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14 May 2013

Vitalea Science and Radiopharma Combine Expertise to Advance Global Pharmaceutical Development

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!

Eckert & Ziegler Vitalea Science and Korea-based BioCore Sponsor Workshop "A Step Forward: Novel Technology For New Drug Development"

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:

  • 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.
  • 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.
  • 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.
  • 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.

Upcoming events

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

About Eckert & Ziegler Radiopharma

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

About Eckert & Ziegler Vitalea Science

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/

About BioCore

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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