2017 Archived Content

Track 8: Clinical Research and Translational Informatics

Transforming biological insights from drug discovery to sustainable clinical and translational research pipelines requires establishing research platforms, integrating systems and using innovative techniques for the integration, visualization and analysis of biological and clinical research data. Track 8 explores new approaches and technologies to the integration, analysis and visualization of biological, clinical trial and real world data with case studies from across pharma and academia.

Tuesday, May 23

7:00 am Workshop Registration and Morning Coffee

8:0011:30 Recommended Morning Pre-Conference Workshops*

(W5) Mobile Health, Virtual Research, Wearables, and Sensors; How to Accelerate Their Use and Adoption in Your Company

12:304:00 pm Recommended Afternoon Pre-Conference Workshops*

(W12) Leveraging Cloud Technologies to Enable Large-Scale Integration of Human Genome and Clinical Outcomes Data

* Separate registration required.

2:006:00 Main Conference Registration Open



GeneData logo5: 007:00 Welcome Reception in the Exhibit Hall with Poster Viewing

Wednesday, May 24

7:00 am Registration Open and Morning Coffee


9:50 Coffee Break in the Exhibit Hall with Poster Viewing


10:50 Chairperson’s Remarks

Jay Bergeron, Director, Research and Early Clinical Development BT, Pfizer

11:00 eTRIKS: Successes, Surprises and Lessons on the Verge of Completing the Largest General Translational Informatics Public Private Partnership to Date

Jay Bergeron, Director, Research and Early Clinical Development BT, Pfizer

The European Translational Research Information and Knowledge Management Services (eTRIKS), Innovative Medicines Initiative project, is finishing a five year, 17 partner, public-private partnership to establish products, services and best practices for translational informatics. eTRIKS has delivered technical platforms, data curation and analytics services, data standards/security/ethical guidelines, confidentiality and materials transfer master agreements, focused marketing platforms to encourage patients to share their health information for translational research and a post-consortium sustainability plan for these established services. eTRIKS has provided these services to over forty academic projects and public-private partnerships during its tenure and is poised to continue providing best practice support to large scale translational projects via the "eTRIKS Network."

11:30 Brain-CODE: A Large-Scale Neuroinformatics Platform Offering Full Research Integration

Brendan Behan, Ph.D., Program Lead, Informatics and Analytics, Ontario Brain Institute

Here we present an example of a functioning large-scale neuroinformatics initiative supported by the Ontario Brain Institute – Brain-CODE www.braincode.ca. Brain-CODE is an extensible, large-scale platform that manages the acquisition, storage, processing and analytics of multidimensional data collected from various brain disorders. In contrast to other large-scale databases that sometimes act merely as data repositories, Brain-CODE offers full research integration in terms of ensuring received data meets particular standards, offering data curation processes and facilitating data sharing through best practice governance, privacy and security guidelines. Brain-CODE also offers the computational infrastructure for researchers to perform analytics on their data.

12:00 pm Text Mining in Translational Research: Bench to Bedside and Back Again

David Milward, Ph.D., CTO, Linguamatics

Critical translational research data is locked in textual format, such as scientific literature, clinical trial reports or electronic health records. Text mining can extract and connect relevant clinical and scientific data, providing evidence for clinical decision making and helping select patients for clinical trials. We will finish with a specific customer use case: mining clinical trial data for drug repurposing.

12:15 Buzzwords Aside: Delivering on the Promise of Big Data in Precision Medicine

Philip R.O. Payne, Ph.D., FACMI, CSO, Signet Accel

Precision medicine and big data are oft-used phrases in BioIT, but we’ll transcend the hype to truly know their impact. Payne strips away industry buzzwords to share why both must be scaled to population levels—and what it takes to get there: Unfettered access to vast quantities of disparate data; advanced data science and machine learning; and new approaches to true interoperability.

12:30 Session Break

12:40 Luncheon Presentation I: Data, Ecosystems and Outcomes using Evidence from Bench to Bedside and Back
Brett Davis, Principal, Deloitte Consulting, LLP

Whitney Kent, Director, Global Program Management, Takeda Pharmaceuticals

Arun Nayar, Executive Director, R&D Informatics, Amgen

Patrick Loerch, Senior Director, Data Scientist, Celgene

The health care ecosystem is in a period of unprecedented change. The combination of value-based reimbursement and precision medicine is directing treatment toward personalized care—and requiring a reorientation around insights. Our panel of industry experts will discuss their approaches to leveraging data, evidence, and knowledge assets to deliver relevant information to researchers for evidence-driven decision making.

1:10 Luncheon Presentation II: Before and After: Improving Laboratory Fitness with BaseSpace® Clarity LIMS

Melanie Febrer, Product Manager, Illumina

BaseSpace Clarity LIMS is a laboratory information management system that helps laboratories track samples and optimize procedures and workflows. Attend this informative session in which Q2 Solutions, a leading global clinical trials laboratory services organization, discusses their lab before and after BaseSpace Clarity LIMS. Presenters will share lessons learned on the implementation, as well as how the LIMS is helping them streamline and optimize their procedures to provide even better service to their customers.

1:40 Session Break


1:50 Chairperson’s Remarks

John Reites, Chief Product Officer and Partner, THREAD

1:55 Briefing on Pharma’s Use of Mobile Health, Virtual Research, Wearables and Sensors

John Reites, Chief Product Officer and Partner, THREAD

Joe Dustin, Director, Mobile Health, Medidata

Georgia Mitsi, Senior Director, Search Evaluation, Digital Healthcare, Sunovion

This will be a briefing on how mobile health, virtual research, wearables and sensors are being used in Pharma-focused programs with insights covering lessons learned, data standards, privacy, platforms in use, adoption strategies and much more.

 Innoplexus 2:55 Artificial Intelligence Powered Data and Insights

Gunjan Bhardwaj, Ph.D., CEO, Innoplexus AG

Innoplexus is creating a new paradigm of continuous decision support in clinical research and translational informatics. Instead of mining data silos, with a novel meta ontology based AI approach, we are bringing in relevant data from all corners of the clinical research space. In addition to this, we are building continuous analytics applications for decision support.

Medable Bolt 3 :10 Democratizing Mobile and Machine Learning in Translational Research

Michelle Longmire, MD, CEO, Co-founder, Medable

Investigators want to leverage mobile for continuous and connected participant data collection. Dr. Longmire will address how Medable is enabling investigators to deploy mobile apps into research studies without any development and then harness the power of machine learning with cloud systems to derive insights from app enabled big data.

3:25 Refreshment Break in the Exhibit Hall with Poster Viewing


4:00 Co-Presentation: Building JAX-CKB: A Public Resource Supporting Tumor Profiling and Complex Queries in Cancer Genomics

Daniel Durkin, Manager, Software Development Computational Sciences, The Jackson Laboratory for Genomic Medicine

Susan Mockus, Ph.D., Manager, Clinical Analytics & Curation, The Jackson Laboratory for Genomic Medicine

The Jackson Laboratory Clinical Knowledgebase (CKB) is a semi-automated/manually curated database of gene/variant annotations, therapy knowledge, diagnostic/prognostic information, and clinical trials related to oncology. Variants are connected to targeted therapies through an efficacy evidence annotation, which has been optimized to capture and query complex molecular tumor profiles. Public CKB is accessible at https://ckb.jax.org. Design considerations, data capture transparency, and the technological platform will be discussed.

4:30 Data-Driven Patient Recruitment with Real World Data at Roche pRED

Liping Jin, Data-Driven Recruitment Lead, Pharmaceutical Research & Early Development, Roche Innovation Center New York

With the increasing use of Real World Data (RWD) in the pharma industry, Data-Driven Recruitment (DDR) team at Roche Pharm Research & Early Development (pRED) would like to share our experience of integrating RWD (e.g. insurance claims, EMR) with trial metrics data to optimize study protocol design and target patient recruitment strategy. While the team has received positive feedback from our business partners (translational medicine, clinical program teams, and study leaders) we would like also to share the challenges to expanding the effort in broader US and international settings.

5:00 A High-Performance Solution for Clinical Genomics and Translational Medicine Research

Janis Landry-Lane, Worldwide SD and Flash Solutions, Life Sciences Industry, IBM Systems, IBM

Kathy Tzeng, Ph.D., STSM, Life Sciences & NGS Solution Enablement IBM Systems, IBM

Clinical genomics and translational medicine research is driving the need to process raw data from a sequencer, and integrate and analyze genomics with complex data sources in a timely manner. IBM’s high performance, secure and scalable integrated NGS and analytics solutions can address the challenges, while minimizing IT resources. IBM will discuss the approach of building these integrated solutions and collaboration with customers and partners.

5:15 Democratizing Data Science: Balancing Flexibility and Usability for Scientific Applications

Jens Hoefkens, Director, Strategic Marketing, PerkinElmer Informatics, Inc.

We will present a novel data analysis pipelining tool which enables even non-expert users to create complex scientific analysis pipelines. Having been developed entirely inside TIBCO Spotfire, the system leverages the full interactivity, connectivity, extensibility, and ease of use of the world’s leading research data analysis platform.

5:30 – 6:30 15th Anniversary Celebration in the Exhibit Hall with Poster Viewing and Best of Show Awards

Thursday, May 25

7:00 am Registration Open and Morning Coffee


8:05 Benjamin Franklin Awards and Laureate Presentation

8:35 Best Practices Awards Program

8:50 Plenary Keynote

9:45 Coffee Break in the Exhibit Hall and Poster Competition Winners Announced


10:30 Chairperson’s Remarks

Tom Plasterer, Ph.D., Director, US Cross-Science Lead & Open PHACTS Lead, AstraZeneca

10:40 Transforming Early Pharmaceutical R&D Strategies with Real World Evidence

Cliona Molony, Ph.D., Senior Director & Head of Computational Biomedicine, Computational Biology & Biomedicine, Pfizer

Pfizer is capitalizing on maturing healthcare informatics, expanding sources of real world evidence, and deeply characterized populations to adopt value-driven and precision medicine R&D strategies. Together these resources (a) fuel a deeper understanding of disease subtypes to dissect novel mechanisms, (b) help to assess the burden of patient co-morbidities and adjacencies for drug development opportunities, and (c) enable precision medicine approaches to test therapeutic hypotheses matched to the pathology of patients. This presentation will discuss our approach and the informatics capabilities that are driving real world data into Pfizer’s early drug discovery pipeline research efforts.

11:10 Co-Presentation: rHEALTH (Real World Evidence Health Analytics Hub): Transition Janssen from Opportunistic to Systematic Strategic Use of Real World Evidence

Xiaoying Wu, M.D., MS, Director, RWE IT CoE & Medical Informatics, Data Sciences, Janssen IT, Johnson & Johnson

Asha Mahesh, Senior Manager, Emerging Technologies, Janssen R&D IT, Johnson & Johnson

rHEALTH is a Janssen developed enterprise Real World Data (RWD) and analytics platform to address challenges that the Janssen RWE community is facing. The ecosystem consists of four components: a global RWE knowledge portal; a Smart Catalog; a data platform that ingests data from disparate data sources and transforms the data to a Common Data Model, and a tailored analytical environment. With the new enterprise RWE-generating platform rHEALTH, we reduced the time for data access and analysis from months to days, enabling business partners to deliver valuable research insights faster than previously possible.

11:40 Accelerating Research through Full Text Semantic Enrichment and Data Integration

Mike Iarrobino, Product Management, Copyright Clearance Center
Anna Lyubetskaya, Data Scientist, Copyright Clearance Center

R&D-focused organizations are processing scientific content at scale to extract relationships between biological features. You will gain insights from diverse cases for applying full-text semantic enrichment integrated with other data sets at your organization. In this session, you’ll learn how to: use a network environment where text, raw data, and structured data are easily connected to help you make informed decisions, save time and increase efficiency by uncovering and integrating expert knowledge computationally to address potential challenges that result from an increased volume of information and novel facts present in unstructured text and experimental output.

12:10 pm Session Break

12:20 Luncheon Presentation I: Addressing the Pain Points of Bioinformatics R&D in Post-Genomic era: Lessons Learnt from the Pharmaceutical Industry

Misha Kapushesky, Ph.D., CEO, Genestack

A key challenge in pharmaceutical R&D is to leverage high-throughput multi-omics data, combined with clinical data to inform the drug discovery process. This requires data federation, data governance, and scalable storage and compute, enabled by a modular environment which would fast-track genomics data analysis. Here, we present case studies illustrating how Genestack has helped its customers achieve these goals.

 12:50 Luncheon Presentation II: Next Gen Research Platform -  NGRP
Anil Verma, Vice President, Life Sciences, HCL

1:20 Dessert Refreshment Break in the Exhibit Hall with Poster Viewing


1:55 Chairperson’s Remarks

Christel Chehoud, Ph.D., Scientist, Data Sciences, Janssen

2:00 Framework for Management, Analysis, and Visualization of Matched Genetic and Clinical & Real World Datasets

Alexandra Dumitriu, Ph.D., Manager, Computational Biomedicine, Genome Sciences and Technologies, Pfizer Worldwide R&D

Coupled Electronic Health Records (EHR) and genetic datasets have recently become more accessible for exploratory clinical research. This advancement brings opportunities for genotype-to-phenotype (G2P) queries, but also poses challenges for researchers who need to address similar issues around data management, analysis, and visualization. The presentation will describe our approach and learning related to building an analytical framework focused on EHR-based G2P resources, which allows for streamlined protocols, including semi-automated computational cohort definitions and PheWAS analyses.

2:30 Clinical Trials Innovations in the Age of Big Data and Advanced Analytics

Christel Chehoud, Ph.D., Scientist, Data Sciences, Janssen

Clinical trials operations have historically been a domain rich in data as by nature clinical trials are heavily regulated processes that entail data collection. As a result, during the entire life cycle of a trial enormous amount of data is collected and stored in all phases, from selection of sites to monitoring and auditing to ensure quality and compliance. This has culminated in sponsors of trials having the unique opportunity to leverage big data and advanced analytics to optimize and improve clinical trials operations at a time when advanced analytics is coming of age. At Janssen, the data sciences group in partnership with global clinical operations has launched initiatives in site selection, risk-based monitoring, and quality and compliance to bring innovations based on big data and advanced analytics to clinical trials operations. This has resulted in improved efficiencies in different aspects of operations during the life cycle of a trial. Additionally, we have pioneered the application of technologies such as machine learning, natural language processing, and artificial intelligence to create novel solutions which have resulted in data driven efficiencies realized from predictive and prescriptive analytics on clinical trials data. This presentation will delve on aspects of this work and present vignettes to highlight the challenges and successes.

3:00 Big Data Analysis of Human Gliomas Using Oncoscape

Eric Holland, M.D., Ph.D., Director, Seattle Tumor Translational Research, Fred Hutchinson Cancer Research Center and University of Washington Medicine

We have developed an open access on-line tool for visualizing and interacting with large clinical/molecular datasets of cancer patients. This tool (oncoscape) collapses large data using MDS and connects tumors with the molecular alterations found in them and with clinical outcome. The analytic tabs are websockets that can be written independently. Subsets of patients or genetic alterations can be identified in one tab and further refined in other tabs.

3:30 Conference Adjourns

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