Huiquan Wu received his Ph.D. in Chemical Engineering with Minor in Materials Science and Engineering from Iowa State University in 2001. With over 20 years full-time working experience across academia, industry, and regulatory agency, he has been involved in a few major FDA initiatives (PAT, cGMP for the 21st Century, Pharmaceutical Inspectorate, QbD) designed to address challenges and opportunities related to pharmaceutical development, manufacturing, and quality assurance in an integrated system approach since 2002. He participated the FDA PAT Guidance drafting and finalizing process (2002-2004), organized and moderated a series of PAT/QbD sessions since 2004. His research interest includes pharmaceutical manufacturing science and chemo-metrics, pharmaceutical process control, application of various PAT tools to understand pharmaceutical unit operations. He published 29 peer-reviewed journal papers and 20 conference or society proceedings papers, and gave many invited talks at both international and national meeting. He is a co-inventor for 7 patents.