On the afternoon of February 29, 2024, R&G PharmaStudies Co., Ltd., in collaboration with Shenzhen Biomedicine Innovations Industrial Park, ECLINCLOUD, and bioisp.com, entered the Shenzhen Pingshan Biopharmaceutical Industrial Park to bring an offline conference themed "How to Accelerate Drug Clinical Research and Improve Drug Development Success Rates?" to the park and surrounding enterprises. This conference invited Professor Hu Bei, Chief Clinical Pharmacologist of R&G PharmaStudies Co., Ltd., Mr. Li Jigang, Chief Medical Officer, Mr. Qiu Jiancheng, Vice President, Dr. Qin Long, Founder and CEO of ECLINCLOUD, and Dr. Gao Zhiwei, General Manager of Shanghai MEAS Laboratories Co., Ltd. Together with more than 60 enterprise professionals in attendance, they conducted in-depth analysis and discussions on innovative drug clinical research strategies, top-level design, regulatory authorities' review and approval focal points, and the application of digital technology, empowering clinical research for Shenzhen's innovative drug companies.

Keynote Speeches

△ Hu Bei, Chief Clinical Pharmacologist of R&G

Professor Hu Bei, Chief Clinical Pharmacologist at R&G, introduced the topic using ADC drugs as an example. She shared content on problem-oriented clinical pharmacology research, current methods for selecting First-In-Human (FIH) doses, challenges and considerations in determining FIH doses, among other topics. Through sharing a case study on the Alcami ADC E-R (Exposure-Response) analysis, she delivered a keynote speech titled "Model-Guided Drug Development" to the participating enterprises. She stated, "All methods, regardless of their complexity, are aimed at reducing the uncertainty of benefit/risk during drug development and evaluation."

△ Li Jigang, Chief Medical Officer of R&G

Mr. Li Jigang, Chief Medical Officer of R&G, then gave a thematic presentation titled "Starting with the End in Mind: Interpreting Regulatory Review Flexibility from the Perspective of Clinical Value". By interpreting several cases of regulatory approval flexibility, he introduced the topic and made trend assessments of domestic and international review and approval policies. He stated that national review standards and innovative methods lead the thinking and strategy selection in product clinical development. Furthermore, he explained risk control in clinical development from aspects such as design, speed, ethnic factors, efficacy consistency, and safety, bringing new inspirations to the clinical development strategies of the enterprises present.

△ Qin Long, Founder and CEO of ECLINCLOUD

With the advancement of technology, digital technology is bringing revolutionary changes to drug development. Mr. Qin Long, Founder and CEO of ECLINCLOUD, shared a topic titled "Starting with the End in Mind: Empowering More Accurate Clinical Outcome Assessments through Digital Intelligence". He stated that clinical study systems have now completed informatization construction and are entering the early stages of digital construction. Regulations and policies both domestically and internationally are increasingly emphasizing the development of digital clinical trials. In clinical research, the use of eCOA (electronic Clinical Outcome Assessment) is greatly beneficial for data collection, making the data collected in studies more complete, accurate, timely, and compliant.

△ Qiu Jiancheng, Head of the Regulatory Affairs Department and Vice President of R&G

Mr. Qiu Jiancheng, Head of the Regulatory Affairs Department and Vice President of R&G, delivered a presentation titled "Introduction and Key Considerations for EU New Drug Registration". Mr. Qiu provided a detailed introduction to EU drug regulatory agencies, registration processes and their characteristics, milestone events in clinical trial applications, precautions for submitting CTAs via CTIS, considerations for transitioning to CTR, as well as the requirements and recommendations for IMPD documents. He offered practical advice to the attending companies regarding EU new drug registration applications.

△ Gao Zhiwei, General Manager of Shanghai MEAS Laboratories

At the end of the keynote speeches, Dr. Gao Zhiwei, General Manager of Shanghai MEAS Laboratories, shared on the topic "Early Prediction of Human PK and Dosage Based on ADME Characteristics of Innovative Drugs" through multiple case studies. The purpose of PK prediction is to minimize the risk of clinical development failure of candidate drugs due to exposure issues. Establishing and clarifying the PK/PD correlation is an important tool in the stages of drug discovery and development. Effective PK/PD experimental design, data analysis, and interpretation can help research scientists elucidate the PK-PD relationship, understand the mechanism of drug action, identify PK characteristics, and facilitate further compound design and optimization.

Round Table Discussion

In the final roundtable discussion session of the conference, Mr. Li Jigang, Chief Medical Officer of R&G, Professor Hu Bei, Chief Clinical Pharmacologist of R&G, Mr. Qiu Jiancheng, Vice President of R&G, Mr. Qin Long, Founder and CEO of ECLINCLOUD, and Mr. Gao Zhiwei, General Manager of MEAS Laboratories, engaged in a lively discussion on the topic "How to Accelerate Drug Clinical Research and Improve Drug Development Success Rates?"

After entering clinical research, 90% of candidate drugs will fail during Phase I, II, and III clinical trials and the drug approval process. This failure rate applies only to candidate drugs that have already entered Phase I clinical trials and does not include those in the preclinical stage. During this roundtable discussion, several experts engaged in in-depth exchanges on the focal points of clinical research for new drugs across various enterprises. The collision of multiple viewpoints and strategies provided attending companies with brand-new ideas. After the meeting, a number of company representatives also had individual exchanges with R&D experts.