Amador Bioscience Completes Global Footprint Across China, U.S., and Europe with New European Hub
Recently, Amador Bioscience, a global CRO specializing in translational science and clinical pharmacology, announced the establishment of its European center in Limburg, Belgium, at a “Seminar on the Development of the Belgian Biopharmaceutical Ecosystem” held in the theater hall of the Corda Campus in Limburg, Belgium.
The functions of Amador Bioscience’s European Center will encompass clinical pharmacology, Phase I clinical trials, bioanalytical laboratory services, clinical project operations management, and a joint graduate training program in quantitative pharmacology with Hasselt University, thereby advancing Amador Bioscience’s global development strategy.
Chen Xiaomin, General Manager of AMADOR BIOSCIENCE, stated, “AMADOR will expand its presence in the European market through joint ventures, strategic partnerships, and other approaches. The company has long been dedicated to translational science and clinical pharmacology services, establishing a mature service model. In the future, AMADOR’s European Center will collaborate with its U.S. and Chinese entities to provide global one-stop translational science and clinical pharmacology services.”
The 2018 “Notice on Organizing and Implementing the Special Project for the Construction of Contract Research, Development, and Manufacturing Service Platforms in the Biopharmaceutical Sector” proposed providing key support for the development of a cohort of high-caliber, internationally oriented, comprehensive contract research, development, and manufacturing service platforms in the biopharmaceutical industry, with a focus on enhancing R&D and manufacturing service capabilities, promoting the doubling of the bioindustry, and fostering new formats and models within the bioeconomy.
Amid the rising tide of innovative drug development, demand for pharmaceutical outsourcing continues to surge. However, for domestic innovative pharmaceutical companies, clinical pharmacology and translational science—key drivers of successful innovative drug R&D—remain emerging fields.
In the same year that national regulatory authorities issued policies encouraging CRO enterprises, Dr. Wang Bing, a renowned expert in clinical pharmacology and pharmacokinetics with over 20 years of experience in new drug R&D and management at multinational pharmaceutical companies; Dr. Zeng Rong, an immunology expert; Dr. Bao Haifeng, a translational science expert; and Ms. Chen Xiaomin, a clinical project operations expert, identified critical gaps in the demand for clinical pharmacology research and translational science. Together, they founded Amador Bioscience, an international CRO specializing in translational science and clinical pharmacology, to provide translation and clinical development services that meet international standards, including clinical pharmacology, laboratory testing (GCP/GLP), clinical project management, and regulatory submissions.
Clinical pharmacology studies span the entire drug development process, with a particularly significant role in the early stages, serving as a crucial safeguard and key bridge for the successful development of innovative drugs. Furthermore, since clinical pharmacology studies often focus on small sample sizes, they can expedite research progress, data acquisition, and result generation under safe conditions, thereby enabling developers to make informed decisions at an earlier stage.
Dr. Wang Bing, Co-founder and Chairman of AMADOR BIOSCIENCE, stated, “In fact, for first-in-class innovative drug development projects, clinical pharmacology provides not only auxiliary support but also guidance for drug R&D, helping enterprises maximize cost reduction and efficiency improvement.”
Furthermore, many pharmaceutical companies frequently encounter the predicament where compounds are poised to enter clinical trials but fail to demonstrate efficacy. This highlights the pivotal role of Translational Science as a bridge between basic research and clinical studies. By integrating pharmacokinetic (PK) and pharmacodynamic (PD) data with biomarkers, translational science can identify changes in compound behavior, thereby bridging the gap between preclinical and clinical phases. This approach helps reduce drug development costs and alleviates the pressure associated with the low productivity of critical new drugs.
AMADOR BIOSCIENCE provides biopharmaceutical companies with global-standard translational science and clinical pharmacology services. As its corporate logo suggests: “AMADOR is a bridge that connects not only the stages from preclinical to clinical development and market approval submissions, but also the Chinese and global markets, serving as the preferred global partner for the successful R&D of innovative drugs.”
As a global CRO specializing in translational science and clinical pharmacology, AMADOR BIOSCIENCE is dedicated to supporting innovative drug development projects across all stages, from preclinical to clinical phases and post-marketing, having established a solid foundation in both China and the United States.
Over the three years since its establishment, Amador Bioscience has provided professional services ranging from early-stage R&D and clinical development to regulatory submissions for more than 100 innovative pharmaceutical companies in China and the United States, successfully supporting multiple drug developers with domestic and international clinical trials and market approval applications. In 2021, Amador Bioscience achieved remarkable growth, with its client base expanding by 200% and order value doubling.
None of this would have been possible without Amador Bioscience.Experienced Team, Robust R&D Capabilities, and Professional Service Systemits global founding DNA.
Dr. Wang Bing, Co-founder of AMADOR BIOSCIENCE, is an internationally renowned expert in clinical pharmacology and pharmacokinetics, with over 20 years of experience in innovative drug research, development, and management at multinational corporations such as Amgen, Abgenix, and AstraZeneca.Dr. Wang Bing has directly participated in or led the Investigational New Drug (IND) applications and global marketing authorization submissions (BLA/NDA) for multiple disease areas, encompassing dozens of drug candidates including small molecules, recombinant proteins, monoclonal antibodies, immunotoxins, antibody-drug conjugates, and bispecific antibodies.
As a pioneer in the industry, Amador Bioscience leverages fully validated and compliant cloud server systems for SAS programming, PK/PD computational modeling, and clinical trial simulations to deliver professional clinical pharmacology services. These services span a wide range of therapeutic areas, including chemotherapy, targeted small-molecule drugs, peptides, monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs). Its high-quality services have gained widespread recognition from international clients in the European and American markets.
Dr. Zeng Rong, another co-founder of Amador Bioscience, as well as its Chief Operating Officer and Head of Laboratory Operations, is an expert in immunology, biomarkers, bioanalysis, and immunogenicity.He has over 20 years of international experience in immunology research and the preclinical and clinical development of innovative drugs (at institutions such as the University of Tokyo, the NIH, and AstraZeneca). He has published numerous highly cited research papers and industry white papers, and is a frequent invited keynote speaker and panelist at many U.S. and international professional conferences.
Amador Bioscience’s laboratory services specialize in the detection and analysis of pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity for innovative drugs. Leveraging analytical platforms such as ligand binding assays, mass spectrometry, cell-based assays, and PCR, we focus on the development and validation of biomarker and bioanalytical methods (PK/PD/ADA) for both small-molecule and large-molecule novel therapeutics, as well as sample analysis and bilingual (Chinese-English) reporting. Our laboratory facilities comply with GLP/GCLP standards, and our global service capabilities enable us to deliver efficient, high-quality, customized solutions to biopharmaceutical enterprises in China and abroad.
AMADOR BIOSCIENCE has established laboratory services in Hangzhou, China, and on the U.S. East Coast (Maryland) and West Coast (California). The laboratories in these three locations are currently undergoing renovation and expansion, with completion expected by March 2022.
Ms. Chen Xiaomin, General Manager of AMADOR BIOSCIENCE, has over ten years of extensive experience in global clinical drug development, including six years of project management experience in clinical development at Novartis in the United States.Under her leadership, Amador Bioscience provides clinical trial project management services to innovative drug R&D enterprises both domestically and internationally. The company assists clients in selecting clinical CROs, controlling project budgets, and overseeing project execution to ensure that projects are completed according to established objectives. It also offers professional services, including liaison with regulatory authorities, research centers, and ethics committees.
Furthermore, in its three core business areas—clinical pharmacology, laboratory testing, and project management—AMADOR BIOSCIENCE adopts global standards across its quality management system (QMS), personnel training framework, standard operating procedures (SOPs), and the establishment of data security, backup, and traceability mechanisms. Committed to rigorous standardization and global compliance, the company has earned a strong reputation within the industry.
Amador Bioscience has signed an agreement with the Belgian government to establish its European Center in the province of Limburg, Belgium. This marks the initial formation of Amador Bioscience’s international “triangular” presence across the three major pharmaceutical markets of China, the United States, and the European Union, signifying the full implementation of the first phase of its global strategic layout.
AMADOR BIOSCIENCE's Global Triangle Strategy | Image Source: AMADOR BIOSCIENCE
In fact, the collaboration between the Limburg government in Belgium and Amador Bioscience is a mutually beneficial partnership that achieves win-win results.
According to Dr. Wang Bing, many innovative pharmaceutical companies often set their sights on the U.S. market. In reality, as a unified entity, the European Union (EU) market is not only highly mature but also comparable in scale to the U.S. market. With substantial investment in R&D for innovative drugs, the EU has become a preferred destination for Phase I clinical trials of many novel therapeutics. However, for Chinese innovative pharmaceutical companies and even some contract research organizations (CROs), the EU market remains a relatively unfamiliar landscape despite its vast potential.
Amador Bioscience not only has extensive operations in China and the United States, but its team also brings years of experience in drug development at renowned European multinational pharmaceutical companies, with deep familiarity with market dynamics and regulatory requirements.Belgium boasts a privileged geographic location, hailed as the “Heart of Europe” and the “Crossroads of Western Europe.” With widespread bilingualism in English and French, along with a highly developed economy and rich cultural heritage, it offers an ideal setting for establishment. By setting up operations here, AMADOR BIOSCIENCE can fully leverage its strengths to expand its European translational science and clinical pharmacology teams, using Belgium as a strategic hub.
Driven by the market, an increasing number of biopharmaceutical companies are seeking to enhance their innovative R&D capabilities and intensity through various avenues, with License-in being one such model.The formation of a “triangular layout” spanning China, the United States, and Europe will help Amador Bioscience further leverage its relationships with the NMPA, FDA, and EMA, as well as its global experience and team, to assist pharmaceutical companies in going global.
Dr. Wang Bing stated“Europe is a key player in the global innovative drug market. The establishment of Amador’s European Center will facilitate exchanges and deepen mutual collaboration among China, the United States, and Europe in new drug research and development. The core team members of Amador all possess over twenty years of industry experience in innovative drug development and an international perspective. The launch of the European Center further enhances Amador’s global platform, enabling it to provide better solutions for new drug R&D enterprises worldwide and build a bridge for their entry into the global market.”
Jos Lantmeeters, Governor of the Province of Limburg, Belgium, stated, the Corda Health Industrial Park integrates advantageous resources from multiple stakeholders, including scientific research institutions, healthcare providers, enterprises, and local government. Located within a university campus, the industrial park enables international companies to directly access talent pools such as doctoral and master’s graduates from the School of Health and Life Sciences, the Academy of Biomedical Sciences, and the School of Global Health. The arrival of AMADOR BIOSCIENCE will significantly boost the development of the local ecosystem and create new global employment opportunities.
Upon establishing operations in Limburg, AMADOR BIOSCIENCE will collaborate with the Department of Biostatistics and Medicine at Hasselt University to cultivate talent in quantitative pharmacology.“Currently, few universities in China and abroad offer specialized programs in clinical pharmacology, leading to an acute shortage of high-end talent, while demand from pharmaceutical companies and regulatory agencies is experiencing explosive growth. We are launching a global graduate training program in quantitative clinical pharmacology and are conducting preliminary preparations in multiple countries, with plans to fully implement the program in China, the United States, and Europe by 2022,” said Dr. Wang Bing.
In the future, Amador Bioscience will continue to refine its global service system, distinguished by clinical pharmacology and translational science, while actively integrating innovative digital technologies such as machine learning and artificial intelligence. The company aims to establish itself as a world-leading CRO brand in clinical pharmacology and translational science, comprehensively driving the development of the new drug R&D industry through a win-win mindset.