Tai Xie, Ph.D.
President & CEO
Dr. Xie is the founder and CEO of Brightech International. Dr. Xie has 27 years of pharmaceutical experience in line of management and statistical analysis for Phase I-IV clinical trials as well as integrated summaries of safety (ISS) and efficacy (ISE) for new drug applications (NDA) in various therapeutic areas, especially in oncology. Prior to founding Brightech, he held an Associate Director position of Biostatistics and Data Management at ImClone (now a part of Eli Lilly) and was heavily involved in the Erbitux BLA submission. Before ImClone, he held leadership positions at Wyeth (5 years, Assistant Director) and at PRI JNJ (2 years, Sr. Statistician). Dr. Xie has extensive experience in clinical study design and statistical analysis and reporting. Since October 2004, Dr. Xie has built Brightech from a company of only a few employees into one with 80 employees globally (50 in the US and 30 in China) providing full scale services for the drug industry including Regulatory (IND/NDA) Submission, Clinical Operation, Data Management, Statistics and Medical Writing. In recent years, Dr. Xie has been actively interacting with the regulatory authority and drug industry in China. He was invited several times by China’s CFDA to participate in authoring the guidance on EDC and by influential professional organizations (such as China Heart Congress, CHC) to deliver courses and speeches on a variety of topics. Dr. Xie is also an active researcher with a number of research papers published in distinguished journals on various topics including cancer prevention, two-stage adaptive design, survival analysis, and more.