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    Home > Medical News > Latest Medical News > Chen Gang: This man who has worked across the academic, regulatory and industrial sectors has started his own business.

    Chen Gang: This man who has worked across the academic, regulatory and industrial sectors has started his own business.

    • Last Update: 2020-09-02
    • Source: Internet
    • Author: User
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    Guide: Dr. Chen Gang has worked in the pharmaceutical industry, regulatory bodies and academic/clinical research institutions.
    many factors in the success of new drug research and development, and every time I give a speech, I talk about how to make the drug successful, but more importantly, I emphasize how to avoid failure.
    Nearly 25 years of experience in the development of new drugs let me feel that the success of new drug research and development is based on 50%-60% of scientific experience plus 40%-50% philosophy and art, the combination of the results of the three, like the same meaning, only 100% of science can not do.
    medicine is used in living people, not to solve a mathematical problem, so, in order to increase the probability of success in drug development, we must take into account all aspects.
    Chen Ganggang has worked in the pharmaceutical industry, regulatory bodies and academic/clinical research institutions.
    has been with the FDA for nearly 8 years, serving as head of the biometrics department of the Oncology Drug Review Center, and as head of the oncology drug research and development statistics department in the United States, and as head and senior director of the quantitative science department of Johnson and Johnson China.
    With his dual role as a drug research and development reviewer and a bidder, Dr. Chen Gang has accumulated extensive theoretical and practical experience in drug development, made significant contributions to statistical and regulatory policy, and published many important papers in his fields of research, including non-poor effectiveness, adaptive design and methodology, and other statistical methods of clinical trials.
    the past six years, Dr. Chen Gang has led the CDE Biometrics Department to do a lot of research on MRCT, consistency research, and bridging experiments.
    Chen Gang is the Chief Scientific Officer and Senior Vice President of Northger Pharmaceutical Technology Co., Ltd.
    the Cultural Revolution, I graduated from primary school and was sent to the countryside with my family.
    1977 when I was admitted to college, I felt that I couldn't do anything but math, because my father was a math teacher and had a lot of math books at home.
    later I read the Department of Mathematics and worked on mathematical statistics all my life.
    In 1983, Chen Gang published his first paper in the Journal of Chinese Mathematics, proving a hypothesis about the distribution of probabilities put forward by the famous mathematical statistician Professor Chen Xixi, who also received his Master of Science and Statistics degree from Anhui University/Chinese University of Science and Technology.
    , he went to the University of Maryland to continue his studies in statistics.
    because of his mentor's work as a consultant at the U.S. National Cancer Institute (NCI), Chen Gang's research began to be related to diseases such as the assessment of the incubation period of AIDS, breast cancer risk, and so on.
    had the opportunity to do design analysis of oncology research with some very well-known biometricians during his postdoctoral research at NCI.
    out of a love of scholarship, after postdoctoral completion Chen Gang in the first step of his career preferred to go to research institutions, in Memphis St. An assistant researcher in the Department of Biometrics at Jude Children's Center Research Hospital became his first job and the beginning of Chen Gang's medical research.
    this is a research hospital donated by the community, free of charge for some children suffering from cancer, leukemia, AIDS treatment.
    There are few children here who have little hope of survival, who can live for up to three or four years, but this has been a great success, working here, Chen Gang has always been respectful, "now, the opportunity I will go back to the hospital with them."
    "Three years later, Chen Gang was going back to work at NCI for family reasons, but a friend who had been at the FDA for more than a decade met Chen Gang in Maryland and they talked for a long time," he told me, telling me that it would be more meaningful to work at the FDA because FDA drug reviews affect human health.
    " Chen Gang was moved by him, in 1996 entered the FDA Oncology Review Office as a senior reviewer, two years later became the head of the oncology drug evaluation center biometrics department.
    "the results of new anti-tumor drug development around the world will be sent for review, and I feel very influential and have the power to change something," he said.
    , as a team leader, Chen Gang brought out a group of industry experts, they are growing rapidly.
    feels great at the FDA these years, and I'm actually going to be there for the rest of my life," he said.
    however, after seven years at the FDA, Chen Gang left the FDA with regret.
    from research institutions to regulators to research and development institutions, my feeling is that doing one thing is going to go all the way, and every time it's done, the whole thing has been raised to a higher level."
    2003, Chen Gang's eldest son was admitted to Stanford University with a tuition fee of $560,000, and when the bill came in, Chen realized the financial pressure on his family and the importance of money.
    this has forced Chen gang to consider a job with more income to pay for his son's school fees and to ensure that his family's life is not affected.
    " son asked me at the time if the family could afford the high tuition fees, and if not, he could choose the school that offered the scholarship.
    ," Chen Gang told him, "to be able to get into Stanford is your success, but you can't read Stanford is your father's failure."
    "Johnson and Johnson's corporate creed is known around the world: businesses are first accountable to patients, to employees, to society, and then to shareholders."
    ,,,,,。
    from regulator to bidder, Chen Gang feels a huge boost.
    In the FDA as a reviewer of regulatory agencies, often put forward high requirements but the complexity of the implementation of the research and development process does not have a profound understanding, in Johnson and Johnson, Chen just started to contact the really very cumbersome research and development process, each step can go wrong, but can not go wrong.
    , who was born in the theory of chinese medicine, hopes to study and enrich solidly in the field he has not been exposed to in clinical areas.
    luckily, Chen gang entered Johnson and Johnson, when Johnson happened to buy the multiple myeloma drug Bortezomib (Chinese: bortezomy).
    was appointed to set up a research and development team in the number of teams, after more than six years of efforts to finally let WanYu listed.
    " started out as a smear, with procedures from data collection clean-up, system setup, trial supervision, clinical trial analysis reports to registration.
    " successfully completed the listing of Wanyu, Chen has just started to take charge of the biometric team of Johnson and Johnson Cancer Drug Research and Development Department, and has been involved in the development of several cancer drugs.
    " at that time, after the results of research and development came out, I often and research and development and company executives virtual multi-party regulatory meetings, I will act as a reviewer.
    natural this same writing forum clinical scene show is also a light car familiar road.
    " Qiang was born around 2011 to build a research and development center in China, because quantitative science plays a crucial role in the development of new drugs, headquarters in 2013 sent Chen Gang back to establish a quantitative science team, including statistics, procedures, data management, medical writing and translation departments.
    in Johnson and Johnson China was a turning point in Chen Gang's career, and unlike his previous status as an expert, it was his real experience with his knowledge, from nothing to build a qualified quantitative science (QS) team.
    is that I'd like to come back because I've done it before at the FDA, and I can share the FDA experience with CDE, academia, and industry in China," he said.
    past few years, Chen Gang has done a lot of research on MRCT, consistency studies, and bridging experiments with colleagues in the CDE Biometrics Department.
    " from the point of view of drug research and development, the success of the basic are foreign enterprises.
    china's national pharmaceutical started late, at least for now, the success is not much.
    is due to the lack of environmental and related technical forces.
    " this is Chen Gang's feeling of returning home for three years.
    Chen Gang has met many outstanding experts in Suzhou Park who have a lot of patent research results and hope to transform them into new drugs in the true sense of the term through research and development in China.
    chen Gang believes that in addition to the support of national policies, they also need strong development partners.
    " to europe and the United States to introduce drugs, and then do a simple test listing, that they are always the second, the market is someone else's.
    develop new drugs simultaneously in China, Europe and the United States, so that Chinese patients can use new drugs developed in China as soon as possible.
    "I turn 60 this year, joining CRO is my last step, hesitating for a long time."
    in my wife's words: "The brain must be in the water, 60 years old and toss something."
    " finally think, or give yourself a few years to accept new challenges to see the results, do it.
    before joining Northger, Chen Gang thought about it for a long time.
    read the business magazine's report on Northerger's boss ten years ago.
    " he was a very special businessman, and his business strategy and ambition were something I appreciated.
    " Chen Gang believes that the CEO has enough courage and mind to work with him to fulfill his entrepreneurial dream.
    Chen Gang's goal is to build a strong, first-class CRO team that can make important contributions not only in China, but also in drug development around the world.
    "The best CRO team is whatever the business, as long as there is a new idea, we can help it successfully develop from start to finish."
    " Chen Gang has accumulated rich theoretical and practical experience in the drug research and development process with his dual role as a drug research and development reviewer and a bidder.
    now, Mr. Chen is Norther's chief scientific officer and senior vice president, and is working hard to build a strong biometrics CRO team.
    the scientist began to consider the company's development strategy and operations.
    chen Gang has been with Norther for more than four months, and his new responsibilities make him very busy and energetic every day.
    't feel the difference between 60 and 40, and I don't want to make a difference, " he said.
    as an expert in drug research and development, I have spanned three areas, from academia and regulation to industry, and one is to make a career in CRO as a businessman."
    .
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