Government launches gene therapy web site

The FDA and the NIH have launched a web-accessible database on human gene transfer, called the Genetic Modification Clinical Research Information System (GeMCRIS).

A statement released by the agencies said the system is meant to provide information to the public and to improve the government’s ability to monitor adverse events in gene transfer research, also known as gene therapy. Database users can learn the locations of trials taking place, which diseases or health conditions are being studied, and what investigational approaches are being taken.

Furthermore, investigators and trial sponsors conducting human gene transfer trials also will be able to report adverse events using a secure electronic interface on the GeMCRIS system.

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New legislation proposed to increase grant access

Biotechnology firms that have been unable to win Small Business Incentive Research grants due to a technicality in the law might be in the game again if legislation recently introduced in the House makes it to the president’s desk.

Rep. Samuel Graves (R-MO.) recently introduced legislation designed to amend Internal Revenue Code language that limits Small Business Incentive Research (SBIR) grants to firms that are 51% owned by individuals who are citizens or permanent residents of the U.S.

At issue here is the definition of "individuals."

Steve Lawton, vice president and general counsel at the Washington-based Biotechnology Industry Organization, says the problem cropped up about two years ago when the term "individuals" was interpreted to exclude venture capital funds, which often heavily fund emerging biotechnology firms.

"That means a lot of our companies were not eligible for the SBIR program because 51% is not owned by individuals," he adds, adding that the Graves legislation resolves that issue.

Lawton notes the language partially was intended to stop a firm that was perhaps a subsidiary of a foreign-based company from accessing SBIR money.

The legislation would allow companies majority owned by venture capitalists to have a chance at SBIR grants. Specifically, Graves’ legislation seeks "to permit business concerns that are owned by venture capital operating companies or pension plans to participate in the SBIR program."