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On July 3, 2024, SDM Bioservices and Shanghai Ruiningkang Bio-Pharmaceutical Technology Development Co., LTD. (" Ruiningkang Bio ") reached a strategic cooperation to work together to help innovative drugs in the quantitative pharmacology, dose exploration level, and promote more innovative drugs with global competitiveness to the market.
Dr. Yuanwu Bao, general manager of Shouyan, and Dr. Wang Yaning, founder of Ruiningkang Biology
In recent years, quantitative pharmacology has developed rapidly in China, and its role in new drug development and precision medicine has become increasingly significant, and has been widely recognized by the industry. Since 2020, CDE of the State Drug Administration has issued important guiding technical principles such as "Technical Guidelines for Population Pharmacokinetic Studies" and "Technical Guidelines for Model-guided Drug Development", which provide strong support for the development of quantitative pharmacology. Quantitative pharmacology uses modeling and simulation (M&S) technology to conduct quantitative and integrated research on pharmacokinetics (PK), pharmacodynamics (PD), and exposure-effect (efficacy and safety) relationships, and guides drug development through mathematical model construction and simulation extrapolation, which can run through the whole life cycle of new drug discovery, preclinical, clinical and post-marketing evaluation.
In this strategic cooperation, the two sides will focus on strengthening cooperation on innovative drugs in the fields of dose exploration optimization, population pharmacokinetics, population pharmacodynamics, expose-effect relationship support drug benefit risk assessment and optimal dose selection, alternative endpoint development, etc., to solve the following problems:
Enhance thescientific research and development decision: Through the construction and verification of pharmacokinetic and pharmacodynamic models, to provide more accurate understanding of drug behavior and mechanism of action in the human body for researchers and developers, and then support the scientific selection and verification of drug targets to ensure the correctness of research and development direction.
Precise guidance for clinical trial design: Quantitative pharmacology technology is used to accurately evaluate the relationship between the safety and effectiveness of new drugs and drug exposure and dose, and to predict the pharmacokinetics, safety and effectiveness of drugs in human body through model and simulation technology, so as to optimize clinical trial design and improve the efficiency of clinical trials.
Support for special population studies: population pharmacokinetic modeling and simulation can help predict the pharmacokinetic characteristics of special populations, helping to provide strong support for drug dose adjustment and safety assessment.
Improve research and development efficiency and success rate: Quantitative pharmacological models to guide early drug research and development can optimize trial design, improve trial success rate, support review decisions, and shorten the process of new drugs to market.
Dr. Yaning Wang, founder of Ruiningkang Biology, said:
I have been engaged in the review of new drugs in FDA for 18 years, experienced many important historical nodes of quantitative pharmacology in the review of new drugs, and served as the director of the review Department of Quantitative Pharmacology. The department I am responsible for is the only review department in FDA that covers all disease areas, and this experience is a very valuable asset for me. Today, we set up Ruiningkang Biological, hoping to help Chinese enterprises optimize the clinical development and registration strategy of innovative drugs through previous review and approval experience, and support the approval of innovative drugs. SDM is a well-known CRO operating for nearly 20 years, and its project experience covers a comprehensive range of disease fields, including cancer, endocrine metabolism, infection, immunity, etc. I believe that in the future cooperation, both parties will work together to give full play to their respective advantages, apply quantitative pharmacology to the whole process of clinical development of innovative drugs, improve the efficiency of drug research and development, shorten the time to market, and provide reliable data support for the research and development of innovative drugs.
Dr. Yuanwu Bao, general manager of Shouyan, said:
SDM has built an integrated clinical development service platform company through self-establishment. As a subsidiary of SDM focusing on early clinical research, Shouyan has higher requirements for professional and scientific clinical research services, in which quantitative pharmacology will play an increasingly important role. The cooperation between SDM and Ruiningkang Biological, with the support of Dr. Yaning's profound expertise in quantitative pharmacology and previous FDA review experience, will provide customers with better service, effectively help enterprises solve the problems and difficulties faced by quantitative pharmacology in the development of innovative drugs, and help China's innovative drug enterprises to move forward steadily on the road of research and development.
Dr. Yuwen, SDM SVP&CBO, said:
Dr. Yanin's capabilities and contributions to the FDA are well known in the industry. At the same time, Dr. Yaning is a very practical doer. In the context of current globalization, SDM can sign a strategic contract with Ruiningkang Bio-founded by Dr. Yaning, which will surely better help China's innovative drug enterprises do a good job in new drug research and development and better benefit patients.
This signing also invited industry colleagues to witness and interact on the spot.
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