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

 

Michael has over 20 years experience in HPLC and pharmaceutical development. He has conducted 130+ training courses at national meetings at Pittcon, ACS, EAS, AAPS, and HPLC conferences, and private clients. He authored 130+ publications and 4 books including a best-seller book in chromatography. He is an advisory board member of LCGC North America, Amer. Pharm. Review, and Chinese American Chromatography Association (CA-CA,org).  He has been a columnist for LCGC North America since 2013 and is a Toastmaster ATM Silver.  Michael is fluent in written and spoken Chinese (Mandarin, Cantonese, and Shanghainese).

Contact Michael at michael@mwd-consulting.com.

Michael was born in Shanghai, raised in Hong Kong, and worked in America (New York, New Jersey, Connecticut, California). He is residing in Connecticut currently.

This is storyboard of my life starting in Shanghai from age 0-2, raised in Hong Kong (3-19), and then college and a working career in America.
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Expertise

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

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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.

WHY MWD Consulting?

  • Pharma/Biotech lab

    –Help integrate UHPLC in your laboratory with advice on the purchase, set up, method translation, and issue avoidance

    –Expedite HPLC method development for assays and impurity analysis with a 3-pronged template approach, universal generic gradient methodology, achiral and chiral separations, and mass spectrometry

    –Design of stability studies and robust stability-indicating HPLC methods  to improve data quality to minimize issues
     

  • Regulatory filings and CMC

    –Streamline CMC quality data for IND/NDA filings with IQ Consortium guidelines

    –CMC data review and help resolve analytical issues

    –Training on the entire drug development process and drug quality fundamentals to increase understanding of this multidisciplinary and complex process
     

  • HPLC instrument and column manufacturers

    –Devise and implement marketing strategies for pharma/biotech customers for instruments, data/applications systems, and columns. LinkedIn Network of ~11,000 chromatographers and pharma scientists
     

EXPERTISE, SPECIALTIES AND STRENGTHS

  • Subject Mater Expert in HPLC, UHPLC, LC/MS, and pharmaceutical Analysis of drug substances and products.
     

  • Small molecule drug development, stability testng, CMC and regulatory filings
     

  • Ultra-fast and ultra-high-resolution UHPLC analysis
     

  • (u)HPLC method development and validation, method conversion (UHPLC/HPLC)
     

  • Offers expert training in HPLC, pharm analysis, drug quality and drug development process.
     

  • Pioneered Fast LC, UHPLC for complex pharmaceuticals, generic methodologies, and quick turnaround methods for complex environmental samples 

  • PhD in Analytical Chemistry with 30+ years industry experience in pharmaceuticals, chemicals, instruments, and research.
     

  • Waters Empower (15 y as a user) and Agilent OpenLab CDS
     

  • Writing and editing technical articles and marketing brochures.  Authored >130 publications and 4 books in chromatography and pharm analysis. Columnist for LCGC since 2013.
     

  • Food and environmental analysis (quick-turnaround methodologies including sample preparation) (amino acids, proteins, pesticides, carbamates, PCR, PAHs, vitamins, organic acids, sugars, etc.)
     

  • Obtained NIH (NIEHS) research grant on environmental analysis of quinolines
     

  • Marketing of HPLC instruments and columns
    (Writes 100+ LinkedIn articles/y).
     

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