Anne Wojcicki - 23andMe

From FDA pariah to regulatory trailblazer

Name: Anne Wojcicki
Title: CEO of 23andMe

Anne Wojcicki's 23andMe went through a regulatory firestorm in 2013, when the FDA demanded the company stop marketing its genetic health test. But the reprimand didn't faze Anne Wojcicki, who spent the next two years working not only to bring her company back from the brink, but also to pave the way for other direct-to-consumer genetic testing companies.

When 23andMe's test hit the market, customers could ship a saliva sample to the company's CLIA-certified labs for sequencing. The outcome would be a wealth of information on gene mutations, health risks and responses to drugs. Because patients could base medical decisions--such as elective surgery or decisions to stop using certain drugs--on these results, the FDA deemed the test a medical device, and that it should thus be regulated as such. But Wojcicki saw the device as a new type of offering for people to better understand their bodies and so, deserved a regulatory process of its own.

23andMe now cites a lack of regulatory experience and expertise for its mishandling of communications with the FDA, including the cease of all response from the company: "We didn't understand the expectations of the FDA... In hindsight, I wish we had," said Andy Page, 23andMe's president, as quoted by Fast Company. So Wojcicki hired a regulatory expert to help her steer the company onto the right course: Kathy Hibbs, a lawyer in the biomedical industry, joined the team as chief legal and regulatory officer.

While 23andme was still allowed to market its genetic ancestry test, it used the downtime from health tests to work with the FDA to propel a product through regulatory channels and to redesign its website to give consumers a more complete idea of what their genetic results mean. But it also gave the team an opportunity to go beyond fixing mistakes and become a better health company. Even though it couldn't sell its genetic health test anymore, it still had the data from existing customers--80% of whom consented to sharing their DNA--on which to do research.

With an eye on growth, Wojcicki made several new hires, including Emily Conley, formerly a neuroscientist at Stanford, who now heads business development at 23andMe. Conley is responsible for sharing genetic data with partners, including Pfizer ($PFE) and Genentech. The company's therapeutics arm, launched in 2015, offers new avenues for collaboration with companies in drug development, allowing 23andMe to reach beyond simply unlocking people's genomes. Now, it is using its huge data repository to inform drug development, betting that this input will result in greater success and speed in developing new treatments and bringing them to market.

To aid in its new foray into biotech, 23andMe poached a couple of Genentech veterans: Richard Scheller, who became 23andMe's chief science officer, is leading the charge into drug discovery, and Robert Gentleman is now 23andMe's vice president of computational biology. And that's not all: In October, the company raised $115 million in Series E funding, bringing its valuation to $1.1 billion. The funding will help 23andMe obtain new lab space to jump-start its nascent drug discovery program.

Today, 23andMe markets an FDA-approved test for 36 autosomal recessive disorders--conditions that can be inherited if both parents are carriers of a specific gene. While the scope of its new and approved test is not as wide as that of its original, Wojcicki counts it as a win. Now, the company has created a path to approval not just for its own direct-to-consumer genetic tests, but for other companies' products too.

"Being the first FDA authorized direct-to-consumer genetic test out there is revolutionary," Wojcicki said, as quoted by Fast Company. "I think a lot about the consumer health movement, and I believe this is an important step forward. This idea that you can take control of your own health and challenge your health care is a new idea. I think that's what we're waking up in a lot of people."

-- Amirah Al Idrus (email | Twitter)

For more:
23andMe poaches another Genentech vet as it delves into biotech
23andMe raises $115M as investors buy into data-driven drug discovery vision
23andMe dives into biotech with Genentech R&D star Richard Scheller on board
FDA wants 23andMe's test off the market, citing risk to patients

Anne Wojcicki - 23andMe
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