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Bio Research Says FDA Asks for Additional Data on Pharmacogenomic Technology

NEW YORK, Oct. 17 (GenomeWeb News) - Bio Research Support said today that the US Food and Drug Administration has asked the company for additional data on the TranscriptPanel, a proprietary method of applying commercially available genomics tools to accelerate drug-gene interaction studies.

 

According to Jim Novakoff, president of Bio Research Support, the company submitted data derived from the technology to the FDA under the voluntary genomic data submissions program the agency initiated earlier this year. Novakoff said the company provided data on the drug Benadryl in order to demonstrate how the TranscriptPanel technology worked and to obtain approval to incorporate data from the technology in new drug application submissions.

 

"What we want to be able to do is incorporate [the TranscriptPanel] into clinical trials," he said. As an example, he said that drug-discovery firms could use the technology to increase the speed and lower the costs of toxicology studies for potential drugs. "The FDA has to be comfortable with the results we're giving before they'll allow us to work with them and pharma companies."

 

Novakoff said that Bio Research conducted a study wherein Benadryl was administered to 25-year-old, healthy males.

 

"We were able to figure out how [the drug] worked, why it was effective in suppressing immune response, why it was effective in helping with Parkinson's [disease], and ... we were able to identify which variant of Parkinson's it would be helpful for and which it would not," Novakoff told GenomeWeb News.

 

He added that the company was also able to identify other indications for which Benadryl might be effective in treating, including cancer.

 

The work was done in collaboration with General Electric Healthcare, which provided CodeLink chips; Genus BioSystems, which conducted wet lab work; and GeneGo, which supplied its MetaCore data analysis platform, Novakoff said. Warner-Lambert, which makes Benadryl, was not involved, he noted.

 

"We submitted [these data] to the FDA and asked what they thought," Novakoff said. "They said, 'So far, so good, but you need to do a whole lot more.'"

 

He said that the FDA has asked for a variety of additional information, including how Bio Research plans to "deal with tracking two medications or more in each patient simultaneously."

 

He noted that the data already submitted to the FDA was obtained through a study administering Benadryl to people not taking any medications. The FDA asked, "What happens if you add Benadryl to the cocktail of medicines someone is already taking?" Novakoff said.

 

He said he expects Bio Research to be able to generate the data requested by the FDA within about six months.

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