Principal Consultant (Founder): Michael W. Dong, PhD

Born in Shanghai and raised in Hong Kong, Michael is a principal consultant at MWD Consulting. He was formerly senior scientist at Genentech, Small Molecule Analytical Chemistry and QC, research director at Synomics Pharma (CRO), research fellow at Purdue Pharma, and senior staff scientist at Applied Biosystems / Perkin-Elmer. He holds a Ph.D. in Analytical Chemistry from the City University of New York and a certificate in Biotechnology from U. C. Santa Cruz.

 

Michael has over 20 years of working experience in HPLC and pharmaceutical development. He has conducted numerous training courses at national meetings at Pittcon, ACS, EAS, and HPLC in the last 20 years. He has 120+ publications in chromatography and authored 4 books including a best-seller in chromatography - "HPLC and UHPLC for Practicing Scientists, 2nd Ed., Wiley, 2019" and "Handbook of pharmaceutical analysis by HPLC, Elsevier, 2005". He is an advisory board member of LCGC magazine, American Pharmaceutical Review, and Chinese American Chromatography Association (CACA).  He has been a columnist for LCGC North America since 2013.  A long-term member of Toastmasters International, Michael is fluent in written and spoken Chinese.

Contact Michael at michael@mwd-consulting.com.

Expertise

Collaborating Consultant: Kim Huynh-Ba of Pharmalytik
cGMP Regulatory, quality systems, stability studies and CRO management

Kim has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is currently the Executive Director of Pharmalytik (www.pharmalytik.com) which provides consulting and training services to pharmaceutical companies, including those operating under FDA’s Consent Decree. She is an adjunct professor at Temple U and Illinois Institute of Technology and an instructor for short courses offered at national meeting (ACS, Pittcon, AAPS and EAS).

 

Kim is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. She is a member of the USP Council of Experts for the 2015-2020 cycle and a Chair of the Chemical Medicines IV Expert Committee and USP Good Documentation Practices Expert Panel.  She is a member of USP Impurities of Drug Products Expert Panel and  AAPS Open editorial board.  Kim co-chaired the development of the Regulatory Sciences 101 and Stability 101 eLearning courses for AAPS. She is the editor of two popular book volumes, “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010). Kim can be reached by email at kim.huynhba@pharmalytik.com.