Jarret Glasscock, CEO of Cofactor Genomics, recently spoke with Patrick Hurban, Senior Director and Global Head, Translational Genomics at Q2 Solutions on the topic of onboarding novel technologies for clinical studies. Dr. Hurban leads a team of laboratory-based and bioinformatics scientists who evaluate, develop, validate, and implement all of the genomic capabilities offered throughout the Q2 global laboratory locations. Dr. Hurban also serves as Laboratory Director for their CAP/CLIA Genomics Center of Excellence laboratory in the Research Triangle Park, North Carolina.

Jarret: How do you see novel technologies making an impact in precision medicine?

Pat: Precision medicine is critically reliant on biomarkers. While contemporary technologies have done a good job of identifying potential biomarkers and translating them to diagnostics, its sobering to realize that as of today in the U.S. there are only 38 approved companion diagnostics, and that doesnt represent 38 distinct targets, many of those are overlapping. The field often thinks of the therapeutic first, with the companion diagnostic then added on. But the paradigm is shifting. Personally, Im really excited by diagnostics that can be tied to multiple therapieswhat some have termed a companion therapeutics strategy. Genomics is particularly relevant in this framework, and weve already seen approvals of NGS-based tests covering multiple therapeutics and multiple indications, as well as tissue-agnostic markers like microsatellite instability-high. I look forward to technology advances that enable cost-effective and rapid integrative multi-omic testing.

Jarret: How does your team onboard new technologies into your laboratory?

Pat: We use a phased approach. We strongly prefer forging technology partnerships, as opposed to simply purchasing things through a customer/vendor relationship. Our technology portfolio must remain current and relevant to our clinical development clients, so we take every client interaction as an opportunity to understand their evolving needs and identify ways of working together to identify and evaluate potentially interesting technologies. Our clients rely on our objectivity, so we conduct evaluations that are designed to pressure-test the claimed capabilities of a technology, but also to determine whether its feasible to deploy the technology as part of clinical trialswe must always be mindful that no matter how interesting a technology is, if we cant collect, store, transport, and process the sample within stability, its not a workable solution for trials. And solutions that work in trials conducted in an academic medical center setting may not work in a community care setting. Once weve identified something of interest, our implementation will include a validation commensurate with the intended use of the technology, and we will work closely with our colleagues in our production laboratory to engineer an operationalized, scalable, and sustainable workflow.

Jarret: Why is immune profiling important to your clients and partners?

Pat: Immuno-oncology approaches have revolutionized cancer research and treatment. Despite the tremendous advances we have made to date, no one would deny that we have only scratched the surface of the vast complexity of the immune response to tumors. Clearly, new therapeutic avenues and biomarker possibilities are opened with each incremental advance of our understanding. In clinical development theres always a tension between having a narrow focus that enables strong, definitive findings, and casting a wider net using broader profiling solutions. We have need of both, since so many trials seek to confirm biomarker hypotheses as well as generate new hypotheses.

Jarret: When do you believe well see the next generation of technologies transition into clinical practice?

Pat: Sooner than any of us are ready for. So many of the newer technologies are showing such promise, with the possibility of illuminating our understanding of tumor biology in fundamentally new ways, so there is a huge push from our clinical development partners to find ways to incorporate nascent technologies. All of this is aimed at ultimately finding biomarkers that can be translated into routine use.

Jarret: What differentiates Q2 Solutions from other CROs?

Pat: Leading with science. We have the most effective combination of operational excellence and scientific acumen available today. We offer outstanding science and a breadth and depth of technical knowledge that is unrivaled in the industry. We take the long view and have a track record of investing in people and technology to propel clinical trials forward. We engage early and understand that the success of our partners is the best measure of our own success..

The rest is here:

RNA, Data Science, and the Future of Precision Medicine - Clinical OMICs News