23andMe, Inc. is one of the first consumer genetics and research company. Founded in 2006, the mission of the company has traditionally been to help people access, understand and benefit from the human genome. A direct business to consumer focus, the company has enabled its users to study their ancestry, genealogy, and inherited traits.
Multi-national pharmaceutical sponsor GSK has announced a co-development partnership with 23andMe. According to the press release, the two inked “an exclusive four-year collaboration that will focus on research and development of innovative new medicines and potential cures, using human genetics as the basis for discovery.”
The two firms seek to potentially commercialize the data-driven insights made possible by the vast treasure trove accumulated by Silicon Valley-based 23andMe. The idea is that with their “large-scale genetic resources and advanced data science skills” combined with GSK’s global scale and power in the fields drug development and commercialization the partnership can uncover insights leading to serious new novel drug targets—potentially leading to therapies for unmet medical needs.
The driving focus will center on translating genetic and phenotypic data into R&D programs driving:
- Improved target selection with goal of safer and more effective precision medicines
- Identification of patient subgroups that are more likely to respond to targeted treatments
- Targeted, precise patient recruitment capabilities
Deal Terms include:
- 4-year collaboration with option to extend to a 5th year
- GSK exclusive collaborator for drug target discovery programs
- Joint 23andMe and GSK discovery team (deep collaboration)
- Mutual opportunity to introduce early stage programs
- GSK contributes its LRRK2 inhibitor (currently in pre-clinical for Parkinson’s Disease)
- The parties seek to target and recruit patients with defined LRRK2 mutations to reach clinical proof of concept
- 50%/50% co-funding of all activities (either company maintains right to reduce its funding share for any collaboration)
- The partnership has goals for number of targets developed per year
- GSK has right to leverage the 23andMe database for all its existing therapeutic portfolio
Some form of revenue share has been established for any successful programs.
TrialSite News staff recognize that 23andMe founder Anne Wojcicki has been a big advocate for consumer data ownership. Over the years she has assured markets and consumers that they are in control of their data and that any research will include consent—and for those that do consent they thereafter de-identify that data.
However, there is big money in genetic data. With the rise of precision and personalized medicine the stakes become unbelievably large. According to the published deal terms GSK can actively capitalize on the entire 23andMe database— in which there is an awful lot of an individual’s data. The Federal Trade Commission recently issued a jarring letter—if you are going to buy and use an at-home DNA testing kit, make sure to think about the privacy considerations—“although most tests require just a swab of the cheek,” the agency wrote, “that tiny sample can disclose the biological building blocks of what makes you you.”
For now, 23andMe advocates that users control their data, but 23andMe arguably owns the individual’s data…