Shanghai ISPE Pharmaceutical Information Company holds 2022 China Pharmaceutical Supply Chain Summit

Summit host: Mr. Gao Xiaowei, Vice President/General Manager of Canton Biologics

Mr. Zhang Ping, Chairman of the SPIC China Committee, Ms. Lynn Wang, Chairman of the Pharmaceutical Supply Chain Subcommittee of the SPIC China Committee, and Ms. Cao Yan from SPIC attended the conference online and delivered welcome speeches. ISPE is an academic leader in the pharmaceutical engineering industry and this summit focused on sharing the latest academic content and successful experiences in the biopharmaceutical field by Chinese experts. Through academic interaction and exchange, they jointly discussed the opportunities and challenges for the development of China's pharmaceutical supply chain.

Exciting pharmaceutical supply chain academic speeches and discussions are shared as follows:

Susan Li, Director of Bioservices and Professional Logistics at Thermo Fisher, gave an academic talk on "Global Integrated Solutions to Cell and Gene Therapy Supply Chain Challenges".

Susan Li recognized ISPE's contribution promoting the high-quality development of the industry based in China and gave a positive forecast on the number of approved drugs in the next 10 years. Susan Li said “the cell and gene therapy (CGT) supply chain still needs to overcome a number of specific challenges. Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. These developments provide a leading integrated solution for the entire clinical industry and accelerates the project development and operation of the sponsors, including China”.

Mr. Zhu Lijun, Quality and Technical Director of Clinschain SPIC gave an interpretation and keynote speech on "China GMP2010 Edition Addendum -IMP".

After nearly 4 years of polishing, China GMP2020 Edition Addendum -IMP was officially implemented on 27 May 2022. Through comprehensive study of the appendices, it was found that the GMP appendices have detailed regulations on the preparation and quality control of experimental pharmaceutical products, the quality responsibility of the applicant for clinical investigational drugs, the establishment of specifications and standards for raw and auxiliary materials and packaging materials, the management of retained samples, and the storage and management of clinical pharmaceutical records.

Mr. Feng He, Director of ZaiLab Clinical Supply Chain, delivered a keynote speech on "Best Practices for Handling Global Joint Clinical Trial Supply (with License holders) in China"

Panel Discussion Session: Appendix of Clinical Investigational Drugs to the New Regulations published by the Drug Administration: Good Practice for the Quality Control of Pharmaceutical Manufacturing.

Mr. Gao Xiaowei moderated the discussion session, Ms. Lynn Wang, Head of Project and Alliance Management of Wuxi Bio；Ms. Wang Fang min, Chairman of Project and Alliance Management, Shanghai Pharmaceutical and Medical Device Adverse Reaction Monitoring Center；Ms. Zhang Nan, General Manager of Thermo Fisher Science and Technology; Ms. Shi Yun, QA Manager of Restone Biomedicine Co., LTD., were invited to participate in the discussion and share. The five experts discussed this topic from different angles, expressed their opinions freely, and actively offered suggestions while also providing suggestions. This offered a path for the understanding and practice of the new regulations.

Mr. Dai Rong fu, Business Development Manager of Cytiva China, shared his keynote This offered “Challenges and Layout of Global Biological Drug Supply Chain"

From the three aspects of supply chain risk management, business continuity management, and communication this paper explains how Cytiva ensures safe supply in practice.

Mr. Zhang Te, Life Science Consultant, Mingdu Zhiyun, introduces "Exploration on Digital Application of Pharmaceutical Supply Chain"

The challenges of the current supply chain operation and the necessity of the digital transformation of supply chain are put forward, and the key points that need to be considered in the design, architecture, and application process of the digital transformation were explained as well as the corresponding solutions.

Led by Ms. Lynn Wang, chairman of SPIC China Supply Chain Sub-committee and Head of Project and Alliance Management of Wuxi Bio, the 2022 China Pharmaceutical Supply Chain Summit was attended by many industry experts and speakers. Special thanks to Ms. Wang and Mr. Gao Xiaowei, as well as to all the speakers, experts, and attendees.

Thank you to the four event sponsors for their contributions to the success of the Summit.

• ClinsChain (Shanghai) Pharmaceutical Technology Co., LTD
• Glace Life Technology (Shanghai) Co., LTD. CYTIVA
• Mingdu Zhiyun (Zhejiang) Technology Co., LTD
• Guangzhou Canton Biologics Co. LTD

Congratulations once again on the success of the 2022 China Pharmaceutical Supply Chain Summit. We look forward to the SPIC Supply Chain Sub-Committee maximizing the strength and voice of market communication, and the continuous high-quality development of China's pharmaceutical supply chain system!

By Li Jie of ClinsChain