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July 23，13:30-17:30

IIT Supervision Model and China’s Innovation Efficiency Session

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Meeting Planning
Jie Li：Senior Vice President, Regulatory Affairs, Aeira Health; Director, All-Chain Pharmaceutical Information Research Institute, Beijing Economic-Technological Development Area
Dan Zhang：Foreign Member, Russian Academy of Engineering; Chief Scientist, PUMC Innovation Port; Professor & Chief Medical Officer, Fudan Institute of Clinical Science; Co-Chairman, Hillgene Biopharma

13:30-13:40　Opening Address
Leader of the Administrative Committee of Zhengzhou Airport Economy Zone

13:40-14:00 Gene Editing and Cell Therapies
Mingyao Liu：Director, Shanghai Key Laboratory of Regulatory Biology; Director, Institute of Biomedical Sciences, East China Normal University; Chairman, BRL Medicine

14:00-14:20 IITs and China's Clinical Research Regulatory Pathway
Chenyan Gao：Lead Scientist, Beijing Changping Laboratory; Former Division Director, Biological Products Clinical Division, Center for Drug Evaluation, NMPA

14:20-14:40 Reflections on Clinical Research in Cellular Gene Therapy in the Context of Regulations 818 and 828
Jinping Xie：Associate Professor, Institute of Regulatory Science for Medical Products, China Pharmaceutical University

14:40-15:00 Protecting Participant Rights in IITs and Registered Clinical Research
Wenlin Huang：Chairman, Doublle Bioproduct

15:00-15:20　The New Hub for the CGT Industry: Zhengzhou Airport Economy Zone, Henan-CGT Industrial Park, Zhongyuan Medical Science City

15:20-15:40 Tea break

15:40-16:10 Dialogue: Global Innovation Partnerships Built on China's IIT Research
Guest: Dan Zhang：Foreign Member, Russian Academy of Engineering; Chief Scientist, PUMC Innovation Port; Professor & Chief Medical Officer, Fudan Institute of Clinical Science; Co-Chairman, Hillgene Biopharma
Interview: Fangfang Zhu：CEO, HemaCell

16:10-16:25 Pharmaceutical Research Requirements for Registered Clinical Studies of Somatic Cell and Gene Therapy Technologies
Jing Chen：Deputy Director, Regulatory Affairs

16:25-16:40 IIT Regulation in Transition: Recent Updates and Compliance Priorities
Tingting Liu：Partner, Life Sciences & Healthcare Practice, AllBright Law Offices, Shanghai

16:40-17:30 Roundtable: Maximizing China's Innovation Efficiency Through the IIT Pathway

July 23，09:00-12:10

Decree No. 818 and a New Era for the Development of Biomedicine Industry session

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Conference Planning
Jie Li，Senior Vice President, Regulatory Affairs, Aeira Health; Director, All-Chain Pharmaceutical Information Research Institute, Beijing Economic-Technological Development Area

moderator
Jinsheng Cheng，General Manager, Life Science Division, Tofflon

09:00-09:20 Interpreting Decree No. 818
Jianzhong Shen：Coordination Commissioner for the Implementation of Regulation 818 of the Biology Center, Second-Class Researcher (Former Deputy Director)

09:20-09:35 Decree No. 818 and the Boao Lecheng Pilot Zone
Jingle Liao：Deputy Director of the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration

09:35-09:50 Cell Therapy-Based Cancer Vaccines: Translational Practice Under Decree No. 818
Genhong Cheng：Fellow of the American Academy of Microbiology,Tenured Professor at UCLA,Distinguished Professor, Guangzhou Laboratory

09:50-10:05 New Biomedical Technologies in the Era of Decree No. 818
Biao Wu：Deputy Director, Changzhou West Taihu Institute of Advanced Cell Therapy Technology; Vice Chairman, China Medicinal Biotech Association

10:05-10:20 Building an End-to-End Support System for Decree No. 818: The West China Hospital Approach
Yuan Li：Deputy Director of the Department of Science and Technology and Director of the Research Platform Management Office, West China Hospital of Sichuan University

10:20-10:40 Tea break

10:40-10:55 Managing Somatic Cell Clinical Research Under Decree No. 818: The SYSUCC Experience and Practices
Tong Xiang，Associate Research Fellow, Experimental Research Department, Sun Yat-sen University Cancer Center

10:55-11:10 The Role of Ethics in Reviewing New Biomedical Technologies Under Decree No. 818
Jie Li:Director, Ethics Committee, Peking University Cancer Hospital

11:10-11:25 A Brief Analysis of CGT Product R&D Pathway Strategies and Prospects Under the 818/828 Policies
Zhihong Wan:Chief Scientist & New Drug Evaluation Expert, Boji Medical

11:25-12:10 Roundtable: Operationalizing Translational Biomedical Technologies Under the 818 Policy
Jie Li:Senior Vice President, Regulatory Affairs, Aeira Health; Director, All-Chain Pharmaceutical Information Research Institute, Beijing Economic-Technological Development Area
Guodong Jia:Distinguished Research Fellow, Nanhu Laboratory
Hongxin Deng:Professor, National Key Laboratory of Biotherapy, West China Hospital, Sichuan University
Xueli Geng:Executive General Manager, SDIC Venture Capital
Jinsheng Cheng:General Manager, Life Science Division, Tofflon
Mingyu Liu :Head of R&D and TIL Program Leader, Biosyngen

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