On March 15, 2024, UnionClin invited insightful and influential experts and leaders in the field of pharmaceutical innovation, together with pharmaceutical colleagues from various sectors, to gather in Gusu, and the UnionClin Suzhou Salon concluded successfully.

The salon was co-hosted by Ms. Lan Jiang, Head of the Central Medical Department of UnionClin, and Dr. Shen Xiao, CMO of 3DMed. The meeting focused on the overall development strategy from new drug research and development to market launch, especially key clinical designs and focal points of international transactions and collaborations for innovative drugs, engaging in in-depth discussions with participating guests on forward-looking considerations for high-quality clinical studies.

Ms. Lan Jiang, Head of Central Medical Department, UnionClin Dr. Shen Xiao, CMO of 3DMed

TOPIC 01 

Professor Ye Guo，East Hospital Director of New Drug Phase I Ward

From a Clinical Perspective
Development of Novel Bispecific Antibodies

Focusing on bispecific drugs with enormous future potential, Professor Guo introduced the targets, clinical studies, and current global approval status of bispecific antibodies sequentially, and deeply analyzed and summarized the advantages and disadvantages of bispecific antibody development, as well as the lessons learned from the successes and failures behind the cases. 

Professor Ye Guo Director of New Drug Phase I Ward, East Hospital

Professor Guo considers that from the development perspective of bispecific antibodies, the synergy of dual targets in mechanism and preclinical studies does not guarantee success in clinical studies. For bispecific antibodies based on immune checkpoints, it is essential to select appropriate tumor types and lines of therapy for development; the existence of unmet needs is extremely important. Under the premise of controllable safety, POC research data should demonstrate superiority over monoclonal antibodies. In the absence of a definite mechanism, blind attempts on populations with primary resistance to immunotherapy should be avoided. For bispecific antibodies based on tumor-associated antigens, it is necessary to rely on single-target data, combine with the domestic and international competitive landscape, select appropriate tumor types and lines of therapy for development, and consider at any time whether combination with other drugs is necessary. Developing ADC drugs may enhance efficacy, but safety remains a challenge. Therefore, exploring possible biomarkers is crucial at all times. 

TOPIC 02

Director Hua Zhang，The First Affiliated Hospital of Soochow University

Director of the Office of Drug Clinical Trial Institution，Director of Phase I Clinical Research Unit

Introduction to Work of Drug Clinical Trial Institution and
Clinical Translation

Through nearly 22 years of clinical research development, The First Affiliated Hospital of Soochow University has now achieved full coverage of clinical diagnosis and treatment specialties. Director Hua Zhang introduced that in the past five years, 1,467 clinical research projects have been carried out, including 647 investigator-initiated clinical research projects and 820 registered studies. The types of projects undertaken cover drug registration trials from Phase I to Phase III, Phase IV clinical studies, and clinical translational research of drugs and devices. 

Director Hua Zhang The First Affiliated Hospital of Soochow University

Director of the Office of Drug Clinical Trial Institution/Executive Head of Phase I Clinical Research Unit

The hospital focuses on strengthening cooperation with enterprises and research institutes, continuously optimizing and innovating service processes, building distinctive platforms for clinical research and translation, promoting industrial transformation and development through multi-party collaboration among industry, academia, research, and medicine, and assisting enterprises in extensive practice and exploration. 

TOPIC 03

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

Key Clinical Study Design and
R&D Risk Control

Compared with the early clinical stage, pivotal clinical studies have clearer trial objectives, more uniform requirements for subjects, fixed and definite dosing regimens, the primary endpoint becomes definitive clinical benefits, and require more confirmatory statistical requirements. 

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

After listing a series of pivotal phase risks, Dr. Han Haixiong pointed out that to cope with risks, it is necessary to conduct sufficient preliminary exploration, continuously strengthen strict control over trial participants, and ensure the accuracy of statistical assumptions. At the same time, there needs to be a certain degree of foresight regarding changes in diagnosis and treatment, and a prediction should be established about the impact on the R&D layout of similar products. The principal investigators involved in R&D need to have strong overall control over the trial, be able to discuss the trial protocol deeply and clearly, and the final protocol should be agreed upon by everyone. 

TOPIC 04

Dr. Zibao Zhang，General Manager of Union Laiya

International Transactions and Cooperation for Innovative Drugs
Requirements for Clinical Study Data

From 2008 to 2023, both the volume and value of Chinese innovative drugs entering overseas markets have risen steadily, especially with the more vigorous licensing collaborations in popular R&D tracks last year. In this regard, Dr. Zipao Zhang considers that data compliance, data quality and authenticity, and meeting scientific requirements are the core demands for international transactions and cooperative data. Whether clinical data is directly used for registration submission, whether it is critical clinical data, the buyer's due diligence requirements, and whether it is executed according to CDISC standards will all have significant impacts on the normative requirements of clinical study data. 

Generating data that meets NDA/BLA requirements not only facilitates accurate understanding and exchange of data between transaction/cooperation parties, internal management within pharmaceutical companies, communication of service requirements with CROs, and future data submission and communication with regulatory authorities, but also helps enterprises continuously explore additional data value and reuse. 

Dr. Zibao Zhang General Manager of Union Laiya

Currently, global clinical study data requirements are becoming increasingly standardized, among which the CDISC standard is one of the main norms. Dr. Zhang introduced that in February this year, Union Laiya (a subsidiary of UnionClin) officially became a corporate member of the Clinical Data Interchange Standards Consortium (CDISC). This is recognition of CDISC for Union Laiya's relentless pursuit of standardized, efficient, and international clinical research data standards, as well as the efforts and achievements of clinical CRO services going abroad. To meet the differentiated development needs of more domestic and international enterprises, Union Laiya will also provide free basic CDISC training and technical support.

PANEL DISCUSSION

Host: Dr. Shen Xiao, CMO of 3DMed

The roundtable session was moderated by Dr. Shen Xiao, CMO of 3DMed, who has 20 years of FDA review experience. Engaging with experts and the entire audience, he facilitated enthusiastic discussions and in-depth exchanges focused on their respective business priorities, yielding fruitful results. 

Dr. Xiao Shen CMO of 3DMed

Under the current domestic economic situation, the primary goal of many Chinese biotech companies is to "go global." Whether for financing needs, product rights transactions, or seeking multinational corporations (MNCs) as global co-development partners, obtaining FDA-IND approval and having patients enrolled and dosed in the United States are two very significant milestones. 

To this end, UnionClin has established advantageous strategic layouts with numerous U.S. partners to help more enterprises reduce costs and increase efficiency. By leveraging a global network of top principal investigators (PIs), mature in-hospital data collection and analysis systems, and standardized processes, we assist domestic biotech companies in completing simultaneous IND filings in China and the U.S., as well as conducting U.S. investigator-initiated trials (IITs). Our services include PI selection and liaison consulting, execution and supervision of U.S. IIT studies, data analysis of research results, meta-analysis, and development strategy consulting, as well as subsequent optimization of clinical study designs based on real-world data.

Based on industry adjustments and environmental impacts, the trend of cooperation and integration within the industry is bound to form more new business patterns. Facing numerous crossroads in the clinical development of innovative drugs, new drug founders need to continuously iterate their composite abilities. They must be both down-to-earth, acting as resilient and patient solitary warriors, and look up at the stars, transforming into strategic masterminds. UnionClin hopes to navigate and safeguard more solitary warriors and strategic masterminds in their critical clinical decisions through professional advantageous resources and integrated solution capabilities, steadily traversing cycles!