From March 21 to 24, 2024, the Innovative Medicine Conference and the 2024 CMAC Annual Meeting, themed "Focusing on Medical Value, Building an Innovative Ecosystem Together," was grandly held in Suzhou. The event brought together more than 6,500 industry experts from regulatory agencies, hospitals, pharmaceutical industries, and other sectors to jointly build an innovative ecosystem and discuss high-quality development.
As a well-known publicly listed CRO enterprise, R&G deeply participated in this grand event, collaborating with CMAC to hold a joint forum themed "Comprehensive Evaluation of the Sufficiency of Efficacy Evidence for Innovative Drugs: Strategy, Design, Quality Control, Execution." Professor Hu Bei, R&G's chief clinical pharmacologist and founder of Lingchu Medical Technology; Dr. Wang Yaning, CEO of Createrna and former director of the Division of Pharmacometrics at the U.S. FDA; Dr. Fang Weijia, director of the Department of Medical Oncology at the First Affiliated Hospital, Zhejiang University School of Medicine; Dr. Sui Ziye, CEO of Lepu Biopharma; Mr. Li Jigang, R&G's chief medical officer; and Ms. Li Juan, statistical director of R&G's subsidiary Aikeman, along with other industry experts, attended the forum to discuss with pharmaceutical R&D colleagues the challenges, trends, and best practices in innovative drug development.
Professor Hu Bei, R&G's chief clinical pharmacologist and founder of Lingchu Medical Technology, shared an insightful and accessible presentation on "Opportunities and Challenges in Clinical Pharmacology Research of Innovative Drugs—Model-Informed Drug Development Strategies". She delved into multiple dimensions including the guidance and urging role of new guidelines, the role of clinical pharmacology in the clinical development of new drugs, model-informed drug development (MIDD) strategies, application cases, as well as opportunities and challenges.
Mr. Li Jigang, Chief Medical Officer of R&G, shared with the participants the considerations for sufficient evidence of effectiveness in innovative drug development. He drew from the FDA's guidelines on "Sufficient Evidence of Effectiveness," the "quality" and "quantity" of efficacy evidence, and the strength of efficacy evidence, combined with hot cases in the industry, elaborating on the concept that "Quality by Design".
Dr. Wang Yaning, CEO of Createrna and former director of the Division of Pharmacometrics at the U.S. FDA, shared with the participants the FDA's requirements for efficacy and safety evidence of drugs with the same target and similar indications during the review process. He provided insights from a global and regulatory perspective, combined with classic FDA review cases.
Dr. Sui Ziye, CEO of Lepu Biopharma, shared with the participants the current status of clinical development of innovative drugs from aspects such as investment trends, stricter review policies, and development strategies. Using ADC drugs as an example to initiate discussion, she elaborated on how to accelerate clinical development.
Dr. Fang Weijia, Director of the Department of Medical Oncology at the First Affiliated Hospital, Zhejiang University School of Medicine, shared innovative patient-centered clinical research with the participants from an investigator's perspective.
In the panel discussion session, the attending guests continued to engage in wonderful discussions and exchanges of ideas around "Sufficient Evidence in Clinical Research of Innovative Drugs". They covered a series of topics such as single-arm design, conditional approval for marketing, clinical trial sample size calculation, and domestic and international requirements and differences in the review of sufficient evidence, providing the clinical research colleagues in attendance with a feast of knowledge in innovative drug clinical development.
During the conference, the R&G team showcased their latest service experiences and R&D achievements across the entire CRO chain, including medical affairs of clinical trials, data management, statistical analysis, clinical pharmacology, clinical operations, regulatory affairs, pharmacovigilance, and biosample testing. They also engaged enthusiastically with booth visitors, providing professional clinical research insights.
