23andMe has charted a different course since running afoul of the FDA for its genetic testing products in 2013, inking deals with biopharma heavyweights to provide genomic data for drug development. Now the Google ($GOOG)-backed company is riding the tailwinds of change, unveiling a new therapeutics group with a biotech veteran at its helm.
The Mountain View, CA-based genomics outfit's therapeutics group will use human genetic data to identify new therapies for common and rare diseases, making the drug development process "more efficient and faster," President Andy Page told FierceDiagnostics. 23andMe will continue to generate new collaborations in 2015, bringing validated targets to partners, Page said.
Leading off the new group as chief scientific officer is Dr. Richard Scheller, a recently retired Genentech executive who brings an extensive background in R&D to the table. Scheller spent 19 years as a professor at Stanford before joining the San Francisco-based biotech to lead its research strategy, drug discovery, business development and early drug development efforts.
"We wouldn't be able to launch a therapeutics group without someone of Richard's stature," Page said. "He brings an absolutely essential skill set to 23andMe, and we really needed to hire someone who not only knows how to bring drugs to market, but also build and recruit a team."
The new therapeutics group comes amid change for 23andMe, as the company strikes deals with biopharma giants to develop new drugs and struggles to get back in the FDA's good graces after fallout over its genetic tests. Earlier this year, Genentech paid 23andMe $60 million to access its genomic health reports for Parkinson's drug R&D. Days later, 23andMe said it would lend a hand to Pfizer ($PFE) for clinical trial recruitment and studies.
Last month, the company scored FDA clearance to market its genetic carrier test for Bloom syndrome directly to consumers, a major win for the company as it looks to make good with regulators. In 2013, the FDA slapped 23andMe with a scathing warning letter for its $99 spit tests, accusing the company of selling the product without proper approval or required data. The company subsequently pulled its TV, web and radio ads for the test.
Although 23andMe is excited about the prospect of its new therapeutics group led by Scheller, the company will remain focused on the consumer, Page told FierceDiagnostics. "We're a direct-to-consumer company and that's what we'll continue to be moving forward," he said. "That will always be at the forefront of our mission."
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