In Vivo Cell Therapy Gains Momentum: Eight Key Insights from Clinical, Regulatory, and Industry Experts
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Experts Say
“In one of our cases, a patient’s tumor mass measured 11 cm and completely disappeared after one month, demonstrating that in vivo therapy remains effective even in certain extreme scenarios.”Stunning Potential。”
“In vivo therapy does not require lymphodepletion, which is a significant advantage for patient safety, but how to select appropriateProphylactic Medication"Still an open question."
“The patients we selected were all in the last-line setting, almost akin to those with solid tumors and an extremely high tumor burden, who would be completely excluded from traditional clinical trials, but we used them for extreme validation.”In VivoTherapeuticSafety。”
“If domestic companies want toInternational Deals, first consider how to conduct production from the perspective of international regulatory compliance; this is not a matter of volume, but ratherThe Rationality of Storytellingthe issue.”
“ In VivoCAR-T may beGoing to ‘Belt and Road’ Countriesa powerful tool, as it is a single-injection therapy that does not require complex ex vivo preparation processes.”
“China did not blindly follow the U.S. black box warning, but rather based its decision on its own clinical data. This reflects China’s approach to cell therapy regulation.”Independence and Advantages。”
“The future development trend of quality standards is ‘Method Substitution“Physicochemical methods should be prioritized over biological ones, and cell-based alternatives should be used in lieu of animal testing, which imposes higher technical demands on R&D enterprises.”
“Considerations must be made during the R&D phaseQuality Control, particularly with respect to method validation and standard establishment; otherwise, even if the data appear favorable, they may still be rejected during regulatory review.”
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The above insights are derived from the joint initiative launched by the CSGCT Alliance and VCBeat.“In Vivo Cell Therapy: Practical Training on Key Points Across the Full Lifecycle of R&D, Delivery, CMC, Regulatory Affairs, and Clinical Development”Wuhan Station Event: Authentic Voices from Clinical, Industry, and Regulatory Sectors.
Undoubtedly, these expert insights from the frontiers of clinical practice, industry, and regulation not only reveal the real-world challenges and broad prospects in the field of in vivo cell therapy but also clearly highlight the urgent need for systematic knowledge integration and enhanced practical capabilities within the industry.
Driven by this consensus and call, and upholding the original intention of continuing to address common practical challenges faced by participants in the in vivo cell therapy sector, the CSGCT Alliance, in collaboration with VCBeat, willFebruary 7-8, 2026InBeijingHolding the Second Practical Training Session, the Event Will Continue to Focus onKey Stages in the Full Process of In Vivo Cell Therapy, bringing togetherFront-line Clinical PI、Regulatory Authority Experts、Pioneer in R&D Technologythree key categories of distinguished guests, and has invited experts with extensive experience and profound insights in the fields of in vivo CAR-T process development, quality control and analytics, and manufacturing, who are committed to translating the aforementioned expertise intoActionable Practice Guidelines, providing industry participants with real-world cases and practical experience to chart a course, avoid common pitfalls, and address genuine challenges.
Phase I · Wuhan Station Training Site
“Clinical+Regulation"Dual-Core Expert Matrix", gathering R&D pioneers and achieving full-chain coverage of core technologies......
In Vivo Cell Therapy: Practical Training on Key Points Across R&D, Delivery, CMC, Regulatory Affairs, and Clinical Development (Phase II · Beijing)
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Training Name：In Vivo Cell Therapy: R&D, Delivery, and CMC, Registration、Practical Training on Key Points Across the Entire Clinical Process
Training Schedule: February 7-8, 2026
Training Venue: Beijing
Organizer：CSGCT Alliance,VCBeat
Co-Organized by: Biologics Circle, Antibody Circle
Supporting Organizations:Zhongguancun Science City Administrative Committee
I. Global Development Strategies and Current Status, R&D Pain Points, and Future Directions for In Vivo CAR-T
In Vivo CAR-T Technology: Origins and a Global Landscape Overview Global R&D Strategy and Current Status of In Vivo CAR-T Global Core Delivery Platforms for In Vivo CAR-T: R&D Bottlenecks and Pain Points Competitive Landscape of In Vivo CAR-T and Strategic Considerations for Future Development
Multidimensional In-Depth Comparison: In Vivo CAR-T vs. Ex Vivo CAR-T Key Technical Indicators for the Design of In Vivo CAR-T R&D Strategic Considerations for Matching Vector Selection with Indications Special Characteristics and Strategies of Preclinical Research
Limitations of Ex Vivo CAR-T Therapy and Significant Advantages of In Vivo CAR-T Key Differences in Clinical Study Design Between In Vivo and Ex Vivo CAR-T Therapies Clinical Execution and Risk Management Clinical Practice Case Analysis
Overview of Research Progress in In Vivo CAR-T Therapy Key Considerations for Non-Clinical Studies of In Vivo CAR-T Therapy Case Analysis Summary and Outlook
Advantages and Core Mechanisms of LNP-mRNA Delivery Technology Representative Companies and Pipelines in LNP-mRNA Delivery Strategies for Optimizing the Targeting of LNP-mRNA Delivery Addressing R&D Challenges in LNP-mRNA Delivery and Future Development Directions
Advantages and Core Mechanisms of Lentiviral Delivery Technology Representative Companies and Pipelines in Lentiviral Delivery Precision Targeting and Enhanced Safety of Lentiviral Delivery Addressing R&D Challenges in Lentiviral Delivery and Future Development Directions
Advances in the Development of Other Vector Delivery Platforms for In Vivo Cell Therapy Other Technical Advantages and Core Mechanisms, R&D Challenges and Responses
CMC Paradigm Shift: From “Cellular Products” to “Injectable Drugs” Key Points in the Large-Scale Production Process of Vectors Formulation and Filling Processes for “Off-the-Shelf” Products Supply Chain and “Spot-Type” Product Management
Quality Research Strategy Analytical Method Development and Validation Non-Clinical Studies and Regulatory Considerations
Global Registration Strategy and Communication Construction of Quality Control and Inspection Standards Regulatory Review Considerations for Advanced Therapy Medicinal Products Such as In Vivo CAR-T
Chief Physician, Professor, Doctoral Supervisor, Recipient of the State Council Special Allowance;
Dr. Mei Heng, Level 2 Professor, Chief Physician,National Distinguished Young ScholarCurrently serves as Director of the Department of Hematology and Director of the Stem Cell Center at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Director of the Hubei Provincial Clinical Medical Center for Cellular Therapy of Oncologic Diseases; National Committee Member and Secretary-General of the Chinese Society of Hematology; Vice Chairperson of the Committee on Cellular Research and Therapy under the Chinese Association of Research Hospitals; Vice Chairperson of the Leukemia Committee under the Chinese Society of Clinical Oncology (CSCO); Associate Editor-in-Chief of the British Journal of Haematology. Has presided over more than 10 major research projects, including key projects funded by the National Natural Science Foundation of China, original exploration projects, and key R&D programs supported by the Ministry of Science and Technology. Has published more than 70 SCI-indexed papers as first or corresponding author, and holds 16 authorized invention patents. Served as Editor-in-Chief of Classic Cases of CAR-T Therapy and Lead Translator of the EBMT/EHA Handbook on CAR-T Cell Therapy. Recipient of the Young Scientist Award from the Chinese Medical Association, one Second Prize of the National Science and Technology Progress Award, and two First Prizes of Provincial/Ministerial-level Science and Technology Progress Awards.
Chief Pharmacist, Master’s Supervisor. Formerly served as Deputy Director, Quality Manager, and Authorized Signatory of the Shanxi Provincial Institute for Food and Drug Control. Member of the Chinese Pharmacopoeia Commission for four consecutive terms (9th–12th); currently serves as Vice Chair of the 12th Committee on Pharmaceutical and Biological Testing. Former Senior GMP Inspector and Registration Verification Team Leader at the National Medical Products Administration (NMPA).
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Phase I · Wuhan Station Highlights
