On June 18, 2023, hosted by UnionClin and co-organized with Genhouse and Taizhou Enze Medical Center, the thematic salon titled "Challenges and Responses Faced in Early Clinical Studies of New Oncology Drugs" was successfully held at Taizhou Hospital. This event aimed to gather industry wisdom and resources to help promote scientific and efficient clinical development of new drugs, empowering sponsors to accelerate the market launch of new drugs.

The salon was jointly hosted by Professor Jiansheng Zhu, Dean of Taizhou Enze Clinical College, and Lan Jiang, Head of the Central Medical Department of UnionClin. Yinghe Xu, Party Secretary of Taizhou Enze Medical Center (Group), Dr. Kuifeng Wang, founder of Genhouse, and Junlin Wang, founder of UnionClin, delivered speeches. (See the list of attending guests at the end of the text.)

"Although innovative drugs only began to emerge around 2010, over the past decade, in terms of quality and innovative achievements—especially in the research and development of new oncology drugs—the gap between China and the international community has been narrowing, and we have significant advantages in certain fields. Whether a drug is good is determined by scientists, but whether it can be successfully developed requires the concerted efforts of clinical doctors, sponsors, and professional CROs. We look forward to the next ten years when we no longer need to look back on which drugs we've worked on but can proudly tell the world which drugs we've successfully developed."

——Mr. Junlin Wang, Founder of UnionClin

"Operation and Development of Phase I Clinical Study"

Director of Phase I Clinical Study Ward, Zhejiang Cancer Hospital

Professor Zhengbo Song

Selecting Suitable Investigators: Renowned investigators vs. frontline investigators? Single-disease investigators vs. pan-cancer investigators? 

A good investigator is genuinely interested in the project itself, not just adding projects; invests time in the project, rather than acting as a hands-off overseer; controls patient enrollment, rather than relying on sub-centers; identifies advantageous diseases and oversees future directions. 

Requirements for Sponsors:

○ Sponsor's medical team: Needs to possess professional medical capabilities, strategic decision-making abilities on key points, and a global perspective

○ Sponsor's preclinical team: conduct comprehensive preclinical research and avoid simply replicating similar foreign studies

○ Sponsor's execution capabilities: dedicated clinical study operation team, provide good medical-related services, keep relevant project information updated

"Several Approaches for Early Clinical Studies Conducted Simultaneously in China and the U.S."

Chief Medical Officer and Registration Director, UnionClin

Dr. Haixiong Han

Key Focuses to Promote Global Synchronous Development of New Drugs

○ Dose Rationality: For medications that require long-term use, doses that are too low or too high may exhibit minor differences in response rates or safety in the short term, but their cumulative effects could affect patients' long-term survival benefits.  Acquiring data from Chinese subjects early helps in formulating dosing regimens that better align with the characteristics of Chinese subjects and maximize benefits. 

○ Sample Size Proportion: Exploratory research phase (no specific proportion requirement), pivotal registration studies (ICH E17)

○ Regional Differences in Disease Diagnosis, Treatment, and Prognosis: Impact of Patient Characteristics, Disease Characteristics, Treatment Goals, Treatment Methods, Lifestyle Habits, and Socio-Cultural Factors on Disease

○ Different Regulatory Requirements across Countries/Regions: Administrative requirements, number of exposed individuals/observation duration, etc.

Dr. Han Haixiong further shared how to integrate into global synchronous development at various stages of research in China: dose-escalation phase, expansion/concept validation after determining RP2D, pivotal registration studies, bridging studies; and shared the case of Zanubrutinib achieving simultaneous development in China and the U.S. 

《How to Effectively Find MTD? - Design Strategies for Early Clinical Studies in Oncology》

Senior Director of Biostatistics, UnionClin

Mr. Lei Zhang

Key Points in Dose-Escalation Design

○ Target toxicity rate? If the drug is highly toxic, the range is 0.20-0.30; if the drug is less toxic or intended for long-term use, the range is 0.10-0.20

○ Enroll subjects in cohorts. Need to set the cohort size (usually 3) and the number of cohorts. 

○ Maximum number of patients enrolled in a single dose group. Need to be confirmed (e.g., set as 9, 12)

○ Determine the exploratory dose levels (e.g., 1mg/10mg/20mg/50mg/150mg/300mg) and consider whether embedding accelerated titration is necessary

Finally, Mr. Lei Zhang provided the guests with a detailed introduction to UnionClin's scientifically standardized statistical services, including biostatistics, data science, statistical analysis and programming, and other supporting services.

"Innovative SMO Supporting Early Clinical Study in Oncology"

Senior Director of START

Ms. Min Zhang

Ms. Min Zhang explained that START, by introducing the mature management system for early clinical research of new anti-tumor drugs from START in the United States and drawing on its rich practical experience, is building a world-class high-level clinical research platform and research team to accelerate the development of new anti-tumor drugs in China. Members of the Shida research team include not only their own operations management, comprehensive management, and quality assurance teams, but also investigators, nurses, and pharmacists from the research centers, with core members having received professional training from START in the United States. Currently, they have formed embedded collaborations with multiple centers such as Shanghai East Hospital, Shandong Cancer Hospital, the First Affiliated Hospital of Nanchang University, and Harbin Medical University Cancer Hospital, providing on-site clinical study management services to large multinational and domestic pharmaceutical companies as well as small and medium-sized innovative biotechnology companies. 

"A Brief Discussion on Designing Clinical Research Based on Clinical Questions"

Taizhou Enze Medical Center (Group)

Director of Respiratory and Critical Care Medicine at Taizhou Enze Hospital

Professor Dongqing Lyu

Through the introduction of several cases, Professor Dongqing Lyu shared her views on designing clinical research based on clinical questions. 

Facing the challenges in early clinical studies of new oncology drugs, as an excellent service provider in the domestic pharmaceutical field, UnionClin relies on a professional team of over 600+, with more than 25+ locations nationwide, specializing in clinical studies of new drugs in the fields of oncology, infectious diseases, and autoimmune diseases, and has accumulated experience in over a hundred projects. On the journey to help sponsors accelerate new drugs to benefit patients as soon as possible, UnionClin has always adhered to "double speed", working hand in hand with peers to deeply cultivate the clinical medical platform, united in purpose, forging ahead, to achieve substantial success in China's anti-tumor new drug research and development. 

pSwipe up to view the list of attendees

Yinghe Xu, Party Working Committee of Taizhou Enze Medical Center (Group)

Jiansheng Zhu, Taizhou Enze Clinical College

Zhengbo Song, Cancer Hospital Chinese Academy of Medical Sciences

Dongqing Lyu, Taizhou Enze Hospital, Taizhou Enze Medical Center (Group)

Kuifeng Wang, Genhouse

Haidan Wang, Genhouse

Yuanyuan Sun, Shuangyun BioMed

Jingwei Jiang, Shuangyun BioMed

Xin Wu, Ranok

Hongliang Jiang, Wuhan Hongren

Jiaqiang Cai, Medilink Thera

Songming Peng, NeoWise

Haihong Ni, Yashen Zhihui

Xin Dong, NEOLOGICS

Yonghan Hu, EVOPOINT

Min Li, Tyercan Biopharmaceuticals

Minjie Hu, Prajna Biotech

Junlin Wang, UnionClin

Haixiong Han, UnionClin

Lan Jiang, UnionClin

Lei Zhang, UnionClin

Min Zhang, START

Zhengrong Wang, Taizhou Hospital

Tienan Bi, Taizhou Hospital

Yafei Mi, Taizhou Hospital

Qin Huang, Taizhou Hospital

Guangbiao Xu, Taizhou Hospital

Zhenghua Hong, Taizhou Hospital

En Wang, Taizhou Hospital

Minghai Shao, Taizhou Hospital

Yangjun Cai, Taizhou Hospital

Yu Chen, Taizhou Hospital

Minli Zhang, Taizhou Hospital

Zhanrong Ye, Taizhou Hospital

Changwei Feng, Taizhou Hospital