![OCM Member](https://d2cax41o7ahm5l.cloudfront.net/cs/ocm/pharmaceutical-2022-david-r-schoneker-2053895443.jpg)
David R. Schoneker
President/Owner/Consultant
Black Diamond Regulatory Consulting, LLC
USA
Biography
David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC. With over 44 years of experience working in these areas, Dave has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an Adjunct Professor at Temple University's School of Pharmacy in their RA/QA Master's Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements. Prior to August 2019, David R. Schoneker was the Global Regulatory Director – Strategic Relationships at Colorcon, Inc. He was at Colorcon from 1977 until 2019. Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee and serves as the Chair of the Excipient QbD/Composition Committee.
Research Interest
New Concepts for Drug Product Innovation & Novel Excipients - FDA Novel Excipient Pilot Program
![OCM Member](https://d2cax41o7ahm5l.cloudfront.net/cs/ocm/pharmaceutical-2022-vladimir-matveevich-gruznov-1294685826.png)
Vladimir Matveevich Gruznov
Professor
Russian Academy of Sciences (Novosibirsk)
Russia
Biography
Vladimir Matveevich Gruznov, Doctor of Sciences (Chromatography, Geophysics), Science Deputy Director of Trophimuk Institute of petroleum geology and geophysics Siberian Branch of Russian Academy of Sciences (Novosibirsk). Field of work: substance and elemental analysis for explosives detection, geophysics and ecological monitoring. Developed the concept for high-speed highly sensitive gas chromatography detection of EXPLOSIVES and chemical control of the environment. The concept is implemented in the portable devices of the world level. Publications: over 190 research papers including 3 monographs and 16 patents.
Research Interest
Substance and elemental analysis for explosives detection, geophysics and ecological monitoring
Biography
Oleg Shpigun received Ph.D. (1974) and Doctor of Sciences (1990) degrees in chemistry from M.V. Lomonosov Moscow State University (MSU). He is the corresponding-member of Russian Academy of Sciences (RAS) (2006), full professor in the Department of Chemistry, MSU, the head of laboratory of chromatography, the head of Analytical Center of MSU. His research program is concerned with basic studies and applications of chromatographic methods of analysis. He has published more than 300 papers in reputed journals. He is the head of the Commission on Chromatographic Methods of Analysis of Scientific Council on Analytical Chemistry of RAS. He has been (since 1995 until now) the Director of 11 projects of Russian Foundation for Basic Research and Russian Science Foundation. He has received different awards, including “Russian State Price Winner in Science†(1991), “Emeritus Professor of Moscow State University†(2005).
Research Interest
Novel approaches to creation of separation materials for HPLC