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    Home > Active Ingredient News > Drugs Articles > New drug research and development "local heroes" may not be able to play

    New drug research and development "local heroes" may not be able to play

    • Last Update: 2017-02-15
    • Source: Internet
    • Author: User
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    [industry trends of China Pharmaceutical network] from the study of biological mechanism to the start of drug production, it involves biochemistry, pharmaceutical chemistry, pharmacology, pharmaceutics Drug testing in human body involves clinical medicine, drug law and so on It involves the cooperation of multiple scientific research teams and requires a large number of highly educated talents According to Chen Bo, a global associate of McKinsey, R & D is internationally known as R & D (Research and development), i.e two steps of research and development When it comes to new drug research and development, people in the industry often mention two figures, one is "ten" years, and the other is about ten years, which is divided into two stages: one is drug discovery, which takes 2-5 years, the other is drug development, which takes 6-10 years, which is very long; the second figure is "one billion" dollars, which costs an average of one billion dollars for each new drug from the laboratory to the official market, It's very expensive Of course, if a company calculates the fund for drug experiment failure, the investment may be far more than one billion dollars, and it may cost more than two billion dollars Screening drug molecules For example, to treat a disease, scientists should first know how the disease is caused and find the target of causing the disease This requires a lot of biological experiments to confirm that the target is indeed related to the disease itself After confirming the target, they need to give it to the team of pharmaceutical chemistry to design a compound around the target, from a large number of Chemical or biological compounds are screened After finding the compound, scientists modify the chemical structure, select the molecules with cell activity, and then make a reasonable preparation with pharmaceutics Through a series of pharmacological experiments, the next step is screening As a screening library, there may be hundreds of thousands of compound molecules, from which we need to find such a series of small molecules that are more suitable for this target After transformation, a large number of compounds will be screened out, which itself will go through a very long process; all compounds are divided into biological products and chemicals, which is also very different Because biological products are macromolecules, polypeptides, glycoproteins, etc., there are many kinds of biological activities, so it has a large development space, but the cost is very high; small molecule chemicals are now screened by large-scale computer, also known as "computer-aided drug design", screened many times at home and abroad, and its development space is very limited The drug itself is not purely synthesized in the laboratory, but also eaten in the body, so a large part of the work still needs to be carried out in the animal body, to see whether the drug can really act on this target and whether there are any side effects That is to say, a drug molecule originally assumed that the drug should have such a role, and the result was the opposite effect, that is, it was constantly eliminated The next step is clinical research, which is also divided into many small links For example, in the above preclinical process, large animals are used to test the effect and toxicity of the drug If the large animals are finished with the expected effect, then human body experiments can be started, and the regulatory department can be reported for filing, saying that clinical experiments will be done Clinical trials are divided into three phases, each with a different purpose The first phase of clinical medicine is to give medicine to healthy people It is just to test whether the safety of people after taking the medicine is good, whether there is any problem, and how the distribution of the body is, that is, to verify it on the human body, not necessarily on the patients, and then the next phase is reached after the safety In the second phase of clinical trials, this is done in real patients Since all the previous results are from animals, it depends on this step whether the drug is useful or not If in a small group of people, such as 50 patients, it can be seen that the effect of their medication is better than that of placebo, they will carry out drug experiments on a larger scale In the third phase of clinical practice, scientists will consider different races, ages, and stages of disease development, as well as the dosage of different drugs, etc to detect what the effective and safe dosage of this drug is on a larger scale, and how to use it better If it turns out to be safe and effective, then apply with the regulatory authorities, saying that it can be listed, then you can start to apply for registration There is also a special case, such as an infectious virus outbreak Due to the scale and strictness of clinical experiments, it often takes many years And for regulators, especially in the United States, to adopt more and more flexible ways, some diseases are very urgent, we can see whether we can skip some of these steps, or combine phase I and phase II, and directly test it on patients - both to see its safety and effectiveness Other drugs can even directly skip the third phase of clinical trials In the second phase, it is found that 50 people who do experiments have good results They can also apply for listing first, and then do the fourth phase of clinical trials later On the one hand, patients can take it, on the other hand, pharmaceutical companies and scientists need to make close observation and recall any problems as soon as they occur There is such a mechanism to prevent the safety situation after the listing, and at the same time, it can continuously collect clinical data So in the aspect of supervision, because of the higher and higher demand, more and more flexible supervision methods should be adopted, and there are many innovations in the supervision methods In some aspects, it is also because of the innovation of regulatory methods that promotes the development of new drug industry For example, a large glass of water can be used to select such a drop or two drops of water The probability of success of new drug research and development is very small, so in essence, this is a very difficult work - capital intensive, talent intensive, and the risk is very huge The countries that really do research and development of new drugs in the world can be counted with two hands Most countries don't do this because it's too expensive In addition, even rich countries don't have so many scientific talents In China, a large number of overseas talents have been introduced in recent years, and the investment in drug research and development is also very high, but compared with the United States and other drug developed countries and enterprises, the investment is still very limited.
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