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Vitalea Science and Radiopharma...
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14 May 2013
Vitalea Science and Radiopharma Combine Expertise to Advance Global Pharmaceutical Development
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Eckert & Ziegler Vitalea Science (EZVS) is pleased to introduce
complementary products and services of Radiopharma, a longstanding business
segment within the Eckert & Ziegler family. Headquartered in Berlin with
technical support and business development locations in Mainz, Bonn,
Brunswick, Washington DC and Boston, Radiopharma specializes in molecular
imaging and nuclear medicine, and supplies radiopharmaceuticals,
radiochemicals and related equipment for synthesis and radiochromatography of
PET/SPECT tracers for the medical and pharmaceutical industries.
As many pharmaceutical companies expand in-house research facilities to include
imaging capabilities, Radiopharma is a strong fit and complement to the
bioanalytical accelerator mass spectrometry (AMS) service offerings of EZVS.
"The two business segments have great synergy and share some of the same
clients. We believe that this partnership will allow Eckert & Ziegler to
add value to our existing customer base, as well as penetrate deeper into the
pharmaceutical market" says Frank Yeager, President & CEO of Eckert &
Ziegler Isotope Products.
Focused on providing continuous client satisfaction in a steadily growing
customer network, this partnering of resources is essential for achieving and
maintaining the innovation and quality expected from the global pharma
industry. Yeager continues, "We look forward to being able to continue
expanding our business and helping our customers by providing an array of
services with world class customer support."
To learn more about our combined products and service offerings, visit with
the Eckert & Ziegler family of companies at the upcoming Society of
Nuclear Medicine and Molecular Imaging Annual meeting in beautiful Vancouver,
BC June 8-12. Come see us in booth 420!
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Eckert & Ziegler Vitalea Science and Korea-based BioCore
Sponsor Workshop "A Step Forward: Novel Technology For New Drug Development"
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Eckert & Ziegler Vitalea Science and BioCore Co. Ltd., South Korea's largest
provider of bioanalytical LC/MS/MS services, brought together top scientists
and researchers early this month to formally introduce AMS microdosing and
microtracing to the growing Korean Pharmaceutical industry. This jointly
hosted workshop "A Step Forward: Novel Technology for New Drug Development"
marks the first major step in an agreement between the two companies to enable
Korea to compete with top pharmaceutical producing countries on the global
market.
Professor In-Jin Jang, from Seoul National University College of Medicine,
directs an ultra-modern phase 1 clinic, served as chairperson of the workshop
that attracted more than 100 representatives from 50 invited pharmaceutical
companies, clinical trial centers, government research centers and the Korean
FDA. The program consisted of four major topics:
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Dr. Stephen Dueker, EZVS CSO opened the session with a presentation on
clinical development applications using AMS technology as an important tool to
improve predictability and efficiency.
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Professor Young Shin of Chungnam National University discussed design of a
microdosing/micro-tracing study that resulted in an NDA filing in the US and
subsequent drug approval.
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Professor Soo Kyung Bae from the Catholic University of Korea presented
results of research microdosing studies conducted in Korea as a fast-track
approach to clinical drug development.
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Dr. Chung Myeon-Woo from the Ministry of Food and Drug Safety spoke of KFDA
regulations on microdosing studies and harmonization with the USFDA and EMEA.
The workshop concluded with interactive discussions between attendees and the
panel of experts over a diverse range of applications and study designs that
included: candidate selection, absolute bioavailability, human mass balance,
metabolite profiling, in addition to difficult issues such as development of
drugs with very long half-lives, solubility, and highly potent and distributed
drugs. Mr. Hyong-Sik Choie, BioCore President & CEO commented, "From this
workshop, we all have confirmed that microdosing/microtracing studies using
AMS technology has already been successfully applied to new drug applications
in the US and Europe. Korean pharma companies are now ready to apply these
innovative technologies for accelerating the drug development timeline to
compete with the global leaders of our industry." BioCore will continue to
support the Korean domestic market and through this partnership with EZVS
expand BioCore's portfolio, adding AMS based services to their suite of
advanced offerings, and facilitate EZVS's entry into the rapidly growing
Asian pharmaceutical market.
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Upcoming events
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June 8 – 12: SNMMI Annual Meeting, Society of Nuclear Medicine and Molecular
Imaging (Vancouver, BC)
June 9 – 13: 61st ASMS Conference on Mass Spectrometry and Allied Topics (Minneapolis, MN)
Nov. 10 – 14: AAPS Annual Meeting and Exposition (San Antonio, TX).
"Microtracer i.v. studies by AMS: The How and the Why?" presentation by
Stephen Dueker, CSO
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About Eckert & Ziegler Radiopharma
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Radiopharma provides customers with research, technology and product support
by offering an all-in-one-solution consisting of: cyclotron sites, synthesis
technology, GMP compliant production facilities and access to research
cyclotrons.
http://www.ezag.com/home/products/radiopharma.html
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About Eckert & Ziegler Vitalea Science
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EZVS is an integrated provider of isotopes and isotope measurement and
calibration services with its Davis, California facility dedicated to GLP
level bioanalysis. Founded in 2003 by researchers from the University of
California, EZVS is the first U.S.-based bioanalytical contract research
organization dedicated to providing services for exploring the
pharmacokinetics and metabolism of drug candidates directly in humans and
non-clinical species using AMS, both prior to and as part of phase I clinical
trials. In our Davis, CA facility, we utilize the BioMICADAS, the only AMS
instrument purpose-built to address the specific needs of the pharmaceutical industry.
http://www.vitaleascience.com/
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About BioCore
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BioCore is South Korea's largest provider of bioanalytical liquid
chromatography-tandem mass spectrometry (LC/MS/MS) services. BioCore was South
Korea's first GLP-compliant centralized bioanalytical CRO (2005) and first to
be certified by the Korea Food and Drug Administration as a Bioequivalence
Testing Institution (2008).
http://www.bio-core.co.kr/
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