Past Events

• AAPS Annual Meeting and Exposition
  
  Nov 10 – Nov 14, 2013
  San Antonio, TX
  
  Dr. Stephen Dueker, Vitalea CSO, will be presenting "Microtracer i.v. studies by AMS: The How and the Why?"
• 61st ASMS Conference on Mass Spectrometry and Allied Topics
  
  Jun 9 – Jun 13, 2013
  Minneapolis, MN
• Society of Nuclear Medicine and Molecular Imaging Annual Meeting
  
  Jun 8 – Jun 12, 2013
  Vancouver, BC, Canada
  
  Please come to exhibit booth 420 and visit with us and our colleagues from Eckert & Ziegler Isotope Products and Radiopharma.
• 7th WRIB Workshop on Recent Issues in Bioanalysis
  
  Apr 8 – Apr 11, 2013
  Long Beach, CA
• ASCPT 2013 Annual Meeting: The American Society for Clinical Pharmacology and Therapeutics
  
  Mar 5 – Mar 9, 2013
  JW Marriott, Indianapolis, IN
• CACO PBS Luncheon Seminar: Biomarkers: overview and applications in clinical trials and clinical molecular diagnostics
  
  Dec 7, 2012
  Crowne Plaza, Foster City, CA
• The 5th Open Meeting of the European Bioanalysis Forum
  
  Nov 14 – Nov 16, 2012
  Barcelona, Spain

  The following resource is available for download: Achieving Regulatory Approval: Overcoming Bioanalytical Challenges in an Onglyza® Micro-tracer Absolute Bioavailability Study with Accelerator Mass Spectrometry.

• Eastern Analytical Symposium
  
  Nov 12 – Nov 15, 2012
  Somerset, NJ
• The 13th Latin American Congress on Organic Geochemistry
  
  Nov 12 – Nov 15, 2012
  Santa Marta, Colombia
  
  Vitalea will be presenting Applications of Accelerator Mass Spectrometry for the Petroleum Industry: Sediment Core Analysis and Biofuel admixture authentication.
• Chemical and Pharmaceutical Structure Analysis
  
  Oct 1 – Oct 4, 2012
  Langhorne, PA
• Applied Pharmaceutical Analysis
  
  Sep 17 – Sep 19, 2012
  Baltimore, MD
• International Isotope Society Symposium
  
  Sep 9 – Sep 13, 2012
  Heidelberg, Germany

  The following resource is available for download: Absolute ¹⁴C IR-MS and the Future of UPLC-Metabolite Quantitation.

• CACO PBS Mini Symposium: Bioanalytical and analytical applications & problem investigation case studies
  
  Aug 10, 2012
  Crowne Plaza, Foster City, CA
• ASMS 60th Conference on Mass Spectrometry
  
  May 20 – May 24, 2012
  Vancouver, BC, Canada
  
  

  Matrix Independent Quantification of Proteins to Attomole Levels in Milligram-sized Samples

  
  
  Novel Aspect: Combustive AMS solves many of the quantitative problems associated with protein or biologics analysis and complements existing MS Identification methods.
  

  Abstract
  
  Mass Spectrometry has rapidly become the tool of choice for quantification of peptides and proteins. This tool is applied for intact protein analysis, pharmacokinetic profiling and determination of degradation products. Variation in ionization, fragmentation and detector response across the protein mass range lead to complexity in quantitation. Combustive isotope ratio Accelerator Mass Spectrometry solves many of quantitative issues by providing standard free quantitation of lightly 14C-labeled large molecules without confounding matrix interferences. We illustrate the process for matrix independent quantification of proteins or protein-small molecule conjugates using combustive IR-AMS on a 14C labeled antibody injected into three test rats.
  

  
  

  Methods
  
  A 150,000 kDa antibody labeled in a sulfhydryl position(s) using 14C radiolabeled N-ethylmaleimide. The resultant specific activity was 55 mCi/mol, showing almost complete labeling at this single reactive site (1 14C per molecule = 62 Ci/mol). After cleanup by multiple dialysis steps, the purified antibody was delivered byn intravenous bolus injection into three rats (10 nCi per animal). Whole blood was serially harvested for 24 hr post dose by tail bleed into K3EDTA tubes. 15 uL aliquots were removed, dried, and combusted to gaseous CO2 in sealed quartz tubes using CuO as a solid oxygen source. The CO2 was reduced to graphite over an iron group catalyst and analyzed for 14C contents by AMS.
  

  
  

  Preliminary Data
  
  The 14C counts were normalized to the stable carbon-12 macroscopic current which in essence serves as the internal standard. Results are reported as pg-antibody equivalents per mL after factoring in the blood total carbon concentration and the specific activity of the antibody. Blood pharmacokinetics displayed a biphasic disappearance that closely mimicked a parallel dataset generated using established ELISA method. Limits of detection were order of magnitude greater for the AMS method (low femotmolar) than the ELISA method and repeatability was <3% CV on independently processed replicates. No method specific development was required. Speciation of 14C labeled fragments was not performed at the time of writing this abstract but is being planned for on-going analyses.
  

  The following resource is available for download: Matrix Independent Quantification of Proteins to Attomole Levels in Milligram-sized Samples.

• Quantitation of 14C-labeled Proteins by Accelerator Mass Spectrometry, presented by Stephen Dueker
  
  Apr 18, 2012
  Langhorne, PA
  
  The Delaware Valley Drug Metabolism Discussion Group presents A Symposium on Mass Spectrometric Analysis of Protein Drugs.
  
  Abstract:
  Accelerator Mass Spectrometry (AMS) is a mass spectrometric method that quantifies 14C for high specificity but uses mass spectrometry for high sensitivity. Originally applied to geochronology, it is now a common tool for human microdosing, low radiative human (and animal) ADME, and the tracing of endogenous molecules in biochemistry, nutrition, and pediatric research. More recently, it has found application to the very difficult bioanalytical area of protein and 'biologics' quantitation. The AMS measurement is well-suited for this task as the measurement process differs from other analytical methods in very important ways: 1) it is independent of molecular structure; 2) it is not susceptible to matrix interferences (non-specific binding in ligand binding assays, ion suppression in mass spectrometry); and 3) quantitation is absolute, not comparative, and proceeds without resorting to compound-specific internal or external standards. The merging of Mass Spectrometry for identification and AMS for quantitation will enable studies into the tissue binding, fate and disposition of biologics in ways not easily achieved by other techniques. This talk will present both the challenges as well as opportunities for AMS as applied to Biologics research. A short background on the principles of AMS operation, sample preparation, and appropriate isotopic labeling methods will begin the presentation.
  
  Presentation available upon request.

  The following resource is available for download: Quantitative Analysis of Proteins by Accelerator Mass Spectrometry.

• Sixth Workshop on Recent Issues in Bioanalysis
  
  Mar 28 – Mar 29, 2012
  San Antonio, TX
• Vitalea sponsors CACO Workshop on Human Mass Balance and Metabolite Profiling Studies
  
  Dec 12, 2011
  Crown Plaza, Foster City, CA
  
  Vitalea Science is proud to be a major sponsor of this full day workshop focused on various aspects of performing radiolabelled human mass balance studies. These studies are required by regulatory authorities for registration of a new drug, and therefore, an integral part of the majority of drug development programs. Mass balance studies provide valuable information on rate and routes of elimination, mass balance, clearance mechanisms, metabolic profiles and relative abundance of metabolites in plasma and excreta but little guidance is available on how to perform and assess these complex studies. CACO organizers have assembled some of our industry's top scientists to address these issues and provide valuable guidance.
• 2011 Eastern Analytical Symposium and Exposition, Celebrating Innovation in Analysis.
  
  Nov 15, 2011
  Garden State Exhibit Center, Somerset, New Jersey
  
  Dr. Dueker will be speaking on Key concepts for Isotope dilution Isotope Ratio-MS (Accelerator Mass Spectrometry) at 4:20 pm on Tuesday, in the Sensitivity for Bioanalysis session.
  
  The symposium and exhibition runs from November 14-17.
• CPSA 2011
  
  Oct 5, 2011
  Sheraton Bucks County Hotel, Langhorne, PA
  
  Vitalea Science will be sponsoring a breakfast workshop, "Isotope Solutions to Address Unmet Analytical Needs" on Wednesday, 5 October.
  
  The meeting runs from October 3 - 6.
• 12th Annual Land O'Lakes Bioanalytical Conference
  
  Jul 11 – Jul 15, 2011
  Devil's Head Resort and Conference Center, Merrimac, WI, USA
  
  Vitalea contributed to the poster Achieving Regulatory Approval: Overcoming Bioanalytical Challenges in an Onglyza^TM Micro-tracer Absolute Bioavailability Study with Accelerator Mass Spectrometry:
  
  Xiaohui (Sophia) Xu, Lisa Christopher, Stephen Dueker, Pete Lohstroh, Vikram Roongta, Laura Cojocaru, Anther Keung, Kai (Kevin) Cao, Bonacorsi, Samuel, William Humphrey, Bruce Stouffer and Mark Arnold
  
  Characterization of absolute oral bioavailability (BA) is useful for oral drug development and is a requirement of some Health Authorities. Here we present results from an absolute BA study in which a microdose of intravenous (IV) [¹⁴C]saxagliptin was administered concomitantly with an efficacious oral dose of saxagliptin (BMS-477118, Onlgyza^TM).
  
  The poster is available for download.
• ASMS Conference on Mass Spectrometry and Allied Topics
  
  Jun 5 – Jun 9, 2011
  Denver, CO
  
  John Vogel presents WP03: Absolute measurement of carbon isotope ratios with accelerator mass spectrometry.
  
  Stephen Dueker presents ThP09: Isotope ratio Accelerator Mass Spectrometry method validations: Single-point calibration and "Zero" drug LLOQs.

  The following resources are available for download: Isotope Ratio Accelerator Mass Spectometry Method Validation: Single-Point Calibration and "Zero" Drug LLOQs and Absolute Measurement of Carbon Isotope Ratios with Accelerator Mass Spectrometry.

• CACO Workshop: Species Differences in Metabolism, Transporters and Pharmacokinetics
  
  May 23, 2011
  Crown Plaza, Foster City, CA
  
  This workshop will cover issues relating to the use of in vitro assays and animal models to predict human ADME properties of new molecular entities. Discussions will focus on species-related differences in drug metabolizing enzymes and transporters and how to best relate data generated from these tools to humans as an aid in the drug discovery and development process.
  
  The FDA Guidance for Industry "Safety Testing of Drug Metabolites" (MIST) states that identification of the difference in drug metabolism between animals used in nonclinical safety assessments and humans should occur as early as possible during the drug development process. A significant application for Accelerator Mass Spectrometry (AMS) in early ADME studies is to establish knowledge of human metabolites and physiochemistry in relation to safety species. Vitalea excels at absolute metabolite quantitation without resorting to comparative reference material or internal standards.
• 12th International Conference on Accelerator Mass Spectrometry
  
  Mar 20 – Mar 25, 2011
  Wellington, New Zealand
  
  John Vogel, Scientific Advisor to Vitalea Science, will be speaking on AMS technical developments contained in his recently submitted patent application. The invention will bring significant advances in quantitative LC-AMS, linking the LC by combustion directly to the AMS ion source allowing for continuous measurement of the tracer isotope in the eluent. This new patent will enable major operational efficiencies for AMS analyses involving chromatographic separations.
  
  See our announcement for more information.
• Pittcon conference on laboratory science
  
  Mar 13 – Mar 18, 2011
  Georgia World Conference Center, Atlanta, Georgia, USA
  
  Vitalea Science will be presenting High Performance UPLC-AMS for Matrix Independent Metabolite Quantitation.
  
  Accelerator Mass Spectrometry is a form of isotope ratio mass spectrometry (¹⁴C/C) that traces low abundance carbon-14 for high isotopic specificity (parts per quadrillion), but detects carbon atoms with mass spectrometry for high sensitivity (attomole). As a result, all the advantages of a radiolabel can be brought to bear on early human clinical research with a low radio-regulatory burden. All selectivity (multi-component resolution) in the AMS determination however arises from the quality of the off-line speciation of metabolites via LC systems. We present LC resolution and LOD data from several common radiometric systems (e.g LC-ARC, LC-LSC, LC-TopCount and UHPLC-RAM) in relation to UPLC-AMS when applied to human and animal metabolism work. The equal and universal quantitation of the AMS methodology towards any metabolite coupled with the high performance selectivity of UPLC is a simple and promising option for addressing the role of metabolites in both safety and primary pharmacology using near ambient levels of the "semi-stable" ¹⁴C isotope.
• Vitalea and Rosa & Co. research results presented at American Society for Clinical Pharmacology and Therapeutics
  
  Mar 2 – Mar 5, 2011
  Dallas, TX
  
  The results of a research collaboration between Vitalea and Rosa Drug Development Advisors will be presented on a poster entitled "Compartmental Analysis of Urosodiol PK in Neonates using AMS" at 8:00 am on March 4.
  
  One of the reasons for the dearth of clinical drug testing in newborns is a lack of sensitive and non-invasive tools to support clinical trials. Most medicines prescribed to children are done off-label, with dosages extrapolated from adult data through body weight and surface-area calculations. Ursodiol (UDCA), while not approved by the FDA for use in newborns, is used to treat pediatric cholestasis. Measurement of UDCA PK requires differentiating between endogenous and exogenous compound by using a labeled tracer. This is the first clinical study of UDCA PK in neonates.
  
  Authors: Rebecca Baillie, James Bosley, Arlin Blood, Herbert Vasquez, Le Vuong
• Vitalea Science is a major sponsor for the CACO Luncheon Seminar
  
  Feb 18, 2011
  Embassy Suites, La Jolla, CA
  
  Vitalea Science is a major sponsor for the CACO Luncheon Seminar Friday, February 18th from 11:00 to 1:30 at the Embassy Suites in La Jolla, CA. Invited Speaker Robert Ings will present from a pharmacokineticist's perspective on applications of Accelerator Mass Spectrometry (AMS).
• EPPIC 2011 Annual Conference - Panel discussion featuring Dr. Stephen Dueker
  
  Jan 9, 2011
  Crowne Plaza-Cabana Hotel, Palo Alto, CA
  
  Dr. Dueker will be speaking on Industry Experience with Phase 0 Microdosing during Session 3: MOLECULES TO MEDICINES: ARE WE GETTING BETTER?
  
  The problem of low NCE productivity continues to bedevil the pharmaceutical industry. This panel will focus on progress in three broad areas aimed at addressing this challenge: Exploratory IND's or Phase 0 Clinical Trials; Advances in Translational Research or Medicine; Impact of expanding trials globally particularly into Asia. Phase 0 Clinical Trials and Translational Research focus on methodologies to minimize late-stage drug failures and ensure higher probability of success by improving the drug candidate selection process early-on. The global outreach for conducting clinical trials, particularly in Asia has two potential benefits: (1) time and cost savings in the form of faster patient accruals and lower per patient expenses for clinical development in therapeutic areas traditionally identified as being "profitable" for the pharmaceutical industry, and (2) setting up infrastructure, incentives and public-private partnerships for addressing so-called "neglected diseases" in poorer countries.
• CACO Workshop: High Clearance and Poor Bioavailability: Case Studies
  
  Nov 4, 2010
  Crowne Plaza, Foster City, California
• AMS Method Validation Summit at CPSA 2010
  
  Oct 18 – Oct 21, 2010
  Sheraton Bucks County Hotel, Langhorne, Pennsylvania, USA
  
  Vitalea Science is sponsoring an Expert Forum at the 13th Annual Symposium on Chemical and Pharmaceutical Structure Analysis (CPSA 2010). On Wednesday October 20, we will be presenting Method Validation for Accelerator Mass Spectrometry Enabled Bioanalysis.
• Dr. John Vogel at APA 2010
  
  Sep 19 – Sep 22, 2010
  Baltimore, MD
  
  Dr. Vogel will be speaking on Innovative Study Design using AMS to address human metabolism
• CACO-San Diego Seminar: Solving Critical ADME/PK Issues in Drug Discovery and Development
  
  Jun 18, 2010
  Embassy Suites, La Jolla, CA
  
  Vitalea Science is cosponsoring this event; Dr. Dueker will be available before and during the seminar to answer any questions.
• 58th ASMS Conference on Mass Spectrometry and Allied Topics
  
  May 23 – May 27, 2010
  Salt Palace Convention Center, Salt Lake City, Utah
  
  Vitalea will be presenting a poster on Tuesday ('Accelerator Mass Spectrometry: Method qualification as the path to valid results') and a paper on Wednesday ('The performance of accelerator mass spectrometry (AMS) for the determination of 14C/C isotope ratios using a newly installed BioMICADAS AMS').
• CACO-San Diego Workshop: Drug Transporters
  
  Apr 20, 2010
  Marriott Del Mar, San Diego, CA
  
  Vitalea Science, Inc. will be appearing at this workshop, entitled "Drug Transporters: Interpretation and Application of the International Transporter Consortium Whitepaper and Draft FDA Guidance."
• CACO-Bay Area workshop: Drug Transporters
  
  Apr 19, 2010
  Crowne Plaza, Foster City, CA
  
  Vitalea Science, Inc. will be appearing at this workshop, entitled "Drug Transporters: Interpretation and Application of the International Transporter Consortium Whitepaper and Draft FDA Guidance."
• CACO Seminar: The Application of Dried Blood Spots for Quantitation of Xenobiotics
  
  Mar 12, 2010
  Embassy Suites - La Jolla, San Diego, CA
  
  The Application of Dried Blood Spots for Quantitation of Xenobiotics - Pre-Clinical DMPK New Directions
  
  Our scientists will be on site to answer any questions and look forward to seeing you there.
• CACO Workshop: ADME Sciences as Applied to Assessing Safety Testing (MIST)
  
  Mar 10, 2010
  Crowne Plaza - Foster City, CA
• NJ-ACS Mass Spectometry Discussion Group
  
  Dec 8, 2009
  The Holiday Inn, Somerset, NJ
  
  Dr. Dueker will be speaking at the Mass Spectrometry Discussion Group of the North Jersey Section of the American Chemical Society.
• 2009 AAPS Annual Meeting and Exposition
  
  Nov 8 – Nov 12, 2009
  LA Convention Center, Los Angeles, CA USA
  
  Contact Dr. Stephen Dueker to schedule a meeting.
• Accelerator Mass Spectrometry: High Performance Clinical Development with Microdoses and Microtracers
  
  Oct 28, 2009
  Sheraton Bucks County Hotel, Langhorne, Pennsylvania
  
  As part of the 12th Annual Symposium on Chemical and Pharmaceutical Structure Analysis — Impacting Biology through Analysis (October 26–29) — Vitalea Science will be hosting an afternoon session on Weds., Oct. 28 on Accelerator Mass Spectrometry: High Performance Clinical Development with Microdoses and Microtracers in Princeton II - 2nd Floor Boardroom Lobby Level)
• 2009 American College of Clinical Pharmacy (ACCP) Annual Meeting
  
  Oct 18 – Oct 21, 2009
  Anaheim, CA
  
  Join the presentation of Vitalea Science on "Accelerator Mass Spectrometry in Neonatal Clinical Research" on Tuesday, October 20.
• CACO Workshop on Drug Metabolite Identification
  
  Sep 30, 2009
  San Francisco, CA
• Land O' Lakes Conference on Drug Metabolism/Applied Pharmacokinetics
  
  Sep 14 – Sep 18, 2009
  Devil's Head Resort, Merrimac, Wisconsin
• Role of Bioanalysis and ADME in Translational Medicine
  
  Sep 13 – Sep 17, 2009
  Harvard Medical Conference Center
  77 Avenue Louis Pasteur, Boston, MA

  The following resource is available for download: Absolute quantification without internal standards: Accelerator Mass Spectrometry (BioMICADAS) and microtracers for pharmacokinetics, metabolite discovery and mass balance.

• CACO/BAADME Joint Workshop on Clinical Pharmacokinetics & Pharmacodynamics
  
  Sep 8, 2009
  
  
  12:45pm – 5:30pm
• 10th International Symposium of the International Isotope Society
  
  Jun 14 – Jun 18, 2009
  Chicago, Illinois
  
  Drs. Keck and Vogel will be attending, presenting and leading discussions. Dr. Bradly Keck will be presenting exciting information on the dosimetry issues related to the use of light radiolabels and will be co-hosting an AMS roundtable to discuss how AMS can contribute to your drug development and research. Drs. John Vogel and Le Vuong will present on AMS use in pediatric research from on-going collaborations with Loma Linda University (Dr. Arlin Blood). This is a landmark achievement in the application of AMS and not to be missed.
• 57th ASMS Conference on Mass Spectrometry and Allied Topics
  
  May 31 – Jun 4, 2009
  Philadelphia, Pennsylvania
  
  Drs. Dueker and Keck will be attending and presenting at ASMS (American Society of Mass Spectrometry). Vitalea will be presenting two talks on the value of microtracing for early ADME in a forum moderated by Dr. Graham Young. We look forward to seeing the latest MS equipment and learning how the scientific partnership of AMS and LC/MS/MS will solve a myriad of development problems when the technologies are working in concert.
• San Diego Biotechnology Discussion Group
  
  May 27, 2009
  San Diego, CA, USA
  
  Vitalea (Dr. Stephen Dueker) will be sponsoring a booth and will provide a short presentation. The meeting is open to all and we would very much like to meet with any local companies to discuss how we can assist them with product development using microdoses or microtracers. California is the global biotechnology center and our technology is ideally suited for biological PK and some PD assessments with speed and sensitivity.