As a service provider, Amador Bioscience Inc (AmadorBio) strives for both high-quality results and a superior customer experience. We offer integrated services that can be customized to all your project needs. With an average of ≥15 years of global industry experience and advanced degrees, our exceptional team brings a combination of subject matter expertise and depth of experience to each project. We are dedicated to your success, maintaining seamless communication and collaboration as an extension of your company.
- AmadorBio is a highly experienced and well-integrated team of clinical pharmacologists, bioanalytical, translational & clinical scientists, clinical trial management experts, biostatisticians, CMC experts, regulatory specialists, quality assurance auditors, and project managers.
- Our support includes the technical, operational, quality, compliance and regulatory phases of preclinical and clinical drug development programs.
- Our experts collaborate with >30 leading biopharma companies on projects from lead candidate profiling to CTD.
- AmadorBio operates in biotech hubs: San Francisco Bay Area, USA and Shanghai-Hangzhou-Suzhou region, China, supporting global drug development and regulatory filings.
- AmadorBio also has representations in South Korea and Hong Kong.
- Clinical development, translational medicine & regulatory submission strategy
- Clinical pharmacology, pharmacometrics, advanced modeling & simulation
- Statistics, SAS programing, protocol development, SAP
- GLP & GCP-compliant bioanalytical laboratory that specializes in PK/PD/ADA/ biomarker assay development and sample analysis
- Fully-integrated & global-standard clinical research teams, including medical (US), safety (China), data management (China), statistics (US), monitoring (US and China), and project management (US and China)
Bing Wang, Ph.D., CEO, Renowned expert in clinical pharmacology & pharmacometrics
- Built & led Clin PKPD & PMx functions at AstraZeneca (AZ) / MedImmune (MEDI);
- 21 years of modeling & 19 years of drug development experience at Amgen, Abgenix, AZ / MEDI
- >90 publications; organizer / speaker at numerous scientific / medical / FDA conferences
Rong Zeng, Ph.D., COO, Recognized expert in immunology, biomarkers, bioanalysis / immunogenicity
- 20 years of experience in immunology research and preclinical / clinical development of biologics for cancer and autoimmune diseases (IMSUT, NIH, AZ / MEDI, OncoMed)
- Published a number of highly cited research articles and some industry white papers; Invited speaker/panelist at several US / international professional conferences
Xiaomin Chen, MBA., Sr. VP and General Manager Expert in clinical development and program management
- Over 11 years’ experience in clinical development in global Biopharma
- 6 years of clinical development project management experience at Novartis (NJ, USA)
- Led 50+ team members in 14 countries to successfully execute multiple global Ph3 trials and submission; authored or contributed to CDP, protocols, SOP & regulatory documents
- 5+ years of GLP TK/PK/PD data analysis & reporting, QC, QA and regulatory filing experience (AZ/MEDI & Exelixis)
Xiaoyan Xing, MD, Ph.D., CMO Expert in clinical development and protocol design
- 12+ years of medical experience in clinical sites, global pharma and CRO
- Leading clinical development strategy for diverse pipelines, especially in oncology
Haifeng Bao, Ph.D. Expert in translational medicine
- Led cross-functional Translational Sciences teams; Built & managed biomarker labs
- 18+ years of industry experience at Incyte, Amgen, AZ/MEDI
- >40 publications; Invited speaker at numerous scientific and medical conferences
- Served on scientific advisory board for NCI’s CSSI
Lingling Zhu, B Pharm, VP, Trial Management Expert in China clinical trial management and related regulatory requirement
- 15 years of China clinical trial management experience in global & local Pharma and CRO
- Managed Phase 1 to 4 trials in major China medical institutes with established relationship
- Vast local knowledge in China site selection, start-up, enrollment, and effective monitoring
Ryan Criste, Pharm.D., Director, Clinical Pharmacology Expert in clinical pharmacology
- 10+ years of clinical development and cross-functional Translational Sciences
- 5+ years of clinical experience in CRO environment (Quintiles, PPD)
- 10+ years of GXP TK/PK/PD data analysis and reporting, QC, QA and regulatory filing experience (AZ/MEDI, PPD)
Zhiyong Xu, MS, Senior Engineer, Laboratory Director Expert in immunoassay for biomarker and antibody engineering
- 3 years of antitumor new drug development experience
- 12+ years of immunoassay for biomarker (Her2, GP73, hCG) and pathogenic microorganism (HB, EV71, TB) experience
- 9+ years of antigen and antibody (for HBs, EV71, GP73, hCG) preparation and production experience
AmadorBio USA & China
Amador USA is located in Pleasanton, San Francisco Bay Area，which was established by the merger of Alpha Pharma (2016-2018) and Lucid CPS LLC (2017-2018). At present, consulting as major business, we provide consultation and clinical/entry declaration services for American Innovative Pharmaceutical Company in clinical pharmacology, bioanalysis and translational medicine, and also the agency supervision services for other CROs and consulting firms.
Amador China is located in Singapore Science Park, Hangzhou China. The design, construction and decoration of internal facilities are in strict accordance with international first-class laboratory and office area standards. The laboratory is equipped with international advanced analytical devices, standard equipments and operating system. The office area is open and bright with several sound-proof meeting rooms. Amador China provides clinical trial management, PK/ADA/Biomarker blood sample analysis, data processing, computer modeling, clinical reporting and registration services for innovative biopharma worldwide.