Qing Liu, Ph.D. and ASA Fellow, is the Founder of Quantitative & Regulatory Medical Science (QRMedSci), LLC. He led the strategic and technical innovations at Amicus Therapeutics with successful FDA approval of Migalastat for Fabry disease and granting a breakthrough therapy designation for AT-GAA in Pompe disease.
Qing’s mission at Phase 1 Oncology is to bring innovative methods and technologies to clinical trials by leveraging his rich clinical trial experience, extensive research and publications in innovative design and statistical methods, and IT expertise in cloud-based parallel- and super-computing.
Qing is a statistical expert who gained rich experience in broad disease areas in oncology, neurology, psychiatry, pain, cardiovascular, anti-infective, anti-virus, immunology, and metabolic diseases from employment in an academic institution, regulatory agency (FDA) and the biopharmaceutical industry. Qing’s clinical research experience includes more than 30 due-diligence projects in new drug licensing & acquisitions, numerous successful dispute resolutions with the FDA, successful implementation of various regulatory acceptable innovative trial designs, and strategic clinical development planning. Qing has substantially contributed to clinical trial design, protocol review, monitoring, analysis, study report, and regulatory submission.
Qing has extensive publications in statistical research for innovative clinical trial designs and in medical research through broad collaborative research with statisticians in academics, the National Institute of Health (NIH), and top tier pharmaceutical companies. Qing has the foresight to develop an evidential paradigm for statistical inference in response to recent ASA’s formal statements on p-values.
Qing’s recent work at Amicus focused on innovative trial designs and statistical analyses for rare disease drug developments. This included randomized delayed start design with an integrated analysis of efficacy as well as a randomized controlled trial with internal comparative real-world evidence.
Qing was named a Fellow of the ASA in 2013. Qing was a Sr. Research Fellow of Janssen R&D, J&J; Head of Biostatistics at Cephalon, Inc.; Senior Statistician at RWJ PRI of J&J; Mathematical Statistician at the FDA/CDER/DB1. Qing started his career as a Faculty at St. Jude Children’s Research Hospital.