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Dr. Mohammad received his Ph.D. in Chemistry from The University of Iowa in 2010 and joined FDA and as a Post-Doctoral Scholar in 2012 in the Division of Product Quality Research (DPQR) at CDER (Center for Drugs). His regulatory research efforts have focused on physiochemical characterization of Prussian blue (a medical countermeasure drug). His research also included development and validation of analytical methods using HPLC, UPLC and ICP-MS to support product quality issues in drug substance and drug product formulations. His most current research is focused on developing and validating analytical methods to screen and quantify trace metals in commonly used bioreactor media. He has also done comprehensive research on studying the effect of trace metals on the production and quality of therapeutic proteins.
Dr. Chikkathur Madhavarao
Biologist, US FDA
Dr. Chikkathur N. Madhavarao obtained doctoral degree in Biotechnology from University of Pune, India with a focus on molecular interactions in biological macromolecules and bioenergetics. Later he pursued post-doctoral research on congenital rare diseases that occur due to deficient or mutant enzymes and normally affect the nervous system. After joining FDA in 2009 he pursued to understand the impact of production processes on product quality attributes of a model for enzyme replacement therapy (ERT) class of therapeutics. Variation in the metal concentration in the cell culture medium during production and its impact on product quality attributes (PQAs) of the therapeutic proteins is one of the research areas of interest of Dr. Madhavarao. He is currently focusing on improving the manufacturing efficiency of protein therapeutics to help produce products with homogeneous PQAs.
Robert Thomas, CSci, CChem, FRSC
Principal Consultant, Scientific Solutions
Robert (Rob) Thomas is the principal of Scientific Solutions, a consulting company that serves the educational needs of the trace element user community. He has worked in the field of atomic and mass spectroscopy for more than 45 years. He has served on the American Chemical Society (ACS) Committee on Analytical Reagents (CAR) for the past 20 years as leader of the plasma spectrochemistry, heavy metals task force, where he has worked very closely with the United States Pharmacopeia (USP) to align ACS heavy metal testing procedures with pharmaceutical guidelines. Rob has written overt 100 technical publications, including a 15-part tutorial series on ICP-MS. He is also the editor and frequent contributor of the Atomic Perspectives column in Spectroscopy magazine. In addition, Rob has authored 5 textbooks on the fundamental principles and applications of ICP-MS. Rob has an advanced degree in analytical chemistry from the University of Wales, UK, and is also a Fellow of the Royal Society of Chemistry (FRSC) and a Chartered Chemist (CChem).
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