Bio IT World Expo 2016  
Bio IT World Expo 2016

Track 7 - April 5 – 7, 2016

Clinical Research & Translational Informatics

Transforming Biological Data to Clinical Development

Transforming biological insights from drug discovery to sustainable clinical and translational research pipelines requires establishing frameworks, integrating systems and using innovative techniques for the integration, visualization and analysis of biological and clinical research data. Track 7 explores new approaches and technologies to the integration, analysis and visualization of biological and clinical trial data with case studies from across pharma and academia.

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Tuesday, April 5

7:00 am Workshop Registration and Morning Coffee

8:00 – 11:30 Recommended Morning Pre-Conference Workshops* Opportunities and Challenges of Mobile Health, Wearables, and Sensors for Pharma

12:30 – 4:00 pm Recommended Afternoon Pre-Conference Workshops* iConquerMS™: A Patient-Centered Research Model

* Separate registration required

2:00 – 6:00 Main Conference Registration


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5:00 – 7:00 Welcome Reception in the Exhibit Hall with Poster Viewing

Wednesday, April 6

7:00 am Registration Open and Morning Coffee


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9:00 Benjamin Franklin Awards and Laureate Presentation

9:30 Best Practices Awards Program

9:45 Coffee Break in the Exhibit Hall with Poster Viewing


10:50 Chairperson’s Opening Remarks

Speaker to be Announced, McKinsey & Company

11:00 Don’t Guess, Get It Right. Problems and Informatics Solutions for Drug Review

Timothy Kropp, Ph.D., Deputy Director for Innovation, Office of Computational Science, OTS/CDER/FDA

Designing a modern review environment for drug review poses unique challenges. Among them are short timeframes for understanding data, small teams for review, and most importantly, the need for surety, not suggestion. On top of this, the data that is submitted is changing and promises to change even more – data from wearables, next wave in vitro toxicology, genomics, or distributed trials. This talk will cover how we are meeting the challenge now, and how we are planning for the next possible phases.

11:30 Establishing, Improving and Sustaining Primary and Secondary Clinical Exploratory Research Pipelines

Jay Bergeron, Director, Translational and Bioinformatics, Pfizer

Vendor-based (e.g. Oracle’s TRC) and open source (e.g. tranSMART) solutions that manage exploratory clinical research data are available. However, establishing sustainable operational processes to support information flow from regulated to exploratory environments poses serious challenges to translational research. This talk will review the process elements that have been put in place at Pfizer to support an emerging exploratory data commons as well as the efforts undertaken to improve methods to prepare clinical exploratory data for access and analysis.

12:00 pm New Informatics for New Science: From Data Acquisition to Biomarker Validation

Jens Hoefkens, Director, Strategic Marketing, PerkinElmer

Here we present PerkinElmer Signals – a cloud-based data management platform that has been designed with flexible and scalable data models to provide the scalability and agility required to support modern life science research. To illustrate the versatility of the platform, we look at examples in areas as varied as Translational Medicine and High Content Screening.

12:15 More Than Code: True Interoperability Realized in Translational Medicine

Dave Billiter, MBA, COO, Signet Accel, LLC

Does the promise of interoperability match the reality? Is the triple mandate of improving care, increasing safety and security, and lowering costs possible? Meet Avec™, a proven, working platform for data integration and sharing in arguably the most complex healthcare and research environment in history, that connects your information management systems, genomic and biospecimen data, clinical trial data, and EMRs.

12:30 Session Break

12:40 Luncheon Presentation I: The Intersection of Translational Informatics with Precision Medicine

John Shon, Vice President, Data Science and Bioinformatics, Illumina, Inc.

The $1,000 genome has unlocked many possibilities toward improved healthcare that are closely linked to the creation of rich patient cohorts. Once data inconsistencies are addressed and coupled to big data analytics, one can uncover patterns for patient response that could ultimately be clinically validated. John will describe a patient-centric data model/big data platform for clinical and/or therapeutic area researchers that is used across disease classification to uncover potential patient stratification models.

1:10 Luncheon Presentation II: Accelerating Insights in Translational Research: Self-Service Analytics and Visualizations at Amgen

George Seegan, Ph.D., Research & Development Informatics, Amgen

David Hardison, Ph.D., Vice President, Health Sciences, ConvergeHEALTH by Deloitte

Translational researchers often have clear ideas about hypotheses that they want to explore to gain insight about a biomarker, to select a new target, etc. They are frustrated by the amount of time they spend "wrangling" data themselves or putting in a request to a bioinformatics or biostatistics group for assistance. The high cost in resources and lack of timeliness means only the high priority questions are even addressed. Researchers want to be able to derive insights from the data interactively as hypotheses emerge. Amgen decided to tackle this problem by taking a cloud-based platform approach to build an information integration factory that delivers relevant data on demand to researchers through an easy to use, extensible analytics and visualization portal. The platform architecture will be described and user examples will be shared.

1:40 Session Break

1:50 Chairperson’s Remarks

Speaker to be Announced, The Hyve

1:55 A Flexible Framework to Systematically Integrate and Report Clinical and Translational Data

John Lin, Manager, Software Engineering, Systems Engineering, Five Prime Therapeutics

Here we present a technology framework designed to systematically process and integrate clinical, safety, and translational data from multiple sources into a centralized data repository. The system encompasses automated data processing and transformation services, a flexible but immutable database schema to capture attribute-rich data, and interactive reporting for exploratory analysis and decision making. Case studies will be presented on how safety, PK, biomarker, and other clinical data from disparate sources and formats are unified globally to feed into dynamic visualizations.

2:25 In Pursuit of Precision Medicine

Brian Wells, Associate Vice President, Health Technology and Academic Computing, Information Systems, Penn Medicine

This presentation will focus on the information technology requirements related to achieving the goals of precision medicine. From next-gen sequencing to CTMS and EMR integration, Mr. Wells will describe the accomplishments, challenges and plans that lie ahead.

2:55 The Benefits of Metadata Towards Successful Translational Research

Erwan David, Chief Technical Officer and Co-Founder, DEXSTR

Managing metadata is becoming as critical as the data itself. Hear how Inquiro, an unstructured data repository that leverages scientific metadata, will help scientists to store, access and share valuable data while facilitating curation and promoting data re-use in a translational approach.

3:10 Sponsored Presentation (Opportunity Available)

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


4:00 From Bedside to Bench: Leveraging Biomarker and Clinical Trial Data to Inform Early Assets in the Pipeline

Som Bandyopadhyay, Ph.D., Translational Bioinformatics, Department of Genetically Defined Diseases and Genomics, Bristol-Myers Squibb

Baseline biomarker data and associated clinical trial data can be very informative in understanding disease pathophysiology and can help identify potential patient populations who may be responsive to other drugs in the development pipeline for that indication. To this end, at BMS, we are leveraging biomarker and clinical data from large clinical trials to help prioritize the development of multiple drugs in the pipeline for a given indication; help identify multiple indications for a given drug or identify new indications for an existing drug.

4:20 Disrupting Clinical Trials through Patient Engagement

Kamal Abbassi, BS, MS, Information Manager & Project Manager, Early Development Workflows, pRED Informatics, Roche Innovation Center NYC

Margaret Chan, Team Leader, Operations, Roche Innovation Ctr New York

Learn how to improve the clinical trial experience for patients through the use of digital technologies. Hear how to improve recruitment, engagement and retention with direct patient involvement. Discuss how to empower patients to make informed decisions.

4:40 Digital Biomarker Development at Roche pRED - From Sporadic Assessments to Continuous Monitoring of Parkinson’s Disease in a Clinical Trial

Christian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early Development

Automated and high frequency measures of disease progression are hard to come by. Traditional physician-led tests are only done periodically, missing the fluctuations of disease activity that strongly affect patient’s quality of life. They also lack the objectivity that is crucial when developing medicines. Roche Pharma Research & Early Development (pRED) has developed a smartphone-based monitoring system for those with Parkinson’s disease that complements the traditional physician-led assessments with automated tests that continuously measure their symptom fluctuations.

5:00 Presentation to be Announced

5:30 – 6:30 Best of Show Awards Reception in the Exhibit Hall with Poster Viewing

Thursday, April 7

7:00 am Registration and Morning Coffee


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10:00 Coffee Break in the Exhibit Hall and Poster Competition Winners Announced


10:30 Chairperson’s Opening Remarks

10:40 Transforming Use of Real World Data Analytics

Minnie Chou, Director, Information Systems, Amgen

Real world data (RWD) analytics is a key enabler for bringing effective and safe medicines to patients faster and cheaper. It can improve study designs, reduce trial enrollment times, facilitate fast-track filing strategies, shorten response time to health authority queries, and support value proposition of medicines. This presentation will discuss our approach and learnings unlocking the power of real world data assets.

11:10 Virtual Systems Pharmacology – The Next Generation of a TR&D Modeling and Simulation Environment

Marko Miladinov, Informatics Lead, Bristol-Myers Squibb

The internally developed Virtual Systems Pharmacology (ViSP) platform was implemented at BMS as a dynamic, highly scalable, model agnostic and therapeutic area agnostic application. The system seamlessly integrates the modelling tool of choice by the user, a web-based application, command line utilities, a database back-end and automatically scaling HPC environment built in the BMS Research Cloud environment that can be used to configure, manage and execute large-scale simulations for multiple models (of any sort) by multiple users.

11:40 The New World: Improving Patient Lives through Clinical Analytics and Real World Evidence

Sastry Chilukuri, Partner, Pharmaceuticals & Medical Products, McKinsey & Company

Jonathan Usuka, Knowledge Expert, Pharmaceuticals & Medical Products, McKinsey & Company

Unprecedented access to RWE is unlocking new insights into treatment & precision medicine, with implications for shifting value in the competitive pharma development ecosystem. A detailed understanding of how a patient will respond to therapy is complex & requires significant clinical trials investment, often leading to failure & frustration. But hidden in medical claims data are clues to predict & demonstrate therapeutic benefit. How will it be used to create value & possibly to replace pharma R&D? We examine just that.

12:10 pm Session Break

Thomson Reuters-Large12:20 Luncheon Presentation I to be Announced

12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

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


1:55 Chairperson’s Remarks

Nirmal Keshava, Ph.D., Senior Principal Informatics Scientist, Research & Development Information, AstraZeneca PLC

2:00 Delivering Standardized Clinical and Pre-Clinical Data to Investigators in Guided Visualization Using Spotfire 6.5

Baisong Huang, Principal Statistical Analyst, NIBR Informatics, Novartis Institutes for BioMedical Research

As visualization tools evolve and become widely accepted in investigating and monitoring drug safety and efficacy, rapid access to standardized, interpretable data views is becoming essential. We will present some examples how we standardized and aggregated data in both translational and clinical settings and provided guided analysis to visualize the data in real time.

2:30 Deriving Knowledge from Real-World Evidence Using Large-Scale Analytics

Nirmal Keshava, Ph.D., Senior Principal Informatics Scientist, Research & Development Information, AstraZeneca PLC

In this talk, I will discuss the effort to develop large-scale analytics to derive knowledge and value from real-world evidence. This will be done in the context of using clinical data in real-world evidence databases to answer critical questions that can arise in both the clinical and pre-clinical problem spaces. I will focus on defining how the business problem is accurately translated into a mathematical problem and how that problem is addressed by data from real-world evidence databases.

3:00 Instrumenting the Healthcare Enterprise for Discovery Research

Shawn Murphy, M.D., Ph.D., Director, Research Computing and Informatics, Partners Healthcare; Associate Professor, Neurology, Harvard Medical School; Associate Director, Laboratory of Computer Science, Massachusetts General Hospital

The Healthcare Enterprise produces enormous amounts of data during clinical care that could potentially be used for human research. However, the quality of the data is very raw, and privacy concerns are paramount. Deriving knowledge from the data requires a combination of searching the data visually for hypotheses, computing derived patient attributes with well understood accuracies, and obfuscating data when necessary to preserve patient privacy.

3:30 Visualizing Variability in Electronic Health Records: The Variability Explorer Tool (VET)

Hossein Estiri, Ph.D., Senior Fellow, Institute of Translational Health Sciences, University of Washington

This presentation describes application of visual analytics in development of the Variability Explorer Tool (VET), which is designed to detect and explore variability in Electronic Health Records (EHR) data. Existing variability in EHR data limits their utility for healthcare decision-making and research. VET provides a suit of open-source statistical solutions to detect and explore variability across time and between units of analysis in EHR data.

4:00 Conference Adjourns

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  • Making the World's Knowledge Computable
  • Bioinformatics in the Cloud
  • The Application of Text Analytics to Drug Safety Surveillance

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