Weili Huang, PhD

Dr. Weili Huang is a Drug Metabolism and Pharmacokinetics (DMPK)/Clinical Pharmacology consultant for Aclairo Pharmaceutical Development Group. As an expert in DMPK, Dr. Huang provides consultation for over 80 pharmaceutical companies on scientific and regulatory issues in drug development including nonclinical and clinical DMPK, due diligence, and strategic planning for drug development. Dr. Huang performed PK analysis, PK-Pharmacodynamics (PD) modeling, and PK simulations in both nonclinical and clinical studies. Before joining Aclairo, Dr. Huang founded Miracle Query Inc and HWL Consulting LLC in Eugene Oregon, and she designed and developed an artificial intelligence (AI) ontology and question-answering system with concepts and relationships, helping healthcare professionals to query drug usage/safety information and make better clinical decisions. As an independent consultant, Dr. Huang was contracted to oversee various projects in drug discovery and development and provide expert advice and strategies. Before starting her own business, Dr. Huang was a pharmacologist reviewer for the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). During her tenure in the Agency, Dr. Huang prepared over 40 drug bioequivalence guidances published on the FDA official website, and she was honored for her work in the Bioequivalence Database Group with the FDA Commissioner’s Special Citation (2008-2009). Before joining the agency, Dr. Huang was a research fellow at the University of Washington, Department of Pharmaceutics, and she was awarded the Elmer M. and Joy B. Plein Fellowship (2006-2007) and the Elmer M. Plein Endowed Research Fund (2006-2007). Dr. Huang received her Ph.D. degree in the Department of Pharmaceutics at the University of Washington, and her doctoral thesis work was chosen as one recipient of four Symposium Awards at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting (2005). Dr. Huang was also the recipient of the Best Presentation Award of Pre-doctoral Research – First Place (one in over 365 presentations) at the International Society for the Study of Xenobiotics (ISSX) Meeting (2003). Before joining University of Washington, Dr. Huang was a clinical pharmacist and studied in the Pharmacology Masters program at Peking Union Medical College in China from 1997 to 1999. In 1999, Dr. Huang moved to U.S. and joined her family in Connecticut. She received her B.S. degree in Pharmacy at the School of Pharmacy, Peking University Health Science Center (China) in 1997.