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Biography

Kim Huynh-Ba is the Founder and Technical Director of Pharmalytik (www.pharmalytik.com). She has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She has been advising pharmaceutical companies including companies operating under Consent Decree on harmonization and optimization of analytical best practices since 2003. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.

In addition to her consulting activities, Kim is a short course instructor and organizer on topics ranging from cGMP compliance and quality issues to stability programs under sponsorship of global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University.

Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS).

Kim has authored numerous technical publications and book chapters. She is invited frequently to present at national and international conferences. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010.

Kim is the founder and past co-chair of the AAPS Stability Focus Group and Chair of the AAPS APQ e-Learning Committee. Kim is a recipient of the 2008 AAPS APQ Service Award and 2008 Recognition Award of AAPS Regulatory Section. She also received the 2001 DPCAA Leadership Award.

Her areas of expertise are listed in the bio (including analytical development, stability, CMC submission, OOS/OOT investigations, QA compliance, validation, cGMP Quality. She has involved with several projects of optimizing or harmonizing quality systems, oversee development activities as well as managing off-shore projects. She also served as expert witness for legal and litigation cases.