MDL Announces Cooperative Research and Development Agreement with United States Food and Drug Administration.TO: ASIAWIRE ATTN: EDITOR
Contact Name/Office: Wanda Glennon/SF Telephone: (415/986-4422) Fax: (415/788-5335) Email: firstname.lastname@example.org
Requested distribution time:
(X) For immediate release ( ) For future release, (please specify date and time):
PLEASE SELECT CIRCUIT OF CHOICE (BE SURE TO CHECK OFF IF TRANSLATION IS NEEDED)
NOTE TO ASIAWIRE: All translation requests (except Malay) will be handled through our vendor in Canada (Multi-Lingual Tek) and they will send the completed translations to you for distribution (in both Word and PDF (Portable Document Format) The de facto standard for document publishing from Adobe. On the Web, there are countless brochures, data sheets, white papers and technical manuals in the PDF format. formats). All releases will be sent directly to you first even when translation is requested so you will know that a translated release is expected.
!!**NOTE: IN THE REGIONAL CIRCUITS THAT REQUIRE TRANSLATIONS; SIMPLIFIED-PRC, TRADITIONAL HONG KONG AND KOREAN ARE THE DEFAULT TRANSLATIONS. BE SURE TO CHECK THEM OFF AT THE BOTTOM OF THE FORM. TRADITIONAL TAIWAN MAY BE SUBSTITUTED FOR EITHER THE SIMPLIFIED-PRC OR TRADITIONAL HONG KONG IF THE CLIENT REQUESTS IT.**!!
( ) ALL ASIA Asia (ā`zhə), the world's largest continent, 17,139,000 sq mi (44,390,000 sq km), with about 3.3 billion people, nearly three fifths of the world's total population. PACIFIC FULL MEDIA (APFM APFM A Place for Mom (Seattle, WA)
APFM Asymmetrical Peristaltic Field Manipulation )
(Including Translations into Simplified-PRC, Traditional
Hong Kong Chinese and Korean through Multi-Lingual Tek --
Be sure to check off appropriate language selections in the
Translations section of this form as well)
(XX ) All Asia Pacific Basic Media (APBM APBM Association of Professionals in Business Management ) (transmission in English)
( ) Asia Pacific AnalystWire (APAW APAW Asphalt Paving Association of Washington
APAW Aboriginal People's Awareness Week ) (transmission in English)
( ) All Asia Pacific Business Media
& High-Tech Trades (APHT APHT Advance Physical Test ) (transmission in English)
( ) Asia Pacific AutomotiveWire (APAU APAU Andhra Pradesh Agricultural University (India) ) ( ) Asia Pacific EnergyWire
(APEW) ( ) Asia Pacific EntertainmentWire (APEN APEN Asian Pacific Environmental Network
APEN Air Pollution Emission Notice ) (XX) Asia Pacific HealthWire (APHW) ( ) Asia Pacific SportsWire
(APSW APSW All Purpose Software
APSW Association for the Promotion of the Status of Women ) ( ) All Asia High Tech Trades Only
OTHER REGIONAL TRADES:
( ) Asia Pacific Advertising/Marketing/Communications Trades ( ) Asia Pacific Electronics/Semiconductor Trades ( ) Asia Pacific Manufacturing Trades ( ) Asia Pacific Mining Trades ( ) Asia Pacific Telecommunications Trades ( ) Asia Pacific Transportation Trades ( ) Asia Pacific Travel Trades
OTHER COUNTRY-SPECIFIC TRADES:
( ) China High-Tech Trades ( ) China Medical Trades ( ) China Entertainment Trades ( ) China Sports Trades
( ) South Korea High-Tech Trades
( ) Asia Pacific Full distribution for Trend Micro Taiwan ( ) Asia Pacific Partial distribution for Trend Micro Taiwan
(excluding PRC-China and Korea) ( ) Custom distribution for McData (Business Wire/Denver client)
(includes translations into: Chinese -- simplified for PRC,
traditional for Hong Kong; Korean)
INDIVIDUAL COUNTRY CIRCUITS:
( ) CHINA ALL MEDIA (Incl. Translation)
(Make sure to check off Simplified-PRC Chinese under the
Translation section as well)
( ) HONG KONG BUSINESS MEDIA/HIGH-TECH TRADES (Incl. Translation)
(Make sure to check off Traditional-Hong Kong Chinese version
under the Translation section as well)
( ) SOUTH KOREA ALL MEDIA (Incl. Translation)
(Make sure to check off Korean under the Translation section
( ) MALAYSIA ALL MEDIA (Incl. Malay Translation) ( ) Singapore All Media (transmission in English) ( ) MALAYSIA/SINGAPORE ALL MEDIA (MSMT MSMT Ministerstvo Školství, Mládeze a Telovýchovy (Ministry of Education, Youth and Sports; Czech Republic)
MSMT Mean Scheduled Maintenance Time
MSMT Multi-Service Management Team ) (Incl. Malay Translation) ( ) MALAYSIA/SINGAPORE BUSINESS MEDIA
& HIGH-TECH TRADES (Incl. Malay Translation)
( ) Bangladesh All Media (transmission in English) ( ) Brunei All Media (transmission in English) ( ) Cambodia All Media
(transmission in English) ( ) India All Media (transmission in English) ( ) Indonesia All Media (transmission in English) ( ) Laos All Media (transmission in English) ( ) Myanmar All Media (transmission in English) ( ) Pakistan All Media
(transmission in English) ( ) Sri Lanka All Media (transmission in English) ( ) Thailand All Media (transmission in English) ( ) Vietnam All Media (transmission in English) ( ) Vietnam, Cambodia, & Laos (transmission in English)
====================================================================== SPECIAL INSTRUCTIONS: ==================== ____________________________________________________________________
====================================================================== ***BW EDITORS: IF TRANSLATION SERVICE REQUIRED: (for any language except Malay, which is handled by ASIAWIRE), Be sure to add the two email addresses (*email@example.com; *firstname.lastname@example.org) to the [I line. This is very important***
TRANSLATION (Check off appropriate translations) ================================================ ( ) Translation approval required __________________________________
(NOTE TO MLTEK: If client requests translation approval, please
send a copy of any correspondence regarding the approval process
to email@example.com for Business Wire's files)
[ ] CHINESE TRANSLATION FORTHCOMING - PROVIDED BY NORTH AMERICAN
(Business Wire Editors: If any Full-Text Chinese or Korean
translations ordered, be sure to check this box as well as the
languages selected - immediately below)
__Simplified-PRC __Traditional-Hong Kong (default) __Traditional-Taiwan (may be substituted for PRC or Hong Kong
upon client's request) ( ) Korean ( ) Malay (by Asiawire) ( ) TRANSLATION(S) INCLUDED - Specify which translations have been provided, and send via GroupWise as attachments to the addresses listed above.
NOTE TO MULTI-LINGUAL TEK: Once translations are completed, please send copies (with this form attached) to the following e-mail addresses:
firstname.lastname@example.org email@example.com firstname.lastname@example.org email@example.com
Business Editors/Health/Medical Writers
SAN LEANDRO, Calif.--(BUSINESS WIRE)--July 10, 2003
Collaborative effort produces MDL MDL - (Originally "Muddle"). C. Reeve, Carl Hewitt and Gerald Sussman, Dynamic Modeling Group, MIT ca. 1971. Intended as a successor to Lisp, and a possible base for Planner-70. Basically LISP 1.5 with data types and arrays. (R) Carcinogenicity
Module for predicting a substance's carcinogenic potential
MDL Information Systems, Inc. (MDL(R)), the leader in discovery informatics for the life sciences and a member of the Elsevier Life Sciences division, today announced that it has entered into a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation).
A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. (CRADA CRADA Cooperative Research And Development Agreement ) with the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (USFDA USFDA United States Food & Drug Administration ), Center for Drug Evaluation and Research The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective. It is one of five Centers at the United States Food and Drug Administration. (CDER CDER Center for Drug Evaluation and Research (US FDA)
CDER Centre de Développement des Energies Renouvelables (French)
CDER Client Development and Evaluation Report ). Under the terms of the CRADA, MDL and the USFDA will jointly develop a series of predictive software modules that represent major toxicological endpoints of interest to the regulatory agencies and the pharmaceutical industry. These endpoints are human adverse effects, carcinogenicity (ability to cause cancer), teratogenicity ter·a·to·ge·nic·i·ty
The capability of producing fetal malformation.
teratogenicity, (terˈ· (ability to cause birth defects), and mutagenicity mutagenicity /mu·ta·ge·nic·i·ty/ (-je-nis´it-e) the property of being able to induce genetic mutation.
the property of being able to induce genetic mutation. (ability to cause changes in genetic material).
The software modules will enable scientists in the pharmaceutical and biotechnology industries to identify and eliminate compounds with high potential for toxicity, such as those likely to be carcinogens, early in the drug discovery process. The ability to make better decisions earlier will accelerate the discovery of safer drugs, while also reducing animal testing.
The software is based on the MDL(R) QSAR QSAR Quantitative Structure-Activity Relationship
QSAR Quality System Audit Report
QSAR Quality Service Activity Report
QSAR Québec Secours Search and Rescue (Canada) platform, a comprehensive predictive modeling system that enables scientists to establish reliable quantitative structure-activity and structure-property relationships, create models for in silico screening, and generate new compound libraries based on the results.
The MDL(R) Carcinogenicity Module is the first module completed, and preliminary validation studies indicate that the MDL(R) QSAR modeling process, as performed by the USFDA, produces good estimates of a substance's carcinogenic potential. The module is based on historic data generated from rodent carcinogenicity studies that are used to predict the potential carcinogenic risk to humans. The predictive model does not require rodent studies to predict the human carcinogenic effect; it calculates a prediction based on chemical structure.
"Applying MDL QSAR's robust analysis capability to the USFDA toxicology databases creates powerful predictive models for the testing of drug candidates," said Lars Barfod, executive vice president and chief business officer of Elsevier Global Life Sciences Business. "This joint initiative underscores MDL's commitment to improving the predictive performance of computational toxicology software and enhancing decision support in both the regulatory and research domains."
The principal investigators for the USFDA are Dr. Joseph F. Contrera, Dr. Edwin J. Matthews, and Dr. R. Daniel Benz of the Informatics and Computational Safety Analysis Staff in the Office of Pharmaceutical Science. The MDL investigator is Philip M. MacLaughlin, product manager with the MDL(R) Discovery Predictive Science group.
MDL will make these toxicity modules, jointly created by MDL and the USFDA, available commercially to provide users with effective tools for the identification of potentially unsafe substances early in the discovery process. The MDL Carcinogenicity Module is available in July 2003.
Over 1,000 life science companies supercharge su·per·charge
tr.v. su·per·charged, su·per·charg·ing, su·per·charg·es
1. To increase the power of (an engine, for example), as by fitting with a supercharger.
2. their discovery engines with MDL software solutions to generate fresh ideas and make breakthrough discoveries. By synchronizing and streamlining the sharing and management of vital information and knowledge, we enable scientists to work more efficiently and invent drugs faster. This saves time, money, and lives. In support of our customers and the momentous challenges they face, everything we do must be reliable, resourceful, innovative, and insightful. We are an international business headquartered in San Leandro, CA with offices worldwide.
MDL is a member of Elsevier Life Sciences division, which combines all of Elsevier's life science content products with MDL's extensive informatics, database, workflow, and decision support solutions. The unique synergy between Elsevier's scientific and biomedical bi·o·med·i·cal
1. Of or relating to biomedicine.
2. Of, relating to, or involving biological, medical, and physical sciences. information and MDL's integrated discovery informatics software enables Elsevier Life Sciences to bring unparalleled solutions to researchers, significantly advancing the efficient, cost-effective development of new medicines. Elsevier is owned by Reed Elsevier PLC (NYSE NYSE
See: New York Stock Exchange : RUK RUK Reserviupseerikoulu (Hamina, Finland, Reserve Officers' School)
RUK Are You Kidding? ) and Reed Elsevier NV (NYSE: ENL Noun 1. ENL - an inflammatory complication of leprosy that results in painful skin lesions on the arms and legs and face
erythema nodosum leprosum
Hansen's disease, leprosy - chronic granulomatous communicable disease occurring in tropical and subtropical ).
For more information, visit www.mdl.com.
MDL is a registered trademark in the United States of MDL Information Systems, Inc. "Powering the Process of Invention" is a trademark of MDL Information Systems, Inc., U.S. registration pending. Elsevier is a registered trademark in the United States of Reed Elsevier US Holdings Inc., and of Reed Elsevier NV in other countries. All other company and/or product names may be trademarks or registered trademarks of their respective owners in the United States and other countries. All rights reserved.