On July 12, 2024, the academic salon titled "The Value and Key Considerations of Quantitative Pharmacology Research in New Drug Development," hosted by Asymchem Clinical (Clin-nov) and Gaobo Clinical Research Center, was successfully held at the Shanghai Drug Hunters Club. The event brought together researchers, pharmaceutical companies, and clinical pharmacology experts to explore the pivotal role of quantitative pharmacology in drug development. Participants shared their latest research findings, practical experiences, and engaged in discussions on the application and future of quantitative pharmacology in the development of new drugs in China.
Ms. Peng Ruiling, Chief Technology Officer (CTO) of Asymchem Clinical, opened the event with an enthusiastic welcome. Mr. Yin Qi, Chief Development Officer & Head of U.S. at Asymchem Clinical and Dr. Hou Jie, Director and Chief Medical Officer of Gaobo Clinical Research Center delivered the opening remarks and co-hosted the event.
The keynote presentations featured several distinguished speakers:
• Dr. Zhao Rong, Head of Clinical Pharmacology at Roche (Genentech) China, addressed the regulatory challenges and technological advancements in "Dose Optimization of Antitumor Drugs." She provided comprehensive criteria for dose selection and optimization illustrated by case studies on TKI targeted drug Asciminib and the CD20/CD3 bispecific antibody Mosunetuzumab. Dr. Zhao showcased how multi-model quantitative pharmacology can accelerate clinical development and the market launch of antitumor drugs.
• Mr. Liu Yuwang, Head of Clinical Pharmacology at BeiGene Innovation Beijing, presented on "The Application of Quantitative Pharmacology in Race Difference Assessment." He discussed the role of quantitative pharmacology in evaluating racial differences during various stages of drug development, highlighting case studies involving Empagliflozin, Alisertib, and Vericiguat.
• Dr. Zhou Xue, Director of Pharmacokinetics and Pharmacodynamics at Asymchem Clinical, explored "Key Clinical Dose Selection and Recommendations Using Quantitative Pharmacology." He analyzed clinical strategies and dose selection methods focusing on the DS8201 case study to guide drug development using quantitative pharmacology methodologies.
• Dr. Xiang Xiaoqiang, Director of Clinical Pharmacy and Pharmaceutical Affairs at Fudan University's School of Pharmacy provided insights into "The Application of PBPK Models in Drug Interaction Assessment." Dr. Xiang reviewed advancements in physiological-based pharmacokinetic (PBPK) models and drug-drug interaction (DDI) studies, using Anlotinib, Ensartinib, Ripretinib and Paxlovid as case examples.
Following the presentations, Dr. Hou Jie moderated a roundtable discussion featuring conference speakers along with Asymchem Clinical, CDO Yin Qi. The session fostered an interactive dialogue on topics such as racial differences, quantitative pharmacology models, clinical dose selection and C-QTc studies of ADC drugs.
This academic salon offered a comprehensive examination of the critical role of quantitative pharmacology in drug development covering regulatory interpretations, theoretical insights, and practical case studies. It reinforced the importance of quantitative pharmacology in optimizing the drug development processes.
As a leading science and technology-driven Clinical Research Organization (CRO), Asymchem Clinical (Clin-nov) has built a robust global presence over the past decade. With a professional team that has supported over 600 clients and completed more than 1,200 projects, Asymchem Clinical provides high-quality, end-to-end new drug development services worldwide. Asymchem Clinical also offers tailored clinical pharmacology research plans for every stage of a drug's lifecycle, serving clients across the United States, Europe, Japan, and other regions. Their innovative solutions provide critical support for decision-making in clinical research, ensuring efficient and successful outcomes for global partners.
