Currently, traditional drug development faces challenges such as low clinical conversion rates and insufficient predictability in animal models. withFDAThe integration of intelligent organoids and artificial intelligence is driving a paradigm shift in drug development, as regulatory agencies recognize non animal experimental methods——By constructing highly biomimetic disease models and combining themAIDriven by high connotation analysis and multi omics techniques, a closed-loop approach is achieved for target discovery, dynamic quantitative analysis of drug metabolic pathways, and precise evaluation.

On October 30th, the "AI Driven Organ Reshaping: A New Paradigm for Next Generation Drug Development" sub forum was jointly hosted by the Shanghai Biomedical Technology Industry Promotion Center and Danaher Group, aiming to gather the forces of "government, industry, academia, research, and capital" to jointly explore AIThe cutting-edge application and future path of organoid technology in drug development.The Director of External Affairs at Danaher Group, Pangdali, stated:As an active participant in this transformation, Danaher has always been committed to providing critical support for research and industry through cutting-edge technology platforms.

According to Dr. Gu Shuyi from the Institute of Pharmacology and Toxicology of Shanghai Institute for Drug Control and Research:The rapid development of organoid technology cannot be separated from policy guidance and regulatory support. On the international stage, regulatory agencies are gradually increasing their acceptance of organoid technology: the FDA Modernization Act 2.0 in the United States is a milestone bill, and the EU led Organ Standardization Initiative is working hard to promote the standardization process of organoid technology. In China, organoid technology has received strong support from the national strategic level. According to the "14th Five Year Plan" national key research and development plan, organoid technology has been listed as an important component of cutting-edge biotechnology. I believe that with the clarification and support of policies, the industrialization of organoid technology will be further paved.

The rapid development of artificial intelligence technology is profoundly reshaping the global industrial structure and social operation mode, and is also becoming a strategic engine leading the modernization of traditional Chinese medicine. Currently,AITechnology is reshaping the logic and efficiency of drug discovery, especially in the field of traditional Chinese medicine,AIThe driven phenotype screening provides a new pathway for the discovery of pharmacological substances. Through Professor Wang Yi's sharing from the School of Pharmacy at Zhejiang University, we feel that artificial intelligence is becoming a key to decoding the millennium wisdom of traditional Chinese medicine. It transforms traditional Chinese medicine from“black box”The holistic therapy of formula is gradually moving towards a new stage of precision medicine where the components can be analyzed, the efficacy can be quantified, and the mechanism can be traced. This is not only a technological empowerment, but also a profound paradigm shift in research.

If AI provides us with a "smart brain" that can insight into drug mechanisms, then building highly biomimetic "human in vitro models" for drug testing is crucial. Organ chip technology, as a representative of non animal methods, not only constructs highly biomimetic human microphysiological systems in the laboratory, but also represents a new research paradigm.Dr. Ye Sen, Director of Scientific Affairs at Yaosu Technology, shared the practice of organ chips in the full drug development chain and the cooperation with FDAVerification:Transforming this cutting-edge technology from researchThe 'tool' has truly become the 'ruler' of the industry, connecting the entire chain from laboratory verification, to industrial application, and finally to regulatory approval.

Danaher Group is committed to accelerating the transformation of cutting-edge technology into tangible impact by integrating scientific, technological, and operational expertise. Its business comprehensively covers the entire process of drug discovery to commercial production, with a focus on future tracks such as organoids and organ-on-a-chip, spatial multi omics, and synthetic biology, aiming to break down barriers from scientific research to industry applications. In the process ofDr. Feng Chao, Senior Market Technology Scientist at Danaher China Life SciencesIn the shared cases, it is demonstrated that“organoid+AI”How to form a closed-loop application in target discovery and precise toxicology assessment. Danaher can provide comprehensive solutions in this field, and its various advanced devices strongly support organoids/Research and development of organ chips. With coverage“sample-data-decision”Danaher is driving the full chain capability“organoid+AI”Moving from conceptual exploration to a reproducible and standardized industrial level new paradigm.

Subsequently, a roundtable discussion focused on the future officially began. Under the guidance of Mr. Zhu Lin, Senior Director of the Strategic Marketing Department of Danaher China Life Sciences, the guests gathered around“AIResearch and development of drugs for reshaping organoids and their future”This topic has sparked deep contemplation. Everyone recognizes that this technological wave is driving a systematic upgrade of the research and development systemAIThe fusion with organoids represents not only a technological breakthrough, but also a deep reconstruction of the entire drug development system. We look forward to gathering through this dialogue“Government, industry, academia, research and funding”The wisdom of all parties will jointly explore the application frontier and development path of this technology.

Professor Wang Qingyang from the Drug Registration Office of the Shanghai Medical Products Administration pointed out that:AIAs an emerging technology, how to use the data generated by organoids for drug registration and evaluation is a new challenge faced by regulatory agencies. It is necessary to gather the joint efforts of regulatory agencies, industry enterprises, and research institutes to overcome the difficulties and bottlenecks in various aspects of organoids, including standard setting, data verification, ethical review, etc., strictly abide by compliance and quality risks, and continuously form industry consensus in order to be able to“AIRelated to organoids”Comprehensively applying it to drug research and development registration is a long and arduous task.

Professor Zeng Hulie, a researcher at the School of Pharmacy, Fudan University, said that the revolutionary opportunity brought by organoid technology lies in its construction of a highly simulated human body“High throughput, high fidelity experimental field”This enables us to more accurately predict the true response of drugs in the human body before entering expensive and time-consuming clinical trials, thus systematically overcoming the fundamental problem of low success rates in current drug development. Looking ahead to the future, we are committed to developing this technology into a more comprehensive standardized in vitro model system, and working together with various sectors to jointly build an open and high-quality data and model platform, ultimately building it into a key infrastructure that empowers global new drug research and development.

Dr. Qin Luoheng, Vice President of Chemistry at Yingsi Intelligent Technology (Shanghai) Co., Ltd., mentioned:AIPharmaceutical and traditional pharmaceuticals are not substitutes, but powerful complements and integrations. New technologies represented by organoids are forming deep synergy with traditional drug development models.AIThe core value lies in breaking down data barriers, achieving efficient integration with wet experiments, and systematically solving research and development problems, reducing costs, and improving efficiency. In the future, we look forward to the collaboration of industry, academia, and research to jointly promote the standardization, scaling up, and low-cost development of organoid technology, providing stronger support for new drug research and development.

Competition foil(Shanghai)Researcher Tang Cong, Chief Scientist of Biotechnology Co., Ltd., believes that organoid technology has obvious advantages: it can solve certain pain points in drug development, such as in drug evaluation, specific disease modeling, etc., through3DBioprinting technology can make organoids more biomimetic, standardized, and rapidly engineered. The biomanufacturing of complex organs, including organoids, will overturn our future understanding of regenerative medicine, precision medicine, and drug development.

Mr. Wu Jie, Deputy General Manager of Shanghai Science and Technology Venture Capital Co., Ltd“Capital perspective”From the perspective of the industry pattern and demand, the organoid field as a whole has long-term investment value, but it also faces challenges at present. Technically, it is a challenge to achieve standardization, similarity, and affordability in classification; In terms of model, it is a challenge to make existing service models more scalable. Faced with these complex situations, investment tends to shift from a single technology platform to cross-border integration (integrated circuits, biotechnology)3DPrintingAIThe composite platform of (etc.),Tend to create a platform that can truly bridge the gap between technology and clinical value, and has commercial value.

Thank you to all the guests for their wonderful sharing, which allowed us to glimpse from multiple perspectives of technology, industry, regulation, and capitalAIComplete puzzle and clear path for fusion with organoids. A new blueprint for pharmaceutical research and development is slowly unfolding, doubling our confidence. We look forward to the sparks of wisdom that we gather today igniting a prairie fire that will drive profound changes in the industry in the near future.