financial guidance

The CEO of Calando parent firm Arrowhead Research also said that the RNAi shop has restarted preclinical research and development — a notable departure from events in 2009 when the company stopped all such work and shuttered Calando's lab amid a cash crunch.

The agency hopes the guidance can lay out a path for drug developers to identify PGx issues before a drug enters the market, instead of emerging PGx data changing the treatment's risk/benefit profile in the post-market setting.

Although the selection of the drug candidate marks the achievement of one of RXi's key goals for 2010, its other — the establishment of an industry partnership — isn't likely to be meet, based on a statement from a company official.

Lawrence Lesko, director of the Office of Clinical Pharmacology and Biopharmaceutics in FDA's Center for Drug Evaluation and Research, said that the agency is working on guidance documents for clinical pharmacogenomics, clinical trial enrichment, and internal standard operating procedures for cross-labeling efforts within FDA offices.

The draft document, titled "Qualification Process for Drug Development Tools," lays out the process by which industry can receive FDA's go-ahead for biomarkers, including pharmacogenomic markers, for use in a specific context. After getting these biomarkers "qualified" by the FDA, industry can use these markers in a similar context in multiple drug trials, drug classes, or clinical disorders, without having to repeatedly seek the agency's approval.

The big pharma's Research Technology Center still anticipates filing an IND before the end of 2011, but now expects it to be for "an in-house nucleic acid drug" in 2011 rather than one necessarily based on RNAi.

Already a pioneer in incorporating pharmacogenetic testing into its PBM programs, Medco's decision to buy DNA Direct signals its intent to be a "one-stop shop" for payors and employers interested in using genetically guided medicine to make healthcare more efficient and lower costs.