Dr. Moheb M. Nasr
Director, Office of New Drug Quality Assessment, Center for Drug Evaluation and Research, FDA, USA

website:
www.fda.gov/cder/Offices/ONDQA/default.htm

Dr. Moheb Nasr is the Director of the Office of New Drug Quality Assessment (ONDQA), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). ONDQA is responsible for quality assessments (pre and post marketing) of new drugs regulated by CDER. Dr. Nasr obtained his Ph.D. degree in Chemistry at the University of Minnesota in Minneapolis. Dr. Nasr holds a B.S. degree in Pharmacy and a Master’s degree in Pharmaceutical Analysis, both from Cairo University, Egypt. After a distinguished academic career, Dr. Nasr joined the FDA in 1990, and assumed his current position in June, 2003. Dr. Nasr is leading the restructuring of the pharmaceutical quality assessment program at the FDA. Several new concepts, initiatives, and programs were developed under his leadership; including the establishment of the new Pharmaceutical Quality Assessment System (PQAS), CMC Pilot Program, CMC Regulatory Agreement, and many others. Dr. Nasr serves as the FDA lead at the International Conference on Harmonization (ICH) Q8 Expert Working Group. Dr. Nasr is a member of FDA’s Council on Pharmaceutical Quality

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Prof. R. Graham Cooks
Department of Chemistry,
Purdue University, West Lafayette, Indiana, USA

website:
http://www.chem.purdue.edu/cooks

Cooks has contributed to advances in instrumentation and methodology for mass spectrometry. By combining soft ionization with two stages of mass analysis, he introduced direct analysis of mixtures by tandem mass spectrometry in the 1970's. He conceived a kinetic method of estimating thermochemical properties based on cluster ion dissociation kinetics He made key contributions - including the first use of matrices - to the modern desorption ionization methods. Many novel instruments have been built in his laboratory, including the first hybrid instrument and early miniature mass spectrometers. Dr. Cooks has demonstrated ultra-trace environmental analysis and reactor control with membrane introduction mass spectrometry and made significant uses of tandem mass spectrometry in mechanistic gas-phase ion chemistry. His studies of ionic collisions at surfaces included the introduction of ion soft landing, a method that uses the separation power of mass spectrometry to soft-land intact biologically active molecules onto surfaces to form protein microarrays.

His group is also responsible for the ambient ionization method of desorption electrospray ionization (DESI). Dr. Cooks has authored over 800 publications and served as PhD thesis advisor to more than 100 Ph. D. students.

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Prof. Dr. Reinhard Niessner

Institute for Hydrochemistry &
Chair for Analytical Chemistry
Technical University of Munich, Germany

website:
www.ws.chemie.tu-muenchen.de

Lecture:
Laser Light or Antibody - Two Good Friends to Analysts

Reinhard Niessner, Full Professor for Analytical Chemistry at the
Technical University of Munich, Germany, was born in 1951. He received a diploma degree in chemistry from the University of Freiburg (1976), a PhD from the University of Dortmund (1981), became a lecturer (1985) and served as a Professor for Inorganic and Analytical Chemistry at the University of Dortmund (1986-1989). He is in his current position since 1989.

His research interests are within Environmental Analytical Chemistry, especially devoted to applications of laser spectroscopy,
chromatography, and immunoserological techniques. The main subjects of interest are aerosols, hydrocolloids and biofilms, within hydro-and atmosphere.

Prof. Niessner received several highly prestigious international awards, e.g. the Emanuel-Merck-Prize for Analytical Chemistry (1990), the Smoluchowski-Award for Aerosol Research of the Association for Aerosol Research (1991), the Fritz-Pregl-Medal of the Austrian Society for Analytical Chemistry (1996) and the Fresenius-Award for Analytical Chemistry of the German Chemical Society (2000).

He is currently an associated editor of the ACS journal “Analytical Chemistry“, and a member of the advisory / editorial boards of ”Analyst“, “Analytical Sciences“, “Microchimica Acta”, “Analytical & Bioanalytical Chemistry” and “Fresenius Environ-mental Bulletin“.

Up to 425 scientific publications under his authorship appeared in international scientific journals and 92 PhD and 121 diploma students have successfully received their academic qualification under his guidance.

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Lecture:
Novel Chiral Ion Exchangers versus More Established Chiral Stationary Phases for LC Enantiomer Separations

Wolfgang F. Lindner was appointed 1996 for a Chair of Analytical Chemistry at the University of Vienna. Already during his studies his research interest was influenced by pharmaceutical (life) sciences and by separation sciences related to HPLC, GC, CE/CEC and MS. In this context particular interest developed in non-covalent interactions and molecular recognition with focus on stereochemistry and enantiomer discrimination. The development of novel synthetic selectors (receptors) useful for enantioselective separation techniques lies at the interface of organic, analytical and biological chemistry, which characterizes best his scientific credo. He was trained in Organic Chemistry at the University of Graz (Austria) receiving his PhD in 1972. Then he moved on to the Institute of Pharmaceutical Chemistry in Graz specializing in pharmaceutical analysis. In 1978 he was awarded a Max Kade postdoctoral fellowship, which he held at North Eastern University in Boston (USA) under the supervision of Prof. Barry L. Karger. In 1986 he was visiting scientist at the FDA/NIH in Bethesda (USA) where he got exposed to biological chemistry, a subject his research group is approaching from various angles.
Prof. Lindner was editor of Journal of Chromatography B from 1995 to 2006 and is serving as editorial/advisory board member for Chirality; Chromatographia; J. Pharmac. Biomed. Anal.; LC-GC International; J. Chromatogr. B, J. Biochromatogr.; J. Analytical and Bioanalytical Chemistry; Current Analytical Chemistry.
He has published more than 300 scientific publications, holds several patents and is active in educational programs for diploma and PhD student as well as for postdoctoral fellows.

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