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    Home > Medical News > Latest Medical News > Shi Yaozhou: Hope the central laboratory to form a climate in China.

    Shi Yaozhou: Hope the central laboratory to form a climate in China.

    • Last Update: 2020-08-14
    • Source: Internet
    • Author: User
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    Guide: It is the master of learning, but also the talents cultivated in China. Dr.
    Shi Yaozhou is a joint training doctor of the Chinese Academy of Sciences and the Chinese Academy of Sciences, has participated in the preparation and research work of the key laboratory of the Chinese Academy of Sciences genome, also participated as a core member in the research on national key topics, and obtained a number of national and Shanghai scientific research funds, is the academic bar, but also the chinese mainland to cultivate outstanding talent.
    has been working in the Clinical Research Center laboratory for more than ten years, and Dr. Shi is familiar with the overall operation of the center's laboratory, as well as knowledge of China's clinical research-related laws and regulations, ISO and CAP certification, quality management practices and compliance requirements.
    he has conducted dozens of laboratory inspections at multinational pharmaceutical companies and has conducted many quality audits on behalf of pharmaceutical companies.
    as an industry representative and the National Health and Planning Commission, the Office of The Administration of Human Genetic Resources and the Customs and Excise Department on many occasions dialogue and communication.
    compared to the big curry who does clinical research, I'm a storyless person.
    after graduating from China University of Science and Technology in 1997, he did not follow the tide of studying abroad, but quietly came to the Shanghai Academy of Life Sciences of the Chinese Academy of Sciences to follow Zhao Guoping academician to do functional genomics and genetic disease research. After graduating from the university,
    went to the Biochip Shanghai National Engineering Center, and gradually took up management positions from research and development.
    2008, quest diagnostics, the largest independent laboratory in the United States, began to set up a team in China, I went there to do the center laboratory GM, where the whole team and technology platform, mainly to undertake some of the world's multi-center clinical research laboratory testing work, GlaxoSmithKline, Merck, Novartis, etc. are our important partners, 20 Between 2008 and 2016, he participated in and was responsible for hundreds of laboratory tests for global multi-center clinical research in China and domesticly registered research, including heavyweight drugs such as Genevi, Benlysta, Afatini, reinadomine, tenofovir, AFINITOR, etc.
    in quest China for several years, thanks to the tide of clinical research in China, our business growth rate in China has been much higher than in the same period around the world.
    last year, the company's clinical research business merged with Kuntai Center Laboratory to form a new joint venture (Q2 Solution), I participated in the integration process in China, and finally for strategic reasons, the headquarters retained the Beijing laboratory, closed the Shanghai laboratory, I chose to leave for personal reasons.
    at the same time, China's largest clinical CRO Tiger Pharmaceuticals and third-party independent medical laboratory Dean Diagnostics also saw this market, as well as clinical research center laboratory forward-looking business to the clinical diagnostic business to lead and industry penetration opportunities, so the two joint lying joint venture of Kwunsin Pharmaceuticals, I joined The Medicine in March 2016, responsible for the overall operation.
    hope to use Tiger's clinical resources and Dean's laboratory resources, focus on clinical research center laboratory business, gradually through comprehensive strategic cooperation with China's local innovative pharmaceutical enterprises, change the traditional domestic clinical research laboratory testing ecological model, in line with the increasingly stringent regulatory requirements of domestic regulatory agencies, to provide domestic and foreign pharmaceutical companies need high-quality, high compliance, rapid flexibility and cost-controlled full-service biological marker development, safety testing, bioanalysis, sample management, logistics management, project management and data management business chain of the central laboratory services. Dr.
    Shi Yaozhou is currently a COO reporter at Shanghai Guanhe Medical Laboratory: How did this kind of institution start in the central laboratory? History: The central laboratory started from abroad twenty or thirty years ago. before
    did not have a central laboratory, many research laboratory testing work by the pharmaceutical company's own laboratory to complete, and then the FDA found that this data is biased, not fair, so the pharmaceutical company has been stripped out of the laboratory, by Quest, Covins, PPD and other independent third-party laboratory purchase, central laboratory concepts and market basically formed, and with the pharmaceutical company's need for the central laboratory development: First, FDA The laboratory data that want to determine drug safety and effectiveness are more independent and impartial; second, clinical research in Europe and the United States will choose a lot of small research hospitals and clinics, there are insufficient conditions for laboratory testing, objectively led to the pharmaceutical companies can only transport samples to third-party laboratories, and the concentration of patients in one laboratory such a model from a scientific point of view, will be different laboratory data generation deviation to a minimum.
    Reporter: What tests are included in the central lab? History: The center laboratory early mainly monitoring safety, that is, the patient's physical signs testing, including blood routine, biochemical, all kinds of liver function testing.
    gradually developed to the detection of important key indicators related to drug efficacy, such as saccharifydhemoglobin, blood lipids, viral load, etc.
    in the past ten years with the application of biomarkers in clinical research screening patients, in order to improve the success rate of clinical research through some biomarkers reasonable grouping of patients in the group, looking for the most suitable treatment patients to do clinical research to improve the effectiveness of the group and efficacy, due to the complexity of these tests and the high requirements for laboratory testing platforms and personnel, more and more biomarker testing will be completed by the central laboratory.
    Reporter: The advantages and disadvantages of the central laboratory compared with the clinical laboratory of the hospital? History: First, the testing of the central laboratory will greatly reduce the system deviation of data generated by different laboratories and increase the success rate of the experiment;
    because it not only provides laboratory testing, but also project management, logistics management, sample collection package and barcode provisioning, guidance of hospital sampling, and data analysis and management.
    and cooperation with each hospital laboratory requires a dedicated team to track and manage, due to institutional problems China's different hospital requirements and service awareness will increase the management costs of the applicant;
    fourth, the cost of data management is relatively low.
    hospital laboratory each report format, reference range, even the decimal place, units are not the same, but also rely on artificial data EDC input, resulting in a significant increase in the cost and time of late data analysis, and the central laboratory will be in the early stage and the host communication to determine the data format and interface transmission mode, to avoid the error of manual input, greatly reducing the workload of the bid DM.
    of course, the central laboratory and the hospital laboratory will be slightly more expensive than the use of the best testing methods and strict quality control procedures, testing costs will be relatively high, as well as logistics costs.
    but from the overall budget for drug development, this increase in costs is only a reallocation of the cost of late-stage data management and the management costs of clinical operations involving laboratory testing, but the reliability of laboratory testing data has greatly increased.
    also has a disadvantage, is that the central laboratory is relatively poor timeliness.
    hospital is the result of receiving the sample on the same day, the central laboratory due to the time of the sample transport takes two to three days to report.
    But for biomarkers, the timeliness of biomarkers in the central laboratory can meet clinical and research requirements due to the complexity of the detection platform and the clinical prevalence.
    Reporter: What are the difficulties in promoting the central laboratory? History: A major challenge in the promotion of the center laboratory is logistics costs and testing prices, the second is the customer personalized requirements faced by the central laboratory, with the CFDA for clinical research data verification, we gradually realize the importance of the central laboratory data and compliance requirements, but the domestic from the regulatory agency to the applicant for the clinical research center laboratory testing work and compliance requirements are still gradually learning, at present in the central laboratory testing business often encountered by research institutions and sponsors with PK standard research to request the center laboratory testing.
    PK bioanalytical testing and central laboratory testing are different in many places, PK as a measure of the efficacy of drugs, especially genericdrugs is a key or even the only indicator, And PK testing is usually a brand-new self-built methodology development and verification process, many test indicators are unknown, need to prove the reliability of methods and substrates through a large number of analytical verification, and central laboratory testing methodology is usually commercial, conventional, mature, and after a large number of clinical verification, and the central laboratory test results must be combined with clinical results and efficacy to prove safety and drug effectiveness, so the requirements of the testing process and the way of data and project management is different.
    for more than a year, we have with domestic pharmaceutical companies and institutions on the central laboratory sample collection, transportation process, stability, raw data and records management and other aspects of all aspects of all-round communication and discussion, fully accept the standards and concepts of the foreign central laboratory industry or face some specific challenges.
    Reporter: Is the central lab the trend of the future? What is the size of the market? S: The market for central laboratories is relatively small compared to clinical CRO, with a global market size of $4 billion.
    China's market is difficult to predict, the vast majority of foreign pharmaceutical companies will use central laboratories, so it is easy to estimate its size, while a large number of Chinese enterprises in the use of hospital laboratories, it is difficult to assess.
    we used to add up large independent center laboratories, estimated that the Chinese market is about 600-800 million yuan, but most of the business is still in the hands of hospitals, of course, it also means that the commercial center laboratory has room to develop.
    nearly two years, local companies will choose the center laboratory testing some important indicators, because know that the difference between hospitals is too big, concentrated in a laboratory can improve the success rate of drugs, but some other tests will also choose hospitals, in fact, separate two parts to do management costs are higher, we need to go publicity, affect the bid and hospital.
    Reporter: It is understood that the GeneticS Office has a more complex approval process for biological sampling? History: Foreign pharmaceutical companies include domestic innovative pharmaceutical companies or CROs containing foreign-funded components, involving the analysis and use of biological samples and data must first pass the pre-approval of the Ministry of Science and Technology Genetics Office (The Office of Management of Human Genetic Resources of the Ministry of Science and Technology).
    the challenge to the pharmaceutical company is to extend the start-up time, waste human and material resources to prepare a large number of documents, the process is cumbersome and the time node is not easy to completely step in.
    the drug research and development industry and the Ministry of Science and Technology Genetic Resources Management Office has maintained channels of communication, the Ministry of Science and Technology in 2016 also did speed up the evaluation of the time, but may be a certain distance from the hope of the industry, the industry has been calling for innovation in the regulatory approach, hope that the approval process and requirements to make changes suitable for clinical research, in the premise of ensuring national interests to further encourage innovation and research and development, it is said that the Office of Genetics will soon introduce some new operating rules, we expect some favorable changes.
    reporter: What is the genetic audit standard, high pass rate? History: Now approval will generally see whether the number and type of sample collection is directly related to clinical research, indeed related to the safety and efficacy of the drug sample collection will be approved, the pass rate is also very high, for some current analysis methods and analysis of the target of the sample and queue collection, the genetic office will adopt more stringent approval criteria.
    the current genetic office or maintain an open communication attitude, accept the various consulting of the pharmaceutical factory, recommend more and the genetic office to accept the team to communicate.
    Reporter: What do you think of your future career plan? History: engaged in laboratory work has been nearly 20 years, compared to the laboratory testing work in clinical research, like the atmosphere and ecological environment of drug research and development, but also in line with their own high quality and data for laboratory testing and scientific and compliance value pursuit, should continue to go on in this area, previously in the Global laboratory work, every year will see how many new DRUGS approved by the FDA are their own laboratory participation, there will be a great sense of participation, will have a great sense of participation and achievement, now in the domestic center of laboratory work also hope to get more responsible for the approval of the CFDA.
    biomarkers and accompanying diagnosis development in China has not been particularly clear strategy and route, in recent years I have been concerned about foreign biomarkers and accompanying diagnosis and drug co-development strategy, we hope to work with Chinese pharmaceutical companies, especially to do cancer drug research and development, in the early stage can be more involved in the program discussion, from the perspective of Biomarker laboratory testing to give advice and advice, for them to do new drug development to help, but also for China's new drug research and development to do some practical work.
    .
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