February Vendor Sponsor - YMC America - Timothy Han - http://www.ymcamerica.com

Main Speaker: Dr. John P. Jasper Chief Executive Officer of Nature’s Fingerprint®  / A Division of Molecular Isotope Technologies LLC (of  Niantic, Connecticut)

Title: The Use of Isotope Ratio Mass Spectrometry for Bio/Pharmaceutical Process Patent Protection

Abstract: J. P. Jasper(1), D. Eyler(2), and M. Pavane(3)  (1)Molecular Isotope Technologies LLC, (2)Gray Plant Mooty, and (3)Cozen O’Connor 

The analyses of the natural distribution of stable isotopes in bio/pharmaceutical products and synthetic processes provide evidence for intellectual property protection.  In particular, they permit the characterization of compound sources and differentiation of potentially-infringing synthetic pathways. After reviewing three cases of product characterization, we will examine three cases of process authentication: two of process patent infringement and one of false advertising.  The cases of product characterization demonstrate the dynamic range of the stable isotopes in differentiating sources of bio/pharmaceutical materials.  The first case of process authentication is a straightforward case of process patent infringement in which the stable-isotopic compositions of paired reactants and products first demonstrated the isotopic fingerprint of the synthetic pathway of interest.  Subsequent analyses of suspect reactants and products overlaid the vector of the authentic pathway.  That evidence was sufficiently compelling to yield a settlement (viz., a license) that protected approximately $1.2 billion of our client’s drug against infringement.  In another case, a plaintiff firm wrongly accused our defendant-client firm of process patent infringement.  Analysis of the isotopic records of both firms’ synthetic pathways revealed that they were non-overlapping and non-parallel.  With that and with the structural chemistry of the synthetic intermediates, the defendant firm was determined not to be infringing upon the plaintiff’s pathway.  This isotopic evidence was the basis for a settlement in which our defendant-client firm was allowed to market their drug product in the U.S.A. resulting in sales of ~0.5 billion dollars.  Finally, in a case of false advertising of green tea theanine, stable-isotopic analyses of theanine from the plaintiff, the defendant, and authentic green tea revealed that the defendant’s theanine did not derive from green tea, but rather corn or sugarcane.  Our mere presentation of the process study -- without even performing it -- contributed to the settlement of the case. The resultant proper advertising of the theanine source helped to protect the multimillion dollar theanine market against false advertising. In summary, the natural stable-isotopic fingerprints of both products and processes have protected almost $2 billion of bio/pharmaceutical products against intellectual property infringement.

Bio:

•    The focus of Nature’s Fingerprint®  is on authentication of  both pharmaceutical products and processes by their natural-abundance stable-isotopic compositions, particularly Intellectual Property Protection.
•    More recently, they have expanded into in-process monitoring.

Brief biography:

•    B.A., Geophysical Sciences and Biology, The University of Chicago.

•    Ph.D., 1988, in Marine Organic and Isotope Chemistry
Jointly granted by M.I.T. and Woods Hole Oceanographic Institution.  

•    Postdoctoral Fellow and  Scientist in Stable Isotope Chemistry, 
Indiana University’s Department of Chemistry, in Bloomington, Indiana.

With:

•    ~30 publications in organic and isotope  geochemistry and in bio/pharmaceutical chemistry; and,

•    20 years in the pharmaceutical industry as an analytical organic and isotope chemist, with:

o    Pfizer-Cultor,
o    Drumbeat Dimensions (a pharmaceutical advisory firm), and
o    Nature’s Fingerprint® / Molecular Isotope Technologies LLC.

Also serving as a pro bono geochemist with the Niantic River Watershed Committee.

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Graduate Student Speaker: Chaoran Wang - University of Connecticut - Dept. of Chemistry - Advisor - Prof. Michael Hern

Title: Stable Isotopic and Molecular Alteration of Soil Organic Biomarkers During Simulated Diagenesis

Abstract: 

Organic molecular and stable isotopic of soil biomarkers are increasingly utilized to address a range of scientific questions, from paleo-environmental reconstruction to understanding of petroleum systems. While there is considerable research on the process of thermal cracking of hydrocarbon molecules, there is still a degree of uncertainty over how carbon and hydrogen isotopes of commonly utilized biomarkers change as a function of increased temperature, pressure and water availability during burial diagenetic and catagenetic processes. This study focused on evaluating carbon and hydrogen isotopic alteration of normal alkanes during simulated diagenesis to understand how the pressure-temperature pathways common to sediments from tectonically active sedimentary basins impact organic molecular records. We conducted an artificial maturation experiments for hydrous and anhydrous experiments over a range of temperatures and pressures comparable to shallow burial diagenesis (25-350 °C). Consistent with prior work, our results show that the distribution of n-alkanes dramatically changed above ~150 °C with a reduction in carbon preference index from 10.8 to 1.6. Despite a shift in compound distributions, the isotopic compositions of hydrogen and carbon of target molecules are stable until ~200 °C in an anhydrous environment. 

Bio:

2012-present   University of Connecticut, CT, United States (Advisor: Dr. Michael Hren)

Ph.D. in Analytical and Environmental Chemistry

Research projects:

·      Stable isotopic and molecular alteration of organic biomarkers during heating process.           

·      Soil n-alkane dD and glycerol dialkyl glycerol tetraethers (GDGTs) distributions along an altitudinal transect.

2009-2012     Shanghai Jiaotong University, Shanghai, China (Advisor: Chao Yan)

M.S. in Pharmaceutical Analysis

Research projects:

·      Applications of pressurized capillary electro chromatography (pCEC) in metabolomics and drug detection.

·      Preparation and application of the affinity monolithic capillary columns to specifically separate glycoproteins.

2005-2009    Tongji University, Shanghai, China

             B.S. in Applied Chemistry