical research

and next i want to talk about who grants approval so i’m sure everybody has heard of the fda the food administration food and drug administration so this is the authority in u.s that approves drugs and every country has an fda alike organization so in singapore we call it the hsa so if you want a drug to be approved you need to get approval from hsa and it doesn’t mean that if it’s approved in the u.s it can be used that means that in singapore it still has to be um approved by hsa but if you do have an fda approval then you’re likely going to get hsa approval more easily and um in china we call it the national medical products administration which is an example of the different regulatories in the different countries

and why are some drugs more expensive

if you ask the pharmaceutical companies actually nobody is controlling how prices are sent the pharmaceutical companies they come up with their price so if you ask them why it is so expensive they will give you reasons like this because they spend millions and billions into the development of the drug so they think that rightfully they should charge higher and the other reason is if you look at the company as a whole they’re not only doing one trial some companies can be doing diabetic drugs they can be doing cardio drugs they can be doing cancer drugs so at the same time they’re running many trials at the same time but not all will succeed so they need coverage for those trials that have failed where do they get coverage from childs that have succeeded so they charge home for those drugs and they also need funds for future research that’s why that’s the reason why you you see some drugs are really more expensive and i can give you an example silvardis uh one of the pharmaceutical companies zolgensma it’s used to treat spinal vascular trophy um this condition is when your nerve cells it’s a it’s it’s genetic it’s inherited from you know in the family line so if you get it your nerve cell will start to generate degenerate and it will cause your muscles to degenerate too and novanese has come up with this drug zolgensmus a single dose is 2.2 million and i want to point out that it doesn’t cure you you spend 2.2 million it still doesn’t cure you it is meant to just slow down your degeneration and you see the same thing for some cancer drugs as well they don’t really cure you you spend a lot of money but they don’t kill you they’re just buying time they’re extending your lifespan yeah so

just an interesting point

and then moving on to copycats uh does everybody know what is generics what a brand have you heard like when nc say oh i can charge it like cheaper when is the time that you can charge it cheaper when you don’t really go through that phase one phase two phase three when you don’t really spend that much um in that development process then you can charge right so the difference between brands and generics is brands went through that whole face one phase two phase street to make to get it marketed they really generated all that data generics on the other hand is different so generic only use that active ingredient that you find in brands and then they use that to make them drown and then they sell it so that’s the difference between grants and generics brands went through the whole process for generics really just like tap on yeah it just tapped on what the research was that’s done by friends and then they did a little bit of research and then it went on to market so that’s the difference between the two so there’s a reason why um generics are cheaper than brands and i want to ask a question do you think generics are as effective as brands

why because it’s a is a requirement set by authorities if you want to market anything you have to go to authorities and this is the requirement that they send you have to show the same safety profile you have to say you have to show the same effectiveness then you will get the approval so the conclusion is um buy generics it’s cheap brand it’s one

and i will give you an example to just put everything into context i’m sure everybody has taken this drug before when you have headaches

oh there’s no any other name evil

okay so to put it into context the active ingredient will be personal okay and oops


so the active ingredient is paracetamol and this is from gsk and then if you look on your right you can see that this is manufactured by herbes and it’s directly called personal the active ingredient you know um so i’m sure this is much cheaper than this yeah but effective wise they’re equally effective because they’re all using parasitic so next time when you look at drugs take note of that active ingredient then you will kind of know like what you’re really eating the brand name is just a name it’s not name of the meditation that you’re taking so there are some of the names for panadolias really the same thing you they can call it tylenol cal pole depending on what country which country is being marketed it has different names but they’re really just personal 500 milligrams

okay and i just want to move on to talk about some facts about the clinical research setting so informed consent is something that’s very important if you ever get a chance to get on any clinical trials you’ll be asked to sign a consent why because there are many bad experiences from a long time ago so even though everybody knows the nazis right so back in the nazis um time those prisoners were asked to do very funny experiments so over here you can see a lady with um you know cuts on her legs she got her muscles removed because they want to test out how what is the effect of them so there are many many this is just one of the examples but there are many other real experiments that have been conducted on this craziness so after that people started to pay more attention and you have to sign the income content so what is in the information is just to tell you what you’re supposed to expect um they’ll tell you what are the risks that you will go through if you apply the study just to save that of the patients yeah so if you join a child but you don’t sign a full consent uh that is not correct so you should ask me some questions

and then phase two if you recall we said that phase two is efficacy right we’re just trying to test if it’s really effective but even if you get if you get even if you get through phase two it doesn’t mean that you’ll get through phase three so thirty percent of the drugs entering phase two studies fail to progress and then the 58 percent of the drugs go on to fill the phase two so if you look at the whole percentage more than half of all the trials fail so that’s the reason why some of your medications are so expensive the pharmaceutical companies are putting part of this cost into those drugs that have succeeded

and uh i think everybody is sick of this now i’m sure so covet 19. um so if you look at the whole clinton research timeline that i presented just now phase one was a couple of years thanks to a couple of years phased through a couple of years so all together on average is about seven to fifteen years before you can market that joint but covet 19 this vaccine drug has made history in two years of clinical research it got marketed so whether it’s safe or not oh actually all of us are beautiful we don’t know if there are underlying side effects until you know many years later yeah but um i’m just saying it doesn’t mean that anything will happen and if you think that we have um fisa modena estrazenica if you think that that’s all that is going to be on the market then you’re wrong at this point there are 8425 trials ongoing for covet 19. so these include um it’s not just vaccine trials it can be for patients who contract or prove it but in a very severe condition they need to test what drug can treat them so it includes this kind of scenarios as

well um yeah so that’s all for my presentation and i hope you know more about the pharmaceutical industry and the processes behind how a drug comes to the market and it’s very important for us to stay healthy so that you don’t have to spend that much money thank you

For Anand’s Evaluation on this Speech, click here.

Check out images from our meeting here.

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