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    Home > Active Ingredient News > Drugs Articles > Chasen's column analyzes the current situation of CMOs of innovative drugs at home and abroad

    Chasen's column analyzes the current situation of CMOs of innovative drugs at home and abroad

    • Last Update: 2022-10-25
    • Source: Internet
    • Author: User
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    CMO is the abbreviation of Chief Medical Officer, which is translated domestically as Chief Medical Officer, corresponding to the CEO translation, which means the main medical person in
    English.
    In recent years, CMO has gradually become a hot position, this article will analyze the author's personal experience of the current development status of CMO and innovative drugs in China
    .

    Current situation of CMOs at home and abroad

    Current situation of CMOs at home and abroad

    Personally, I believe that CMOs at home and abroad have a gap in clinical development design, and how to design an effective and valuable clinical medical program according to patient
    needs.

    The second gap: the real CMO, this to understand what a real CMO is, about this, you can listen to the cornerstone CMO Yang Jianxin, Rongchang CMO He Ruyi and other bigwigs described:

    Here's why:

    China's experience in early research on the medical environment (scientific discovery, translational medicine) is weak
    .
    The MD-PhD program in the United States, launched in the 50s of the 20th century, aims to train medical scientists
    who can integrate scientific research and medical practice.
    To date, more than 90 MD-PhD programs have been offered in the United States, and the current enrollment is about 5,400.

    Since 1964, the NIH has launched the Medical Scientist Training Program (MSTP), a medical scientist training program that has funded 50% of the nation's MD-PhD schools, and has funded more than 10,000 people
    .
    About 60% of MD-PhD's research work is related to translational research and 50% to basic research, providing a sustained core driver of
    pharmaceutical innovation in the United States.

    In contrast, most of the MD-PhD programs of China's leading medical schools began in the 21st century, and the domestic education and scientific research evaluation system pays more attention to the short-term publication of academic achievements (such as the number of SCI papers), and pays insufficient
    attention to the parts that are difficult to quantify (such as the clinical application value of research results, students' translational medical thinking training).
    。 Compared with graduates who have undergone a single basic science or clinical medical training, MD-PhD program graduates are more likely to take on leadership roles in academic research centers, large pharmaceutical companies and biotechnology companies because of their solid basic research experience and systematic clinical medical knowledge, and carry out cutting-edge exploration and undertake important research and development tasks
    guided by clinical problems.

    There is no such education system in the country, it is impossible to cultivate real medical cattle, and basic research is very weak
    .

    The real CMO can be summarized in one sentence: you have to know early research and development, basic research, non-clinical, clinical medicine, this process you have to do, only after systematic training, you know how to design this medicine, most of the CMOs in pharmaceutical companies in the United States have licensed physicians, including FDA clinical review officials
    .

    On the contrary, domestic doctors rarely have such training, especially in local pharmaceutical companies or people who do medicine in China, if they are overseas doctors, who have worked in big pharmaceutical companies for many years and can become CMOs
    after returning to China.

    As for the clinical development centers of foreign companies in China, the gold content of CMOs is not high, in other words, people who do medicine in China only know one and do not know the other
    .

    So why are CMOs paid so much?

    So why are CMOs paid so much?

    CMOs are worth this value, and the CMOs in the United States are worth money because they do what they do, and they can carry his value, because this platform is in the United States, their goal is Europe and the United States, an innovative drug into Europe and the United States, it has completed 50% of the things, you know that European and American countries are making money for 7 billion people around the world, so they are worth this value
    .

    On the contrary, when you return to China, whether it is a big cow returning from overseas or a local CMO, why is the salary still so high?

    After thinking about it, I finally understood that this is not a matter of whether China's innovative drugs can afford to pay, a CMO ranges from 3-10 million, it is simply the CMO you invite back, which exceeds your carrying capacity
    .

    It's the CMO you bring back that exceeds your carrying capacity
    .

    I think those bosses who return from overseas to start a business, the first is definitely not for money, if for money, in the United States they have already achieved material freedom, their original intention is to make innovative drugs for the countrymen, break foreign monopolies, break import restrictions, break dependence on the West, think about the 20th century when human beings have discovered atoms, know the structure of life, know biological theories, etc.
    , by the 21st century, Europe and the United States have long entered the ranks of developed countries, they enjoy the best medical conditions in the world, And the average life expectancy of our country's population, when the country was founded, was only 60 years old, in the 21st century, our medical conditions are still very poor, many drugs rely on imports, so these doctors who have been overseas for many years, catching up with the wave of China's reform and opening up, returning to China to start a business, it is indeed not easy
    .

    The original intention is to make innovative drugs for the Chinese people, break foreign monopolies, break import restrictions, and break dependence on the West

    So what about the current returnee doctors coming back to start a business, I can only say that the current environment is much better, I think they also have the original intention, but there are other things
    .

    Having said that, the salary of the CMO hired back from the United States and Europe is in line with the national standards of European and American medicine, but does not meet the standards of China's pharmaceutical environment, and inviting a CMO of 1 million US dollars back cannot meet the standards of
    the pharmaceutical industry in developed countries.

    Some people say that you can take a pay cut, but the salary cut is not applicable to every returnee Chinese
    .

    Although the value of CMOs has a measure, but we have high expectations to let these CMOs to change China's pharmaceutical environment, is a little stretched, China's pharmaceutical environment problems, not relying on a few returnees, not relying on high salaries of capital, not relying on feelings can make everyone make high-quality, in line with international standards of innovative drugs, China's pharmaceutical development problems, is a historical problem, this is no way, we are decades behind, it is difficult to return, all need to sacrifice time
    .

    The second issue of reform and policy, China's medicine and medicine, after half a century of rectification and reform, learning from the Western management system, has finally embarked on a path that conforms to China's national conditions; this is a historical choice; by now all systems have been perfected and management has also been perfected, but reform cannot be stopped, and some optimization
    needs to be made.

    For example, until 2015, Bi Jingquan, then director of the Food and Drug Administration, reformed the quality of drug clinical trials, and then to clinical acquiescence, priority approval, MAH system, the first step of the promulgation of the vaccine bill, and then to the implementation of 4+7 generation procurement
    .

    Some people say that collective procurement is one size fits all, so that pharmaceutical companies no longer have profits to speak of, how can there be motivation for research and development later, I want to say that in the past 40 years of reform and opening up, there are still many poor people in China, very serious, the gap between the rich and the poor is very large, this process, sacrificing 1 generation of time, the money made are those who catch up with the wave of reform collective procurement is a double-edged sword, but he is in line with China's national conditions, only when people enter the hospital, they know that collective procurement is good
    .

    The time is not yet ripe

    The time is not yet ripe

    Having said that, when it comes to the problem of CMO, I talked about the value of CMO, and it is difficult
    to ask a real CMO abroad to solve the clinical development of innovative drugs in China.

    If you think about it, you know that the CMO can only solve the problems that he can solve, and if you want him to solve the entire environmental problem, I think it is impossible because the time is not ripe
    .

    The time is not yet ripe

    The design of clinical development is based on the data of basic research to analyze and be further verified, looking at China's innovative drug environment, there are several real FICs, BICs, and several have invested huge funds in basic research, no Chinese innovative drugs are working patents, basically mee too, me better, you say this drug, how can it enter the FDA review in the future, but it is difficult to say, there are only a few innovative drugs in China, Hengrui is not easy ah, Hengrui's strategy is fast Fllow, FIC, generic drugs, without generic drug revenue there is simply no money to do innovative drugs
    .

    From 2015-2022, 8 years we began to reform, version policy, from 2017 began to do our so-called innovative drugs, in just 6 years, we are catching up with the speed, did not catch up with good quality, really not easy to listen, praise for those who do innovative drugs in our country

    Be the rule-maker

    Be the rule-maker

    Innovative drugs we must do, if we don't do it, we will lag behind more, some people say that corners overtaking, cells, gene therapy, nucleic acids, the fault is wrong here, our basic research has basically not made much progress, how do you say to overtake in curves?

    The basic research of Chinese medicine is not in the research and development department of pharmaceutical companies, but in scientific research institutes, universities, institutions, which involves a problem of human resource structure, our basic research and pharmaceutical companies are actually broken, and university professors only do experiments
    in universities.

    So when it comes to the situation of this CMO, I will say so much, at present, it seems that the best way is to take several generations of efforts to reverse, China's innovative drugs are not short of money, and China's capital is not short of money, which is
    correct.

    What China lacks is to really make rules and rules that are in line with international standards, and if one day China's innovative drugs go to sea, it will show that our rules are right, and China's innovative drugs will be successful
    .

    Truly set the rules, the rules in line with international standards

    Looking forward to this day
    .

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