Interfacing Chemical Metrology with Pharmaceutical and Compendial Science

Dr. William Koch
Chief Metrology Officer
U.S. Pharmacopeial Convention
12601 Twinbrook Parkway, Rockville, MD 20852-1790, USA



WFK@usp.org

Dr. William F. Koch is the Chief Metrology Officer for the United States Pharmacopeial Convention (USP). USP is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. Dr. Koch leads USP's metrology initiatives. He oversees the organization's research and development laboratories and manages the production of USP reference standards, which when used n concert with the USP documentary standards ensure that healthcare products meet the USP standards for quality, strength, and purity.

Prior to joining USP in 2007, Dr. Koch served for 32 years in the U.S. Department of Commerce, retiring from government service as the Deputy Director of the Chemical Science and Technology Laboratory at the National Institute of Standards and Technology (NIST). He started at NIST (then the National Bureau of Standards) in 1975 as a NBS/NRC Postdoctoral Research Associate in the Electricity Division continuing his research in the refinement of the Faraday constant. In 1977, he joined the staff of the Center for Analytical Chemistry at NBS as a research chemist, where he expanded his research interests to include pH, electrolytic conductivity, ion selective electrodes, ion chromatography, and standards for in vitro diagnostics and clinical chemistry. In 1994, he became the Deputy Director of the Chemical Science and Technology Laboratory and a member of the Senior Executive Service.

Dr. Koch received his B.S. in chemistry at Loyola University of Chicago, and was conferred a Ph.D. in analytical chemistry at Iowa State University in 1975. He was awarded the Silver Medal by the Department of Commerce in 2002. He is a Fellow of the National Academy of Clinical Biochemistry. He has served as President of the National Committee for Clinical Laboratory Standards (now the Clinical and Laboratory Standards Institute) and as a member of the Governing Board of the Council for Chemical Research. He currently serves on the Board of Directors of the American National Standards Institute (ANSI). He also serves on the Committee of Distinguishers Advisors for the Department of Chemistry and Biochemistry, University of Maryland - College Park. He has authored over 70 scientific publications and has had direct involvement in the certification of over 70 Standard Reference Materials.

Fostering measurement science education in Europe - the Measurement Science in Chemistry consortium

Prof. Ivo Leito
Professor of Analytical Chemistry
University of Tartu, Institute of Chemistry, Estonia

ivo.leito@ut.ee

Scientific research (http://tera.chem.ut.ee/~ivo/RD.html)
a) Experimental and theoretical studies of acid-base equilibria and solvent effects in nonaqueous solvents and in the gas phase.
b) Metrology in chemistry, measurement uncertainty in chemistry.
c) Analytical chemistry (instrumental analytical methods IR spectroscopy, GC-MS, LC-MS, SEM EDS, etc) applied to analysis of materials and objects of cultural heritage.
d) Methodical aspects of teaching analytical chemistry and metrology in chemistry

Number of international scientific publications: 65 (all in journals indexed by ISI)

Supervising
Has supervised 5 PhD students more than 10 MSc and more than 20 BSc students.
Is currently supervising 4 PhD students, 3 MSc students and 1 BSc student.

Teaching
- Has set up and is the program director of the international Master Curriculum Applied Measurement Science http://www.ut.ee/ams which is a part of the Euromaster consortium Measurement Science in Chemistry http://www.msc-euromaster.eu/
- Has set up around 10 new courses and compiled numerous teaching materials of different courses. The full list can be seen at http://tera.chem.ut.ee/~ivo/oppetoo.html.
- Is currently teaching 8 courses.

Administrative
- Program director of the master degree program "Applied Measurement Science"
- Coordinator of the consortium “Measurement Science in Chemistry”

Basic metrological concepts in chemistry and associated terms (VIM)

Prof. Paul De Bievre
Independent Consultant on Metrology in Chemistry (MiC),
Kasterlee,
Belgium

paul.de.bievre@skynet.be

37 years (1961-1998) at EU-IRMM directing "absolute" isotopic measurements including atomic weight determinations, IDMS as Primary Reference Measurement Procedure, Isotope Reference Materials a.o. for “Nuclear Safeguards”, Metrology in Chemistry; global Avogadro project (Si) since 1981.

Professor Inorganic/Isotope Mass Spectrometry University of Antwerpen (1972-1998).
Founded “REIMEP” (1977) (nuclear external quality assurance ILC), “IMEP” (1986) (non-nuclear external quality assurance ILC), “NUSIMEP” (1997) (environmental Safeguards external quality assurance ILC), all intended to establish equivalence of chemical measurement results of any participant with respect to independent “metrologically traceable” or “SI-traceable” reference values.

Introduced concept “Target Measurement Uncertainties for Measurement Results” in 1979 for use in U and Pu measurements (now defined in VIM) for the international Nuclear Material Inventory Control.

President National Committee on Chemistry of the Royal Academies of Belgium, leading the Belgian Delegation to the IUPAC Council (1987-2007).

Advisor to the Director IRMM on Metrology in Chemistry – MiC (1998-2002).
Co-founder of EURACHEM (and 2nd Chairman).

Co-Founder of CITAC.

IUPAC Delegate to the Joint Committee for the Guides on Metrology (VIM and GUM) and to the JCGM-WG2 on the VIM, as well as to CCQM and ISO/TAG 4 on the implementation of VIM and GUM.

Editor-in-Chief of the Journal "Accreditation and Quality Assurance" (SPRINGER) (1996-to date).

Independent Consultant on “Metrology in Chemistry – MiC” (1998-to date).
Task Leader of IUPAC Project on “Metrological Traceability of Measurement Results in Chemistry –Concepts and Implementation” (2001-2009).

Received CITAC 2008 Award for best 2008 paper on MiC.

More details are available in http://www.iupac.org/web/per/debievre.

Impact of Innovative Mass Spectrometric Instrumentation on the Analytical Determinations for Forensic and other Legal Aims

Prof. Marco Vincenti
Professor of Analytical Chemistry
Department of Analytical Chemistry, University of Torino, Italy
Director of the Regional Antidoping and Toxicology Center “A. Bertinaria”
Orbassano (Torino), Italy

marco.vincenti@unito.it

Marco Vincenti is Professor of Analytical Chemistry at the University of Torino (Turin, Italy), where he teaches Instrumental Analysis and Chemometrics. He co-founded and currently supervises a Master Degree in "Clinical, Forensic Chemistry and Doping Control".
After the Turin 2006 Winter Olympic Games, Prof. Vincenti was appointed as Technical and Scientific Director of the Regional Antidoping and Toxicology Laboratory “A. Bertinaria" of Turin, built for the olympic event. This Laboratory recently achieved ISO 17025 accreditation for a wide range of analytical determinations regarding drugs of abuse and alcohol abuse in a variety of biological matrices (blood, urine, hair, oral fluid). He collaborates with the Justice, the Police forces, and the Regione Piemonte administration for the chemical analysis of biological samples and drug mixtures seized during law enforcement and crime prosecution activities.
Prior to joining the University of Torino in 1990, Prof. Vincenti worked for 7 years in the corporate research center of a chemical industry (Istituto Guido Donegani – Montedison Group – Novara, Italy), as the person in charge of the mass spectrometry lab. In 1986, he was Visiting Scientist in the "Aston Laboratory" of Prof. Graham R. Cooks at the Purdue University (Indiana - USA). He investigated innovative tandem mass spectrometric techniques, associated with collisional activation on solid surfaces and gases.
In his academic career, Prof. Vincenti became Associate Professor in 1998 and Full Professor in 2006. During both industrial and academic periods of activity, he developed an expertise in various aspects of mass spectrometry, including collisional spectroscopy, ionization methods, polymer characterization, environmental analysis, forensic investigation, doping control. In the field of environmental analysis, he collaborated with the U.S. Environmental Protection Agency for the determination of new and unpredictable water disinfection byproducts in potable water. His current research interests are directed toward various applications of analytical chemistry, including toxicology, forensic investigation and doping control, and the development of innovative methods for determining new drugs with anabolic activity, illegally used in sport as well as in animal breeding.
Prof. Vincenti authored 96 scientific publications, most of which on journals of either the American Chemical Society or other European Chemical Societies, and 4 European patents. He collaborated with eminent scientists, including Donald Cram (UCLA, Nobel Prize for Chemistry), Graham Cooks (Purdue University), Robert Blackledge (Forensic Laboratory of the U.S. Navy, San Diego), Susan Richardson (U.S. EPA, Athens, Georgia, USA) and Pirjo Vainiotalo (University of Joensuu, Finland). He is a member of Italian Chemical Society and the American Society for Mass Spectrometry.

Quantitative Micro-Proteomics Profiling Studies Of Pancreatic Cancer Stem Cells

David M. Lubman

University of Michigan
USA


dmlubman@umich.edu

David M Lubman is currently the Maude T Lane Professor of Surgery at the University of Michigan Medical Center. He is also Professor of Chemistry, Professor of Pathology, an Associate Member of the Comprehensive Cancer Center and an Associate Member of the BioInformatics Program. He received his A.B. from Cornell University in 1975 and his Ph.D. in 1979 under the direction of Professor Richard N Zare at Stanford University in Physical Chemistry. He was a fellow at the Weizmann Institute in 1981 in the Department of Chemical Physics. He has been at the University of Michigan since 1983 initially in the Department of Chemistry where he developed a program in the areas of laser chemistry and mass spectrometry. His lab has published over 235 papers and graduated 56 Ph.D.s many of whom have gone on to hold leadership positions in the pharmaceutical and biotech industries. Most recently he has undergone a career switch and joined the Department of Surgery to develop a program in new technologies aimed at discovering markers of early cancer and prognosis of disease. Much of this work is focused in on glycoproteomic changes in proteins during cancer progression and newer work on mapping pathways in disease using a mass spec based approach. The group has filed numerous patents resulting in the development of new companies and new products involved in liquid mapping of proteins, protein microarrays, and new mass spec based technology and hardware. Dr Lubman is a Fellow of the American Association for the Advancement of Science and a member of the American Association of Cancer Research.