Clinical OMICS

NOV-DEC 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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30 Clinical OMICs November/December 2018 www.clinicalomics.com Introduction Modern biomarker-guided drug development has been driven, in part, by the need to target specific patient pop- ulations and create efficient, cost-effective methods for developing transformative therapeutics. A key component of the discovery process involves characterizing the cascade of biological pathways and processes that ultimately drive response and potentially define patient populations. Sponsors frequently invest substantial time and capital into advancing novel technologies and approaches in this realm, particularly as the cost of using complex assays to interrogate biological pathways decreases. And yet, we have only uncovered the tip of the iceberg when it comes to uti- lizing the massive volumes of data these new technologies create. In particular, we are in the early stages of effectively aggregating and harmonizing this data to make it action- able. Additionally, the rise of platform licensing and part- nership structures has led to the prioritization of enabling the efficient consumption of complex analytical results and establishing a foundation to foster collaborative analyses to fuel the drug development process. In this article, we explore biomarker data trends and challenges, and share how drug developers, translational scientists, and clinical researchers evaluating biomarkers in early-phase studies can: • Move beyond data overload and leverage cutting-edge technologies to seamlessly transform millions of data points into actionable insights • Harness advanced informatics and visualization tools to harmonize dis- parate sources of biomarker data and warehouse them for effective on-study use (e.g., dose selection), as well as downstream use • Build flexibility, efficiency, and compli- ance into the rapidly evolving biomark- er-informed development process • Accelerate go/no-go decision-making to reduce time and cost Biomarkers in Clinical Trials Since 2013, there has been a sharp increase in the number of clinical trials citing a biomarker-guided precision medicine design. 1 Evaluating biomarkers in clinical trials and inte- grating specialty lab data (e.g., flow cytometry, gene expres- sion profiling, immunosequencing) with pharmacokinetics, safety lab, and clinical data can provide a more comprehen- sive picture for assessing the efficacy, pharmacodynamic effect, and safety of an investigative compound. A recent report revealed that drugs developed using a precision medicine design had a higher likelihood of launch across all therapeutic areas, with the most significant difference in oncology (see Figure 1). The message: The impact of a precision medicine design may be even more powerful when biomarkers are used for patient selection. A study of clinical development success rates over the 10-year period from 2006 to 2015 demon- strated that the use of biomarkers for patient selection was associated with a three-fold increase in the likelihood of suc- cess from Phase 1 to approval. 2 An ever-growing set of biomarker assays are available, Unlocking the Value of Complex Biomarker Data By Scott Marshall, Ph.D., Managing Director, Translational Informatics and Diagnostic Sciences; Tobias Guennel, Ph.D., Senior Director, Translational Informatics and Biometrics; and Cliff Culver, SVP, Precision for Medicine Figure 1. Average Gain for Precision Medicine Trials: 15 Percentage Points Trialtrove | Pharmaintelligence, 2018. Data: 2012-2017. Adapted from The Economist Intelligence Group. The Innovation Imperative: The Future of Drug Development | Part I: Research Methods and Findings.

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