Project GENIE Announces Biopharma Collaboration

Next-generation sequencing has made collecting patient-specific genomic information practical—and it's beginning to transform clinical care. However, realizing the promise of precision oncology requires the backing of powerful data. To further accelerate progress, the American Association for Cancer Research's (AACR) Project Genomics Evidence Neoplasia Information Exchange (GENIE) has initiated a 5-year partnership with nine biopharmaceutical companies, each of which will provide funding—$36 million in all—as well as technical expertise.

Project GENIE is a pan-cancer registry of real-world, de-identified genomic and clinical data assembled via data sharing among 19 international academic cancer centers. The goal is to improve clinical decision-making, says Shawn M. Sweeney, PhD, director of the AACR Project GENIE Coordinating Center. The data, which are updated every 6 months, are already being used to determine the prevalence of certain mutations in various cancers, provide cohorts for external validation, and clinically annotate genetic variants as part of individual hospitals' workflows.

The objective of the collaboration is to speed progress in obtaining additional clinical data. Although Project GENIE has already amassed genomic and baseline clinical data from more than 80,000 patients since its inception 4 years ago, and collected deeper, more detailed clinical information on individual cohorts, such data are currently lacking at a larger scale. Nine biopharma companies joined the consortium:

• Amgen Inc.

• AstraZeneca

• Bayer HealthCare Pharmaceuticals Inc.

• Boehringer Ingelheim

• Bristol-Myers Squibb Company

• Genentech, a member of the Roche Group

• Janssen Research & Development, LLC

• Merck

• Novartis

By collaborating with biopharma, Project GENIE is adopting a common data model to allow details about each patient's journey with cancer to be collated—and obtain the research and development capital needed to collect these data at a larger scale, Sweeney says. At the end of the 5-year collaboration, the aim is to have detailed clinical data and genomic data from at least 50,000 patients.

“We're really trying to bring together the idea of clinical care and clinical research so that we can speed up innovation for patients,” says Mimi Huizinga, MD, MPH, FACP, head of US Oncology Medical at Novartis. A large part of that comes down to obtaining and interpreting data contained in patients' electronic health records (EHR). Even when different institutions use the same EHR systems, it can be technically challenging to integrate their data—for example, information about disease progression may be buried in a radiograph or in a doctor's notes.

Even determining how to best compile such data is resource intensive. For instance, natural language processing might be the most efficient way to interpret large volumes of written notes, and implementing that would require personnel with specific skillsets. Regardless of the methods used to extract the information, having standardized, detailed clinical information for such a large patient cohort would be a boon for academic researchers and those in the biopharmaceutical industry alike—and that should translate to better care for patients.

“I think this is a great first step. I would love to see more institutions involved,” Huizinga says. “I think that this is the way forward.” –Nicole Haloupek