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.
Virginia Ellen Maher, M.D.
Principal Clinical Consultant
Dr. Maher has 17 years of FDA clinical oncology review experience and joined DataRevive from FDA on July 1, 2019. Dr. Maher has been an oncology clinical team leader for 10 years in CDER Office of Hematology and Oncology Products and for three years in the CBER Office of Cellular, Tissue and Gene Therapies. Before that Dr. Maher was a medical officer for biological oncology product review in the Office of Oncology Drug Products. She also functioned as a clinical project director as Schering-Plough Research Institute and worked at NIH for four years at NCI. She was an assistant clinical professor in hematology and medical oncology in Tulane University Medical Center and oncology chief for four years.
Dr. Moher reviewed numerous oncology products including:
She reviewed numerous efficacy supplements for both New Drug Applications and Biologics Licensing Applications, participated in FDA-Industry meetings, including advice to industry concerning their product development pathway, and reviewed of many Investigational New Drug applications for small molecules and biologics.
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.