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Qualitative and quantitative methods using LC-MS/MS have been becoming
increasingly important and useful to support drug research and development.
Automation with high throughputplays a signifi
cant role in discovery and development
programs withobvious tributes and prospects. Method selectivity, sensitivity and
reliability are necessary to ensure the quality and integrity of data required for
regulatory submissions and approvals. Applications of LC-MS/MSwithcase studies (in-
vitro ADME, in-vivo PK/TK and preclinical and clinical bioanalysis) will be presented
and discussed. It is apparent that Bioanalysis is a central and vital function for drug
discovery & development processes. Fast turnaround and reliability of data facilitate
optimization and enhance successful evaluation and selection process. Accelerated and
accurate evaluationsmake right decisions for nomination and development programs.
Automation and robustness of bioanalysis ensure high quality and integrity of data for
successful submissions (IND/NDA).
Dr. Michael Zhou is currently Senior Director of Global R&D at BioAnalytical Systems,
Inc., with most recent roles as Senior Associate at Lachman Consultants and Director
of Bioanalytical Chemistry/DMPK at Synta Pharmaceuticals Corporation. He previously
held positions at DuPont, Purdue Pharma LP, Johnson & Johnson, Cardinal Health, and
Scynexis with increasing responsibilities for analytical, bioanalytical and DMPK R&D in
support of drug/product discovery and development.
His career has focused on analytical and bioanalytical R&D plus DMPK programs for
over 20 years, with expertise in regulatory compliance such as GLP, GCP, GCLP, cGMP
regulations (or GxPs), and ICH, AMV and BMV guidelines. During his career tenure, he
has gone through a few FDA audits with great success. He has been actively involved
in organizing conferences, speaking at presentations and sharing his knowledge at
workshops / short courses for numerous national and international proceedings.
He serves as a member of scienti
c steering committees for PBA and NABF, and is a
member of AAPS, ACS, ASMS and AACR. He authored over 40 research articles and
2 book chapters in the areas of analytical/bioanalytical chemistry. He is a peer-reviewer
for several renowned technical journals including J. AOAC International, J. Analytical
Chemistry, J. PBA, and J. Chromatogr. B, etc. He serves as an Editorial Board Member
for ?Bioanalysis,? edited by Future Science Group of London, UK. He was retained by
John Wiley and Sons (a world renowned scienti
c publisher) for a book entitled ?Regulated
Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives?
(published in January 2011). He received his Ph.D. from the University of Delaware under
the supervision of Dr. Donald L. Sparks, Chair and DuPont Professor.
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