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Volume10, Issue 12 (Suppl) J Proteomics Bioinform, an open access journal
ISSN: 0974-276X
Page 90
conferenceseries.com
World Biomarkers & Pharma Biotech 2017
December 07-09, 2017
December 07-09, 2017 | Madrid, Spain
&
20th International Conference on
PHARMACEUTICAL BIOTECHNOLOGY
9th WORLD BIOMARKERS CONGRESS
JOINT EVENT ON
Microdosing/microtracing clinical trials using accelerated mass spectrometry in clinical drug
development
Howard Lee
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea
Microtracing/microdosing is an innovative technology that can revolutionize the current paradigm of clinical drug
development. Typically, a very small amount of the drug, i.e., ‘microdose’, which is less than 100 micrograms (or 30
nmoles for proteins), is administered to humans. Since this is much smaller than 1/100 of the pharmacologically active dose,
microtracing/microdosing technology can be employed at a very early stage of clinical drug development even when there
is limited animal toxicology data. Furthermore, in order to trace minute doses, an accelerator mass spectrometer (AMS) is
required and the compound should be labeled, typically with 14C. The microtracing/microdosing study allows clinical drug
development scientists for generating the intravenous pharmacokinetics, mass balance, metabolite profiling, and absolute
bioavailability data much easier, faster, and at a significantly lower cost. Based on this understanding, this study investigated
the current status and employment of AMS-based microtracing/microdosing studies in actual drug development. To achieve
this objective, we performed an extensive search of the literature and public information, Delphi focus group interviews,
surveys, and personal communications with the key players in the field. The number of the clinical studies that used 14C
and AMS dramatically increased from only 3 in 2001-2005 to 59 in 2011-2015. The survey showed that 31.6% of new drug
development scientists were planning to performmicrotracing/microdosing studies. Furthermore, 73.7% of survey responders
replied that they would consider AMS-based microtracing/microdosing studies if there is a well-established service provider.
This study confirmed that the frequency of AMS-based microtracing/microdosing studies for drug development has been in
a steady increase for the past decade or so. This increase was partly because several issues of AMS application in the previous
era, such as dose-linearity, sample pre-processing, and high cost, have been adequately addressed. In conclusion, AMS-based
microtracing/microdosing studies have been steadily employed in actual drug development, which is expected to increase
further in the future.
Recent Publications
1. Kim YK, Kim A, Park SJ, Lee H. New tablet formulation of tacrolimus with smaller interindividual variability may
become a better treatment option than the conventional capsule formulation in organ transplant patients. Drug
Design Dev Ther. 2017 (11): 2861-2869
2. Kim Y, Kim A, Lee S, Choi SH, Lee DY, Song JS, Lee H, Jang IJ, Yu KS. Pharmacokinetics, Safety and Tolerability of
Tedizolid Phosphate After Single-Dose Administration in Healthy Korean Male Subjects. Clin Ther. 2017. Sep;39(9):
1849-1857
3. Lee H, Chung H, Lee S, Lee H, Yang SM, Yoon Sh, Cho JY, Jang IJ, Yu KS. LBEC0101, AProposed Etanercept Biosimilar:
Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy
Male Subjects. BioDrugs. 2017 May 27. doi: 10.1007/s40259-017-0230-9.
Biography
Howard Lee is the Founder and Director of the Center for Convergence Approaches in Drug Development (CCADD). Dr. Lee serves as a Professor at the
Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University. Dr. Lee is also appointed at Seoul
National University College of Medicine and Hospital, affiliated with the Department of Clinical Pharmacology and Therapeutics. Dr. Lee previously served
as Head of Global Strategy and Planning, Clinical Trials Center, SNUH. As of August 2017, Dr. Lee was appointed Chair of the Graduate Program in Clinical
Pharmacology, Seoul National University. Dr. Lee has spearhead the introduction of Accelerator Mass Spectrometry (AMS)-enabled exploratory early clinical drug
development studies to the Korean biopharmaceutical R&D sector, which has awarded Dr. Lee 2 government grants.
Howard Lee, J Proteomics Bioinform 2017, 10:12(Suppl)
DOI: 10.4172/0974-276X-C1-110