Leadership Lessons From 23andMe's Jump Into Drug Discovery

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

23andMe has been the center of attention quite a bit recently — not only because of its high profile partnerships with Pfizer and Genentech, but also because of the recent FDA approval of its carrier test for Bloom Syndrome. However, perhaps the biggest news for the company as of late was the announcement it is jumping into the drug discovery space.

Given the company’s struggles in the past to garner FDA approval for its services, as well as its lack of drug discovery/development experience, 23andMe’s move might seem gutsy. But the company’s willingness to take the risk illustrates the company’s dedication to leadership. In all of the media coverage touting the launch of its therapeutics division, there were several key points I noted that defined the company’s strategies for entering this new space, and which also, incidentally, serve as best leadership practices.

Remain Humble

As one consultant told Bloomberg Business, the company has been building its street cred in the pharma space through its partnerships with high profile players; however, it will take some time — and most likely lots of outside help — before it can actually develop anything it should discover. The company’s knowledge of just how far it has to go to build credibility is perhaps one of its greatest assets to take note of in this transition.

It no doubt took some long-term strategic planning to establish the proper image for the company so its announcement to enter into drug discovery would be taken seriously. To boost its credibility, as well as gain the skill sets it would need to succeed, the company snatched up Genentech’s former head of R&D, Richard Scheller, just a few short months after the two companies signed a partnership agreement to find Parkinson’s disease drug targets.

As 23andMe President Andy Page told Bio IT World, “Without Richard, we don’t have the skillset [to make drugs] internally.” In fact, Page admitted that CEO Anne Wojcicki held off on entering into therapeutics because she wanted to snap up an executive from a highly reputed pharma or biotech company — just to make sure the company would stand a chance in the risky and difficult business of drug discovery.

Embrace Collaboration, Consider Outsourcing

Scheller’s mission at 23andMe is ambitious. According to TIME, 80 percent of the firm’s 850,000 customers have given 23andMe permission to use their data for research, and Scheller has made it his mission to “ask hundreds or maybe thousands of times more questions of the database than any pharmaceutical partner.” Some of his goals include determining the hallmark genetic changes that occur in certain diseases, as well as the genetic reasons behind why patients overcome or succumb to particularly aggressive diseases.

But taking this knowledge and turning it into a viable drug candidate is not something the company is equipped to do — at least not right away. Just as Wojcicki acknowledged the need for someone in charge with Big Pharma experience, there is also the need for outside partners. As the company does not have a drug development team in place, and most likely won’t for some time, the company is likely to outsource a lot of the drug creation, screening, and, if all goes well, future clinical work to CROs and potentially even Big Pharma partners, said Bloomberg Business.

It might even be that the company is never a solo player when it comes to developing its drug leads. Page told Bio IT World, “It’s very likely [Scheller] will be taking targets that are qualified, and bringing them out to our partners” at early and/or later stages in the process, as he deems fit.  

The partnerships the company has forged to date will also remain in place, even though there were some concerns that this move could lead to some conflicts or overlapping research. However, the data remains fair game. “The idea of multiple entities accessing the database concurrently is something we’re comfortable with,” said Page.

Let The Data Be A Guide

What indications will the company be looking into? The company has remained pretty quiet about its target therapeutic areas — but not on purpose. The company has established patient communities in the sarcoma, lupus, and inflammatory bowel disease indications, however it already has Big Pharma partnerships earmarked for some of these diseases, and therefore, might wish to stake out its own niche to avoid too much competition with partners.

According to TIME, when asked about the future, Scheller remained “democratic,” saying, “We are going to be opportunistic. That’s the nice thing about being part of 23andMe. We don’t really have a say. We can look generally at the database and try and let it teach us what we should be working on.”

Maintain Perspective On Company Strengths

When asked by Bio IT World if the company was going to realign its business focus in favor of drug development in the future, Page said, “We’re not becoming a drug company.” First and foremost, the company’s main focus will remain consumer services for the foreseeable future. After all, as the 23andMe core values emphasize, the company was built upon the notion that “having access to one’s genetic information is good,” as it will empower customers to “take a bold, informed step toward self-knowledge.”

To do this, the company will need to continue on its path towards gaining FDA approval for its services, which, despite the recent approval of its Bloom Syndrome carrier test, has been fraught with challenges. (For instance, in 2013, the FDA ordered that 23andMe cease selling its Personal Genome Service to the public because it was not approved under the Food, Drug, and Cosmetic Act.)

It will also need to maintain its focus on keeping the consumer happy. While the company has been open about its lack of expertise in drug discovery, this isn’t to say the company is a “shrinking violet” about what it can bring into the space. CEO Wojcicki remains confident the company’s skills with customer engagement will improve its chances for success in drug discovery. As mentioned earlier, the fact that 80 percent of customers have given 23andMe the rights to use their data for future research initiatives implies the public’s trust in the organization — a big deal in this age that stresses patient data privacy.

Wojcicki told Bloomberg Business, “Part of what we’re trying to do here is drug discovery in a more efficient model. Pharma companies don’t have a direct relationship with consumers, so they’re always subjects. By engaging them and giving it to them as a prize, saying, ‘You’ve powered this study and you’ve made this happen,’ we can do things in a different way.”

Remain Open To New Ventures

Overall, the move seems to have drawn a lot of industry attention, though the firm is hardly redefining drug discovery. As Bio IT World points out, turning to genetic information to find new treatments has been a strategy employed by other pharma companies, including Amgen and Regeneron, both of which discovered the cholesterol-lowering variants of the gene PCSK9. (In fact, Regeneron could owe a lot to the process of investigating gene variants, considering its PCSK9-inhibitor Praluent, co-developed with Sanofi, is pending a decision from the FDA by the end of July and could be the first PCSK9 inhibitor on the market — and it’s likely to be a big earner.)  

Drug discovery does seem like a natural next step for the company. The company already has the data to find the genetic culprits behind diseases — why not take it a step farther and start seeking actionable drug targets on its own?

From a business standpoint, as well, if partnering to mine 23andMe’s data has thus far been an alluring business proposition for Big Pharma, how appealing would a drug development program be to potential partners or buyers, and how could this impact the data company’s growth? As Wojcicki said, “With an FDA-cleared product, we need to continue to accelerate growth. I want to push the limits.”

However, 23andMe’s entrance into the drug discovery realm does leave a lot of questions and perhaps raises some concerns that only time will be able to answer. What therapeutic areas will the firm set its sights on, and what might set it apart from its competitors? What kind of success will 23andMe see with this initiative, and, equally important, what failures will the company encounter, and what could pharma learn from them?