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In order to further improve the diagnosis and treatment level of
in Harbin on November 10-11.
Among them, the high-profile drug regulatory policy (UCLI-CDE) session, as the most eye-catching section in the field of anti-tumor new drug research and development, will be officially held at 13:30 on November 11 in the form of "offline + online" linkage, and you are invited to participate here!
The origin of the special session - anti-tumor innovative drugs continue to emerge, and the UCLI-CDE special session came into being
The same is true in the field of drug discovery
.
With the acceleration and deepening of the reform of China's drug review and approval system, the innovative potential of China's anti-tumor drugs has been stimulated, and breakthrough therapeutic drugs have continued to emerge
.
Since 2018, the number of new drug clinical trials (IND) applications in China has increased year by year, of which the annual increase in the activity of anti-tumor drug research and development in China can reach 37.
5%, exceeding the global average
.
Even in 2021, when the new crown epidemic was extremely severe, CDE approved a variety of anti-tumor drugs including CAR-T cell therapy, antibody drug conjugates, bispecific antibodies, and small molecule drugs, many of which are innovative therapies, bringing new treatment options for tumor patients and providing clinicians with new anti-tumor weapons
.
In order to comply with the current R&D status in China, accurately guide the research and development of innovative anti-hematological cancer drugs, and meet the urgent clinical needs of patients, a high-quality platform for discussion and exchange between the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, hematological oncology experts and pharmaceutical companies should be built, and the UCLI-CDE special session came into being
.
Special content - focusing on the frontier of review, multi-party cooperation to promote the research and development process of innovative drugs for hematological oncology
The UCLI-CDE session will focus on the current hot topics in the field of hematological oncology drugs, and invite a number of CDE review experts to exchange and discuss
with experts from academia and industry 。 In terms of content setting, a number of drug review experts will authoritatively elaborate on a number of reports in the research and development of anti-hematological tumor drugs, including clinical review considerations for innovative drugs in hematology, review considerations for single-arm clinical trials to support the applicability of antitumor drug marketing applications, special points for clinical approval of hematological tumor cell therapy products, etc.
, to guide the communication between clinicians and pharmaceutical companies in the field of hematological oncology in the process of new drug research and development, and jointly promote the research and development and innovation process of anti-hematological tumor drugs
。
The 7th Anti-leukemia and Lymphoma International Summit Forum UCLI-CDE (13:30 on November 11th), the fusion of views, the collision of ideas, sincerely invite you to participate online, share the academic feast!
