Accium BioSciences and CMIC Announce Strategic Alliance to Provide Exploratory IND and Low-Radiation PK/ADME Services to the Japanese Pharmaceutical Industry.SEATTLE & TOKYO -- Accium BioSciences, Inc., (Accium) the first U.S. provider of commercial Accelerator Mass Spectrometry accelerator mass spectrometry n. Mass spectroscopy in which a particle accelerator is used to disassociate molecules, ionize atoms, and accelerate the ions. (AMS AMS - Andrew Message System ) services, and CMIC CMIC CPU Management Interface Controller CMIC Caucasus Media Investigations Center (Baku, Azerbaijan) CMIC Combined Military Interrogation Center (Vietnam) CMIC Configuration Management Information Center Co., Ltd. (CMIC) Japan's premier pharmaceutical contract research organization, today announced a partnership to offer Exploratory-IND (microdosing) and low-radiation PK/ADME clinical trials services to Japan pharmaceutical clients. Accium offers ultra-sensitive AMS bioanalysis, and a network of clinical and regulatory providers to reduce the time and cost of drug development. Under the terms of this agreement, CMIC will integrate Accium's service package for Japanese clients. "This partnership leverages Accium's unique bioanalytical and clinical trials capabilities with CMIC's proven value creating clinical development processes. CMIC is recognized as the trusted source for clinical development services in Japan. Together our companies provide seamless access to the tools described in FDA's recent Exploratory-IND Guidance," stated Michael Chansler, Director of Business Development for Accium. "Clinical studies conducted within the CMIC/Accium framework will provide the benefits of conducting trials to U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. standards while preserving Japanese drug development requirements." "There is a growing interest among Japanese pharmaceutical researchers to implement time and cost saving strategies in drug development. The Exploratory IND Guidance recently issued by the U.S. FDA under their 'Critical Path Initiative' combined with recently developed Accelerator Mass Spectrometry techniques offered by Accium open new opportunities for cost saving to the Japanese drug developers," said Kazuo Nakamura Kazuo Nakamura was a Japanese-Canadian painter and sculptor (born Vancouver October 13 1926; died Toronto April 9 2002) and a founding member of the Toronto-based Painters Eleven group in the 1950s. , President & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of CMIC. "Accium and CMIC have been in discussion for some time to develop an effective partnering plan that will help our clients take advantage of these new tools for drug development. We are pleased to offer Accium's services and partner network to the Japan pharmaceutical industry." About Accium BioSciences Accium BioSciences (http://www.acciumbio.com) operates the first commercial Accelerator Mass Spectrometry (AMS) facility in the U.S. Accium provides a full range of services for preclinical ADME ADME Absorption, Distribution, Metabolism, and Excretion ADME Association of Destination Management Executives ADME Active Duty Medical Extension testing, Exploratory IND/Microdosing studies and low-radiation Phase 1 PK/ADME clinical trials. About CMIC Since its founding in 1985, CMIC Co., Ltd. (http://www.cmic.co.jp/e), Japan's leading clinical research organization (CRO), has rapidly expanded its pharmaceutical development business to service the booming pharma-medical industry in Japan. With more than 1,500 employees throughout Japan, CMIC provides a portfolio of comprehensive clinical development solutions including planning regulatory strategies, conducting feasibility studies The analysis of a problem to determine if it can be solved effectively. The operational (will it work?), economical (costs and benefits) and technical (can it be built?) aspects are part of the study. Results of the study determine whether the solution should be implemented. , and bridging assessments, reviewing pre-clinical and clinical data to comply with Japanese regulations, developing Japanese Protocol, Investigator Brochures, Case Report Forms, Informed Consent and Clinical Study Reports, and providing clinical development services including site selection, document management, site management, investigator contracts, monitoring, data management, etc. Furthermore, CMIC offers clinical research coordinators (CRC (Cyclical Redundancy Checking) An error checking technique used to ensure the accuracy of transmitting digital data. The transmitted messages are divided into predetermined lengths which, used as dividends, are divided by a fixed divisor. ) and a patient recruitment center. In addition to its Japanese operations, CMIC has operations in Korea, China and most recently in Brazil. As of September 1, 2005, CMIC was listed on the first section of the Tokyo Stock Exchange Tokyo Stock Exchange Main stock market of Japan, located in Tokyo. It opened in 1878 to provide a market for the trading of government bonds newly issued to former samurai. Market. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion