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On January 20th, the first live broadcast of "Drug Precision", a series of live broadcasts of "Focus on Drug Target Accompanying" co-planned by Genetron Health and Translational Medicine Network, successfully concluded.
The head of Kaji's new drug research and development team, from a technical point of view, combined with actual clinical practice, introduced in detail the clinical application of MRD in the field of hematological tumors and the progress of drug research and development
.
The wonderful moments of the first live broadcast of "Medicine Precision" First, the live broadcast was opened by the invited guest, Dr.
Li Yanchen, Senior Director of the Pharmaceutical Enterprise Cooperation Department of Genetron Health.
The guests and audience members expressed their warm welcome and thanks to the experts for taking time out of their busy schedules to participate in the first online live broadcast of "Medicine Precision"
.
During the presentation session, Dr.
Li Yanchen, Director Xu Xiaojun of Children's Hospital Affiliated to Zhejiang University School of Medicine, made a report entitled "Detection Methods and Clinical Significance of Minimal Residual Disease in Leukemia"
.
According to Director Xu's explanation, MRD monitoring is an important means to evaluate the response to leukemia treatment.
It is of great significance for leukemia risk stratification, prognosis judgment, and adjustment of treatment plans.
It is closely related to the late efficacy and event-free survival (long-term survival) of patients.
MRD monitoring can also be used as an end point in leukemia-related clinical research, which has been widely recognized; MRD detection methods include flow cytometry, fluorescence quantitative PCR, digital PCR, NGS, etc.
, the sensitivity of these different methods Sex is different, and each has advantages and disadvantages
.
Finally, Director Xu explained in detail the NGS method for monitoring MRD with a classic case.
NGS is a new method for monitoring MRD developed this year.
It has high sensitivity and is more accurate than flow cytometry, and has good clinical application prospects, but its accuracy still needs clinical Verify
.
Director Xu is the chief physician of the Children's Hospital Affiliated to Zhejiang University School of Medicine, the deputy director of the Pediatric Hematology and Oncology Center, and the deputy director of the Department of Hematology and Oncology.
He is good at childhood leukemia, malignant lymphoma, hemophagocytic syndrome, Langerhans histiocytosis, and hematopoietic stem cells.
He has extensive clinical experience in the diagnosis and treatment of transplantation, various anemia, thrombocytopenia and other diseases
.
Director Xu Xiaojun then, Dr.
Yu Yiling, Director of BeiGene's Clinical Biomarkers Department, expressed his unique insights on the "application of MRD in the research and development of new hematological tumors"
.
MRD has high application value and potential in the research and development of new hematological tumors, and can be used for screening high-risk groups, patient stratification, efficacy endpoints, and guiding drug withdrawal.
Validation, pay attention to the validation of MRD detection to ensure the repeatability of measurement results
.
Dr.
Yu explained the application of MRD in new drug development in detail with many classic cases
.
Dr.
Yu has more than 10 years of experience in new drug research and development.
He is responsible for the clinical research and development of biomarkers related to hematological and tumor fields, co-development of companion diagnostics and translational medicine research in BeiGene
.
After Dr.
Yu Yiling, Dr.
Hu Yunfu, Chief Medical Officer of Genetron Health, shared "Thinking about MRD Application in Policies and Regulations"
.
Dr.
Hu first explained the different classifications of clinical applications of MRD: different types of applications, different clinical trial designs, and different verification requirements; secondly, he introduced in detail the use of MRD as a marker for drug development, which is different from MRD detection as an IVD product, which is different from FDA The review requirements for MRD; next, the demonstration required for MRD as a marker for drug development is clearly stated - the clinical validity of MRD as a biomarker, and the analytical validity of MRD assays (approved MRD assays The materials to be submitted are simpler, and the clinical application does not need to submit IDE if the intended use is the same); finally, the MRD test as an IVD product, its analytical validity and clinical validity verification requirements are summarized, and the specific requirements should refer to the requirements of similar De novo products (Class II 510(k))
.
In addition, Dr.
Hu also mentioned that the use of MRD tests that have not been approved by the FDA in clinical medicine needs to be used according to regulations.
If you want to sell them in the United States, you must obtain FDA approval
.
Dr.
Hu has more than 20 years of experience in enterprise management and government supervision in the fields of medical device and pharmaceutical research and development
.
Before joining Genetron Health, he was the Deputy Director of the Molecular Genetics and Pathology Division of the Center for Medical Devices and Radiological Health (CDRH)/Office of In Vitro Diagnostics and Radiological Health (OIR) at the US FDA, responsible for the supervision of in vitro diagnostic devices (IVD) in various fields.
Has extensive regulatory experience
.
Finally, Dr.
Hu Yunfu entered the Q&A session.
During the live broadcast, many audience members asked their questions to the three sharing guests
.
The three guests also answered these questions in detail
.
If you missed this live broadcast, you can scan the QR code below to join the "Medicine Precision" WeChat communication group to get the link to watch it back! The live broadcast came to a successful conclusion with the unfulfilled expectations of all the guests and the audience
.
This live broadcast officially kicked off the loud and clear first shot of the "Medicine Precision" series of live broadcasts! Precision medicine, diagnosis first, this series of live broadcasts aims to promote academic exchanges on innovative drug R&D, facilitate high-quality R&D of innovative drugs, and jointly promote the R&D exploration and industry thinking of Chinese pharmaceutical innovative enterprises
.
The "Medicine Accuracy" column adopts a combination of online live broadcast and offline meetings.
It is held once a month and the third week.
You are welcome to continue to use the translational medicine website public account, Genetron Health's online public account, and the "Medicine Accuracy" WeChat group.
Come get live information and participate in the discussion! Thank you for your attention, see you in the second issue in February!
The head of Kaji's new drug research and development team, from a technical point of view, combined with actual clinical practice, introduced in detail the clinical application of MRD in the field of hematological tumors and the progress of drug research and development
.
The wonderful moments of the first live broadcast of "Medicine Precision" First, the live broadcast was opened by the invited guest, Dr.
Li Yanchen, Senior Director of the Pharmaceutical Enterprise Cooperation Department of Genetron Health.
The guests and audience members expressed their warm welcome and thanks to the experts for taking time out of their busy schedules to participate in the first online live broadcast of "Medicine Precision"
.
During the presentation session, Dr.
Li Yanchen, Director Xu Xiaojun of Children's Hospital Affiliated to Zhejiang University School of Medicine, made a report entitled "Detection Methods and Clinical Significance of Minimal Residual Disease in Leukemia"
.
According to Director Xu's explanation, MRD monitoring is an important means to evaluate the response to leukemia treatment.
It is of great significance for leukemia risk stratification, prognosis judgment, and adjustment of treatment plans.
It is closely related to the late efficacy and event-free survival (long-term survival) of patients.
MRD monitoring can also be used as an end point in leukemia-related clinical research, which has been widely recognized; MRD detection methods include flow cytometry, fluorescence quantitative PCR, digital PCR, NGS, etc.
, the sensitivity of these different methods Sex is different, and each has advantages and disadvantages
.
Finally, Director Xu explained in detail the NGS method for monitoring MRD with a classic case.
NGS is a new method for monitoring MRD developed this year.
It has high sensitivity and is more accurate than flow cytometry, and has good clinical application prospects, but its accuracy still needs clinical Verify
.
Director Xu is the chief physician of the Children's Hospital Affiliated to Zhejiang University School of Medicine, the deputy director of the Pediatric Hematology and Oncology Center, and the deputy director of the Department of Hematology and Oncology.
He is good at childhood leukemia, malignant lymphoma, hemophagocytic syndrome, Langerhans histiocytosis, and hematopoietic stem cells.
He has extensive clinical experience in the diagnosis and treatment of transplantation, various anemia, thrombocytopenia and other diseases
.
Director Xu Xiaojun then, Dr.
Yu Yiling, Director of BeiGene's Clinical Biomarkers Department, expressed his unique insights on the "application of MRD in the research and development of new hematological tumors"
.
MRD has high application value and potential in the research and development of new hematological tumors, and can be used for screening high-risk groups, patient stratification, efficacy endpoints, and guiding drug withdrawal.
Validation, pay attention to the validation of MRD detection to ensure the repeatability of measurement results
.
Dr.
Yu explained the application of MRD in new drug development in detail with many classic cases
.
Dr.
Yu has more than 10 years of experience in new drug research and development.
He is responsible for the clinical research and development of biomarkers related to hematological and tumor fields, co-development of companion diagnostics and translational medicine research in BeiGene
.
After Dr.
Yu Yiling, Dr.
Hu Yunfu, Chief Medical Officer of Genetron Health, shared "Thinking about MRD Application in Policies and Regulations"
.
Dr.
Hu first explained the different classifications of clinical applications of MRD: different types of applications, different clinical trial designs, and different verification requirements; secondly, he introduced in detail the use of MRD as a marker for drug development, which is different from MRD detection as an IVD product, which is different from FDA The review requirements for MRD; next, the demonstration required for MRD as a marker for drug development is clearly stated - the clinical validity of MRD as a biomarker, and the analytical validity of MRD assays (approved MRD assays The materials to be submitted are simpler, and the clinical application does not need to submit IDE if the intended use is the same); finally, the MRD test as an IVD product, its analytical validity and clinical validity verification requirements are summarized, and the specific requirements should refer to the requirements of similar De novo products (Class II 510(k))
.
In addition, Dr.
Hu also mentioned that the use of MRD tests that have not been approved by the FDA in clinical medicine needs to be used according to regulations.
If you want to sell them in the United States, you must obtain FDA approval
.
Dr.
Hu has more than 20 years of experience in enterprise management and government supervision in the fields of medical device and pharmaceutical research and development
.
Before joining Genetron Health, he was the Deputy Director of the Molecular Genetics and Pathology Division of the Center for Medical Devices and Radiological Health (CDRH)/Office of In Vitro Diagnostics and Radiological Health (OIR) at the US FDA, responsible for the supervision of in vitro diagnostic devices (IVD) in various fields.
Has extensive regulatory experience
.
Finally, Dr.
Hu Yunfu entered the Q&A session.
During the live broadcast, many audience members asked their questions to the three sharing guests
.
The three guests also answered these questions in detail
.
If you missed this live broadcast, you can scan the QR code below to join the "Medicine Precision" WeChat communication group to get the link to watch it back! The live broadcast came to a successful conclusion with the unfulfilled expectations of all the guests and the audience
.
This live broadcast officially kicked off the loud and clear first shot of the "Medicine Precision" series of live broadcasts! Precision medicine, diagnosis first, this series of live broadcasts aims to promote academic exchanges on innovative drug R&D, facilitate high-quality R&D of innovative drugs, and jointly promote the R&D exploration and industry thinking of Chinese pharmaceutical innovative enterprises
.
The "Medicine Accuracy" column adopts a combination of online live broadcast and offline meetings.
It is held once a month and the third week.
You are welcome to continue to use the translational medicine website public account, Genetron Health's online public account, and the "Medicine Accuracy" WeChat group.
Come get live information and participate in the discussion! Thank you for your attention, see you in the second issue in February!
