On May 10, 2023, the thematic salon "Clinical Studies, Efficiency First"—Biomatrix Medicine Talk, co-hosted by UnionClin and Biomatrix, concluded successfully in Nanjing. The event gathered numerous leading figures, including Professor Shukui Qin, President of Nanjing Tianyinshan Hospital China Pharmaceutical University; Dr. Feng Sun, Director of the Clinical Research Department at the National Medical Center for Infectious Disease Medicine; Professor Fangrong Yan, Head of the Department of Biostatistics at the School of Science, China Pharmaceutical University; Professor Juan Li, Director of Phase I Clinical Study at Nanjing Drum Tower Hospital; along with experts, executives from related enterprises, investors, and scientists in attendance, totaling 40 persons. (For the detailed list of attendees, please see the end of the text.)

The opening host—Mr. Junlin Wang, founder of UnionClin, stated that the high efficiency of clinical studies is inseparable from the joint support of experienced clinical experts, pharmaceutical companies, investors, and professional CRO companies. He hopes to explore more efficient solutions through the event.

Host: Mr. Junlin Wang, Founder of UnionClin

Expert Sharing

Accelerating New Drug Clinical Studies from the PI's Perspective

Director of the Department of Clinical Research, National Medical Center for Infectious Diseases

Dr. Feng Sun

Innovative Early Phase Clinical Study Design Considerations and Applications

Head of Department of Biostatistics, School of Science, China Pharmaceutical University

Professor Fangrong Yan

Design Considerations and Key Points for Clinical Studies of Innovative Drugs for Liver Cancer

President of Nanjing Tianyin Mountain Hospital China Pharmaceutical University

Professor Shuku Qin

The brilliant sharing by the three experts kept the audience continuously exhilarated. Regarding the challenges and differences in clinical studies of new drugs for infectious diseases and new drugs such as cancer, Dr. Haixiong Han, Chief Medical Officer of UnionClin, also shared his views.

Dr. Haixiong Han, Chief Medical Officer of UnionClin

He considered that most clinical studies are inseparable from three key factors: subjects, dosing regimens, and endpoints. However, clinical studies of new drugs for infectious diseases are completely different from those of other new anti-tumor drugs. 

1. Subjects: Unlike the field of oncology, which has decades of basic research, new types of infectious diseases have many understandings that are constantly changing over time. The diagnosis and treatment of first infections, second infections, different ages, and different underlying diseases all vary significantly. 

II. Dosing Regimen: Compared with infectious diseases, cancer treatments have longer durations and are relatively chronic diseases; even for late-stage patients, they may last as long as three months. However, for infectious diseases like COVID-19, the treatment period may be just five days. Therefore, when designing clinical protocols, it is necessary to consider how many times the medication is administered, when sufficient exposure levels are reached, and when the therapeutic effect needs to manifest. 

III. Endpoint Indicators (Extremely Important): The efficacy and safety indicators for new oncology drugs have a very comprehensive system, but many indicators for infectious diseases are unknown. For example, for COVID-19, if we look at survival, the trial may require tens of thousands of samples. Apart from survival, what other indicators are there? How much clinical value do they actually have? We see that some drugs reduce the symptomatic period from 6 days to 5 days, but does this truly have clinical value? There may still be significant debate within the industry.

Host: Dr. Zibao Zhang, LC Ventures

Finally, the roundtable moderator Dr. Zhang Zibao, partner of LC Ventures, led all the guests in discussing the following topics:

Q1: The initiation of drug projects always originates from unmet clinical needs, and the changes in clinical needs are dynamic. How can we better determine the clinical needs and development directions of new drugs? 

Q2: What aspects need special attention in the design of clinical studies for new therapies such as antibody-drug conjugates, nucleic acid drugs, cell therapies, etc.? 

Q3: What are the differences between BOIN Comb, U-BOIN, and BOIN12? 

Q4: What are the key points and risks that need the most attention in early clinical research? How to improve the success rate of translation in early clinical research? 

Event Site

As a professional CRO service company, UnionClin adheres to the mission of "accelerating clinical studies for new drugs, bringing new life to thousands of patients", enhances the accessibility of clinical research and patient participation, and is committed to promoting the early market launch of more clinically valuable new drugs.

Continuously building clinical research networks and specialized service systems, UnionClin has provided services for over 200 projects. We have established extensive cooperation with numerous clinical research experts and clinical research centers, integrating a global perspective on clinical development, Phase I-III clinical study services, integrated digital tool systems, and upstream and downstream resources to form end-to-end, whole-process solutions, continuously reducing R&D costs, improving R&D efficiency, and helping our clients succeed. 

▲Swipe up to view the list of attendees

Feng Sun, National Medical Center for Infectious Diseases

Fangrong Yan, China Pharmaceutical University

Shuku Qin, Nanjing Tianyinshan Hospital China Pharmaceutical University

Junlin Wang, Shanghai UnionClin Co., Ltd.

Zibao Zhang, LC Ventures

Juan Li, Nanjing Drum Tower Hospital

Hongliang Jiang, Wuhan Hongren Biopharmaceutical Co., Ltd.

Qun Dang, Henan Zhenshi Biotechnology Co., Ltd.

Haixiong Han, Shanghai UnionClin Co., Ltd.

Lei Zhang, Shanghai UnionClin Co., Ltd.

Xinjun Yu, Jiangsu JEBEL Pharmaceutical Co., Ltd. 

Xiaoling Jiang, Sunho Biopharmaceutical (China) Co., Ltd.

Jing Shao, Nanjing Youke Biotechnology Co., Ltd.

Chenghai Zhang, Shanghai Mabgeek Biotechnology Co., Ltd.

Xinsheng Shi, Sanhome Pharmaceutical Co., Ltd.

Qingqiao Tan, Shanghai RRGENER Co., Ltd.

Hongpeng Luo, Yiqi (Guangxi) Pharmaceutical Technology Co., Ltd. 

Jian Hong, Arromax Pharmaceutical Technology (Suzhou) Co., Ltd.

Jianxin Duan, Shenzhen Ascentawits Biotech Co., Ltd.  

Juan Li, Yangtze River Pharmaceutical Group

Hui Wang, Yangtze River Pharmaceutical Group

Bingjie Huang, Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. 

Chijian Zuo, Suzhou CureMed Biotech Co., Ltd.  

Wenbin Liu, Usynova Biopharma (Shanghai) Co., Ltd.

Qiang Zhang, 
SciTech Pharma (Beijing)

Kexiu Wang, 
SciTech Pharma (Beijing)

Shaoyang Qin, SciTech Pharma (Beijing)

Xin Cheng, Suzhou Neologics Therapeutics, Inc. 

Senlin Liu, Zhongjin Zhide

Xinhao Zhao, Zhongjin Zhide

Hongyu Gui, Nanjing IASO Medical Technology Co., Ltd.

Jie Chen, Nanjing Bioheng Biotech Co., Ltd.

Zhipeng Su, Nanjing RegeneCore Biotech Co., Ltd.

Minqiang Zheng, Nanjing RegeneCore Biotech Co., Ltd. 

Tao Li, Nanjing Leadsbiolabs Co., Ltd. 

Shengli Cai, Nanjing Leadsbiolabs Co., Ltd. 

Malian Dong, Yinocon (Nanjing) Biomedical Technology Co., Ltd. 

Maoyuan Tian, Hangzhou Hechengyuan Biotech Co., Ltd.

Yao Liu, Hangzhou Hechengyuan Biotech Co., Ltd.

Wenbin Dou, Nanjing Nanyi Medical Investment Management Co., Ltd.

Shanghai UnionClin Co., Ltd (UnionClin) was founded in 2017. The headquartered is based in Shanghai. UnionClin focuses on oncology, infectious diseases, and autoimmunity, and delivers an integrated service from the strategy to implementation for clinical studies of new drugs.  Our services include clinical strategy consultation, protocol design, registration, pharmacovigilance, data management and statistics, clinical operations, independent medical imaging assessment, bioanalysis, clinical pharmacology, on-site management services at study sites, and personnel outsourcing. UnionClin’s team members are over 660, distributed across more than 25 cities nationwide.

An open industry exchange platform, held once a month, with 30 people, by invitation only, offline closed-door meetings, and high-level discussions. Here gathers founders, entrepreneurs, investment institutions, regulatory and clinical experts, and other industry professionals in the emerging biotechnology field, bringing together cutting-edge emerging technologies, capital market environments, equity and option design, challenges and pain points in enterprise development, entrepreneurial growth experiences, major macro policies, and other hot topics. Every month, founders, entrepreneurs, investors, regulatory and clinical experts, and other industry professionals gather here at the summit, exchange ideas, share resources, and efficiently communicate and share entrepreneurial experiences, innovation hotspots, clinical pain points, industry challenges, business strategies, investment and fundraising, IPO timing, and other popular focal topics.

The "Biomatrix Medicine Talk" themed salon empowers enterprises and spreads positive energy for the industry, promoting understanding, attention, and support for the biopharmaceutical industry from various sectors, including capital, scientific research, clinical, regulatory supervision, third-party service agencies, and others.