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Precision for Medicine’s next generation biomarker data management platform paves the way for the future of translational research and biomarker-guided drug development.
We sat down with Scott Marshall, Managing Director, Translational Informatics and Diagnostic Sciences, and Chad Clark, President of Precision for Medicine to learn more about their growth and plans for 2018 and beyond.
"We have had a very successful 2017, and we are thrilled with industry advancements in bioinformatics and our own success in this area," says Scott Marshall. During 2017, Precision Medicine Group, expanded its translational informatics footprint into Europe with the opening of new offices and continued to expand their proprietary technology platform, "a game changer for translational scientists."
What are some of the trends that you expect to have an impact on Bioinformatics?
Chad: We have seen transformative trends emerging over the last five years in the space of translational research and biomarker-guided drug development, many in the area of advanced biological data production such as whole genome sequencing, immuno sequencing, complex flow cytometry, and proteomics to name a few. These developments are driving the need for new technology platforms to support the management and analysis of this high-content, high-throughput data. From the perspective of translational research, the diversity in assays being run in early-phase studies continues to expand, especially in the space of immuno-oncology. As part of this evolution of biomarker-guided drug development, we are seeing that new types of data are being generated to support clinical trial decision-making. Examples include dose selection or patient stratification and the characterization of mechanistic properties used to support regulatory submissions.
All of this points to the need for more advanced tools with greater rigor and regulation. With the increases in regulation and the implications on patient care, the time spent managing these data is quite extensive. By our estimates, 60 to 80 percent of time is spent on data management-related tasks, as opposed to analysis to derive insights, and with millions of dollars spent on running assays, much of the value is often left on the table. This is why we built our biomarker data management platform that is focused on more rapidly synthesizing, assimilating, and analyzing biomarker data, which can help reduce the cost of clinical trials and make therapies available to patients sooner.
What are some challenges CIOs in your industry face?
Chad: Advances in genomics, proteomics, and other areas have made the production of data much easier, cheaper, and subsequently more ubiquitous across the industry. However, managing the wealth of data—often greater than 10s of millions of data points for a single study—is a significant pain point. Today, our clients are overwhelmed just in the collection and reconciliation of this information and have very little bandwidth to actually extract valuable insights. As CIOs and their informatics teams are using our biomarker data management platform to synthesize and interpret this information, they are seeing significant cost reductions and getting insights faster with reduced risk. Of course, security, scalability, and regulatory compliance remain significant concerns for our clients and, therefore, a key focus of ours.
Precision is specifically engineered to support and advance biomarker-driven research and development
- Chad Clark, President, Precision for Medicine
Scott: Precision manages all aspects of translational research and biomarker-guided drug development efforts to address the demands of modern drug development by leveraging our biomarker data management and data delivery platform, which enables rapid data assimilation, secure access, advanced visualization, analysis, and on-demand reporting in a highly robust, scalable framework.
These teams work day-in and day-out with clinical trial experts who can design and implement novel programs to stratify and enroll patients more likely to respond to therapies based on biomarkers. Our clinical trial teams are expert in managing oncology trials and rare disease trials where the majority of trials are biomarker driven. Our trial experts, scientists, informaticians, and global regulatory experts are helping clients identify and enroll patients faster and more efficiently to bring new therapies to the global markets at unprecedented rates.
How does Precision for Medicine leverage biomarkers?
Scott: In an age where a single biomarker may not be sufficient to fully characterize a response profile of interest, Precision’s team leverages complex yet intuitive methodologies to integrate data across assays for the purpose of characterizing response and, ultimately, stratifying patients. We combine subject matter expertise with advanced informatics/technology platforms to streamline this effort. Once the complex data are synthesized, our translational informatics teams can focus on the scientific questions that will drive the development process forward. Seamlessly integrating biomarker data with clinical results allows real-time analysis and decision-making to guide biomarker-driven patient and trial decisions.
Most people realize translational science is no longer an optional element in modern clinical studies; it must be regarded as an integral component. The onslaught of diverse and complex data sets requires a biomarker data management strategy to be in place during the planning stages to more effectively integrate all the data. We’ve assembled an unrivaled translational team with diverse expertise that can harness the prospective findings within a multifaceted analysis of complex biological variation to help guide the decision-making process in clinical studies. Leveraging a secure, scalable, cloud-based technology platform to harmonize data from different sources to be visualized and analyzed more easily can greatly reduce the time needed to make those decisions. We’ve implemented a platform that successfully obtains transformative insights so that precision medicine can be fully realized.
What differentiating factors does Precision havethat give it a competitive edge?
Scott: Precision is specifically engineered to support and advance biomarker-driven research and development. We believe in our focus on advanced analytics, translational sciences, and the conduct of novel clinical trials for oncology and rare disease. Most of our competitors are small, niche companies not able to support the growing scientific demands of next generation research programs. Our competitors are massive, inflexible firms unable to adapt to today’s research realities. We believe that we have the size and scale to deliver global programs and the entrepreneurial spirit to adapt and evolve as fast as science can take our industry.
What are Precision’s plans for 2018 and beyond?
Chad: Precision will continue our expansion to support global clinical studies, and we will continue to develop and acquire novel technologies needed to advance biomarker research. Over the past few months we have announced the opening of offices in Paris and Edinburgh and the acquisition of a patent-protected immune monitoring technology in Berlin. I believe you will continue to see similar investments in other geographies as we expand to continue to meet the needs of our innovative biopharmaceutical clients.