Pleasanton, California and Hangzhou, China
12 August 2019
Earlier this month, a paper coauthored by Bing Wang, PhD, CEO of Amador Bioscience, was published online by Nature Scientific Report. This paper focuses on the development of a multi-scale, quantitative systems pharmacology (QSP) model to characterize the complex interactions between tumor cells, immune system (APC, naïve and effector T cells, regulatory T cells, MDSC), and checkpoint inhibitors (CTLA-4, PD-1 and PDL-1) in tumor microenvironment, tumor draining lymph nodes, peripheral tissue, and central (blood) compartments in cancer patients. The mathematical model was subsequently used to simulate various clinical scenarios of mono-, combo- and sequential immune-oncology therapies. The model predictions agreed well with the actual outcome of clinical trials.
“Unlike conventional treatments, immune-oncology therapies rely on the activated immune system in particular CD8+ T cells to discern and kill cancerous cells”, said Dr. Wang. “This complicates the drug exposure-response assessment and proper design of clinical trials evaluating combination therapies. The QSP model not only provides deeper insight into how tumor and immune system react to checkpoint therapies, but also can project the clinical response to various treatment strategies. With this model we can now conduct in silico clinical trials to evaluate dose optimization, translation across tumor types, and combination therapies“.
The online publication can be found at https://www.nature.com/articles/s41598-019-47802-4. This is the most recent paper of a series of publications by scientists at AstraZeneca and Johns Hopkins University. Other publications from the collaboration include agent-based model for spatio-temporal response to PD1/PDL1 inhibition (https://doi.org/10.1098/rsif.2017.0320), in silico clinical trial simulation of anti-CTLA-4 and anti-PDL1 therapy (https://doi.org/10.1098/rsos.190366), and neoadjuvant PD-1 Inhibition in NSCLC (in press). Dr. Wang initiated and led the joint effort on systems pharmacology modeling of immune-oncology products when he worked at AstraZeneca. The collaboration started in 2015 when Lawrence Chu, then a fifth-year PhD student in Dr Aleksander Popel’s lab at Johns Hopkins University, did a summer internship at AstraZeneca developing a mathematical model for T cells under Dr. Wang’s guidance.
About Amador Bioscience
Amador strives to provide global-standard laboratory, clinical research, strategy consulting and regulatory filing services to biopharmaceutical companies. The laboratory services focus on PK/PD/ADA assay development and sample analysis. Amador clinical research unit specializes in innovative clinical development strategy and protocol design, and initiation and monitoring of clinical studies in China and US. In addition to R&D strategy and regulatory pathway, our consulting services perform global-standard data analysis and generate submission-ready study reports. We have successfully supported CTD filings in China and US.
For further information please visit AmadorBio.com.
Pleasanton, California and Hangzhou, China
July 1st, 2019
Amador Bioscience, a leading global partner for biotherapeutics development, announces the appointment of Rakesh Dixit, Ph.D, DABT, as Scientific Advisor
“The mission of Amador is to provide global-standard services facilitating the development of novel biotherapeutics. As we continue to build up Amador team and capability, advice and guidance from key opinion leaders are crucial for the long-term success of our business. We are pleased to welcome Dr Rakesh Dixit to Amador as our first scientific advisor. His vast industry experience, stellar reputation and broad connections are invaluable asset to us and our clients”, said Bing Wang, PhD, CEO of Amador Bioscience.
Dr. Dixit was former VP and Global Head of Biologics Safety Assessment, Pathology and Laboratory Animal Medicine at AstraZeneca. As a senior executive member of World-wide Research and Development, he was among key voting members of AstraZeneca Safety Review Board, Research Review Committees, Early Product Development Decision Committee, Research & Development Leadership Teams.
Dr. Dixit is an accomplished key opinion leader in biologics development, with over 30 years of industry experience (Merck, JNJ, AZ), over 10 global NDA/BLA filings, over 80 peer-reviewed papers in renowned scientific journals and 130+ invited lectures/presentations at international conferences. He 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.
“I am extremely delighted to join the AMADOR team”, said Rakesh Dixit, Ph.D, DABT. “The uniqueness of the Amador is its very strong team of biotech professionals with many decades of experience in developing medicines of all classes. No other CRO has this much depth in providing solutions to biotech companies worldwide in developing medicines. The team also has excellent regulatory experience worldwide in filing INDs, NDAs, and BLAs successfully. It is noteworthy that I have worked with most of the US staff of Amador at MedImmune-AstraZeneca for many years and I feel very lucky to work with them again.”
About Amador Bioscience
Amador strives to provide global-standard laboratory, clinical research, strategy consulting and regulatory filing services to biopharmaceutical companies. The laboratory services focus on PK/PD/ADA assay development and sample analysis. Amador clinical research unit specializes in innovative clinical development strategy and protocol design, and initiation and monitoring of clinical studies in China and US. In addition to R&D strategy and regulatory pathway, our consulting services perform global-standard data analysis and generate submission-ready study reports. We have successfully supported CTD filings in China and US. For further information please visit AmadorBio.com.
Amador Bioscience held the third phase of the “Biopharma Series Forum” on June 19, 2019 successfully and fruitfully. AmadorBio is dedicated to help pharmaceutical companies to carry out innovative drug research and development more scientifically and effectively, introduce state-of-the-art biomarker assay technology and new clinical trial concepts and regulations, further promote academic communication and exchanges among companies in biopharma industry, and contribute to the improvement of China's new drug research and development industry chain. In this forum, we increased the way of online participation, thereby breaking geographical restrictions and attracting more biopharma companies to participate. AmadorBio forum has expanded its influence nationwide.
“Bioanalytical support for pre-clinical and clinical development of biotherapeutics”
Shared by Dr. Zeng（From Amador Bioscience）
Macromolecules such as antibody drugs, recombinant protein drugs, vaccines, etc. are widely used in the treatment and prevention of major diseases such as cancer, cardiovascular and cerebrovascular diseases, arthritis, hepatitis, AIDS, etc., Thereby macromolecules are highly valued by governments and pharmaceutical companies in various countries，which are regarded as the most promising area in the development of biotechnology drugs in the century.
“Driving biomarker research in Chinese clinical trials”
Shared by Dr. Guo（From Teddy Clinical Research Laboratory）
Local central laboratory in China shall continue to provide high quality services to MRCT by continuously expanding its international business and strengthening its ability to transfer/establish and manage processes.
Questions and answers round between On-site attendees and speakers
Amador Bioscience will continue to inherit the spirit of medical academic research and maintain the deep communication and cooperation with insiders in the industry. In the future, we will insist to launch the Biopharma Series Forum, so stay tuned for the next issue!
More information, please scan QR code or email to email@example.com
Amador Bioscience Inc (AmadorBio) is focusing on the development of new biomedicine ，to provide global advanced services such as clinical protocol design, trial management, pharmacokinetic /pharmacodynamic / immunogenicity (PK/PD/ADA) assay development, sample testing, data analysis, result reporting, and IND/CTD submission. Amador scientist core leadership are experts with averaging 20 years of extensive biopharmaceutical industry and professional R&D service experiences. Amador strives to offer integrated and professional pre-clinical and clinical stage services of biomedicine development for domestic and multinational biopharmaceutical companies.
Founded in 2018，Amador Bioscience Inc (AmadorBio)，as a global CRO，consists of four co-founders with global industry experience and profound academic background.
After one year's dedicated efforts and business expansion, Amador’s team of scientists has been growing stronger rapidly. The highlighted achievements include exceeding our revenue targets, successfully exploring customer channels to become partners with many companies from small & medium-sized innovative biotech companies to large multinational biopharma, and collaborate with ivy league universities and wall-street investors.
Amador has bio-hubs in the Bay Area of San Francisco in USA and Yangtze delta area in China. In 2019, we will continue to expand the scale of our laboratories as business and projects increasing.
In the future, Amador will continue to set sail, upholding the concepts of senior academic background with profound industrial experience, trans-Pacific resource allocation, excellent operation, and providing outstanding services for domestic and multinational customers in clinical development stages of biomedicine.
Xiaoyan Xing, M.D., Ph.D joined Amador Science（Hangzhou）as Chief Medical Officer (CMO) on Monday, April 15.
Xiaoyan Xing obtained her Ph.D degree from Peking University in 2004 and M.D. degree from Baotou Medical College in 1994. She further received her training as Postdoc in USA on prostate cancer. Dr. Xiaoyan has 24 years of medical experience in academia and pharmaceutical & biotech companies, including clinical practice, drug discovery and development, with profound study of the development of clinical development plan (CDP), protocol design & writing, medical monitoring, the operation process of clinical trials and CSR writing，and has more than 30 clinical trials experience as a clinical lead, therapeutic area covers oncology, CNS, respiratory, hematology, digestive, anti-infection, rheumatology /autoimmune, analgesic anesthesia etc.
As a CMO, Dr. Xiaoyan will lead Amador scientists to develop into the one of the best clinical development strategy team and medical monitoring system in China, as well as further expand the business opportunities in China.
It’s a great pleasure to have Dr. Ryan Criste join Amador Consulting Sector (USA) as Director of Clinical Pharmacology on Monday, March 18.
Ryan obtained his Doctor of Pharmacy (PharmD) degree from Duquesne University (Pittsburgh, Pennsylvania) in 2006. He further received clinical and PKPD postdoc trainings at Allegheny General Hospital and School of Pharmacy, University of North Carolina before joining the industry, initially at Quantiles and then MedImmune/AstraZeneca. During his tenure at MedImmune (2009-2013) Ryan was involved in essentially all phases of projects supported by the clinical pharm group from CMC through clinical development while at the company headquarters in Gaithersburg, Maryland. Ryan spent the past 5+ years working as senior/lead pharmacokineticist at PPD, providing integrated biopharmaceutical consulting services and clinical development reports in a format suitable for submission to the US FDA. Recently, Ryan has joined Amador from Altria, where he was a principal scientist and regulatory study lead for e-vaping sciences. Many of Amador team who previously worked at MedImmune/AstraZeneca know Ryan well; it is our great pleasure to have him back. In addition to the biopharma experience, Ryan holds the pharmacy licensure in North Carolina and Pennsylvania.
With Ryan‘s expertise and experience，AmadorBio Team will be stronger and growing promptly！
Amador Forum I – fulfilled perfectly
Amador Bioscience Inc (AmadorBio) has determined to launch “Amador Bioscience Series Forum“，in order to help pharmaceutical companies develop innovative drugs more scientifically, effectively and normatively，to introduce advanced bioassay technology and clinical trial ideas and regulations，and to contribute to the improvement of the R&D industry chain for new drug in China.
AmadorBio has collaborated with Precision Medicine (Hangzhou) Research Center to co-hold “AmadorBio Forum I”, which has attracted the attention of numerous nationwide enterprises. The forum conference room was fully seated.
Amador held the activity of “ Entering into Amador” to promote popularity after the forum, we invited the leaders and the departmental heads from AstraZeneca, CBMG，Shijian Biology and Kira etc. to visit AmadorBio Analysis Laboratory in Hangzhou. Under the guidance of Dr. Bing Wang (CEO of AmadorBio), Dr. Rong Zeng (COO) and Xiaomin Chen (GM), the delegation visited Amador labs. The attendees listened with interest to Dr. Zeng's introduction on the division of functions in different areas of the lab.
After visiting the lab area, Amador Team made the presentation of our business development to everyone，illuminating from biological analysis to clinical management. With a relaxed and active atmosphere, the attendees made enquiries to the speaker one after another. This activity made Amador further known by local enterprises in biopharmaceutical industry about our current laboratory construction the planned business projects. Meanwhile, Amador has received opinions and suggestions, which provided valuable experience for the development of the laboratory in future.