A: Despite substantial advances in precision oncology, the majority of advanced cancer patients still do not benefit from comprehensive tumor molecular profiling or precision therapy trials. At the same time, precision therapy trial enrollment is slow and unpredictable, resulting in delays bringing new medicines to market.

Health systems need a cost-effective, system-wide solution for precision oncology, one that integrates cutting-edge molecular profiling and precision therapy trials with routine care, so that all advanced cancer patients have the opportunity to benefit. In addition to improving patient outcomes, a comprehensive precision oncology solution attracts new patients, faculty and research opportunities.

Biopharma companies need a partner to rapidly and predictably enroll registration-enabling precision therapy trials. This requires a large network of trial-ready health systems with fully pre-screened advanced cancer populations.

A: We are systematizing precision oncology across a network of healthcare systems and biopharma companies to both broaden patient access and accelerate precision therapy trials. Our screening protocol, the Strata Trial, is the largest ever, providing comprehensive tumor molecular profiling to 100,000 advanced cancer patients at no cost and proactive enrollment support for a portfolio of pharma-sponsored clinical trials.

Our data and software solutions integrate EMR-based clinical histories with molecular profiling data to ensure that all eligible advanced cancer patients are tested, considered for precision trial enrollment and tracked post-enrollment.

For biopharma partners, we provide a streamlined and accelerated path to new and expanded precision therapy drug approvals, with rapid trial activation and accrual across a fully functional network of sites with prescreened patient populations.

A: I co-founded Strata Oncology and serve as CEO. It is an exciting time to be in cancer medicine, and precision oncology in particular, where research is progressing at an incredible pace. Two things excite me most about our work – patient stories and the data. There is nothing more rewarding than learning about a metastatic cancer patient with an unexpected genomic finding that led to a remarkable treatment response. On the data-side, it is exciting to dig into 1,000’s of clinical-genomic metastatic patient profiles to consider and devise new treatment strategies.

A: The first tissue-agnostic drug approval, pembrolizumab for patients with microsatellite instability high (MSI-H) or mismatch repair deficient solid tumors, was a landmark for the field. Also in 2017, two drugs (larotrectinib and entrectinib) were given Orphan Drug status for treatment of NTRK fusion-positive solid tumors, pan-cancer. An important story on the diagnostic side is recent FDA approval, and parallel national coverage determination from CMS, of FoundationOne CDx for any solid tumor. Together, these developments suggest that tumor molecular profiling and pan-cancer drug development will soon become the new norms.

A: One of the biggest challenges is ensuring cancer patients have broad access to both tumor molecular profiling and precision therapies. While lack of reimbursement is a major barrier to broad adoption of tumor sequencing, we know coverage is not sufficient to enable universal tumor molecular profiling across a large health system. Nor does tumor profiling itself constitute a comprehensive precision medicine strategy for a leading cancer center.

Additional infrastructure support is required to implement an integrated, streamlined program that facilitates routine testing, efficient utilization of molecular data, and novel precision therapy trials. Health systems that successfully implement these approaches will lead the way in precision oncology research and care. We address this challenge by providing our health system partners the essential pillars needed to empower a leading precision cancer medicine program.

Data also presents a significant challenge on several fronts, including integration of genomic data into electronic health records. We are working closely with partners like Kaiser Permanente, who is a leader in embedding data collection with ongoing care delivery, to address these challenges.

A: I’d like to welcome PMWC 2018 attendees to Ann Arbor. I was born, raised, and educated (B.S., PhD University of Michigan) in the state of Michigan and we are thrilled to have such a remarkable group of thought leaders in town for PMWC.