23^rd International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems February 21-22, 2022 Berlin, Germany

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.

New Concepts for Drug Product Innovation & Novel Excipients - FDA Novel Excipient Pilot Program

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.

Substance and elemental analysis for explosives detection, geophysics and ecological monitoring

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).

Novel approaches to creation of separation materials for HPLC

Gerhard Kratz has completed his studies at University of Applied Sciences in Berlin. His dissertation was about Planning, calculation and construction of a Fluidized bed reactor. Deepening during his studies was Water economy, chemical technology, plastic technology, varnish and paints, oil processing. First positions in industry were in pharmaceutical industry doing HPLC method development on various HPLC brands. Specialized in HPLC column selection and teaching customers in troubleshooting all over the world he is supporting several internet forums for HPLC questions. He is interested in troubleshooting.

HPLC Troubleshooting Analytics

Gilles Goetz is a Principal Scientist at Pfizer in Groton, Connecticut, USA. Gilles received his B.Sc. (1991) and Ph.D. (1995) at the University of Strasbourg in France. After post docs at the University of Hawaii (1996-97) and of Neuchatel (CH) (1998-99) studying marine and fungal natural products, he joined Monsanto in 2000. There he worked through mergers and acquisitions for Pharmacia and Pfizer successively in the Natural Product group, the HTS group (analytical support), and the Purification Group. In 2010 he transferred to the Expert Purification Group at Pfizer Groton and in 2011 to the Molecular Properties Group. He is part of the team influencing medicinal chemistry design through insights into molecular properties such as polarity, lipophilicity, shape, and conformation that will impact molecular behaviors like solubility, permeability, and efflux. They develop and use mainly chromatographic techniques (EPSA) to assess those properties, and work towards predicting molecular behaviors.

SFC, HPLC applications, Immobilized Artificial Membrane (IAM) chromatography as well as Micellar Liquid Chromatography (MLC), along with EPSA

Dr. Norberto Guzman received a B.Sc. degree in biochemistry from the University of Chile, Santiago, Chile; a M.Sc. degree in biochemistry (cell and molecular biology) from the Medical College of Georgia, Augusta, Georgia, U.S.A.; and a Ph.D. degree in biochemistry from a Joint Graduate Program of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School and Rutgers, The State University of New Jersey, New Brunswick, New Jersey, U.S.A. Dr. Guzman has worked for the last 30 years in academic medical institutions, diagnostic and pharmaceutical companies, including Mount Sinai School of Medicine, Roche Diagnostic Systems, Hoffman-La Roche, and Johnson & Johnson. He is currently the Chief Scientific Officer-Director of Research at Princeton Biochemicals, Inc. Princeton, New Jersey, U.S.A.

Dr. Norberto Guzman main research interest is in the studies of protein biomarkers in biological fluids using miniaturized immunoaffinity capillary electrophoresis instruments.

Dr Haifei Zhang is a senior lecturer in the Department of Chemistry at the University of Liverpool. Zhang was educated in chemical engineering for both undergraduate and Master degrees and obtained a PhD in physical chemistry from Chinese Academy of Science. He has published 90 peer reviewed research papers with a h-index of 29 and filed 9 international patents as a co-inventor. One of the patents was assigned to Unilever and led to the formation of a spin-out company IOTA Nanosolutions funded through Unilever Venture. The SOS silica patent is currently considered for commercialization by Thermo Fisher Scientific. He won the 12th Desty Memorial Award in 2007 for his innovative work in the manufacture of porous materials and their possible application in chromatography. He has also written 5 book chapters and one book (to be published by Wiley in 2018). Zhang’s main research interests are on porous materials, colloids, carbon materials, and nanostructured materials for separation and energy storage applications.

Porous materials, colloids, carbon materials, and nanostructured materials for separation and energy storage applications.

Miloš Netopilík has completed his PhD at the age of 30 years from Institute of Macromolecular Chemistry and postdoctoral studies from Virginia Polytechnic Institute and Technical University. Now, he works in Institute of Macromolecular Chemistry, Academy of Sciences of the Czech Republic and works in the theory of separation. He has published more than 68 papers in reputed journals.

Chromatography, Separation techniques