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June 7, 2025
Shanghai
SDM Bioservices (or SDM) successfully held a closed-door workshop titled "The Power of Quantitative Pharmacology," featuring Dr. Yaning Wang, SDM’s Scientific Advisor, and former Director of the Quantitative Pharmacology Review Division at the FDA’s Center for Drug Evaluation and Research (CDER), as the keynote speaker. The event attracted over 40+ professionals from pharmaceutical companies, research institutions, and clinical organizations to explore the cutting-edge applications and practical value of quantitative pharmacology in innovative drug development.
Spotlight on Quantitative Pharmacology: Fueling Drug Innovation
Dr. Wang delivered a keynote presentation titled "The Power of Quantitative Pharmacology: Critical Insights from Landmark Clinical Development and Regulatory Cases," providing an in-depth analysis of the central role of quantitative pharmacology across the entire clinical development lifecycle of investigational drugs. With a dedicated focus on the core value of the closed-loop "predict-validate-optimize" methodology, he systematically demonstrated its implementation through multiple paradigm-shifting case studies.
Using Everolimus as a prime example, Dr. Wang showcased how quantitative pharmacology evolved from a "supportive tool" to a "core decision-making driver." By leveraging precise modeling and data analysis, it provided critical insights into pharmacokinetics and pharmacodynamics across patient populations, informing key decisions on dosing, regimen design, and patient stratification—proving its indispensable value in drug development.
Controversial cases like Aduhelm and Elevidys further demonstrated quantitative pharmacology’s role in accelerating approvals via surrogate endpoints. Dr. Wang explained how, in complex fields like neurology and rare diseases—where traditional trials face challenges—surrogate endpoints validated by quantitative pharmacology enable faster approvals. The FDA’s flexible regulatory approach in these areas, grounded in robust quantitative pharmacology methods, offers a blueprint for addressing unmet patient needs while maintaining scientific rigor.
Expanding the Frontiers of Innovation in Quantitative Pharmacology
When discussing future innovations and breakthroughs in quantitative pharmacology, Dr. Wang outlined a digital roadmap spanning molecular design to patient stratification. On the discovery front, AI-powered molecular screening can compress development timelines by severalfold. In clinical translation, multidimensional data integration enables unprecedented precision in patient stratification. This deep convergence not only accelerates R&D efficiency but also redefines the standards of precision medicine implementation.
Regarding differences in quantitative pharmacology guidelines between FDA and CDE, Dr. Wang emphasized that amid the rapid emergence of novel therapies, companies must adopt an open innovation mindset, proactively implement cutting-edge quantitative methods, and establish efficient communication channels with regulatory agencies to gain a competitive edge in this fast-evolving landscape.
SDM Biosciences Delivers One-Stop Quantitative Pharmacology and Early-Phase Clinical Solutions
According to Ms. Ruixian Wang, Senior Business Director at SDM Bioservices, as a leading Chinese CRO, the company has built a complete early-phase clinical development service package. Their early-phase clinical work covers full-spectrum research involving oncology patients, non-oncology patients, and healthy volunteers, with deep expertise across multiple drug development platforms including XDCs, small nucleic acids, cell and gene therapies, radiopharmaceuticals, and specialized drug delivery methods.
To date, SDM has successfully conducted more than 100 early-phase clinical projects, developing particular strengths in drug-drug interaction (DDI) studies, concentration-QT interval (CQT) analysis, mass balance research, and studies in patients with liver or kidney impairment. Their project portfolio includes innovative treatments like AAV gene therapy, ADC drugs, and oncolytic viruses, as well as specialized administration approaches such as glucose clamp studies, inhaled formulations, and joint cavity delivery.
Backed by a specialized early-phase clinical team of over 100 professionals and global resources, SDM combines quantitative pharmacology, bioanalysis, and early clinical development to significantly improve trial design efficiency, supporting clients' regulatory submissions both domestically and internationally while facilitating global expansion.
Interactive Exchange: Advancing Drug Development Through Quantitative Pharmacology
The workshop concluded with an engaging Q&A session, where participating experts held in-depth discussions with Dr. Yaning Wang and SDM's early-phase clinical development specialists on key topics including quantitative pharmacology modeling/simulation and regulatory submission strategies. Attendees unanimously agreed the event provided valuable practical insights.
"Quantitative pharmacology is transforming the paradigm of innovative drug development," summarized Dr. Hui Zhao, Deputy General Manager of SDM's Medical and Pharmacovigilance Center. "SDM will continue hosting these high-level exchanges while providing end-to-end support for early-phase clinical development through our 'model-informed + clinically validated' approach. Our full-service capabilities span from Phase I studies through pivotal registration trials, with specialized quantitative pharmacology and early-phase clinical services in cutting-edge areas like XDCs and CGTs to help clients optimize trial designs and mitigate development risks. Moving forward, we'll leverage these strengths to accelerate global patient access to China's innovative therapies."
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Beijing Shouyan Lab is certified by NGSP in the United States.
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At the intersection of the end of the year, we sincerely invite you to join us in focusing on the shining points of the year, and to look back together and cherish the bright moments that have illuminated our way forward in the past year.
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Dr. Wang delivered a keynote presentation titled "The Power of Quantitative Pharmacology: Critical Insights from Landmark Clinical Development and Regulatory Cases," providing an in-depth analysis of the central role of quantitative pharmacology across the entire clinical development lifecycle of investigational drugs.
As BaoPharm's strategic regulatory partner, SDM Bioservices' global registration team delivered comprehensive support for this project, including gap analysis, technical dossier compilation, and submission management services.
As a clinical development pioneer with twenty years of China-focused expertise, SDM Bioservices provides comprehensive clinical research solutions to pharmaceutical partners worldwide. Our integrated capabilities include proven regulatory submission experience across China, U.S. and EU markets, innovative early-phase development approaches, reliable bioanalytical services, and demonstrated expertise in managing large-scale clinical trials for therapeutic drugs, and specialized knowledge in vaccines and medical aesthetics.
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