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eTOX Project From GGA Software Contracts With Major Pharmaceutical Companies In Working With Information to Predict Toxicity of

Posted Sep 19 2012 5:08pm

You can read the press release below and certainly this can be a good thing to study outcomes with treatments and be able to determine toxic behaviors in drugs before they are prescribed.  image We already have black box warnings and a ton of warnings on side effect we hear already.  In addition with data as such available they are looking to potentially avoid some of these areas if possible during drug development. In addition to such data bases of information it is also interesting to see what is being done with stem cells to also speed up the process of creating new drugs with again finding adverse reactions with cells being studied and using sequencing technologies together. 




[PRESSWIRE] Cambridge, MA, USA - 19.02.2012 -- GGA Software Services LLC, the leading provider of outsourced scientific informatics services to the life sciences industry, announced that it has been selected to provide data curation services to nine global pharmaceutical companies that are participating in a pan-European collaboration to develop in silico tools for predicting the toxicity of drug candidates.

 

This project, known as eTOX, is part of the European Innovative Medicines Initiative (IMI), a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). After a rigorous selection procedure in which several companies worldwide were evaluated, nine of the pharmaceutical companies in the project decided to use GGA as their subcontractor to curate more than 5,000 legacy toxicity reports for inclusion into a joint database.

Richard Golob, President and CEO of GGA Software Services, said, “GGA’s scientific domain expertise and data curation capabilities are an excellent match with the curation needs for the eTOX Project, and we are pleased that we will serve as the curation partner for nine global pharmaceutical companies participating in the eTOX Project.” The following companies have decided to contract with GGA for curation services: AstraZeneca, Bayer Pharma, Boehringer Ingelheim, GlaxoSmithKline, H. Lundbeck, Novartis, Sanofi-Aventis, Servier, and UCB Pharma.

The primary focus for the data curation effort is systemic toxicity studies (1 to 4 week repeated dose studies in rodents, dogs, and other non-rodents), but the data curation effort has been extended to longer studies, as well as to pharmacokinetic/toxicokinetic studies and in vivo safety pharmacology.

“The overall goal of the eTOX Project is to develop in silico predictive systems for organ and in vivo toxicity and thereby help improve the drug development process and reduce animal use, and the project’s backbone is the database of preclinical toxicity data that GGA will help us curate”, according to Francois Pognan, eTOX Project Leader and Executive Director of Biochemical, Analytical, and Translational Safety at Novartis Institutes for BioMedical Research. He said, “The eTOX Project emerged from the understanding that the pharmaceutical industry has not used efficiently the wealth of preclinical toxicity data generated in studies, and that a database bringing together curated data from previously unpublished, legacy preclinical toxicity studies would provide the basis for powerful data mining to build predictive tools.”

Pognan said, “The eTOX database will likely become one of the largest repositories for high-quality repeat dose toxicity data.” He continued, “This project will be the first time in pharmaco-toxicological research that unused or poorly used, highly relevant preclinical drug safety data will be combined to improve the quality of drug candidates and the processes for their development.”

GGA will receive the archived studies in batches from the nine pharmaceutical companies over the next three years, and will extract the data according to a specified format and use a rigorous quality control process to ensure high data quality. These pharmaceutical companies selected GGA among the possible data curation partners for the eTOX Project on the basis of capacity, quality, data security, reliability, and cost. According to Golob, “We understand the importance of building a high-quality database in ensuring the construction and validation of effective predictive toxicity models, and we appreciate the opportunity to participate in this important initiative.”

 

About GGA Software Services LLC

 

GGA Software Services is a leading provider of outsourced scientific informatics services to the life sciences industry. Headquartered in Cambridge, Massachusetts, with a 400-person development center in St. Petersburg, Russia, and with teams in Finland and Switzerland, GGA offers broad capabilities in scientific software engineering, algorithm development, and data curation, especially in cheminformatics, bioinformatics, and development informatics. Global pharmaceutical, medical device, and scientific instrumentation companies rely on GGA to provide ongoing scientific informatics services, including support, maintenance, and QA services, to enhance their internal resources. Since 1994, GGA has successfully served as an extended workbench for its clients, allowing them to both achieve their critical objectives and optimize their scientific informatics budget.


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