my presentation on drug glucotrol xl for the online course all its development and commercialization.
Hello this is charlie samui and i’m glad to give my prison the lifecycle strategic plan presentation over here and i am a graduate of pharmacy i’ve completed my be firm recently and i don’t have any partners right now because i have seen the deadline that is extended from my meal so i have only three to four days to prepare it and and hence i didn’t have a time to
Consult others were to form groups and hence i’ve done it myself for full four weeks and coming to the presentation my drug claim is glucotrol that is lip aside extended-release tablet oral and other brand names are like al rehab daya preside libertine and lydia next coming to this let us know about this in brief this is an extended-release tablet and which is a
Controlled rate of delivery of glipizide into the lumen that is gastro intestinal lumen and this is independent of ph and also the gastrointestinal motility and as this is an extended-release tablet it is it like it’s actually depends upon the osmotic gradient between the bilayer and the fluid in the gi tract and how it acts is like it’s automatically male radiant
Remains almost constant and as it goes on as it is extended-release tablet as it goes so and as time goes on it gradually falls to zero then the the biologically inert compounds of this tablet which which are not functional and what they do is they are reformed like an insoluble she’ll and about the faces and they are eliminated from by the faces in the process
Of fists and coming to the presentation objectives the objectives of this presentation are the market and the preclinical the description and the early clinical development and the late clinical development next the regulatory strategy next comes the intellectual property strategy and the marketing strategy then the sales strategy and the managed markets and find
Out any remarks or if we want to give any conclusions then we can agree that coming to the market let’s see the medical unmet need of the glucotrol and as given by the international diabetes federation that is which is purely gives the detail or the database of the diabetes and this this gift database that is it’s the growing problem nowadays that is it is a very
Significant and many people many more number of people every day are dying because of this diameters which is a growing problem nowadays and which the only class of drugs which are referral referred as insulin sensitizers are used to root cause of that type 2 diabetes insulin resistance type 2 which is like non-insulin-dependent diabetes which is very dangerous
Nowadays because because of that many other complications are also occurring so we have to treat it as soon as possible a good drug should be discovered then for this improving of insulin sensitivity we have to discover more drugs such that this problem can be overcome ok those are there and here comes a graph which which know which gives us the database of the
Visitors of different diseases to the physicians and we can know that we can see the appendicitis kohli aunt eliza’s chest pain upper respiratory and coming to the diabetes mellitus it is like it’s number is like 800 to 900 800 to 900 patients visit every day due to the diabetes mellitus this is and see have more it is and coming to the market analysis globally
As the database says 36 26 million people may also be affected in the future and they are estimating it to be 552 million in 2030 and you just believe that 552 million is a very large number and we have to decrease it by at any cost there either now a situation is like that we have to decrease the number if not many people will die due to the diabetes mellitus
And an idf even estimates that 183 million people with diabetes are undiagnosed and coming to the elderly people went in in case of elderly people it is very very difficult for them to diagnose the diabetes it enhanced many are undiagnosed many are dying because they are undiagnosed by this disease and that is really a great problem nowadays and twenty five point
Eight million children and adults in the united states eight point three percent of the population have diabetes can you believe that seven million our undying in this oh then an additional 79 million people in us with our with pre-diabetes and it will be very very good a sign if these people can be treated before they improve before the diabetes is growing in
Them like they are suffering more and more from diabetes and i really hope that they would get a good medication and be treated as early as possible then coming to the market opportunity the u.s. cost of diabetes have been calculated as 132 billion in 2012 and this this is have taken front and earlier stages both the industry and public at a large sector then oral
Daya oral diabetes drugs generated more than eight point two billion u.s. dollars in sales in 2001 then new drugs to be added during the few years will yield both a broadening of therapeutic options as well as an overall expansion of the diabetes market okay then coming to an example like writing exit an id exenatide is a final stages of fda review for approval
And represents the leading edge of a group exploiting non antidiabetic mechanisms and model of delivery and a dpp-4 inhibitors along with ppl gamma or alpha gl agonist could offer an attractive advantage over glp-1 analogs because there are there olay orally administered and the most enough they are preferring oral administration because that is easy for anyone to
Take it and even medication girl even the doctors are prescribing orally because that is an easy medication for anyone any type of persons of any persons of any which contain them and the market opportunity is like many many trucks are coming out now and i think as researchers even are improving nowadays all over the world many drugs will be discovered and
Mechanisms will be inked mechanisms of them will be modified and the efficacy and safety would be improved such that good and safe drugs would come which treat diabetes completely not only diabetes all the nerve current problems current dc is this work could be cured then coming to the benchmarking analysis what is like benchmarking is the comparison of all the
Ones organization practices and performance to others like we would see how how we are and how others are and if we are not the reaching their level then how can we do that how can we improve out like it’s a quality improvement in implement tool okay like what what you are doing like you see what you are doing we are inventing like discovering a drug this this
Obvious mechanism and they are saying this but it should go unclear phase 1 clinical trial first preclinical phase 1 phase 2 and phase 3 then again regulatory should approve it and there are many process and we can’t say that our drug will be approved finally and payton will be given so we should ensure each and everything we’re properly such that we would not
Miss anything and our drug will be surely approved lexi what you are doing how we are doing it how others do it we just compare yours and others if you are if you if you think you are not up to the level then improve it just think how could how could we ensure that we will cross even come to their level just think and improve your yes then how well you are doing
It in the in reference to measures just compare then what and how to improve after you may compare it after your comparison and all the data is given up then you will know what to improve and how to improve so do according to that and this is the benchmark analysis tool and let’s come into the competitive landscape of this drug particularly type 2 diabetes is
A comprising of ninety percent of all diabetes cases in both united states and europe and it’s close two hundred percent in asia oh my god this is really really a worst case of this is okay in in particular the insulin resistance is closely linked to obesity also because all the e not only obesity all the diseases like heart problems and other bp blood pressure
And other and some other diseases will be automatically develop due to diabetes because this is the main cause of all the diseases and the resistance power will also be lower due to this and that’s why this should be treated and immediately checked if any symptoms are seen in the patients then the numerous pathologies at the loews atherosclerosis coronary heart
Disease kidney failure policy polycystic ovarian syndrome as i have said these all the disease the main main reason is the diabetes and someone enough calm as we are talking about the competitive landscape now in the market presently the oral therapies are more prominently occurring like the metformin it is the bike or night of class by garnett and it is the only
Marketed therapy that directly combats diabetes by reducing the production of glucose by the liver okay then coming to the combination therapy which is a standard one as we know the combinations of our continued from many years and then the enough emerging therapies like the new glock oh look i got like peptides like jeep glp-1 analogues because these agents could
Help fill several holes in current type 2 diabetes management this these are the emerging therapies nowadays such that the diabetes can be cured very much efficiently than previous one next coming to the burden of the disease that how much it is affecting both the population the patient and the economy of the government and the country all these can be discussed
In the version of the disease this diabetes right stunning medical costs as i’ve said that globally diabetes is estimated to have cost at least for 65 billion dollars in health care expenditures in 2001 and eleven percent of the total healthcare expenditures in errors only needles like in 20 they in between the age of 22 79 years the eleven percent of the total
Healthcare expenditures are going of the country are going with that the us national economic burden of clear diabetes and diabetes reached 218 billion dollars as of 2007 and this estimates includes 153 billion in high medical costs and what 65 billion in reduced productivity see how much burden it is causing to the country’s economy and the extended toll of diabetes
As i’ve said that is the it can include the blindness kidney failure amputations her disease and increased risk of various cancers dementia hearing loss osteoporosis not only these and many many other causes are also there only due to this this is dangerous one you
Transcribed from video
LIFE CYCLE STRATEGIC PLAN LCSP) PRESENTATION By Shamili Sammohi
