5 minutes of fame

1. The AMS Solution:
It’s Sensitive and Saves You Time
Milestone
Development
October 1 – 4, 2012
Innovation
Leadership
Communication

2. EZAG Parent –
550 Employees in 14 Locations Worldwide
Longevity – 45 years
Stability – Worldwide network
Committed - On-time delivery
Quality – Zero defects
HQ: Berlin
Vitalea Science located in Davis, CA
www.vitaleascience.com

3. EZAG Parent –
High-Tech Specialist Focussed on Isotope Applications
Isotope Products
for Measurement & Control
Radiation Therapy
(Cancer Treatment) 4 Business Segments
Nuclear-pharmacy
and Radiopharmaceuticals
Environmental
Services

4. AMS Solutions: Sensitive, Fast, Simple
• Ultra Sensitive 14C Analysis
• Absolute counting machine
• Quantitation at attomole levels
• Ideal for metabolite profile
• With no standards
• Independent of Matrix
• All matrices reduced to carbon
• Independent of Molecular Weight
• Small molecules
• Proteins
• ADCs
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5. Sensitivity Required
• Microdosing (14C)
• Candidate selection based upon HUMAN data under
an exploratory IND application (<100 ug/100 nCi)
• Microtracing – Low radiation Human A(D)ME
• Mass balance and metabolism (A(D)ME) at
therapeutic doses using “microtrace” 14C (~ 100 – 500
nCi)
• No animal dosimetry Save 6 months to 1 year
• Non-GMP material Perform earlier, phase 1
• Mitigation of MIST liabilities PO Dose
Absolute Bioavailability (single test design)
IV Dose
• 103
Time Const. = 177 hr
No cross-over
Microtracer IV given at Tmax of cold therapeutic oral
C signal ( arbtrary units )
•
dose
102 10 3
Time Const. = 177 hr
Total Plasma
14
• Biologics PK/Biodistribution
10 2
No method development
24 48 72 96 120 144
101
10-1 100 101 102
Time post PO Dose ( hr )
• Quantification independent of structure
• Pediatric PK
• Defensible blood volumes and 14C exposures
• Medical Diagnostics (Personalized Medicine)
• Malabsorption assays
• Prediction of responsiveness to interventions
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6. MIST Plot Radiochromatogram
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7. Accelerators Are a Mystery
Evolving Technology
smaller, robust, easy
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8. The CRO Culture: Communication and On-time Delivery
• Technical Depth
• 2003 Founders : Stephen Dueker, Le Vuong,
John Vogel
• Innovators of next generation BioMICADAS
AMS technology
• Founders of applied AMS methods for
biological determinations
• CRO Industry Experience (GLP Facility)
• Strong commitment to QA and regulated
bioanalysis
• Project Leadership - Responsible for all
technical aspects of the study
• Bioanalytical method development expertise
• Timelines
• Understanding the critical nature of the
business
• QA’d data within 2 weeks of completion of
analysis
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9. Thank You and Come Talk to Us
Poster
• Matrix Independent Quantification of Proteins to Attomole Levels in
Milligram-sized Samples, Poster by Stephen Dueker, et.al.
August Issue Bioanalysis 2012 Vol. 4 No. 15
• Overcoming bioanalytical challenges in an Onglyza intravenous
14Cmicrodose absolute bioavailability study with accelerator MS, Xu,
Dueker, Christopher, et.al.
• Applications of accelerator MS in pediatric drug evaluation, Vuong,
Blood, Vogel, et.al.
Contacts:
Ann Hoffman, ahoffman@vitaleascience.com
Stephen Dueker, stephen.dueker@vitaleascience.com
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10. AMS Solutions: Sensitive, Fast and Within Grasp
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