On December 11, the "Forum on New Drug/Vaccine Development in the Field of Infectious Diseases" jointly organized by the National Medical Center for Infectious Diseases (Shanghai) (NMCID) and UnionClin, was successfully held in Shanghai. The meeting focused on discussing the collaborative needs throughout the entire process from the laboratory stage to commercialization and aiming to promote exchanges and cooperation among all parties to jointly advance the research and development of innovative drugs in the fields of anti-infection and infectious diseases. 

The Great Challenge Between Basic Research and Clinical Application

Professor Wenhong Zhang, Director of the National Medical Center for Infectious Diseases

Professor Wenhong Zhang, Director of the National Medical Center for Infectious Diseases and Director of the Department of Infectious Diseases at Huashan Hospital Fudan University, delivered the opening speech. Based on presentations of multiple research achievements, He showcased the importance of interactive cooperation between the National Medical Center for Infectious Diseases (Shanghai) and pharmaceutical companies and research institutions in accelerating the research and development speed and accomplishing the transition from basic research to clinical application. 

TOPIC 01

Professor Jing Zhang

Drug Clinical Trial Institution, Huashan Hospital，Executive Vice Director

Introduction to Huashan Hospital's GCP Platform and Phase I Ward

Professor Jing Zhang, Executive Deputy Director of Drug Clinical Trial Institution, Huashan Hospital

Professor Jing Zhang, Executive Deputy Director of the Drug Clinical Trial Institution of Huashan Hospital Fudan University, introduced the development of Huashan Hospital's Department of Infectious Diseases and Clinical Pharmacology Research Center, as well as its outstanding contributions to vaccine and anti-infective drug research. In addition, Professor Jing Zhang emphasized Huashan Hospital's innovative practices as one of the first institutions in China to conduct clinical studies and promote innovative drug development, such as the pre-review by ethics committees, pre-academic review, and pre-contract signing, along with advanced measures in clinical study quality control and information management. Finally, Professor Jing Zhang looked forward to the prospects of cooperation between Huashan Hospital and domestic and foreign partners in clinical translation and innovative drug development.

TOPIC 02

Professor Feng Sun

National Medical Center for Infectious Diseases，Director of Clinical Research

ational Medical Center for Infectious Diseases (Shanghai)

Introduction to the Clinical Study Platform

Professor Feng Sun, Director of Clinical Research at the National Medical Center for Infectious Diseases

Professor Feng Sun, Director of Clinical Research at the National Medical Center for Infectious Diseases, introduced the original intention and mission behind the establishment of the National Medical Center for Infectious Diseases (Shanghai), as well as the three core missions of the Clinical Study Platform of the National Medical Center for Infectious Diseases (Shanghai) (a member of the WHO Clinical Study Platform): pandemic preparedness, elimination of infectious diseases, and biomedicine translation. Professor Feng Sun particularly emphasized the service functions of building a network of infectious disease clinical study base hospitals and the central Academic Research Organization (ARO) team. The medical center should not only provide excellent medical services but also support clinical research with scientific evidence from guidelines, technology, products, and other aspects.

TOPIC 03

Dr. Haixiong Han

Chief Medical Officer of UnionClin ，Registration Director

Vaccine Clinical Study Protocol Design

Key Points and Implementation Essentials

Dr. Haixiong Han, Chief Medical Officer/Registration Director of UnionClin

Dr. Haixiong Han, Chief Medical Officer/Registration Director of UnionClin, elaborated in detail on the general principles of vaccine development and the issues addressed in clinical studies at different stages based on strategies and key implementation points in vaccine clinical research. He focused on the design of control studies in vaccine clinical studies, the evaluation of immunogenicity, and the importance of direct evidence for protective efficacy. Dr. Han listed practical cases to highlight the contributions of Huashan Hospital and the National Medical Center for Infectious Diseases (Shanghai) in accelerating drug approval and patient enrollment.

PANEL DISCUSSION

Host: Ms. Lan Jiang, Head of the Central Medical Department, UnionClin

Professor Wenhong Zhang, Director of the National Medical Center for Infectious Diseases

Under the chairmanship of Ms. Lan Jiang, Head of the Central Medical Department of UnionClin, the meeting proceeded to the grand round table interactive session. Each company representative participating in the meeting either delivered a speech or posed questions. Professor Wenhong Zhang conducted enthusiastic discussions with all the guests on considerations such as technical barriers, market prospects, and regulatory norms, including how to attract capital through technological innovation and market strategies, how to promote project progress using national-level platforms, and how to assist with the industrial chain through methods such as domestic and international cooperative development.