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the core functions of a pharmaceutical company are to identify and develop new medicines manufacture them safely and bring them to the healthcare market that sounds simple enough when you're saying it in one quick sentence but the complexities of bringing a pharmaceutical product to the market are enormous and the knowledge and the upfront financial investment that are needed are huge there needs to be expertise in drug discovery molecular modelling clinical research drug manufacturing regulatory affairs marketing and compliance and patents to name a few professionals working in each of these areas bring their expertise together to support the pharmaceutical industry in being able to bring these new medicines to market it's important for anyone who's considering a career in pharma to think about how they would like to serve this process and where their skills can best help so today i'd like to focus on the drug development process and its associated challenges for anyone who's considering a career in pharma [Music] hi i'm vicki author of the biomed badass blog and host of the youtube channel where we discuss all things career related for stem professionals working in academia and beyond today i'm going to focus on the drug discovery and drug development process and highlight some of the major challenges involved for farm companies i think it's important for anybody who's considering a career in pharma to think about how new medicines are brought to market and how your career of choice within that industry would fit into this process so let's get started [Music] it typically takes the pharma industry 12 to 14 years to bring a new medicine to market with the exception of the covered vaccines that were brought to market within nine months which is an astonishing achievement but an anomaly given the desperate need that the world found itself in to find a solution it's far more normal it will take 12 to 14 years to launch a new product and we'll look at why this is such a long process in this video if we think about standard drug compounds small molecules that we use to treat disease traditionally it would take around 10 000 compounds to be tested to develop one new drug starting with 10 000 molecules of the candidate selection process from there you would find lead compounds through high throughput screens of compound libraries to see how many molecules might interact with a target or a known molecular basis for disease and how this interaction could prevent the disease these leads are then tested alongside structurally related compounds in preclinical models and compounds can be further modified using computer-aided molecular modelling to refine and enhance the compound target interaction these types of tests identify compounds with the desired effect but also ones that are likely to be well tolerated and won't cause unacceptable side effects and aside from efficacy and safety considerations about how the compound is absorbed or how long it stays in the body after dosing also need to be considered once lead compounds have been selected they can be tested as drug candidates before candidates can be tested in man they have to be cleared in a number of pre-clinical hurdles that will assess the safety tolerability and efficacy of the candidates probably less than a thousand at this point and most of these tests will be performed in cell culture but also some in vivo testing for the most promising candidates to assess side effects animal tests within the pharma industry however are constantly being revised and removed from the drug development process as much as possible which is a good thing but drug candidates have to pass these in vivo safety tests before they can be cleared to be tested in man [Music] then starts the clinical trial process once you have a series of drug candidates that have passed the pre-clinical tests you'll perhaps only have a handful of candidates that would make it to the safety testing in man maybe less which is the first phase of the clinical trial process from an ethical standpoint scientists have to show that the drug does no harm in patients ideally it will show benefit the first important thing to do is to show that it does no harm so the first phase one trials will establish safety in up to 100 participants and side effects will be monitored along with the pharmacokinetic parameters of the drug phase 2 trials establish the efficacy of a drug candidate in up to 500 patients depending on the therapy area it's basically a proof of concept study to determine the effectiveness in a smaller cohort of patients optimal dosing roots of administration and dosing schedules can also be established in phase 2 trials phase 3 trials are designed to establish clinical benefit these can be up to five thousand patients for very large phase three studies where the clinical benefit of a drug candidate is tested against the current standard of care or placebo patients in these studies will be randomized across the study arms and the trials are often double-blinded meaning that both patients and the treating physicians won't know whether they're receiving or administering the control of the new drug itself this is termed a randomized control trial and it's the gold standard to show regulators that a drug works results from clinical trials are written up and presented at congresses and in medical journals and also presented to internal employees whilst phase three studies are ongoing interim analysis are monitored and preparations are made for the manufacturing the new product on a commercial scale product launch preparations are also made by commercial and medical teams drug manufacturing is extremely stringent and facilities need to comply with the highest standards in terms of quality hygiene and precision and this takes time to establish and confirm medicines cannot be sold without approval and rightly so we're talking about patient safety the regulatory process is extensive producing an enormous amount of documentation for registering one drug which can take months or sometimes years to prepare if results from the randomized control trial are positive and regulators are convinced that the drug candidate works and is safe they'll award a license and the drug can be sold in the relevant country the assessed patient population the drug is sold with a package insert containing a label which states who can use this medicine and for what all the most important existing knowledge generated during the drug development process is summarized here and supplied with the medicine including any known side effects and the pivotal trials that were completed during the drug development process now phase four studies can begin and these include post-marketing studies and surveillance to ensure close monitoring of the medicine once it's been released any adverse events are recorded in central registries and small-scale trials are designed to assess how medicines are performing in the real world this information is fed back to the regulatory authorities and the package insert is updated ingly [Music] drug development is a complex process and it requires a lot of know-how and upfront investment both in terms of time and money 12 to 14 years as an average for a traditional drug molecule for biological molecules large complex molecules such as antibodies or proteins for example they're produced in different ways for example an antibody is often prepared by inducing a host with a target and then the antibodies are isolated and tested for how effective they are in targeting so they're more complicated again relative to traditional drug molecules in terms of modifications and manufacturing but they still need to comply with the rigorous drug development process so getting back to that 12 to 14 years for standard compound this time includes those 9999 failures and cumulative costs that are associated with the success ratio of 10 000 to 1. all those compounds that didn't work out or had unacceptable side effects associated with them add to those costs which are on average around 2 billion for a fully licensed successful product or medicine i suspect this is probably one of the largest upfront costs that any industry faces most industries cite their biggest upfront costs as manufacturing but for farmer it's a drug development process so why do pharma companies do it well they're given a chance to recoup their investment in the form of patent protection which lasts usually around 20 years and allows them to sell their medicine exclusively for this period if this incentive was to disappear i suspect many of the companies would also disappear and the innovation and investment in new drugs just wouldn't happen however once the pattern expires so too does the marketing exclusivity and other companies are free to manufacture and sell generics in the form of small compounds or biosimilars in terms of the large biomolecules [Music] if you enjoyed this content and you want to learn more about working in pharma and farmer careers for stem professionals you can receive this content direct into your inbox by subscribing to the biomed badass blog at .biomedbadass.com forward slash subscribe blog focuses on careers in pharma including medical and scientific writing and career transitions from academia to industry more generally when you sign up you'll get free stem career tools including a 40 page booklet on non-academic career options for scientists [Music] so in summary the drug development process has complicated time consuming and expensive can take up to 14 years to bring a small compound medicine to market with a cost of around 2 billion to bring a new medicine to market pharma companies have to navigate the drug development process including candidate selection pre-clinical and clinical research approval product launch and post-marketing work it takes millions of hours of work thousands of experiments and hundreds of professionals to develop and produce one new medicine if you're considering a career in pharma it's important to think about how your skills and interests can contribute to this process and if you want to learn more about grids in pharma sign up to the biomed ballast blog thanks for watching [Music] you