28 the ams solution ann hoffman - vitalea
DESCRIPTION
5 minutes of fameTRANSCRIPT
The AMS Solution:
It’s Sensitive and Saves You Time
Innovation
Leadership
Communication
Milestone Development
October 1 – 4, 2012
EZAG Parent – 550 Employees in 14 Locations Worldwide
HQ: Berlin
Longevity – 45 years
Stability – Worldwide network
Committed - On-time delivery
Quality – Zero defects
Vitalea Science located in Davis, CA
www.vitaleascience.com
EZAG Parent – High-Tech Specialist Focussed on Isotope Applications
4 Business Segments
EnvironmentalServices
Nuclear-pharmacyand Radiopharmaceuticals
Radiation Therapy (Cancer Treatment)
Isotope Products for Measurement & Control
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
5
• 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 • Non-GMP material • Mitigation of MIST liabilities
• Absolute Bioavailability (single test design)• Microtracer IV given at Tmax of cold
therapeutic oral dose
• Biologics PK/Biodistribution• Quantification independent of structure
• Pediatric PK• Defensible blood volumes and 14C exposures
• Medical Diagnostics (Personalized Medicine)• Malabsorption assays
• Prediction of responsiveness to interventions
10-1 100 101 102101
102
103
Time post PO Dose ( hr )
Tota
l Pla
sm
a
14 C s
ign
al
( a
rbtr
ary
un
its
)
PO Dose
IV Dose
24 48 72 96 120 144
102
103
Time Const. = 177 hr
Time Const. = 177 hr
Sensitivity Required
Save 6 months to 1 yearPerform earlier, phase 1
No cross-over
No method development
6
MIST Plot Radiochromatogram
7
Accelerators Are a Mystery
Evolving Technologysmaller, robust, easy
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
9
Poster
• Matrix Independent Quantification of Proteins to Attomole Levels in Milligram-sized Samples, Poster by Stephen Dueker, et.al.
• 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.
August Issue Bioanalysis 2012 Vol. 4 No. 15
Contacts:
Ann Hoffman, [email protected]
Stephen Dueker, [email protected]
Thank You and Come Talk to Us
10
AMS Solutions: Sensitive, Fast and Within Grasp