About AmadorBio - Amador Bioscience

Our Company

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.

Scientific Excellence

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 >20 leading biopharma companies on projects from lead candidate profiling to CTD.

Global footprint

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.

Capabilities

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)

Our People

Co-founders / Leadership Team / Scientific Advisors

Co-founders

Bing Wang, Ph.D., CEO?, Renowned expert in clinical pharmacology & pharmacometrics?

Built & led Clin PKPD & PMx functions at AstraZeneca (AZ) / MedImmune (MEDI);
22 years of modeling & 20 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

21 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)

Leadership Team

Xiaoyan Xing, MD, Ph.D., CMO Expert in clinical development and protocol design

26 years of medical experience in academia, pharmaceutical & biotech companies, including clinical practice and R&D
12+ years of medical experience in clinical sites, global pharma and CRO
Clinical lead of 15+ global and domestic clinical trials, therapeutic area covers oncology, CNS, respiratory, hematology, digestive, anti-infection, rheumatology/autoimmune, analgesic anesthesia and others

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)

Zhenxing Xu, Director of Laboratory Services

12 years experience in leading pharmaceutical and CRO companies in China (Wuxi AppTec,CrownBio,CTI)
Enriching experience in bioanalysis laboratory team management, GLP specifications both in China & US, Regulatory inspection and response
BS and MS degrees in Biopharmaceutical from Suzhou University

Kamille O’Connor, PMP - Amador Bioscience

Kamille O’Connor, PMP Global Project Management & Medical/Technical Writing

Over 18 years combined biopharma, pharma and business experience at Amgen, Abgenix, and Medimmune/AstraZeneca
Led the project development team to MedImmune’s first successful POC and Phase 3 trial start in Oncology
Provided medical writing and formatting support for INDs, NDAs, BLAs, CSRs, amendments and supplements, etc
BS degree in Biology from California Lutheran University

Angela Xu, BD Director

Over 6 years’ experience in CRO companies, senior in new drug R&D industry
Enriching experience in managing BD activities and familiar to the industry development of new drug R&D
Solid client base; has provided services for multiple studies successfully submitted

Scientific Advisors

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

Rakesh Dixit, Ph.D.

Over 30 years of industry experience (Merc & Co., Inc, Johnson and Johnson, AstraZeneca-Medimmune)
Serves as the Global VP and Global Head of Biologics Safety Assessment, Pathology and Laboratory Animal Medicine at AstraZeneca for nearly 13 years
Over 10 global NDA/BLA filings, over 80 peer-reviewed papers in renowned scientific journals,130+ invited lectures/presentations at international conferences
Serves as an expert reviewer and in appointed committees for many programs managed by U.S. National Academy of Sciences and US National Institutes of Health (including National Cancer Institute)
In 2015 Rakesh was selected by pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE

Frank Li, MD, Ph.D., RAC - Amador Bioscience

Frank Li, MD, Ph.D., RAC Expert for Clinical Regulatory Affairs

More than 15 years working experience in the Biopharmaceutical industry(AstraZeneca, MedImmune, AZ BioVenture, Ascentage Pharma, and SNBL)
Contributed significantly as the Regulatory Lead to the development of FASENRA (Benralizumab, an anti- IL5R antibody for Asthma) from Ph-2 to Worldwide Marketing applications and approvals including US, EU, Switzerland, Canada, Australia, Japan, and Brazil
Obtained PhD degree in Molecular Medicine from Kyoto University, School of Medicine, Japan
Studied/Contributed to clinical studies of Adoptive Immunotherapy using T lymphocytes and Dendritic cells for treatment of Breast cancer and Melanoma patients
Obtained Regulatory Affairs Certificate (RAC) from Regulatory Affairs Professionals Society (RAPS) in 2005

Harry Yang, Ph.D.

Industry-recognized expert and leader in statistics
25 years of industry experience in all aspects of biological and biosimilar product development, from early target discovery, through pre-clinical, clinical, and CMC programs to regulatory approval and post-approval life cycle management
Strong expertise in advanced statistical methods, pre-clinical safety assessment, innovative clinical trial design, modelling & simulation, precision medicine and CMC statistics
Published 6 statistical books, 15 book chapters, over 100 peer-reviewed papers, 3 industry white papers, and 2 USP chapters, and gave over 90 invited speeches at international conferences
Accomplished researcher at Pittsburgh Cancer Institute and Senior Director and Global Head of Statistical Sciences at AstraZeneca for 12 years
Significant contributions to > 50 IND applications and 6 BLA/MAA filings, and > 100 PAS across major therapeutic areas. Led dozens of meetings with regulatory authorities around the global, either face-to-face or via tele-conference
Invited developer and trainer of statistical courses at the FDA, USP, and Peking University, a member (2010 – 2019) and Vice Chair (2015 – 2017) of USP Statistics Expert Committee, and a member of the Regulatory-Industry Statistics Workshop Steering Committee
BS and MS degrees in Applied Mathematics from Peking University and Ph.D. in Statistics from the University of Pittsburgh

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 CHITIC Science & Technology 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.