ORACLE HEALTH SCIENCES INFORM ADVANCED MOLECULAR ANALYTICS

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1 ORACLE HEALTH SCIENCES INFORM ADVANCED MOLECULAR ANALYTICS INCORPORATE GENOMIC DATA INTO CLINICAL R&D KEY BENEFITS Enable more targeted, biomarker-driven clinical trials Improves efficiencies, compressing study cycle-times and accelerating time to launch Increase data integrity with comprehensive 21CRF-Part11- compliant solution for data management and analysis Improve capturable marker estimate with correlation analysis between clinical outcomes and molecular biomarkers Clinical and genomic scientists can utilize public domain data to draw and compare insights, resulting in faster identification of targets Identify potential risks to trial timelines and data quality KEY FEATURES Capture and manage molecular data collected during a clinical trial Obtain genomic profiling and analysis reports Integrate with well-established public domain data for joint analysis with your own data Deployed as software-as-a-service (SaaS) and fully integrated with Oracle Health Sciences InForm Cloud Service Secure, role-based access control, encryption, and auditing Oracle Health Sciences InForm Advanced Molecular Analytics enables life sciences organizations to incorporate genomic data into clinical R&D, enabling more targeted, biomarker-driven clinical trials to optimize trial outcomes and increase efficiency. The solution extends the capabilities of Oracle Health Sciences InForm, the industry-leading clinical data capture and management solution to effectively collect, store and analyze genomic data in clinical trials. Pressing Need for Managing Biomarker Data In Clinical Trials As the industry moves aggressively forward to expand the effective application of personalized medicine, biomarkers are becoming a key component of clinical development programs. The use of prospective genomic testing can optimize patient inclusion into clinical trials, ensuring enrollment of patients that have the best chance of demonstrating a positive therapeutic effect. Oracle Health Sciences InForm Advanced Molecular Analytics (AMA) is the first commercially available cloud-delivery solution to incorporate genomics into the clinical data capture and management process. The solution is integrated with Oracle Health Sciences InForm EDC platform, letting clinical researchers effectively capture, aggregate and analyze molecular data along with clinical data, providing the information needed to identify new predictive biomarkers. Oracle Health Sciences InForm AMA facilitates the prospective dynamic randomization of patients with or without omics signatures into respective treatment arms to optimize study conduct. Leveraging this seamless process enables improved trial efficiency by reducing the sample sizes and potentially the treatment duration required to demonstrate statistical and clinical outcomes. The solution leverages proven technology from the Oracle Health Sciences cloud-based Translation Research Center to deliver the first molecular-aware clinical data capture and management solution. Oracle Health Sciences InForm AMA helps life sciences organizations to: Stratify patients and reduce research and development costs and time by leveraging targeted drug development approaches and decreasing study size and length. The solution also helps researchers explore synergistic programs through post-trial, cross-study analysis with combined molecular and clinical data. Reduce or eliminate the difficult manual methods to collect and integrate data into a single database for prospective analysis and faster decision-making. With InForm Advanced Molecular Analytics, researchers have consolidated access to both clinical and genomic data for numerous purposes such as submission or the design of more exploratory translational research studies. Create competitive clinical differentiation messages for new drugs in highly competitive markets where comparative effectiveness, outcomes, clinical utility and cost-effectiveness are critical factors to ensure commercial success.

2 Enable clinical researchers to study patient genomic profiles, analyze differences and compare molecular data against common large public domain data sets, increasing statistical power. InForm Advanced Molecular Analytics is deployed as software-as-a-service (SaaS) and is fully integrated with the Oracle Health Sciences InForm Cloud Service. As a comprehensive and commercially available SaaS solution, life sciences organizations avoid the cost and time associated with building and maintaining custom solutions. Define a Better Outcome Measure for a Trial Endpoint Through the ability to integrate data from multiple sources, including clinical outcomes data and molecular biomarker data, Oracle Health Sciences InForm AMA lets you analyze the correlation between efficacy and safety data with patient-specific molecular data. As a result, these findings can be used as inputs to an adaptive design trial or refine the achievable trial endpoint thus optimizing the design of the next study. Overall, these efforts enhance data analyses and enable better decisions, strengthening the evidence for regulatory approval. Figure 1. Oracle Health Sciences InForm Advanced Molecular Analytics lets you analyze the correlation between efficacy and safety data with patient-specific molecular data to optimize study design and strengthen the evidence for regulatory approval. 2

3 Figure 2. Clinicians and scientists can plan for the next study protocol based on biomarkers identified in a patient cohort with similar outcomes to a treatment. As just one example, with a few clicks at the user interface, clinicians and translational medicine scientists can explore the common variants in the responder group. Combine Broad and Deep Data Capture and Translational Research Capabilities Developing targeted therapies that work for individuals with a specific genetic signature requires identification of carefully selected cohorts. This helps researchers discover therapies that will be most effective with the fewest adverse events. InForm AMA lets scientists compare patient genomic profiles and analyze their differences with a simple user interface. You can quickly generate a variety of prebuilt demographic, clinical and genomic reports based on a custom cohort to conduct analysis and research into relevant features. Figure 3. The ability to collect, manage, and view molecular data with Oracle Health Sciences InForm Advanced Molecular Analytics allows scientists and researchers to effectively capture patients clinical and genomic profiles. 3

4 Figure 4. Patient details can be viewed through configurable tables, timeline views and graphical reporting to obtain a better view of the selected patient cohort, including multiple demographic reports such as age, race, gender distribution of the cohort, and a composite of age and gender distribution. Rapidly Identify Subjects with Similar Characteristics Stratifying patient populations is not a simple task. Cohort identification queries do not follow a set pattern. Researchers need the flexibility to select from hundreds or even thousands of different criteria to correctly filter results. Oracle Health Sciences InForm AMA enables researchers and clinicians to be self-sufficient in identifying study subjects with similar clinical and omics attributes, reducing the burden on the IT group. Researchers can iterate using dynamic, ad hoc queries to find the desired patient groups. The solution also supports drilling down to individual-subject level detail, with the resulting queries able to be saved and run again as populations change. Figure 5. The ability to collect, manage, and view molecular data with Oracle Health Sciences InForm Advanced Molecular Analytics allows clinicians and translational scientists to stratify patients with combinations of clinical and genomic criteria in an integrated fashion. 4

5 Conduct Molecular Searches and Get Visual Results Oracle Health Sciences InForm Advanced Molecular Analytics enables researchers to run gene-centric queries. It provides state-of-the-art molecular visualizations displaying holistic views of multiple omics data modalities stored in the cross-platform Oracle Health Sciences Omics Data Bank. This integrated view is the foundation for systems-biology based approaches to further the molecular understanding of disease leading to new drug targets. Scalability to Answer Big Data Challenges from Small to Mega Trials When defining cohorts, large amounts of clinical information must be analyzed and distilled to drive decisions. Omics data adds even more information that can be managed and analyzed in the pursuit of biomarkers. The Oracle Health Sciences InForm EDC platform has effectively managed Phase I trials as well as many of the largest mega trials in the world, featuring thousands of sites and tens of thousands of subjects. InForm AMA offers the flexibility to support small trials with a smaller gene panel, as well as integrating thousands of trials with hundreds of thousands of whole genome sequences in a single query letting you scale easily as your needs for genotype/phenotype analysis expand. Why Oracle Health Sciences Backed by the resources of a Global 500 company, Oracle Health Sciences provides you with the industry s most comprehensive set of software solutions addressing every aspect of the health value chain from discovery to care delivery. With thousands of professionals in offices throughout North America, EMEA, and Asia, Oracle Health Sciences offers unmatched resources to enable your organization s goals today and in the future. Contact Us For more information about Oracle Health Sciences InForm Advanced Molecular Analytics visit oracle.com, healthsciences_ww_grp@oracle.com, or call to speak to an Oracle representative. Copyright 2014, Oracle and/or its affiliates. All rights reserved. This document is provided for information purposes only and the contents hereof are subject to change without notice. This document is not warranted to be error-free, nor subject to any other warranties or conditions, whether expressed orally or implied in law, including implied warranties and conditions of merchantability or fitness for a particular purpose. We specifically disclaim any liability with respect to this document and no contractual obligations are formed either directly or indirectly by this document. This document may not be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without our prior written permission. Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners. Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks are used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD, Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced Micro Devices. UNIX is a registered trademark licensed through X/Open Company, Ltd