The Mutagenicity Data Sharing Consortium

In the first phase of this major undertaking, supported by NIH, we have established a pilot data-sharing model with the pharmaceutical industry to acquire the results of their Salmonella mutagenicity studies. Our major effort is geared at obtaining data from pharmaceutical companies. The advantages of this consortium are:

1. A joint Salmonella mutagenicity knowledge base.

2. A mechanism for the release of industry study data that protects the proprietary nature of the data.

3. Highly reliable estimates of Salmonella mutagenicity in a mechanism-based discovery format.

4. Efficient use of time and resources for both parties.

Under this project, the CDER office of the FDA has helped us convince pharmaceutical companies to participate in our project by sharing with us the results of mutagenicity studies and contributing some of their proprietary molecules. We have held two meetings with representatives of Big Pharma and the FDA in Cleveland, in June 2002, and in Brussels in July 2002.  As a result of extensive consultations, we have reached a ground-breaking agreement for data exchange protocols and security measures. Presently, we have developed a model contract which was distributed among the data -sharing group. So far, five major pharmaceutical companies have signed the data-sharing agreement contracts and all of them have sent us data. A dozen other companies are still negotiating the terms of the contract, and are expected to join the consortium within a year.

Please contact Dr Klopman or Dr Saiakhov if you wish to receive more information or would like to discuss the advantages of joining the Consortium.

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Last modified: 08/06/08