Research directors are revisiting the notion of consortia--considering whether and how Big Pharma companies and possibly some of the larger biotech firms might join forces to develop infrastructure and gather data that would benefit the industry broadly, or at least benefit all who contribute to a group effort.
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Until now, Perlegen contends, pharmacogenomics has failed to deliver because no one has had the statistical power to show connections. With its whole genome scanning technology, Perlegen aims to prove that it can come up with usable and predictive markers of drug response by inexpensively screening for millions of SNPs and analyzing subsequent patterns--even without any significant biological understanding. The start-up aims to use its technology to help compounds win regulatory approval and more market share than they otherwise could. Perlegen also plans to support in-licensed drug candidates and seek disease genes. It wants a share of drug sales its studies enable, and to leverage all the IP it can capture. Absent its own drug discovery and development program, Perlegen needs partners to provide the compounds and clinical samples with which it can create pharmacogenomic data and secure an FDA imprimatur. Competitors argue that smaller sets of data, informed by a clearer biological understanding, will provide equally effective pharmacogenomic data, cheaper.
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With the threat of potentially hefty fines, China's newly passed Biosecurity Law will fundamentally change how the life science sector handles human genetic resources over years to come, legal experts say.