DataRevive Consultants / 咨询专家
Herbert Wayne Hutman, M.D.
Dr. Hutman is an internal medicine doctor by training and has worked in the pharmaceutical industry for over 20 years. Dr. Hutman was the principal investigator at a phase 1 unit of a contract research organization and conducted over 100 clinical studies including oncology, first in man, drug-drug interaction, PK, PD, food effect and bioequivalence. He was Associate Director at Aventis Behring and led a phase 3 study for a surgical sealant used in liver resections.
For almost nine years at Johnson and Johnson, Dr. Hutman worked in phase 3 and 4 studies in oncology, women's health, dermatology, and interventional cardiology. He spent nearly five years as an independent consultant on medical, safety and regulatory issues for diabetes, oncology, and cardiovascular diseases. Finally, in 2014, he joined AstraZeneca as the lead study physician for two multi-national phase 3 study in systemic lupus erythematosus involving over 250 clinical sites worldwide.
Dr. Hutman received his B.S. from the University of Miami in chemistry and an M.D. from Ross University. He completed his residency in internal medicine in Phoenix, and he is licensed to practice medicine in Florida and Arizona.
Nino Joy, M.D.
Dr. Joy served as a clinical research faculty at the University of Maryland and she has over ten years of experience as an investigator for clinical research studies in diabetes, endocrinology, and metabolism. She also has two years of fellowship training in cell and developmental biology from Vanderbilt University. Dr. Joy has a strong scientific background and experience in diabetes cardiovascular complications. Additionally, she managed all aspects of clinical research studies, including regulatory and scientific matters, GCP compliance in directed investigator initiated trials (IIT), phase 1 studies, and NIH funded studies. Her area of expertise include endocrinology, cardiology, oncology, and autoimmune disease.
Dr. Joy has an extensive experience in writing and development of clinical research documents including clinical protocols, consent forms, CRFs and IB. She has a considerable knowledge with ICH, GCP, GLP, FDA, and IRB guidelines. Additionally Dr. Joy is an expert in glucose and pancreatic clamp trial development and conductance. She led multiple projects using hypo-, hyper-, eu- and isoglycemic glucose clamp and pancreatic clamp techniques in humans. Dr. Joy is also a published author in high-ranked peer reviewed journals in the field.
Dr. Joy earned her M.D. from AIETI Medical University in Georgia, and is ECFMG certified. At DataRevive, Dr. Joy is the lead MD for oncology and autoimmune product clinical dossier writing, including clinical protocol development, starting dose justification and investigational brochure.
Zhao Liu, M.D.
Zhao Liu, M.D., Ph.D. is a medical officer at DataRevive, responsible for consulting on clinical trial design, preparing synopsis and clinical protocols. Dr. Liu is specialized in oncology and gastrointestinal diseases. Dr. Liu received his medical degree and Ph.D. from Tongji Medical School, Wuhan, China. He finished the residency training and practiced as an attending physician in China.
In the US, he passed USMLE step 1 to 3 and obtained his ECFMG (certificate for foreign medical graduates). Before joining DataRevive, Dr. Liu completed extensive research related to drug development at Massachusetts General Hospital/Harvard University and worked for UpToDate as a clinical editor for years.
At DataRevive, Dr. Liu successfully finished several clinical protocol designs and writings for oncology and GI diseases.
Lily Jin, M.D.
Dr. Jin graduated from Capital Medical University in Beijing, China, and worked at Beijing Tiantan Hospital as a neurology physician. She passed United State Medical License Examination and obtained her ECFMG certificate for all steps (step 1, 2, 3 and clinical skill assessment), and holds a medical license from State of Michigan. Dr. Jin has extensive clinical experience and strong knowledge of Good Clinical Practice. She has been a medical clinical researcher in the neurology field for more than ten years.
At DataRevive, Dr. Jin is responsible for the clinical plan design, and clinical protocol writing for all the neurological diseases including, but not limited to, pain, autism, migraine, Alzheimer’s disease and seizures. She is also responsible for the clinical design and protocol writing of the oncology drugs. She leads FDA clinical discussions in clinical meetings with FDA and prepares clinical synopsis for FDA meetings.
Susan Zarr, M.D., M.P.H.
Dr. Zarr is an analyst with training in biostatistics, epidemiology, medicine and biology. She has worked in academics, clinical contract research organizations, pharmaceutical/ biotech companies and regulatory agency in the past 20 years.
Her experience covers the entire cycle of studies from drafting study proposals, conducting statistical analyses and generating study reports. Her professional skills can be summarized in the following categories: use statistical analysis approaches to support business strategies, policy decisions, marketing and sales activities; be able to analyze enormously complex data sets including clinical trials, health care claims, relational databases and multi-stage surveys and be able to translate the information from data to insightful reports; support and manage medical and healthcare related studies that collect data in different dynamic data collecting systems; generate various SAS programs including macros for different type of reports and publications.
In the past ten years, her professional interest was on the statistical analyses on clinical trials and epidemiology studies. She has worked with numerous multidisciplinary teams on the clinical and health care data to support their pre and post-marketing products.
Jun Li, Ph.D.
Statistician and PK modeling
Dr. Li earned his Ph.D. degree with an emphasis on Bayesian Statistics and Statistical Genetics/Genomics in 2011 from the University of Alabama at Birmingham, and obtained a postdoc fellowship to study Bayesian hierarchal generalized linear models and apply these models to biological and clinical data analysis. This line of research led him to receive the Young Investigator Award from the American Statistical Association. Dr. Li then joined the National Institutes of Health as a research fellow where his research focused on analyzing high-throughput genome sequencing data using Bioinformatics/Computational Biology/Statistics tools. At DataRevive, he plays a scientific and strategic role within clinical trial and clinical Pharmacology, which provides statistical science, nonclinical and clinical pharmacokinetics/pharmacodynamics, and bioanalytics support for biotherapeutics projects at all R&D stages from discovery research to NDA/BLA registration.